%0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e22460 %T Effectiveness of the Use of Augmented Reality in Teaching the Management of Anaphylactic Shock at the Primary Care Level: Protocol for a Randomized Controlled Trial %A Klemenc-Ketis,Zalika %A Poplas Susič,Antonija %A Ružić Gorenjec,Nina %A Miroševič,Špela %A Zafošnik,Uroš %A Selič,Polona %A Tevžič,Špela %+ Ljubljana Community Health Centre, Metelkova ulica 9, Ljubljana, 1000, Slovenia, 386 1 300 3928, zalika.klemenc-ketis@zd-lj.si %K augmented reality %K education %K emergency medicine %K primary health care %D 2021 %7 4.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Augmented reality (AR) has benefits and feasibility in emergency medicine, especially in the clinical care of patients, in operating rooms and inpatient facilities, and in the education and training of emergency care providers, but current research on this topic is sparse. Objective: The primary objective is to evaluate the short-term and long-term effectiveness of the use of AR in the treatment of patients with anaphylactic shock. The secondary objectives are to evaluate the safety in the treatment of patients with anaphylactic shock, evaluate the short-term and long-term effectiveness of stress management in this process, and determine the experiences and attitudes towards the use of AR in education. Methods: The study will be conducted in 3 phases. In the first phase, we will develop and test the scenario for simulation of anaphylactic shock and the evaluation scale for assessing the effect of the intervention. In the second phase, a single-blinded, randomized controlled trial will be conducted. In the third phase, the use of AR in teaching the management of anaphylactic shock using focus groups will be evaluated qualitatively. All participants will participate in a 1-day training program consisting of a lecture on emergency care and anaphylactic shock as well as exercises in manual dexterity (aspiration, airway management, alternative airway management, artificial respiration, chest compressions, safe defibrillation, oxygen application, use of medication during emergency care). The test group will also focus on education about anaphylactic shock in AR (the intervention). The main outcome will be the evaluation of the participants' performance in coping with a simulated scenario of anaphylactic shock using a high-fidelity simulator (simulator with high levels of realism) and a standardized patient in an educational and clinical environment. The study will be conducted with primary care physicians. Results: A scenario for the simulation with a high-fidelity simulator and standardized patient has already been developed. For the time being, we are developing an evaluation scale and starting to recruit participants. We plan to complete the recruitment of participants by the end of December 2020, start the randomized controlled trial in January 2021, and finish 1 year later. The first results are expected to be submitted for publication in 2021. Conclusions: This will be the first study to evaluate the effectiveness of the use of AR in medical teaching. Specifically, it will be based on a clinical case of anaphylactic shock at the primary care level. With our study, we also want to evaluate the translation of these educational results into clinical practice and assess their long-term impact. Trial Registration: ISRCTN Registry ISRCTN58047410; http://www.isrctn.com/ISRCTN58047410 International Registered Report Identifier (IRRID): PRR1-10.2196/22460 %M 33393927 %R 10.2196/22460 %U https://www.researchprotocols.org/2021/1/e22460 %U https://doi.org/10.2196/22460 %U http://www.ncbi.nlm.nih.gov/pubmed/33393927 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e20011 %T Coaching While Waiting for Autism Spectrum Disorder Assessment: Protocol of a Pilot Feasibility Study for a Randomized Controlled Trial on Occupational Performance Coaching and Service Navigation Support %A Bernie,Charmaine %A Williams,Katrina %A Graham,Fiona %A May,Tamara %+ Department of Paediatrics, The University of Melbourne, 50 Flemington Rd, Parkville, Melbourne, VIC, Australia, 61 93456487, Charmaine.Bernie@rch.org.au %K coaching %K Occupational Performance Coaching %K feasibility %K parents %K caregivers %K ASD %K autism %K waiting list %K referral %K service navigation %D 2021 %7 7.1.2021 %9 Original Paper %J JMIR Res Protoc %G English %X Background: In Australia, the average time between a first concern of autism spectrum disorder (ASD) and diagnosis is over 2 years. After referral for assessment, families often wait 6-12 months before their appointment. This can be a time of uncertainty and stress for families. For some families, other forms of assistance are not accessible and thus timely intervention opportunities are missed. There is little evidence about how to provide the best support for children or caregivers while on assessment waiting lists. Objective: The aim of this study is to determine whether use of a coaching intervention called Occupational Performance Coaching (OPC) combined with service navigation support is feasible for families waiting for ASD assessment, as a crucial first step in planning a randomized controlled trial. Methods: A pilot and feasibility study will be conducted using recommended constructs and associated measures, which will be reported using CONSORT (Consolidated Standards or Reporting Trials) guidance. Participants will be child and caregiver dyads or triads, recruited within 4 months of their child (aged 1-7 years) being referred to one of two services for an ASD assessment in Victoria, Australia. A blinded randomization procedure will be used to allocate participants to one of three trial arms: (1) coaching and support intervention delivered face to face, (2) coaching and support intervention via videoconference, and (3) usual care. Descriptive statistics will be used to describe the sample characteristics of parents and children, inclusive of service access at baseline and follow up. Recruitment rates will be reported, and retention rates will be evaluated against a predicted rate of 70%-80% in each intervention arm. Goal attainment, using the Canadian Occupational Performance Measure, will indicate preliminary evidence for efficacy within the intervention arms, with an increase of 2 or more points on a 10-point performance and satisfaction scale considered clinically significant. Results: The study was approved by The Royal Children’s Hospital Research Ethics and Governance Department in September 2018. As of October 2020, 16 families have been recruited to the study. Data analysis is ongoing and results are expected to be published in 2021. Conclusions: Study findings will support planning for a future randomized controlled trial to assess the efficacy of OPC and service navigation support for caregivers of children awaiting ASD assessment. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000164998; www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378793&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/20011 %M 33410761 %R 10.2196/20011 %U https://www.researchprotocols.org/2021/1/e20011 %U https://doi.org/10.2196/20011 %U http://www.ncbi.nlm.nih.gov/pubmed/33410761 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e18021 %T Assessing the Effectiveness and Acceptability of a Personalized Mobile Phone App in Improving Adherence to Oral Hygiene Advice in Orthodontic Patients: Protocol for a Feasibility Study and a Randomized Controlled Trial %A Sharif,Mohammad Owaise %A Newton,Jonathon Timothy %A Cunningham,Susan J %+ Eastman Dental Institute, University College London, Rockefeller Building, 21 University Street, London, WC1E 6DE, United Kingdom, 44 02034561067, mohammad.sharif.16@ucl.ac.uk %K orthodontics %K adherence %K smartphone apps %K mobile phone apps %K personalized health care %K information provision %D 2021 %7 13.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Orthodontic treatment is a common health care intervention; treatment duration can be lengthy (2-3 years on average), and adherence to treatment advice is therefore essential for successful outcomes. It has been reported that up to 43% of patients fail to complete treatment, and there are currently no useful predictors of noncompletion. Given that the National Health Service England annual expenditure on primary-care orthodontic treatment is in excess of £200 million (US $267 million), noncompletion of treatment represents a significant inefficient use of public resources. Improving adherence to treatment is therefore essential. This necessitates behavior change, and interventions that improve adherence and are designed to elicit behavioral change must address an individual’s capability, opportunity, and motivation. Mobile phones are potentially an invaluable tool in this regard, as they are readily available and can be used in a number of ways to address an individual’s capability, opportunity, and motivation. Objective: This study will assess the effectiveness and acceptability of a personalized mobile phone app in improving adherence to orthodontic treatment advice by way of a randomized controlled trial. Methods: This study will be conducted in 2 phases at the Eastman Dental Hospital, University College London Hospitals Foundation Trust. Phase 1 is feasibility testing of the My Braces app. Participants will be asked to complete the user version of the Mobile Application Rating Scale. The app will be amended following analysis of the responses, if appropriate. Phase 2 is a randomized controlled trial to test the effectiveness and acceptability of the My Braces app. Results: This study was approved by the London – Bloomsbury Research Ethics Committee on November 5, 2019 (reference 19/LO/1555). No patients have been recruited to date. The anticipated start date for recruitment to phase 1 is October 2020. Conclusions: Given the availability, affordability, and versatility of mobile phones, it is proposed that they will aid in improving adherence to treatment advice and hence improve treatment completion rates. If effective, the applicability of this methodology to developing behavior change/modification interventions and improving adherence to treatment across health care provides an exciting opportunity. Trial Registration: ClinicalTrials.gov NCT04184739; https://clinicaltrials.gov/ct2/show/NCT04184739 International Registered Report Identifier (IRRID): PRR1-10.2196/18021 %M 33439142 %R 10.2196/18021 %U http://www.researchprotocols.org/2021/1/e18021/ %U https://doi.org/10.2196/18021 %U http://www.ncbi.nlm.nih.gov/pubmed/33439142 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e23592 %T A Text Messaging Intervention for Coping With Social Distancing During COVID-19 (StayWell at Home): Protocol for a Randomized Controlled Trial %A Figueroa,Caroline Astrid %A Hernandez-Ramos,Rosa %A Boone,Claire Elizabeth %A Gómez-Pathak,Laura %A Yip,Vivian %A Luo,Tiffany %A Sierra,Valentín %A Xu,Jing %A Chakraborty,Bibhas %A Darrow,Sabrina %A Aguilera,Adrian %+ School of Social Welfare, University of California Berkeley, 105 Havilland Hall, Berkeley, CA, 94709, United States, 1 5106436669, c.a.figueroa@berkeley.edu %K COVID-19 %K mental health %K depression %K reinforcement learning %K microrandomized trial %D 2021 %7 14.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Social distancing is a crucial intervention to slow down person-to-person transmission of COVID-19. However, social distancing has negative consequences, including increases in depression and anxiety. Digital interventions, such as text messaging, can provide accessible support on a population-wide scale. We developed text messages in English and Spanish to help individuals manage their depressive mood and anxiety during the COVID-19 pandemic. Objective: In a two-arm randomized controlled trial, we aim to examine the effect of our 60-day text messaging intervention. Additionally, we aim to assess whether the use of machine learning to adapt the messaging frequency and content improves the effectiveness of the intervention. Finally, we will examine the differences in daily mood ratings between the message categories and time windows. Methods: The messages were designed within two different categories: behavioral activation and coping skills. Participants will be randomized into (1) a random messaging arm, where message category and timing will be chosen with equal probabilities, and (2) a reinforcement learning arm, with a learned decision mechanism for choosing the messages. Participants in both arms will receive one message per day within three different time windows and will be asked to provide their mood rating 3 hours later. We will compare self-reported daily mood ratings; self-reported depression, using the 8-item Patient Health Questionnaire; and self-reported anxiety, using the 7-item Generalized Anxiety Disorder scale at baseline and at intervention completion. Results: The Committee for the Protection of Human Subjects at the University of California Berkeley approved this study in April 2020 (No. 2020-04-13162). Data collection began in April 2020 and will run to April 2021. As of August 24, 2020, we have enrolled 229 participants. We plan to submit manuscripts describing the main results of the trial and results from the microrandomized trial for publication in peer-reviewed journals and for presentations at national and international scientific meetings. Conclusions: Results will contribute to our knowledge of effective psychological tools to alleviate the negative effects of social distancing and the benefit of using machine learning to personalize digital mental health interventions. Trial Registration: ClinicalTrials.gov NCT04473599; https://clinicaltrials.gov/ct2/show/NCT04473599 International Registered Report Identifier (IRRID): DERR1-10.2196/23592 %M 33370721 %R 10.2196/23592 %U http://www.researchprotocols.org/2021/1/e23592/ %U https://doi.org/10.2196/23592 %U http://www.ncbi.nlm.nih.gov/pubmed/33370721 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e19506 %T Optimizing an Obesity Treatment Using the Multiphase Optimization Strategy Framework: Protocol for a Randomized Factorial Trial %A Bennett,Gary G %A Steinberg,Dori %A Bolton,Jamiyla %A Gallis,John A %A Treadway,Cayla %A Askew,Sandy %A Kay,Melissa C %A Pollak,Kathryn I %A Turner,Elizabeth L %+ Duke Global Health Institute, Duke University, 310 Trent Drive, Room 236, Durham, NC, 27708, United States, 1 9193954119, jamiyla.bolton@duke.edu %K text message %K digital health %K weight loss %K personalized %D 2021 %7 18.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Effective weight loss interventions exist, yet few can be scaled up for wide dissemination. Further, none has been fully delivered via text message. We used the multiphase optimization strategy (MOST) to develop multicomponent interventions that consist only of active components, those that have been experimentally determined to impact the chosen outcome. Objective: The goal of this study is to optimize a standalone text messaging obesity intervention, Charge, using the MOST framework to experimentally determine which text messaging components produce a meaningful contribution to weight change at 6 months. Methods: We designed a 6-month, weight loss texting intervention based on our interactive obesity treatment approach (iOTA). Participants are randomized to one of 32 experimental conditions to test which standalone text messaging intervention components produce a meaningful contribution to weight change at 6 months. Results: The project was funded in February 2017; enrollment began in January 2018 and data collection was completed in June 2019. Data analysis is in progress and first results are expected to be submitted for publication in 2021. Conclusions: Full factorial trials are particularly efficient in terms of cost and logistics when leveraged for standalone digital treatments. Accordingly, MOST has the potential to promote the rapid advancement of digital health treatments. Subject to positive findings, the intervention will be low cost, immediately scalable, and ready for dissemination. This will be of great potential use to the millions of Americans with obesity and the providers who treat them. Trial Registration: ClinicalTrials.gov NCT03254940; https://clinicaltrials.gov/ct2/show/NCT03254940 International Registered Report Identifier (IRRID): RR1-10.2196/19506 %M 33459600 %R 10.2196/19506 %U http://www.researchprotocols.org/2021/1/e19506/ %U https://doi.org/10.2196/19506 %U http://www.ncbi.nlm.nih.gov/pubmed/33459600 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e25291 %T Self-Administered Behavioral Skills–Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial %A Garcia,Laura M %A Darnall,Beth D %A Krishnamurthy,Parthasarathy %A Mackey,Ian G %A Sackman,Josh %A Louis,Robert G %A Maddox,Todd %A Birckhead,Brandon J %+ Division of Health Services Research, Department of Medicine, Cedars-Sinai Health System, Pacific Theaters Building, Suite 800 116 N. Robertson Blvd., Los Angeles, CA, 90048, United States, 1 818 850 0814, bbirckhead@appliedvr.io %K chronic pain %K virtual reality %K behavioral medicine %K behavioral health %K pain treatment %K randomized controlled trial %D 2021 %7 19.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic pain is one of the most common and debilitating health conditions. Treatments for chronic low back pain typically focus on biomedical treatment approaches. While psychosocial treatments exist, multiple barriers prevent broad access. There is a significant unmet need for integrative, easily accessible, non-opioid solutions for chronic pain. Virtual reality (VR) is an immersive technology allowing innovation in the delivery of behavioral pain treatments. Behavioral skills-based VR is effective at facilitating pain management and reducing pain-related concerns. Continued research on these emerging approaches is needed. Objective: In this randomized controlled trial, we seek to test the efficacy of a self-administered behavioral skills-based VR program as a nonpharmacological home-based pain management treatment for people with chronic low back pain (cLBP). Methods: We will randomize 180 individuals with cLBP to 1 of 2 VR programs: (1) EaseVRx (8-week skills-based VR program); or (2) Sham VR (control condition). All participants will receive a VR headset to minimize any biases related to the technology’s novelty. The Sham VR group had 2D neutral content in a 3D theater-like environment. Our primary outcome is average pain intensity and pain-related interference with activity, stress, mood, and sleep. Our secondary outcomes include patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction. We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition. Team statisticians blinded to treatment assignment will assess outcomes up to 6 months posttreatment using an approach suitable for the longitudinal nature of the data. Results: The study was approved by the Western Institutional Review Board on July 2, 2020. The protocol (NCT04415177) was registered on May 27, 2020. Recruitment for this study was completed in July 2020, and data collection will remain active until March 2021. In total, 186 participants were recruited. Multiple manuscripts will be generated from this study. The primary manuscript will be submitted for publication in the winter of 2020. Conclusions: Effectively delivering behavioral treatments in VR could overcome barriers to care and provide scalable solutions to chronic pain’s societal burden. Our study could help shape future research and development of these innovative approaches. Trial Registration: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177 International Registered Report Identifier (IRRID): RR1-10.2196/25291 %M 33464215 %R 10.2196/25291 %U https://www.researchprotocols.org/2021/1/e25291 %U https://doi.org/10.2196/25291 %U http://www.ncbi.nlm.nih.gov/pubmed/33464215 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e23679 %T Impact of Teleconsultation on Patients With Type 2 Diabetes in the Brazilian Public Health System: Protocol for a Randomized Controlled Trial (TELEconsulta Diabetes Trial) %A Rodrigues,Daniela Laranja Gomes %A Belber,Gisele Silvestre %A Padilha,Frederica Valle De Queiroz %A Spinel,Ligia Fonseca %A Moreira,Frederico Rafael %A Maeyama,Marcos Aurélio %A Pinho,Ana Paula Neves Marques %A Júnior,Álvaro Avezum %+ Hospital Alemão Oswaldo Cruz, Rua Treze de Maio, 181, São Paulo, 01323-020, Brazil, 55 11985421342, dlgvascular@gmail.com %K remote consultation %K diabetes mellitus %K telemedicine %K telehealth %K costs %K public health %D 2021 %7 21.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although the Brazilian Unified Health System (SUS) offers universal health coverage, access to quality care is often limited by social inequality and location. Although telemedicine has been shown to be an important tool in the efforts to overcome this problem, because it can provide access to specialist care and break the geographical barriers to health care, there are no national studies demonstrating its use in public health. Objective: This study aims to test the hypothesis that remote consultation can be as effective as standard face-to-face consultation for type 2 diabetes mellitus in the Brazilian public health system and to assess the associated costs related to teleconsultation in public health scenarios, for patients referred from Primary Health Care units of the SUS for specialist care. Methods: This is a pragmatic, phase 2, unicentric, open-label, noninferiority, blinded allocation, data-blinded, centrally randomized clinical trial. The inclusion criteria will be adults, both sexes, ≥18 years old, glycated hemoglobin (HbA1c) ≥8%. Outcomes will be evaluated by assessing symptoms, laboratory exams, anthropometric measurements, blood pressure, adverse events, and satisfaction level for 6 months. The costs of the teleconsultation will be assessed using the time-driven activity-based costing (TDABC) method to compare the costs with the face-to-face consultations. The noninferiority margin was set at 0.5%. Assuming an SD of 1.3% for both groups, true difference between the means of zero, and a type I error level of 5% (one-sided), it was estimated that 117 individuals per group would be necessary to achieve 90% power. Statistical analysis of the efficacy will be done using intention-to-treat and per-protocol approaches. Results: The results from this trial will be reported according to the CONSORT guidelines. The trial was approved by the institutional review board on October 5, 2019. Data collection started in January 2019 and is expected to finish in 2022. At the time of manuscript submission, 18 participants were recruited. Conclusions: Our expectations are that providing remote access to health care will result in improvements in the health and quality of life of patients with type 2 diabetes and reduce costs and that both patients and clinicians will benefit from and be satisfied with this technology. Trial Registration: Registro Brasileiro de Ensaios Clínicos RBR-8gpgyd; https://ensaiosclinicos.gov.br/rg/RBR-8gpgyd International Registered Report Identifier (IRRID): DERR1-10.2196/23679 %M 33475516 %R 10.2196/23679 %U https://www.researchprotocols.org/2021/1/e23679 %U https://doi.org/10.2196/23679 %U http://www.ncbi.nlm.nih.gov/pubmed/33475516 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e21585 %T Evaluating the Effectiveness of an E-Mental Health Intervention for People Living in Lebanon: Protocol for Two Randomized Controlled Trials %A van 't Hof,Edith %A Heim,Eva %A Abi Ramia,Jinane %A Burchert,Sebastian %A Cornelisz,Ilja %A Cuijpers,Pim %A El Chammay,Rabih %A Harper Shehadeh,Melissa %A Noun,Philip %A Smit,Filip %A van Klaveren,Chris %A van Ommeren,Mark %A Zoghbi,Edwina %A Carswell,Kenneth %+ Department of Mental Health and Substance Use, World Health Organization, Avenue Appia 20, Geneva, 1211, Switzerland, 31 641692545, edithvanhof@gmail.com %K e-mental health %K psychological interventions %K guided-self-help %K global mental health %K adversity %K Lebanon %K Syrians %D 2021 %7 28.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The lack of availability of evidence-based services for people exposed to adversity globally has led to the development of psychological interventions with features that will likely make them more scalable. The evidence for the efficacy of e-mental health from high-income countries is compelling, and the use of these interventions could be a way to increase the coverage of evidence-based psychological interventions in low- and middle-income countries. Step-by-Step is a brief (5-session) intervention proposed by the World Health Organization as an innovative approach to reducing the suffering and disability associated with depression. Objective: This study aims to evaluate the effectiveness and cost-effectiveness of a locally adapted version of Step-by-Step with Syrian nationals (trial 1) and Lebanese nationals and other populations residing in Lebanon (trial 2). Methods: This Step-by-Step trial involves 2 parallel, two-armed, randomized controlled trials comparing the e-intervention Step-by-Step to enhanced care as usual in participants with depressive symptoms and impaired functioning. The randomized controlled trials are designed and powered to detect effectiveness in 2 populations: Syrians in Lebanon (n=568) and other people residing in Lebanon (n=568; Lebanese nationals and other populations resident in Lebanon). The primary outcomes are depressive symptomatology (measured with the Patient Health Questionnaire-9) and functioning (measured with the World Health Organization Disability Assessment Scale 2.0). Secondary outcomes include anxiety symptoms, posttraumatic stress disorder symptoms, personalized measures of psychosocial problems, subjective well-being, and economic effectiveness. Participants are mainly recruited through online advertising. Additional outreach methods will be used if required, for example through dissemination of information through partner agencies and organizations. They can access the intervention on a computer, tablet, and mobile phone through a hybrid app. Step-by-Step has 5 sessions, and users are guided by trained nonspecialist “e-helpers” providing phone-based or message-based support for around 15 minutes a week. Results: The trials were funded in 2018. The study protocol was last verified June 20, 2019 (WHO ERC.0002797) and registered with ClinicalTrials.gov (NCT03720769). The trials started recruitment as of December 9, 2019, and all data collection was completed in December 2020. Conclusions: The Step-by-Step trials will provide evidence about the effectiveness of an e-mental health intervention in Lebanon. If the intervention proves to be effective, this will inform future scale-up of this and similar interventions in Lebanon and in other settings across the world. Trial Registration: ClinicalTrials.gov NCT03720769; https://clinicaltrials.gov/ct2/show/NCT03720769 International Registered Report Identifier (IRRID): DERR1-10.2196/21585 %M 33507158 %R 10.2196/21585 %U http://www.researchprotocols.org/2021/1/e21585/ %U https://doi.org/10.2196/21585 %U http://www.ncbi.nlm.nih.gov/pubmed/33507158 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e15350 %T Effect of Switching to the Tobacco Heating System Versus Continued Cigarette Smoking on Chronic Generalized Periodontitis Treatment Outcome: Protocol for a Randomized Controlled Multicenter Study %A Pouly,Sandrine %A Ng,Wee Teck %A Benzimra,Muriel %A Soulan,Alexandre %A Blanc,Nicolas %A Zanetti,Filippo %A Picavet,Patrick %A Baker,Gizelle %A Haziza,Christelle %+ Philip Morris Products SA, Quai Jeanrenaud 5, Neuchâtel, 2000, Switzerland, 41 582421111, sandrine.pouly@pmi.com %K smoking %K tobacco %K periodontitis %K oral health %K Tobacco Heating System %K modified risk tobacco product %K clinical attachment level %K probing depth %K periodontal pocket %D 2021 %7 18.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Smoking is a significant risk factor for periodontal disease and tooth loss, as shown in several clinical studies comparing smokers and nonsmokers. Although only a few longitudinal studies have assessed the outcome of periodontal disease after smoking cessation, they indicated that recovery after nonsurgical treatment was more successful in those who had quit smoking. As part of tobacco harm reduction strategies, substituting cigarettes with alternative, less harmful tobacco products is an approach complementary to cessation for smokers who would otherwise continue to smoke. The Tobacco Heating System (THS), developed by Philip Morris International (commercialized as IQOS), is part of the heat-not-burn product category. The IQOS device electrically heats tobacco instead of burning it, at much lower temperatures than cigarettes, thereby producing substantially lower levels of harmful and potentially harmful constituents, while providing the nicotine, taste, ritual, and a sensory experience that closely parallel those of cigarettes. Phillip Morris International has published the results from a broad clinical assessment program, which was established to scientifically substantiate the harm reduction potential of the THS among adult healthy smokers switching to the THS. The program is now progressing toward including adult smokers with smoking-related diseases. Objective: The goal of this study is to demonstrate favorable changes of periodontal endpoints in response to mechanical periodontal therapy in patients with generalized chronic periodontitis who completely switched to THS use compared with continued cigarette smoking. Methods: This is a randomized controlled two-arm parallel-group multicenter Japanese study conducted in patients with chronic generalized periodontitis who switch from cigarettes to THS compared with smokers continuing to smoke cigarettes for 6 months. The patients were treated with mechanical periodontal therapy as per standard of care in Japan. The primary objective of the study is to demonstrate the beneficial effect of switching to THS use compared with continued cigarette smoking on pocket depth (PD) reduction in all sites with an initial PD≥4 mm. The secondary objectives include evaluation of other periodontal parameters (eg, clinical attachment level or gingival inflammation) and overall oral health status upon switching to THS. Safety was monitored throughout the study. Results: In total, 172 subjects were randomized to the cigarette (n=86) or THS (n=86) groups, and all 172 completed the study. The conduct phase of the study is completed, while data cleaning and analyses are ongoing. Conclusions: This study is the first to test a heat-not-burn tobacco product in smokers with an already established disease. The results should further strengthen the evidence that switching to THS can significantly reduce the risk of smoking-related diseases if favorable changes in the evolution of chronic generalized periodontitis after mechanical therapy are found when compared with continued cigarette smoking. Trial Registration: ClinicalTrials.gov NCT03364751; https://clinicaltrials.gov/ct2/show/NCT03364751 International Registered Report Identifier (IRRID): DERR1-10.2196/15350 %M 33459599 %R 10.2196/15350 %U http://www.researchprotocols.org/2021/1/e15350/ %U https://doi.org/10.2196/15350 %U http://www.ncbi.nlm.nih.gov/pubmed/33459599 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e18154 %T He Korowai Manaaki (Pregnancy Wraparound Care): Protocol for a Cluster Randomized Clinical Trial %A Lawton,Beverley %A Storey,Francesca %A Sibanda,Nokuthaba %A Bennett,Matthew %A Lambert,Charles %A Geller,Stacie %A Edmonds,Liza %A Cram,Fiona %+ Centre for Women's Health Research, Victoria University of Wellington, 44 Kelburn Parade, Wellington, 6140, New Zealand, 64 021463762, bev.lawton@vuw.ac.nz %K maternity %K inequity %K Indigenous health %K Māori %K pregnancy %K Kaupapa Māori %K socioeconomic %K primary health care %K methodology %D 2021 %7 29.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Maternal and infant health inequities between Māori (the Indigenous peoples of Aotearoa New Zealand) and New Zealand European women are well documented and cannot be explained solely by socioeconomic status. A research center-iwi (tribal group) partnership aims to address these disparities and improve maternal and infant health outcomes by implementing an augmented maternity care pathway (He Korowai Manaaki) to improve access to services and evidence-informed care. Objective: The objective of this study is to test whether an augmented maternity care pathway improves Māori infant health outcomes. Methods: This is a Kaupapa Māori (by, with, and for Māori) cluster randomized clinical trial involving 8 primary care practices allocated to either an intervention arm or control arm. The intervention arm comprises an augmented maternity care pathway (He Korowai Manaaki) offering clinical care through additional paid health care appointments and improved access to social support (eg, housing, transport). The control arm is usual care. The primary outcome is increased timely vaccination for Māori infants, defined as all age-appropriate vaccinations completed by 6 months of age. Results: Recruitment commenced in November 2018 and was completed in June 2020, with 251 enrolled women recruited in intervention primary care practices before 20 weeks of pregnancy. Publication of results is anticipated in late 2023. Conclusions: The results will inform primary health care policy including whether the provision of augmented maternal care pathways reduces disparities in the structural determinants of health. If effective, He Korowai Manaaki will strengthen the health and well-being of pregnant Māori women and their babies and improve their health outcomes, laying a strong foundation for lifelong health and well-being. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001155189; https://tinyurl.com/yypbef8q International Registered Report Identifier (IRRID): DERR1-10.2196/18154 %M 33512321 %R 10.2196/18154 %U http://www.researchprotocols.org/2021/1/e18154/ %U https://doi.org/10.2196/18154 %U http://www.ncbi.nlm.nih.gov/pubmed/33512321 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e25351 %T Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study %A Mace,Ryan A %A Doorley,James D %A Popok,Paula J %A Vranceanu,Ana-Maria %+ Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, 1 Bowdoin Sq, 1st floor, Suite 100, Boston, MA, 02114, United States, 1 617 724 4977, avranceanu@mgh.harvard.edu %K chronic pain %K cognitive decline %K physical activity %K mind-body therapies %K aged %K telemedicine %K mobile phone %D 2021 %7 4.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, prevalent among older adults, and worsen each other over time. We are iteratively developing Active Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual increases in step count. AB-F has demonstrated feasibility; acceptability; and signs of improvement in emotional, physical, and cognitive functions when delivered in person to older adults. Objective: We are conducting a feasibility randomized controlled trial (RCT) of AB-F versus a time- and dose-matched educational control (health enhancement program [HEP]) in older adults with CP and CD. Here, we describe virtual adaptions to our study protocol, manualized treatments, evaluation plan, and study design in response to feedback from former participants and COVID-19. We will evaluate the feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive functions. Methods: This is a single-blind pilot RCT. Participants are randomized to AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and flyers. Interested participants are screened for eligibility via telephone and provide electronic informed consent. After randomization, participants are mailed all study documents, including their treatment manual, an ActiGraph accelerometer, and a Fitbit (separate envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via Zoom. Participants complete self-report and performance-based (6-min walk test and Montreal Cognitive Assessment) outcome measures via Zoom at baseline and post intervention. Primary outcomes are a priori set feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional functions as well as intervention targets (social function, pain intensity, pain-specific coping, and mindfulness). Results: The trial is ongoing. We have recruited 21 participants (10 AB-F and 11 HEP) across 2 rounds. Only 2 participants have withdrawn (1 before baseline and 1 before the first session). All 19 remaining participants have completed the baseline assessment. In the first round, attendance is high (11 out of 12 participants completed all 4 sessions so far), and AB-F participants are adherent to their Fitbit and step goals (5 out of 6 participants). Conclusions: Preliminary findings are promising for the feasibility of our completely virtual AB-F intervention. However, these findings need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind-body activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple digital platforms for virtual assessments and intervention delivery will inform treatment development for older adults and those with comorbid CP and CD, which is crucial during the COVID-19 pandemic. Trial Registration: ClinicalTrials.gov NCT04044183; https://clinicaltrials.gov/ct2/show/NCT04044183 International Registered Report Identifier (IRRID): DERR1-10.2196/25351 %M 33208301 %R 10.2196/25351 %U https://www.researchprotocols.org/2021/1/e25351 %U https://doi.org/10.2196/25351 %U http://www.ncbi.nlm.nih.gov/pubmed/33208301 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e18029 %T Using a Mobile Health Intervention (DOT Selfie) With Transfer of Social Bundle Incentives to Increase Treatment Adherence in Tuberculosis Patients in Uganda: Protocol for a Randomized Controlled Trial %A Sekandi,Juliet Nabbuye %A Onuoha,Nicole Amara %A Buregyeya,Esther %A Zalwango,Sarah %A Kaggwa,Patrick Evans %A Nakkonde,Damalie %A Kakaire,Robert %A Atuyambe,Lynn %A Whalen,Christopher C %A Dobbin,Kevin K %+ Global Health Institute, College of Public Health, University of Georgia, 100 Foster Road, Athens, GA, 30606, United States, 1 706 542 5257, jsekandi@uga.edu %K tuberculosis %K mHealth %K digital health %K eHealth %K directly observed therapy %K video observed therapy %K DOT Selfie %K treatment adherence %K Africa %D 2021 %7 5.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The World Health Organization’s End TB Strategy envisions a world free of tuberculosis (TB)—free of deaths, disease, and suffering due to TB—by 2035. Nonadherence reduces cure rates, prolongs infectiousness, and contributes to the emergence of multidrug-resistant TB (MDR-TB). Moreover, MDR-TB is a growing, complex, and costly problem that presents a major obstacle to TB control. Directly observed therapy (DOT) for treatment adherence monitoring is the recommended standard; however, it is challenging to implement at scale because it is labor-intensive. Mobile health interventions can facilitate remote adherence monitoring and minimize the costs and inconveniences associated with standard DOT. Objective: The study aims to evaluate the effectiveness of using video directly observed therapy (VDOT) plus incentives to improve medication adherence in TB treatment versus usual-care DOT in an African context. Methods: The DOT Selfie study is an open-label, randomized controlled trial (RCT) with 2 parallel groups, in which 144 adult patients with TB aged 18-65 years will be randomly assigned to receive the usual-care DOT monitoring or VDOT as the intervention. The intervention will consist of a smartphone app, a weekly internet subscription, translated text message reminders, and incentives for those who adhere. The participant will use a smartphone to record and send time-stamped encrypted videos showing their daily medication ingestion. This video component will directly substitute the need for daily face-to-face meetings between the health provider and patients. We hypothesize that the VDOT intervention will be more effective because it allows patients to swallow their pills anywhere, anytime. Moreover, patients will receive mobile-phone–based “social bundle” incentives to motivate adherence to continued daily submission of videos to the health system. The health providers will log into a secured computer system to verify treatment adherence, document missed doses, investigate the reasons for missed doses, and follow prespecified protocol measures to re-establish medication adherence. The primary endpoint is the adherence level as measured by the fraction of expected doses observed over the treatment period. The main secondary outcome will be time-to-treatment completion in both groups. Results: This study was funded in 2019. Enrollment began in July and is expected to be completed by November 2020. Data collection and follow-up are expected to be completed by June 2021. Results from the analyses based on the primary endpoint are expected to be submitted for publication by December 2021. Conclusions: This random control trial will be among the first to evaluate the effectiveness of VDOT within an African setting. The results will provide robust scientific evidence on the implementation and adoption of mobile health (mHealth) tools, coupled with incentives to motivate TB medication adherence. If successful, VDOT will apply to other low-income settings and a range of chronic diseases with lifelong treatment, such as HIV/AIDs. Trial Registration: ClinicalTrials.gov NCT04134689; http://clinicaltrials.gov/ct2/show/NCT04134689 International Registered Report Identifier (IRRID): DERR1-10.2196/18029 %M 32990629 %R 10.2196/18029 %U https://www.researchprotocols.org/2021/1/e18029 %U https://doi.org/10.2196/18029 %U http://www.ncbi.nlm.nih.gov/pubmed/32990629 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e19770 %T A Community-Developed, Web-Based Mobile App Intervention Addressing Social Work and Legal Needs of Black Sexual Minority Men Living With HIV: Protocol for a Randomized Comparison Trial %A Miyashita Ochoa,Ayako %A Paneda,Christian Corpuz %A Wu,Elizabeth SC %A Maxwell,Katherine Elizabeth %A Garth,Gerald %A Smith,Terry %A Holloway,Ian Walter %+ Department of Social Welfare, UCLA Luskin School of Public Affairs, 337 Charles E Young Dr E, Los Angeles, CA, 90095, United States, 1 310 825 7840, holloway@luskin.ucla.edu %K HIV %K AIDS %K mobile apps %K African Americans %K men’s health %K sexual minority %K treatment adherence %K mobile phones %D 2021 %7 6.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Black sexual minority men (BSMM) are disproportionately affected by HIV. Los Angeles County (LAC) carries a substantial burden of the HIV epidemic in California. Negative effects of both psychosocial and structural barriers highlight the timely need to increase HIV treatment among BSMM. Successful HIV interventions based on social media and mobile phone technology have been demonstrated. This protocol describes LINX LA, a study that tests LINX, a web-based mobile app that provides tailored social services, legal resources, and peer support for BSMM living with HIV (BSMM+) in LAC using a randomized comparison trial. Objective: During phase 1, the LINX LA study aims to engage in an iterative design process to develop the LINX App using qualitative data to inform and tailor the mobile app technology and its functionality. In phase 2 of LINX LA, we will test the efficacy of the LINX App compared with the LINX App Plus to improve HIV treatment outcomes (ie, antiretroviral therapy adherence, viral suppression) among BSMM+ in LAC by addressing social work and legal needs and developing a forum for peer support. Methods: In this study funded by the California HIV/AIDS Research Program, we will recruit and enroll BSMM+ participants (aged ≥18 years) in LAC (N=400) to participate in a 12-month study that includes access to the LINX App, which provides a forum for peer support and tailored content aimed at improving the use of social and legal resources. All participants will also receive survey-based interviews at 3 time points (at baseline and 6- and 12-month intervals) and weekly text message surveys that assess medication and treatment adherence. Treatment adherence and viral suppression will be extracted from medical record data. Half of the participants will also be randomly assigned to receive 3 individualized coaching sessions (at 1-, 3-, and 6-month intervals) and the ability to directly message their coach via the LINX App. Over the course of the study, LINX App participants will receive a minimum of US $130 in cash and LINX App Plus participants will receive a minimum of US $190. We hypothesize that participants enrolled in LINX App Plus will demonstrate greater improvement in HIV outcomes compared with LINX App participants. Results: The LINX study will test the efficacy of a web-based mobile app intervention for BSMM+ in LAC (N=400). The LINX App seeks to increase participants’ knowledge of HIV; to facilitate access to necessary social and legal services, including information and referrals; and to increase social support across participants by providing a mediated forum for engagement. Conclusions: The implementation of LINX LA aims to develop and test a culturally tailored approach to improve the HIV treatment outcomes of BSMM+. International Registered Report Identifier (IRRID): PRR1-10.2196/19770 %M 33404514 %R 10.2196/19770 %U https://www.researchprotocols.org/2021/1/e19770 %U https://doi.org/10.2196/19770 %U http://www.ncbi.nlm.nih.gov/pubmed/33404514 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e22186 %T Use and Effect of Web-Based Embodied Conversational Agents for Improving Eating Behavior and Decreasing Loneliness Among Community-Dwelling Older Adults: Protocol for a Randomized Controlled Trial %A Kramer,Lean L %A Mulder,Bob C %A van Velsen,Lex %A de Vet,Emely %+ Consumption and Healthy Lifestyles, Wageningen University & Research, PO Box 8130, Wageningen, 6700 EW, Netherlands, 31 317 483401, lean.kramer@wur.nl %K embodied conversational agent %K health behavior change %K loneliness %K eating behavior %K older adults %D 2021 %7 6.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: An unhealthy eating pattern and loneliness negatively influence quality of life in older age. Embodied conversational agents (ECAs) are a promising way to address these health behaviors in an engaging manner. Objective: We aim to (1) identify whether ECAs can persuade community-dwelling older adults to change their dietary behavior and whether ECA use can decrease loneliness, (2) test these pathways to effects, and (3) understand the use of an ECA. Methods: The web-based eHealth app PACO is a fully automated 8-week intervention in which 2 ECAs engage older adults in dialogue to motivate them to change their dietary behavior and decrease their loneliness. PACO was developed via a human-centered and stakeholder-inclusive design approach and incorporates Self-determination Theory and various behavior change techniques. For this study, an unblinded randomized controlled trial will be performed. There will be 2 cohorts, with 30 participants per cohort. Participants in the first cohort will immediately receive the PACO app for 8 weeks, while participants in the second cohort receive the PACO app after a waiting-list condition of 4 weeks. Participants will be recruited via social media, an online panel, flyers, and advertorials. To be eligible, participants must be at least 65 years of age, must not be in paid employment, and must live alone independently at home. Primary outcomes will be self-assessed via online questionnaires at intake, control, after 4 weeks, and after 8 weeks, and will include eating behavior and loneliness. In addition, the primary outcome—use—will be measured via data logs. Secondary outcomes will be measured at the same junctures, via either validated, self-assessed, online questionnaires or an optional interview. Results: As of July 2020, we have begun recruiting participants. Conclusions: By unraveling the mechanisms behind the use of a web-based intervention with ECAs, we hope to gain a fine-grained understanding of both the effectiveness and the use of ECAs in the health context. Trial Registration: ClinicalTrials.gov NCT04510883; https://clinicaltrials.gov/ct2/show/NCT04510883 International Registered Report Identifier (IRRID): PRR1-10.2196/22186 %M 33404513 %R 10.2196/22186 %U https://www.researchprotocols.org/2021/1/e22186 %U https://doi.org/10.2196/22186 %U http://www.ncbi.nlm.nih.gov/pubmed/33404513 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e25746 %T A Live Video Mind-Body Treatment to Prevent Persistent Symptoms Following Mild Traumatic Brain Injury: Protocol for a Mixed Methods Study %A Greenberg,Jonathan %A Singh,Tanya %A Iverson,Grant L %A Silverberg,Noah D %A Macklin,Eric A %A Parker,Robert A %A Giacino,Joseph T %A Yeh,Gloria Y %A Vranceanu,Ana-Maria %+ Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, 1 Bowdoin Square Suite #100, Boston, MA, 02114, United States, 1 6176439402, jgreenberg5@mgh.harvard.edu %K mild traumatic brain injury %K anxiety %K mixed methods %K intervention development %D 2021 %7 14.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Every year, approximately 42 million people sustain a mild traumatic brain injury (mTBI, also known as concussion), with particularly high rates among college-aged individuals. A substantial proportion of these people (44%-64%) develop persistent symptoms that are challenging to treat, costly, and associated with significant disability. Anxiety has emerged as a risk factor for progression from acute to persistent mTBI symptoms. Objective: This study aims to develop, adapt, and establish the feasibility of the Toolkit for Optimal Recovery after Concussions (TOR-C), an innovative mind-body program aimed at preventing persistent symptoms among young adults with mTBI and comorbid anxiety. Here, we describe the proposed study design, methodology, measurement, and treatment manuals. Methods: In phase 1, we will conduct individual, live video qualitative interviews (up to n=20) with college-aged individuals with mTBI and comorbid anxiety to inform adaptation of the intervention and study procedures. In phase 2, an open pilot of the live video TOR-C (n=5) with exit interviews will be conducted to explore the initial feasibility, acceptability, and credibility of the program and to refine the study procedures. Phase 3 will involve conducting a feasibility randomized controlled trial (N=50) of the TOR-C versus a health education control (Health Enhancement for Concussions; HE-C), both delivered via live video, to establish feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection; feasibility, credibility, and acceptability of the live video TOR-C and HE-C (adherence, retention, fidelity, and satisfaction) following prespecified benchmarks; and a signal of improvement in outcomes. Results: Phase 1 of the study has been approved by the Massachusetts General Hospital Institutional Review Board. Study completion is anticipated by early 2025. Conclusions: We will develop and test the first mind-body intervention focused on prevention of persistent symptoms following mTBI in young adults with comorbid anxiety problems. This will allow us to establish feasibility markers in postconcussive symptoms, anxiety, disability, and fear avoidance to inform a future efficacy trial of the TOR-C versus HE-C. International Registered Report Identifier (IRRID): PRR1-10.2196/25746 %M 33443484 %R 10.2196/25746 %U https://www.researchprotocols.org/2021/1/e25746 %U https://doi.org/10.2196/25746 %U http://www.ncbi.nlm.nih.gov/pubmed/33443484 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e25424 %T Mobile Health Intervention to Close the Guidelines-To-Practice Gap in Hypertension Treatment: Protocol for the mGlide Randomized Controlled Trial %A Lakshminarayan,Kamakshi %A Murray,Thomas A %A Westberg,Sarah M %A Connett,John %A Overton,Val %A Nyman,John A %A Culhane-Pera,Kathleen A %A Pergament,Shannon L %A Drawz,Paul %A Vollbrecht,Emily %A Xiong,Txia %A Everson-Rose,Susan A %+ Division of Epidemiology & Community Health, School of Public Health, University of Minnesota, 1300 S 2nd Street, Suite 300, Minneapolis, MN, 55415, United States, 1 6126249492, laksh004@umn.edu %K hypertension %K mobile health technology %K health disparities %K randomized controlled trial %D 2021 %7 25.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Suboptimal treatment of hypertension remains a widespread problem, particularly among minorities and socioeconomically disadvantaged groups. We present a health system–based intervention with diverse patient populations using readily available smartphone technology. This intervention is designed to empower patients and create partnerships between patients and their provider team to promote hypertension control. Objective: The mGlide randomized controlled trial is a National Institutes of Health–funded study, evaluating whether a mobile health (mHealth)-based intervention that is an active partnership between interprofessional health care teams and patients results in better hypertension control rates than a state-of-clinical care comparison. Methods: We are recruiting 450 participants including stroke survivors and primary care patients with elevated cardiovascular disease risk from diverse health systems. These systems include an acute stroke service (n=100), an academic medical center (n=150), and community medical centers including Federally Qualified Health Centers serving low-income and minority (Latino, Hmong, African American, Somali) patients (n=200). The primary aim tests the clinical effectiveness of the 6-month mHealth intervention versus standard of care. Secondary aims evaluate sustained hypertension control rates at 12 months; describe provider experiences of system usability and satisfaction; examine patient experiences, including medication adherence and medication use self-efficacy, self-rated health and quality of life, and adverse event rates; and complete a cost-effectiveness analysis. Results: To date, we have randomized 107 participants (54 intervention, 53 control). Conclusions: This study will provide evidence for whether a readily available mHealth care model is better than state-of-clinical care for bridging the guideline-to-practice gap in hypertension treatment in health systems serving diverse patient populations. Trial Registration: Clinicaltrials.gov NCT03612271; https://clinicaltrials.gov/ct2/show/NCT03612271 International Registered Report Identifier (IRRID): DERR1-10.2196/25424 %M 33492231 %R 10.2196/25424 %U http://www.researchprotocols.org/2021/1/e25424/ %U https://doi.org/10.2196/25424 %U http://www.ncbi.nlm.nih.gov/pubmed/33492231 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e23690 %T A Tailored Web- and Text-Based Intervention to Increase Physical Activity for Latino Men: Protocol for a Randomized Controlled Feasibility Trial %A Gans,Kim M %A Dulin,Akilah %A Palomo,Vanessa %A Benitez,Tanya %A Dunsiger,Shira %A Dionne,Laura %A Champion,Gregory %A Edgar,Rachelle %A Marcus,Bess %+ Department of Human Development and Family Sciences, University of Connecticut, 348 Mansfield Road, U-1058, Storrs, CT, 06269-1058, United States, 1 8604863865, kim.gans@uconn.edu %K physical activity %K Latino %K Hispanic %K men %K eHealth %K expert system %K internet %K text messaging %K mobile phone %K social media %D 2021 %7 29.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Latino men in the United States report low physical activity (PA) levels and related health conditions (eg, diabetes and obesity). Engaging in regular PA can reduce the risk of chronic diseases and yield many health benefits; however, there is a paucity of interventions developed exclusively for Latino men. Objective: To address the need for culturally relevant PA interventions, this study aims to develop and evaluate Hombres Saludables, a 6-month theory-based, tailored web- and text message-based PA intervention in Spanish for Latino men. This protocol paper describes the study design, intervention, and evaluation methods for Hombres Saludables. Methods: Latino men aged 18-65 years were randomized to either the individually tailored PA internet intervention arm or the nutrition and wellness internet control arm. The PA intervention included 2 check-in phone calls; automated SMS text messages; a pedometer; a 6-month gym membership; access to a private Facebook group; and an interactive website with PA tracking, goal setting, and individually tailored PA content. The primary outcomes were feasibility, acceptability, and efficacy (minutes per week of total moderate-to-vigorous PA assessed via the ActiGraph GT3X+ accelerometer worn at the waist and 7-day physical activity recall at baseline and 6 months). Secondary outcomes examined potential moderators (eg, demographics, acculturation, and environmental variables) and mediators (eg, self-efficacy and cognitive and behavioral processes of change) of treatment effects at 6 months post randomization. Results: This study was funded in September 2016. Initial institutional review board approval was received in February 2017, and focus groups and intervention development were conducted from April 2017 to January 2018. Recruitment for the clinical trial was carried out from February 2018 to July 2019. Baseline data collection was carried out from February 2018 to October 2019, with a total of 43 participants randomized. Follow-up data were collected through April 2020. Data cleaning and analysis are ongoing. Conclusions: We developed and tested protocols for a highly accessible, culturally and linguistically relevant, theory-driven PA intervention for Latino men. Hombres Saludables used an innovative, interactive, web- and text message–based intervention for improving PA among Latino men, an underserved population at risk of low PA and related chronic disease. If the intervention demonstrates feasibility, acceptability, and preliminary efficacy, we will refine and evaluate it in a larger randomized control trial. Trial Registration: Clinicaltrials.gov: NCT03196570; https://clinicaltrials.gov/ct2/show/NCT03196570 International Registered Report Identifier (IRRID): DERR1-10.2196/23690 %M 33512327 %R 10.2196/23690 %U http://www.researchprotocols.org/2021/1/e23690/ %U https://doi.org/10.2196/23690 %U http://www.ncbi.nlm.nih.gov/pubmed/33512327 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e25144 %T Repeated Transcranial Magnetic Stimulation for Improving Cognition in Patients With Alzheimer Disease: Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial %A Moussavi,Zahra %A Rutherford,Grant %A Lithgow,Brian %A Millikin,Colleen %A Modirrousta,Mandana %A Mansouri,Behzad %A Wang,Xikui %A Omelan,Craig %A Fellows,Lesley %A Fitzgerald,Paul %A Koski,Lisa %+ Biomedical Engineering Program, The University of Manitoba, 75 Chancellor Circle, E2-390 Engineering Complex, Winnipeg, MB, R3T5V6, Canada, 1 204 474 7023, Zahra.Moussavi@umanitoba.ca %K repetitive transcranial magnetic stimulation %K Alzheimer disease %K double blind %K treatment %K placebo controlled %K randomized %D 2021 %7 8.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Alzheimer disease has no known cure. As existing pharmacologic interventions only modestly slow cognitive decline, there is a need for new treatments. Recent trials of repetitive transcranial magnetic stimulation (rTMS) have reported encouraging results for improving or stabilizing cognition in patients diagnosed with Alzheimer dementia. However, owing to small samples and lack of a well-controlled double-blind design, the results to date are inconclusive. This paper presents the protocol for a large placebo-controlled double-blind study designed with sufficient statistical rigor to measure the efficacy of rTMS treatment in patients with Alzheimer dementia. Objective: The objectives are to (1) recruit and enroll up to 200 eligible participants, (2) estimate the difference in treatment effects between active treatment and sham treatment, (3) estimate the difference in treatment effects between two doses of rTMS applications, (4) estimate the duration of treatment effects among responders to active rTMS treatment, and (5) estimate the effect of dementia severity on treatment outcomes among patients receiving active rTMS treatment. Methods: We have designed our study to be a double-blind, randomized, placebo-controlled clinical trial investigating the short- and long-term (up to 6 months) benefits of active rTMS treatment at two doses (10 sessions over 2 weeks and 20 sessions over 4 weeks) compared with sham rTMS treatment. The study will include patients aged ≥55 years who are diagnosed with Alzheimer disease at an early to moderate stage and have no history of seizures and no major depression. The primary outcome measure is the change in the Alzheimer Disease Assessment Scale-Cognitive Subscale score from pretreatment to posttreatment. Secondary outcomes are changes in performance on tests of frontal lobe functioning (Stroop test and verbal fluency), changes in neuropsychiatric symptoms (Neuropsychiatric Inventory Questionnaire), and changes in activities of daily living (Alzheimer Disease Co-operative Study-Activities of Daily Living Inventory). Tolerability of the intervention will be assessed using a modification of the Treatment Satisfaction Questionnaire for Medication. We assess participants at baseline and 3, 5, 8, 16, and 24 weeks after the intervention. Results: As of November 1, 2020, we have screened 523 individuals, out of which 133 were eligible and have been enrolled. Out of the 133 individuals, 104 have completed the study. Moreover, as of November 1, 2020, there has been no serious adverse event. We anticipate that rTMS will considerably improve cognitive function, with effects lasting up to 3 months. Moreover, we expect rTMS to be a well-tolerated treatment with no serious side effect. Conclusions: This protocol design will allow to address both the rTMS active treatment dose and its short- and long-term effects compared with sham treatment in large samples. Trial Registration: ClinicalTrials.gov NCT02908815; https://clinicaltrials.gov/ct2/show/NCT02908815 International Registered Report Identifier (IRRID): DERR1-10.2196/25144 %M 33416500 %R 10.2196/25144 %U http://www.researchprotocols.org/2021/1/e25144/ %U https://doi.org/10.2196/25144 %U http://www.ncbi.nlm.nih.gov/pubmed/33416500 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e22680 %T Program for Healthier School Cafeterias in Rio Grande do Sul, Brazil: Protocol for a Community-Based Randomized Trial %A Balestrin,Mariana %A Brasil,Carla Cristina Bauermann %A Bellei,Ericles Andrei %A Kirsten,Vanessa Ramos %A Wagner,Mario Bernardes %+ Faculty of Medical Sciences, Federal University of Rio Grande do Sul (UFRGS), 2400 Ramiro Barcelos, Room 220, Porto Alegre, 90035-003, Brazil, 55 51 33085601, mari_dalmolin@hotmail.com %K school health services %K healthy diet %K pediatric obesity %K schools %K snacks %D 2021 %7 19.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: School cafeterias can promote poor eating habits, as these retail outlets have a variety of foods considered to be nonnutritive and unhealthy. However, despite the need for effective preventive strategies, there is still disagreement on the best approach due to the lack of evidence on interventions to prevent and treat obesity in the school settings. Objective: We aim to verify the efficacy of an educational intervention program to improve the hygienic conditions and the composition of the menu offered in school cafeterias in the state of Rio Grande do Sul, Brazil. Methods: We will conduct a randomized, parallel, two-arm, community-based controlled study. Elementary and high schools, both public and private, in the State of Rio Grande do Sul, Brazil, that have a cafeteria will be eligible. Schools will be recruited and randomly assigned to the intervention (n=27) or control (n=27) group. The intervention group will receive an educational intervention program based on the guidelines issued by the Ministry of Health of Brazil, consisting of a 160-hour distance-learning qualification course, for 10 weeks, and using the Moodle platform and WhatsApp app. The intervention targets the owners and people in charge of the cafeterias, food handlers, principals, vice principals, teachers, pedagogical coordinators, dietitians, representatives of students' parents, and students over 16 years old. Meanwhile, the control group will receive only a printed copy of the book containing the guidelines used. The efficacy of the intervention will be determined by the hygienic conditions of the cafeteria and the composition of the menu offered, also considering the levels of processing of food sold. All outcomes will be analyzed as intention-to-treat and per-protocol. We will use covariance analysis or a generalized linear model for continuous data and ordinal logistic regression for ordinal categorical data. The level of statistical significance considered will be P<.05 for a 95% CI. Results: This project was funded in early 2018. We administered the intervention program in 2019. All data have already been collected, and we are analyzing the data. The results are expected in 2021. Conclusions: To our knowledge, this may be the first randomized controlled study in school cafeterias held in Brazil. The results will provide evidence for the formulation of public food and nutritional security policies and for the development of effective strategies to provide safe and healthy school meals. Trial Registration: Brazilian Clinical Trials Registry RBR-9rrqhk; https://ensaiosclinicos.gov.br/rg/RBR-9rrqhk International Registered Report Identifier (IRRID): DERR1-10.2196/22680 %M 33464219 %R 10.2196/22680 %U http://www.researchprotocols.org/2021/1/e22680/ %U https://doi.org/10.2196/22680 %U http://www.ncbi.nlm.nih.gov/pubmed/33464219 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e25382 %T The Current State and Diagnostic Accuracy of Digital Mental Health Assessment Tools for Psychiatric Disorders: Protocol for a Systematic Review and Meta-analysis %A Martin-Key,Nayra A %A Schei,Thea S %A Barker,Eleanor J %A Spadaro,Benedetta %A Funnell,Erin %A Benacek,Jiri %A Tomasik,Jakub %A Bahn,Sabine %+ Department of Chemical Engineering and Biotechnology, Cambridge Centre for Neuropsychiatric Research, University of Cambridge, Philippa Fawcett Drive, Cambridge, CB3 0AS, United Kingdom, 44 1223 334151, sb209@cam.ac.uk %K diagnostic accuracy %K digital mental health %K digital questionnaire %K meta-analysis %K psychiatry %K systematic review %D 2021 %7 8.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite the rapidly growing number of digital assessment tools for screening and diagnosing mental health disorders, little is known about their diagnostic accuracy. Objective: The purpose of this systematic review and meta-analysis is to establish the diagnostic accuracy of question- and answer-based digital assessment tools for diagnosing a range of highly prevalent psychiatric conditions in the adult population. Methods: The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) will be used. The focus of the systematic review is guided by the population, intervention, comparator, and outcome framework (PICO). We will conduct a comprehensive systematic literature search of MEDLINE, PsychINFO, Embase, Web of Science Core Collection, Cochrane Library, Applied Social Sciences Index and Abstracts (ASSIA), and Cumulative Index to Nursing and Allied Health Literature (CINAHL) for appropriate articles published from January 1, 2005. Two authors will independently screen the titles and abstracts of identified references and select studies according to the eligibility criteria. Any inconsistencies will be discussed and resolved. The two authors will then extract data into a standardized form. Risk of bias will be assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool, and a descriptive analysis and meta-analysis will summarize the diagnostic accuracy of the identified digital assessment tools. Results: The systematic review and meta-analysis commenced in November 2020, with findings expected by May 2021. Conclusions: This systematic review and meta-analysis will summarize the diagnostic accuracy of question- and answer-based digital assessment tools. It will identify implications for clinical practice, areas for improvement, and directions for future research. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020214724; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020214724. International Registered Report Identifier (IRRID): DERR1-10.2196/25382 %M 33416508 %R 10.2196/25382 %U http://www.researchprotocols.org/2021/1/e25382/ %U https://doi.org/10.2196/25382 %U http://www.ncbi.nlm.nih.gov/pubmed/33416508 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e25126 %T Technology-Supported Guidance Models Stimulating the Development of Critical Thinking in Clinical Practice: Protocol for a Mixed Methods Systematic Review %A Zlamal,Jaroslav %A Gjevjon,Edith Roth %A Fossum,Mariann %A Solberg,Marianne Trygg %A Steindal,Simen Alexander %A Strandell-Laine,Camilla %A Larsen,Marie Hamilton %A Pettersen,Fredrik Solvang %A Nes,Andréa Aparecida Gonçalves %+ Lovisenberg Diaconal University College, Lovisenberggata 15b, Oslo, 0456, Norway, 47 95963522, Jaroslav.Zlamal@ldh.no %K critical thinking %K technology %K guidance models %K nursing education %K clinical practice %D 2021 %7 19.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Critical thinking is an essential skill that nursing students need to develop. Technological tools have opened new avenues for technology-supported guidance models, but the challenges and facilitators of such guidance models, as well as how they stimulate the development of critical thinking, remain unclear. Objective: We developed a protocol for a mixed methods systematic review to investigate the use of technology-supported guidance models that stimulate the development of critical thinking in nursing education clinical practice. Methods: A convergent integrated design following the Joanna Briggs Institute Manual for Evidence Synthesis will be employed. A pair of authors will select the articles by screening titles and abstracts, and the methodological quality of the articles included in the review will be assessed by a pair of authors according to checklists for specific study designs. The data will be extracted using the standardized Joanna Briggs Institute mixed methods data extraction form and following a convergent integrated approach. The thematic synthesis for data transformation will be used. Results: Development of a comprehensive systematic search strategy was completed in October 2020. The database searches were performed on October 21, 2020. As of January 2021, analysis and synthesis is ongoing. Completion of this review is expected by January 2021. Conclusions: By combining evidence from studies with varied methodological approaches, the results should provide broad insight into the use of technology-supported guidance models for clinical practice in nursing education with a focus on the development of nursing students’ critical thinking. The results of this mixed methods systematic review can also be used to develop or improve current technology-supported guidance models for clinical practice in nursing education. International Registered Report Identifier (IRRID): PRR1-10.2196/25126 %M 33464214 %R 10.2196/25126 %U http://www.researchprotocols.org/2021/1/e25126/ %U https://doi.org/10.2196/25126 %U http://www.ncbi.nlm.nih.gov/pubmed/33464214 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e18229 %T Risk Factors and Prevalence of Dilated Cardiomyopathy in Sub-Saharan Africa: Protocol for a Systematic Review %A Fundikira,Lulu Said %A Chillo,Pilly %A van Laake,Linda W %A Mutagaywa,Reuben Kato %A Schmidt,Amand Floriaan %A Kamuhabwa,Appolinary %A Kwesigabo,Gideon %A Asselbergs,Folkert W %+ Department of Cardiology, Division of Heart and Lungs, University Medical Centre Utrecht, Utrecht University, Heidelberglaan 100, Utrecht, 3584 CX, Netherlands, 31 887559408, L.W.vanLaake@umcutrecht.nl %K dilated cardiomyopathy %K cardiomyopathy %K heart failure %K cardiovascular risk factors %K sub-Saharan Africa %D 2021 %7 21.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cardiomyopathies, defined as diseases involving mainly the heart muscles, are linked to an estimated 5.9 of 100,000 deaths globally. In sub-Saharan Africa, cardiomyopathies constitute 21.4% of heart failure cases, with dilated cardiomyopathy (DCM) being the most common form. The etiology of DCM is heterogeneous and is broadly categorized as genetic or nongenetic, as well as a mixed disease in which genetics interact with intrinsic and environmental factors. Factors such as age, gender, family history, and ethnicity are nonmodifiable, whereas modifiable risk factors include poor nutrition, physical inactivity, and excessive alcohol consumption, among others. However, the relative contribution of the different risk factors to the etiology of DCM is not known in sub-Saharan Africa, and the prevalence of DCM among heart failure patients has not been systematically studied in the region. Objective: The aim of this review is to synthesize available literature from sub-Saharan Africa on the prevalence of DCM among patients with heart failure, as well as the literature on factors associated with DCM. This paper outlines the protocol that will be followed to conduct the systematic review. Methods: A limited search of the PubMed database will be performed to identify relevant keywords contained in the title, abstract, and subject descriptors using initial search terms “heart failure,” “cardiomyopathy,” and “sub-Saharan Africa.” These search terms and their synonyms will then be used in an extensive search in PubMed, and will address the first research question on prevalence. To address the second research question on risk factors, the terms “heart failure,” “cardiomyopathy,” and “cardiovascular risk factors” in “Sub-Saharan Africa” will be used, listing them one by one. Articles published from 2000 and in the English language will be included. Indexed articles in PubMed and Embase will be included, as well as the first 300 articles retrieved from a Google Scholar search. Collected data will be organized in Endnote and then uploaded to the Rayyan web app for systematic reviews. Two reviewers will independently select articles against the inclusion criteria. Discrepancies in reviewer selections will be resolved by an arbitrator. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for reporting systematic reviews will be applied. A map of sub-Saharan Africa with colors to show disease prevalence in each country will be included. For quantitative data, where possible, odds ratios (for categorical outcome data) or standardized mean differences (for continuous data) and their 95% CIs will be calculated. Results: The primary outcomes will be the prevalence of DCM among patients with heart failure and cardiovascular risk factors associated with DCM in sub-Saharan Africa. The literature search will begin on January 1, 2021, and data analysis is expected to be completed by April 30, 2021. Conclusions: This review will provide information on the current status of the prevalence and associated factors of DCM, and possibly identify gaps, including paucity of data or conflicting results that need to be addressed to improve our understanding of DCM in sub-Saharan Africa. International Registered Report Identifier (IRRID): PRR1-10.2196/18229 %M 33475522 %R 10.2196/18229 %U http://www.researchprotocols.org/2021/1/e18229/ %U https://doi.org/10.2196/18229 %U http://www.ncbi.nlm.nih.gov/pubmed/33475522 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e22905 %T Efficacy and Safety of Medicines Targeting Neurotrophic Factors in the Management of Low Back Pain: Protocol for a Systematic Review and Meta-analysis %A Rizzo,Rodrigo R N %A Ferraro,Michael C %A Wewege,Michael A %A Cashin,Aidan G %A Leake,Hayley B %A O’Hagan,Edel T %A Jones,Matthew D %A Gustin,Sylvia M %A McAuley,James H %+ School of Medical Sciences, University of New South Wales, Wallace Wurth Building – UNSW Sydney, 18 High Street, Kensington, Sydney, NSW 2052, Australia, 61 2 9399 1870, james.mcauley@unsw.edu.au %K back pain %K analgesics %K drug therapy %K monoclonal antibodies %K nerve growth factor %K review %K meta-analysis %K antibodies %K pain %K back %K growth factor %K disability %K sciatica %D 2021 %7 22.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Low back pain (LBP) is the leading cause of years lived with disability worldwide. Most people with LBP receive the diagnosis of nonspecific LBP or sciatica. Medications are commonly prescribed but have limited analgesic effects and are associated with adverse events. A novel treatment approach is to target neurotrophins such as nerve growth factor (NGF) to reduce pain intensity. NGF inhibitors have been tested in some randomized controlled trials (RCTs) in recent years, showing promise for the treatment of chronic LBP; however, their efficacy and safety need to be evaluated to guide regulatory actions. Objective: The aim of this study is to evaluate the efficacy and safety of medicines targeting neurotrophins in patients with LBP and sciatica. Methods: In this systematic review, we will include published and unpublished records of parallel RCTs and the first phase of crossover RCTs that compare the effects of medicines targeting neurotrophins with any control group. We will search the CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, EU Clinical Trials Register, and WHO International Clinical Registry Platform databases from inception. Pairs of authors will independently screen the records for eligibility, and we will independently extract data in duplicate. We will conduct a quantitative synthesis (meta-analysis) with the studies that report sufficient data and compare the medicines of interest versus placebo. We will use random-effects models and calculate estimates of effects and heterogeneity for each outcome. We will assess the risk of bias for each study using the Cochrane Collaboration tool, and form judgments of confidence in the evidence according to GRADE recommendations. We will use the PRISMA statement to report the findings. We plan to conduct subgroup analyses by condition, type of medication, and time point. We will also assess the impact of a potential new trial on an existing meta-analysis. Data from studies that meet inclusion criteria but cannot be included in the meta-analysis will be reported narratively. Results: The protocol was registered on the Open Science Framework on May 19, 2020. As of December 2020, we have identified 1932 records. Conclusions: This systematic review and meta-analysis will assess the evidence for the efficacy and safety of NGF inhibitors for pain in patients with nonspecific LBP and sciatica. The inclusion of new studies and unpublished data may improve the precision of the effect estimates and guide regulatory actions of the medications for LBP and sciatica. Trial Registration: Open Science Framework; https://osf.io/b8adn/ International Registered Report Identifier (IRRID): DERR1-10.2196/22905 %M 33480861 %R 10.2196/22905 %U http://www.researchprotocols.org/2021/1/e22905/ %U https://doi.org/10.2196/22905 %U http://www.ncbi.nlm.nih.gov/pubmed/33480861 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e20615 %T Tui Na for Chronic Nonspecific Low Back Pain: Protocol for a Systematic Review and Meta-analysis %A Yang,Juan %A Brault,Jeffrey S %A Jensen,Mark A %A Do,Alexander %A Ma,Qingyu %A Zhou,Xuan %A Shen,Longbin %A Zhao,Canghuan %A Cheong,Kwok Chee Philip %A He,Kejie %A Guo,Yu %A Chen,Zhuoming %A Tang,Shujie %A Tang,Yong %A Tan,Celia Ia Choo %A Chen,Jiaxu %A Bauer,Brent A. %+ Division of General Internal Medicine, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, United States, 1 5072842511, Bauer.Brent@mayo.edu %K Tui na %K Tuina %K low back pain %K protocol %K systematic review %D 2021 %7 27.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic nonspecific low back pain (CNLBP) is one of the most common complex pain conditions, and it is strongly associated with high rates of disability. Even though several studies on Tui na for CNLBP have been reported, to our knowledge there has been no systematic review of the currently available publications. Objective: This study aims to develop a protocol for a systematic review and meta-analysis that will evaluate the effectiveness and safety of Tui na therapy for patients with CNLBP. Methods: An electronic literature search of PubMed, Embase, MEDLINE, Cochrane Library, Springer, Scopus, World Health Organization International Clinical Trials Registry Platform, Physiotherapy Evidence Database (PEDro), Clarivate Analytics, and Chinese biomedical databases (the China National Knowledge Infrastructure, Wan-fang database, Chinese Scientific Journals Database, and Chinese Biomedical Literature Databases) will be conducted. Studies will be screened by two reviewers independently based on titles and abstracts, followed by a full-text reading with eligibility criteria. Randomized controlled trials involving Tui na for patients with CNLBP will be reviewed. The primary outcomes of the study are improvement of pain, analgesic medication reduction, improvement of functional disability, and degree of satisfaction with the intervention. A secondary outcome is any adverse event of Tui na intervention. Methodological quality and risk of bias will be assessed with the Cochrane Collaboration Risk of Bias Tool. If studies are sufficient, a meta-analysis of the effectiveness will be performed. If possible, we will evaluate publication bias using funnel plots. If substantial heterogeneity between studies is present, and there are sufficient studies, subgroup analyses will be conducted to explain the study findings. Results: The review database searches will be initiated in December 2020, with findings expected by January 2021. Conclusions: This protocol will establish a framework of a high-quality literature synthesis on the impact of Tui na treatment in patients with CNLBP. The proposed review will determine whether Tui na is effective and safe for CNLBP patients. Trial Registration: PROSPERO CRD42020166731; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=166731 International Registered Report Identifier (IRRID): PRR1-10.2196/20615 %M 33502327 %R 10.2196/20615 %U http://www.researchprotocols.org/2021/1/e20615/ %U https://doi.org/10.2196/20615 %U http://www.ncbi.nlm.nih.gov/pubmed/33502327 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e21804 %T A Bayesian Network Decision Support Tool for Low Back Pain Using a RAND Appropriateness Procedure: Proposal and Internal Pilot Study %A Hill,Adele %A Joyner,Christopher H %A Keith-Jopp,Chloe %A Yet,Barbaros %A Tuncer Sakar,Ceren %A Marsh,William %A Morrissey,Dylan %+ Sport and Exercise Medicine, Queen Mary University of London, Mile End Road, London, E1 4NS, United Kingdom, 44 7971495806, a.hill@smd18.qmul.ac.uk %K back pain %K decision making %K Bayesian methods %K consensus %D 2021 %7 15.1.2021 %9 Proposal %J JMIR Res Protoc %G English %X Background: Low back pain (LBP) is an increasingly burdensome condition for patients and health professionals alike, with consistent demonstration of increasing persistent pain and disability. Previous decision support tools for LBP management have focused on a subset of factors owing to time constraints and ease of use for the clinician. With the explosion of interest in machine learning tools and the commitment from Western governments to introduce this technology, there are opportunities to develop intelligent decision support tools. We will do this for LBP using a Bayesian network, which will entail constructing a clinical reasoning model elicited from experts. Objective: This paper proposes a method for conducting a modified RAND appropriateness procedure to elicit the knowledge required to construct a Bayesian network from a group of domain experts in LBP, and reports the lessons learned from the internal pilot of the procedure. Methods: We propose to recruit expert clinicians with a special interest in LBP from across a range of medical specialties, such as orthopedics, rheumatology, and sports medicine. The procedure will consist of four stages. Stage 1 is an online elicitation of variables to be considered by the model, followed by a face-to-face workshop. Stage 2 is an online elicitation of the structure of the model, followed by a face-to-face workshop. Stage 3 consists of an online phase to elicit probabilities to populate the Bayesian network. Stage 4 is a rudimentary validation of the Bayesian network. Results: Ethical approval has been obtained from the Research Ethics Committee at Queen Mary University of London. An internal pilot of the procedure has been run with clinical colleagues from the research team. This showed that an alternating process of three remote activities and two in-person meetings was required to complete the elicitation without overburdening participants. Lessons learned have included the need for a bespoke online elicitation tool to run between face-to-face meetings and for careful operational definition of descriptive terms, even if widely clinically used. Further, tools are required to remotely deliver training about self-identification of various forms of cognitive bias and explain the underlying principles of a Bayesian network. The use of the internal pilot was recognized as being a methodological necessity. Conclusions: We have proposed a method to construct Bayesian networks that are representative of expert clinical reasoning for a musculoskeletal condition in this case. We have tested the method with an internal pilot to refine the process prior to deployment, which indicates the process can be successful. The internal pilot has also revealed the software support requirements for the elicitation process to model clinical reasoning for a range of conditions. International Registered Report Identifier (IRRID): DERR1-10.2196/21804 %M 33448937 %R 10.2196/21804 %U http://www.researchprotocols.org/2021/1/e21804/ %U https://doi.org/10.2196/21804 %U http://www.ncbi.nlm.nih.gov/pubmed/33448937 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e20819 %T A Mindfulness-Based Brain-Computer Interface to Augment Mandala Coloring for Depression: Protocol for a Single-Case Experimental Design %A Daudén Roquet,Claudia %A Sas,Corina %+ School of Computing and Communications, Lancaster University, InfoLab21, Lancaster University, Lancaster, LA1 4WA, United Kingdom, 44 01524510321, c.daudenroquet1@lancaster.ac.uk %K brain-computer interface %K mental well-being %K depression %K mindfulness %K mandala coloring %D 2021 %7 18.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The regular practice of mindfulness has been shown to provide benefits for mental well-being and prevent depression relapse. Technology-mediated interventions can facilitate the uptake and sustained practice of mindfulness, yet the evaluation of interactive systems, such as brain-computer interfaces, has been little explored. Objective: The objective of this paper is to present an interactive mindfulness-based technology to improve mental well-being in people who have experienced depression. The system, Anima, is a brain-computer interface that augments mandala coloring by providing a generative color palette based on the unfolding mindfulness states during the practice. In addition, this paper outlines a multiple-baseline, single-case experimental design methodology to evaluate training effectiveness. Methods: Adult participants who have experienced depression in the past, have finished treatment within the last year, and can provide informed consent will be able to be recruited. The Anima system, consisting of 2 tablets and a nonintrusive mental activity headband, will be delivered to participants to use during the study. Measures include state and trait mindfulness, depression symptoms, mental well-being, and user experience, and these measures will be taken throughout the baseline, intervention, and monitoring phases. The data collection will take place in the form of a questionnaire before and after each mandala-coloring session and a semistructured interview every 2 weeks. Trial results will be analyzed using structured visual analysis, supplemented with statistical analysis appropriate to single-case methodology. Results: Study results will offer new insights into the deployment and evaluation of novel interactive brain-computer interfaces for mindfulness training in the context of mental health. Moreover, findings will validate the effectiveness of this training protocol to improve the mental well-being of people who have had depression. Participants will be recruited locally through the National Health Service. Conclusions: Evidence will assist in the design and evaluation of brain-computer interfaces and mindfulness technologies for mental well-being and the necessary services to support people who have experienced depression. International Registered Report Identifier (IRRID): PRR1-10.2196/20819 %M 33459604 %R 10.2196/20819 %U http://www.researchprotocols.org/2021/1/e20819/ %U https://doi.org/10.2196/20819 %U http://www.ncbi.nlm.nih.gov/pubmed/33459604 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e20184 %T Improving Patient Prioritization During Hospital-Homecare Transition: Protocol for a Mixed Methods Study of a Clinical Decision Support Tool Implementation %A Zolnoori,Maryam %A McDonald,Margaret V %A Barrón,Yolanda %A Cato,Kenrick %A Sockolow,Paulina %A Sridharan,Sridevi %A Onorato,Nicole %A Bowles,Kathryn %A Topaz,Maxim %+ Center for Home Care Policy & Research, Visiting Nurse Service of New York, 5 Penn Plaza, 12th floor, New York, NY, 10001, United States, 1 (212) 609 1774, maxim.topaz@vnsny.org %K clinical decision support system %K homecare agencies %K rehospitalization %K RE-AIM framework %K PREVENT %K effective implementation %D 2021 %7 22.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Homecare settings across the United States provide care to more than 5 million patients every year. About one in five homecare patients are rehospitalized during the homecare episode, with up to two-thirds of these rehospitalizations occurring within the first 2 weeks of services. Timely allocation of homecare services might prevent a significant portion of these rehospitalizations. The first homecare nursing visit is one of the most critical steps of the homecare episode. This visit includes an assessment of the patient’s capacity for self-care, medication reconciliation, an examination of the home environment, and a discussion regarding whether a caregiver is present. Hence, appropriate timing of the first visit is crucial, especially for patients with urgent health care needs. However, nurses often have limited and inaccurate information about incoming patients, and patient priority decisions vary significantly between nurses. We developed an innovative decision support tool called Priority for the First Nursing Visit Tool (PREVENT) to assist nurses in prioritizing patients in need of immediate first homecare nursing visits. Objective: This study aims to evaluate the effectiveness of the PREVENT tool on process and patient outcomes and to examine the reach, adoption, and implementation of PREVENT. Methods: Employing a pre-post design, survival analysis, and logistic regression with propensity score matching analysis, we will test the following hypotheses: compared with not using the tool in the preintervention phase, when homecare clinicians use the PREVENT tool, high-risk patients in the intervention phase will (1) receive more timely first homecare visits and (2) have decreased incidence of rehospitalization and have decreased emergency department use within 60 days. Reach, adoption, and implementation will be assessed using mixed methods including homecare admission staff interviews, think-aloud observations, and analysis of staffing and other relevant data. Results: The study research protocol was approved by the institutional review board in October 2019. PREVENT is currently being integrated into the electronic health records at the participating study sites. Data collection is planned to start in early 2021. Conclusions: Mixed methods will enable us to gain an in-depth understanding of the complex socio-technological aspects of the hospital to homecare transition. The results have the potential to (1) influence the standardization and individualization of nurse decision making through the use of cutting-edge technology and (2) improve patient outcomes in the understudied homecare setting. Trial Registration: ClinicalTrials.gov NCT04136951; https://clinicaltrials.gov/ct2/show/NCT04136951 International Registered Report Identifier (IRRID): PRR1-10.2196/20184 %M 33480855 %R 10.2196/20184 %U https://www.researchprotocols.org/2021/1/e20184 %U https://doi.org/10.2196/20184 %U http://www.ncbi.nlm.nih.gov/pubmed/33480855 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e24414 %T Long-Term Morbidity and Health After Early Menopause Due to Oophorectomy in Women at Increased Risk of Ovarian Cancer: Protocol for a Nationwide Cross-Sectional Study With Prospective Follow-Up (HARMOny Study) %A Terra,Lara %A Hooning,Maartje J %A Heemskerk-Gerritsen,Bernadette A M %A van Beurden,Marc %A Roeters van Lennep,Jeanine E %A van Doorn,Helena C %A de Hullu,Joanne A %A Mom,Constantijne %A van Dorst,Eleonora B L %A Mourits,Marian J E %A Slangen,Brigitte F M %A Gaarenstroom,Katja N %A Zillikens,M Carola %A Leiner,Tim %A van der Kolk,Lizet %A Collee,Margriet %A Wevers,Marijke %A Ausems,Margreet G E M %A van Engelen,Klaartje %A Berger,Lieke PV %A van Asperen,Christi J %A Gomez-Garcia,Encarna B %A van de Beek,Irma %A Rookus,Matti A %A Hauptmann,Michael %A Bleiker,Eveline M %A Schagen,Sanne B %A Aaronson,Neil K %A Maas,Angela H E M %A van Leeuwen,Flora E %+ Department of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, H8. PSOE, Amsterdam, 1066CX, Netherlands, 31 020 5122480, f.v.leeuwen@nki.nl %K risk-reducing salpingo-oophorectomy %K BRCA1/2 %K cardiovascular disease %K osteoporosis %K cognition %K health-related quality of life %D 2021 %7 22.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: BRCA1/2 mutation carriers are recommended to undergo risk-reducing salpingo-oophorectomy (RRSO) at 35 to 45 years of age. RRSO substantially decreases ovarian cancer risk, but at the cost of immediate menopause. Knowledge about the potential adverse effects of premenopausal RRSO, such as increased risk of cardiovascular disease, osteoporosis, cognitive dysfunction, and reduced health-related quality of life (HRQoL), is limited. Objective: The aim of this study is to assess the long-term health effects of premenopausal RRSO on cardiovascular disease, bone health, cognitive functioning, urological complaints, sexual functioning, and HRQoL in women with high familial risk of breast or ovarian cancer. Methods: We will conduct a multicenter cross-sectional study with prospective follow-up, nested in a nationwide cohort of women at high familial risk of breast or ovarian cancer. A total of 500 women who have undergone RRSO before 45 years of age, with a follow-up period of at least 10 years, will be compared with 250 women (frequency matched on current age) who have not undergone RRSO or who have undergone RRSO at over 55 years of age. Participants will complete an online questionnaire on lifestyle, medical history, cardiovascular risk factors, osteoporosis, cognitive function, urological complaints, and HRQoL. A full cardiovascular assessment and assessment of bone mineral density will be performed. Blood samples will be obtained for marker analysis. Cognitive functioning will be assessed objectively with an online neuropsychological test battery. Results: This study was approved by the institutional review board in July 2018. In February 2019, we included our first participant. As of November 2020, we had enrolled 364 participants in our study. Conclusions: Knowledge from this study will contribute to counseling women with a high familial risk of breast/ovarian cancer about the long-term health effects of premenopausal RRSO. The results can also be used to offer health recommendations after RRSO. Trial Registration: ClinicalTrials.gov NCT03835793; https://clinicaltrials.gov/ct2/show/NCT03835793. International Registered Report Identifier (IRRID): DERR1-10.2196/24414 %M 33480862 %R 10.2196/24414 %U http://www.researchprotocols.org/2021/1/e24414/ %U https://doi.org/10.2196/24414 %U http://www.ncbi.nlm.nih.gov/pubmed/33480862 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e20225 %T Using Big Data to Estimate Dementia Prevalence in New Zealand: Protocol for an Observational Study %A Rivera-Rodriguez,Claudia %A Cheung,Gary %A Cullum,Sarah %+ Department of Statistics, University of Auckland, 2/1576 Great North Road, Waterview, Auckland, 1026, New Zealand, 64 0223920565, c.rodriguez@auckland.ac.nz %K routinely collected data %K repeated measures %K dementia %K Alzheimer disease %K modeling %K complex sampling   %D 2021 %7 6.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Dementia describes a cluster of symptoms that includes memory loss; difficulties with thinking, problem solving, or language; and functional impairment. Dementia can be caused by a number of neurodegenerative diseases, such as Alzheimer disease and cerebrovascular disease. Currently in New Zealand, most of the systematically collected and detailed information on dementia is obtained through a suite of International Residential Assessment Instrument (interRAI) assessments, including the home care, contact assessment, and long-term care facility versions. These versions of interRAI are standardized comprehensive geriatric assessments. Patients are referred to have an interRAI assessment by the Needs Assessment and Service Coordination (NASC) services after a series of screening processes. Previous estimates of the prevalence and costs of dementia in New Zealand have been based on international studies with different populations and health and social care systems. This new local knowledge will have implications for estimating the demographic distribution and socioeconomic impact of dementia in New Zealand. Objective: This study investigates the prevalence of dementia, risk factors for dementia, and drivers of the informal cost of dementia among people registered in the NASC database in New Zealand. Methods: This study aims to analyze secondary data routinely collected by the NASC and interRAI (home care and contact assessment versions) databases between July 1, 2014, and July 1, 2019, in New Zealand. The databases will be linked to produce an integrated data set, which will be used to (1) investigate the sociodemographic and clinical risk factors associated with dementia and other neurological conditions, (2) estimate the prevalence of dementia using weighting methods for complex samples, and (3) identify the cost of informal care per client (in number of hours of care provided by unpaid carers) and the drivers of such costs. We will use design-based survey methods for the estimation of prevalence and generalized estimating equations for regression models and correlated and longitudinal data. Results: The results will provide much needed statistics regarding dementia prevalence and risk factors and the cost of informal care for people living with dementia in New Zealand. Potential health inequities for different ethnic groups will be highlighted, which can then be used by decision makers to inform the development of policy and practice. Conclusions: As of November 2020, there were no dementia prevalence studies or studies on informal care costs of dementia using national data from New Zealand. All existing studies have used data from other populations with substantially different demographic distributions. This study will give insight into the actual prevalence, risk factors, and informal care costs of dementia for the population with support needs in New Zealand. It will provide valuable information to improve health outcomes and better inform policy and planning. International Registered Report Identifier (IRRID): DERR1-10.2196/20225 %M 33404510 %R 10.2196/20225 %U https://www.researchprotocols.org/2021/1/e20225 %U https://doi.org/10.2196/20225 %U http://www.ncbi.nlm.nih.gov/pubmed/33404510 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e21453 %T Natural Language Processing–Based Virtual Cofacilitator for Online Cancer Support Groups: Protocol for an Algorithm Development and Validation Study %A Leung,Yvonne W %A Wouterloot,Elise %A Adikari,Achini %A Hirst,Graeme %A de Silva,Daswin %A Wong,Jiahui %A Bender,Jacqueline L %A Gancarz,Mathew %A Gratzer,David %A Alahakoon,Damminda %A Esplen,Mary Jane %+ de Souza Institute, University Health Network, 222 St Patrick St Rm 503, Toronto, ON, M5T 1V4, Canada, 1 844 758 6891, yvonne.leung@desouzainstitute.com %K artificial intelligence %K cancer %K online support groups %K emotional distress %K natural language processing %K participant engagement %D 2021 %7 7.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cancer and its treatment can significantly impact the short- and long-term psychological well-being of patients and families. Emotional distress and depressive symptomatology are often associated with poor treatment adherence, reduced quality of life, and higher mortality. Cancer support groups, especially those led by health care professionals, provide a safe place for participants to discuss fear, normalize stress reactions, share solidarity, and learn about effective strategies to build resilience and enhance coping. However, in-person support groups may not always be accessible to individuals; geographic distance is one of the barriers for access, and compromised physical condition (eg, fatigue, pain) is another. Emerging evidence supports the effectiveness of online support groups in reducing access barriers. Text-based and professional-led online support groups have been offered by Cancer Chat Canada. Participants join the group discussion using text in real time. However, therapist leaders report some challenges leading text-based online support groups in the absence of visual cues, particularly in tracking participant distress. With multiple participants typing at the same time, the nuances of the text messages or red flags for distress can sometimes be missed. Recent advances in artificial intelligence such as deep learning–based natural language processing offer potential solutions. This technology can be used to analyze online support group text data to track participants’ expressed emotional distress, including fear, sadness, and hopelessness. Artificial intelligence allows session activities to be monitored in real time and alerts the therapist to participant disengagement. Objective: We aim to develop and evaluate an artificial intelligence–based cofacilitator prototype to track and monitor online support group participants’ distress through real-time analysis of text-based messages posted during synchronous sessions. Methods: An artificial intelligence–based cofacilitator will be developed to identify participants who are at-risk for increased emotional distress and track participant engagement and in-session group cohesion levels, providing real-time alerts for therapist to follow-up; generate postsession participant profiles that contain discussion content keywords and emotion profiles for each session; and automatically suggest tailored resources to participants according to their needs. The study is designed to be conducted in 4 phases consisting of (1) development based on a subset of data and an existing natural language processing framework, (2) performance evaluation using human scoring, (3) beta testing, and (4) user experience evaluation. Results: This study received ethics approval in August 2019. Phase 1, development of an artificial intelligence–based cofacilitator, was completed in January 2020. As of December 2020, phase 2 is underway. The study is expected to be completed by September 2021. Conclusions: An artificial intelligence–based cofacilitator offers a promising new mode of delivery of person-centered online support groups tailored to individual needs. International Registered Report Identifier (IRRID): DERR1-10.2196/21453 %M 33410754 %R 10.2196/21453 %U https://www.researchprotocols.org/2021/1/e21453 %U https://doi.org/10.2196/21453 %U http://www.ncbi.nlm.nih.gov/pubmed/33410754 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e18643 %T Creating Respectful Workplaces for Nurses in Regional Acute Care Settings: Protocol for a Sequential Explanatory Mixed Methods Study %A Hawkins,Natasha %A Jeong,Sarah %A Smith,Tony %+ The School of Nursing & Midwifery, The University of Newcastle Australia, 69a High Street, Taree, 2430, Australia, 61 0412341415, tash.hawkins@newcastle.edu.au %K bullying %K culture %K negative behavior %K nurses %K methods %K workforce %D 2021 %7 11.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Negative workplace behaviour among nurses is an internationally recognised problem, despite the plethora of literature spanning several decades. The various forms of mistreatments and uncaring attitudes experienced by nurses include workplace aggression, incivility, bullying, harassment and horizontal violence. Negative behaviour has detrimental effects on the individual nurse, the organisation, the nursing profession and patients. Multi-level organisational interventions are warranted to influence the “civility norms” of the nursing profession. Objective: The aim of this study is to investigate the self-reported exposure to and experiences of negative workplace behaviours of nursing staff and their ways of coping in regional acute care hospitals in one Local Health District (LHD) in NSW before and after Respectful Workplace Workshops have been implemented within the organisation. Methods: This study employs a mixed methods sequential explanatory design with an embedded experimental component, underpinned by Social World’s Theory. This study will be carried out in four acute care regional hospitals from a Local Health District (LHD) in New South Wales (NSW), Australia. The nurse unit managers, registered nurses and new graduate nurses from the medical and surgical wards of all four hospitals will be invited to complete a pre-survey examining their experiences, perceptions and responses to negative workplace behaviour, and their ways of coping when exposed. Face-to-face educational workshops will then be implemented by the organisation at two of the four hospitals. The workshops are designed to increase awareness of negative workplace behaviour, the pathways to seek assistance and aims to create respectful workplaces. Commencing 3 months after completion of the workshop implementation, follow up surveys and interviews will then be undertaken at all four hospitals. Results: The findings from this research will enhance understanding of negative workplace behaviour occurring within the nursing social world and assess the effectiveness of the LHD’s Respectful Workplace Workshops upon the levels of negative workplace behaviour occurring. By integrating qualitative and quantitative findings it will allow for a dual perspective of the social world of nurses where negative and/or respectful workplace behaviours occur, and provide data grounded in individuals lived experiences, positioned in a macro context Conclusions: It is expected that evidence from this study will inform nursing practice, and future policy development aimed at creating respectful workplaces. Trial Registration: Australian New Zealand Clinical Trials Registry (Registration No. ACTRN12618002007213; 14 December 2018). International Registered Report Identifier (IRRID): PRR1-10.2196/18643 %M 33427678 %R 10.2196/18643 %U http://www.researchprotocols.org/2021/1/e18643/ %U https://doi.org/10.2196/18643 %U http://www.ncbi.nlm.nih.gov/pubmed/33427678 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e20463 %T Online Self-Determination Toolkit for Youth With Disabilities: Protocol for a Mixed Methods Evaluation Study %A Lindsay,Sally %A Kosareva,Polina %A Sukhai,Mahadeo %A Thomson,Nicole %A Stinson,Jennifer %+ Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital and University of Toronto, 150 Kilgour Road, Toronto, ON, Canada, 1 416 425 6220 ext 3654, slindsay@hollandbloorview.ca %K disability %K involvement %K occupational therapy %K rehabilitation %K youth %D 2021 %7 11.1.2021 %9 Proposal %J JMIR Res Protoc %G English %X Background: Youth with disabilities encounter many challenges during their transition to adulthood including finding employment. Jobs are often inaccessible, and youth often face a lack of support, discriminatory attitudes, and sometimes low self-confidence. Therefore, it is critical to help youth enhance their self-determination skills to advocate for their needs in the workplace. Objective: The aim of this paper is to describe how an online toolkit aimed to improve self-determination in advocating for needs, including disability disclosure and accommodation requests to employers, was co-created with youth with disabilities. Methods: We will use a mixed method design in which qualitative data (ie, focus groups and mentored discussion forum) are collected to understand the contextual factors during the intervention that could affect outcomes or explain results through the pre-post questionnaires. Fifty youths with disabilities aged 15 to 24 years will be recruited. Results: Data collection is in progress. Planned analyses include focus groups and pre-post surveys to determine the impact of the intervention on self-determination. A qualitative content analysis of the focus groups and all open-ended survey questions will be conducted to understand the impact of the toolkit. Conclusions: Our online toolkit includes evidence-informed content that was co-created with youth who have a disability. It has potential for educational and vocational programming for youth with disabilities. International Registered Report Identifier (IRRID): PRR1-10.2196/20463 %M 33427688 %R 10.2196/20463 %U http://www.researchprotocols.org/2021/1/e20463/ %U https://doi.org/10.2196/20463 %U http://www.ncbi.nlm.nih.gov/pubmed/33427688 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e21727 %T Evaluation of Self-Care Activities and Quality of Life in Patients With Type 2 Diabetes Mellitus Treated With Metformin Using the 2D Matrix Code of Outer Drug Packages as Patient Identifier: Protocol for the DePRO Proof-of-Concept Observational Study %A Mueller,Christian %A Schauerte,Isabel %A Martin,Stephan %+ Pharmaceuticals Medicine, Pharmaceuticals, Medical Excellence & Innovation Management, Data Generation, Bayer Vital GmbH, Building K 56, 1D321, Leverkusen, 51368, Germany, 49 214 30 46587, christian.mueller4@bayer.com %K self-care activities %K quality of life %K type 2 diabetes mellitus %K patient-reported outcome measures %K digital observational study %K bring your own device %D 2021 %7 11.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Diabetes mellitus (DM) is one of the most common noncommunicable diseases. DM has a substantial negative impact on patients’ quality of life, which is measured using a variety of diabetes-specific measures covering multiple aspects of patients’ psychological state, behavior, and treatment satisfaction. A fully digital data collection system, including patient identification, would represent a substantial advance in how these patient-reported outcome (PRO) data are measured. Within the European Union, one way to identify patients without the involvement of health care professionals is to use the unique 2D matrix codes on the packaging of prescription medication—for example, metformin, the recommended initial treatment for patients with type 2 DM (T2DM). Objective: In the DePRO study we aim to (1) describe the self-care activities of patients with T2DM using metformin-containing medication; (2) describe the self-reported health status (eg, presence of diabetes complications and quality of life) of these patients; (3) describe associations between self-care activities and demographics and disease characteristics; and (4) assess the usability of the my ePRO app. Methods: DePRO is an observational, multicenter, cross-sectional, digital, patient-driven study conducted in Germany. Patients with a prescription for a metformin-containing medication will be given a postcard by their pharmacist, which will include a download link for the my ePRO app. In total, 12 diabetes-focused pharmacies, selected to represent urban and rural areas, will be recruited. Participants will use their own mobile device (bring your own device) to download the my ePRO app and access the DePRO study, for which they can register using the 2D matrix code on their medication. An electronic informed consent form will be displayed to the patients and only after giving consent will patients be able to complete the study questionnaires. The PRO instruments used in the study are the Summary of Diabetes Self-Care Activities Scale, the Diabetes Treatment Satisfaction Questionnaire, and the 5 level, 5-dimension EuroQol Questionnaire. Patients will also be asked to complete a questionnaire with items addressing demographics, patient characteristics, disease history, complications, and concomitant medications. Data will be transferred to the study database by the app upon completion of each questionnaire. Statistical analyses of primary and secondary endpoints will be exploratory and descriptive. Results: Enrollment began in June 2020. The estimated study completion date is December 31, 2020, and the planned sample size is 300 patients. Conclusions: The DePRO study uses completely digital data collection, including authentication of eligible patients and completion of the study questionnaires. Therefore, the design of the DePRO study represents a substantial advance in the evaluation of the digital capturing of PRO data. Trial Registration: ClinicalTrials.gov NCT04383041; https://clinicaltrials.gov/ct2/show/NCT04383041 International Registered Report Identifier (IRRID): PRR1-10.2196/21727 %M 33427685 %R 10.2196/21727 %U http://www.researchprotocols.org/2021/1/e21727/ %U https://doi.org/10.2196/21727 %U http://www.ncbi.nlm.nih.gov/pubmed/33427685 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e22463 %T Investigating Users' and Other Stakeholders' Needs in the Development of a Personalized Integrated Care Platform (PROCare4Life) for Older People with Dementia or Parkinson Disease: Protocol for a Mixed Methods Study %A Ahmed,Mona %A Marín,Mayca %A Bouça-Machado,Raquel %A How,Daniella %A Judica,Elda %A Tropea,Peppino %A Bentlage,Ellen %A Brach,Michael %+ Institute of Sport and Exercise Sciences, Münster University, Horstmarer Landweg 62b, Münster, 48149, Germany, 49 251 83 ext 34889, mona.ahmad@uni-muenster.de %K dementia %K older adults %K neurodegenerative diseases %K integrated care %K health care technologies %K user-centered design %D 2021 %7 12.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Dementias—including Alzheimer disease—and Parkinson disease profoundly impact the quality of life of older population members and their families. PROCare4Life (Personalized Integrated Care Promoting Quality of Life for Older Adults) is a European project that recognizes the benefit of technology-based integrated care models in improving the care coordination and the quality of life of these target groups. This project proposes an integrated, scalable, and interactive care platform targeting older people suffering from neurodegenerative diseases, their caregivers, and socio-health professionals. PROCare4Life adopts a user-centered design approach from the early stage and throughout platform development and implementation, during which the platform is designed and adapted to the needs and requirements of all the involved users. Objective: This paper presents the study protocol for investigating users’ needs and requirements regarding the design of the proposed PROCare4Life platform. Methods: A mixed qualitative and quantitative study design is utilized, including online surveys, interviews, and workshops. The study aimed to recruit approximately 200 participants, including patients diagnosed with dementia or Parkinson disease, caregivers, socio-health professionals, and other stakeholders, from five different European countries: Germany, Italy, Portugal, Romania, and Spain. Results: The study took place between April and September 2020. Recruitment is now closed, and all the data have been collected and analyzed in order to be used in shaping the large-scale pilot phase of the PROCare4Life project. Results of the study are expected to be published in spring 2021. Conclusions: This paper charts the protocol for a user-centered design approach at the early stage of the PROCare4Life project in order to shape and influence an integrated health platform suitable for its intended target group and purpose. International Registered Report Identifier (IRRID): DERR1-10.2196/22463 %M 33433394 %R 10.2196/22463 %U https://www.researchprotocols.org/2021/1/e22463 %U https://doi.org/10.2196/22463 %U http://www.ncbi.nlm.nih.gov/pubmed/33433394 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e21262 %T Step and Distance Measurement From a Low-Cost Consumer-Based Hip and Wrist Activity Monitor: Protocol for a Validity and Reliability Assessment %A Carlin,Thomas %A Vuillerme,Nicolas %+ AGEIS, University Grenoble Alpes, Faculty of Medicine, Grenoble, , France, 33 4 76 63 71 04, nicolas.vuillerme@univ-grenoble-alpes.fr %K activity monitor %K pedometer %K measurement %K validity %K reliability %K walking %K step count %K distance %D 2021 %7 13.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Self-tracking via wearable and mobile technologies is becoming an essential part of personal health management. At this point, however, little information is available to substantiate the validity and reliability of low-cost consumer-based hip and wrist activity monitors, with regard more specifically to the measurements of step counts and distance traveled while walking. Objective: The aim of our study is to assess the validity and reliability of step and distance measurement from a low-cost consumer-based hip and wrist activity monitor specific in various walking conditions that are commonly encountered in daily life. Specifically, this study is designed to evaluate whether and to what extent validity and reliability could depend on the sensor placement on the human body and the walking task being performed. Methods: Thirty healthy participants will be instructed to wear four PBN 2433 (Nakosite) activity monitors simultaneously, with one placed on each hip and each wrist. Participants will attend two experimental sessions separated by 1 week. During each experimental session, two separate studies will be performed. In study 1, participants will be instructed to complete a 2-minute walk test along a 30-meter indoor corridor under 3 walking speeds: very slow, slow, and usual speed. In study 2, participants will be required to complete the following 3 conditions performed at usual walking speed: walking on flat ground, upstairs, and downstairs. Activity monitor measured step count and distance values will be computed along with the actual step count (determined from video recordings) and distance (measured using a measuring tape) to determine validity and reliability for each activity monitor placement and each walking condition. Results: Participant recruitment and data collection began in January 2020. As of June 2020, we enrolled 8 participants. Dissemination of study results in peer-reviewed journals is expected in spring 2021. Conclusions: To the best of our knowledge, this is the first study that examines the validity and reliability of step and distance measurement during walking using the PBN 2433 (Nakosite) activity monitor. Results of this study will provide beneficial information on the effects of activity monitor placement, walking speed, and walking tasks on the validity and reliability of step and distance measurement. We believe such information is of utmost importance to general consumers, clinicians, and researchers. International Registered Report Identifier (IRRID): DERR1-10.2196/21262 %M 33439138 %R 10.2196/21262 %U http://www.researchprotocols.org/2021/1/e21262/ %U https://doi.org/10.2196/21262 %U http://www.ncbi.nlm.nih.gov/pubmed/33439138 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e23771 %T Technology Enabled Clinical Care (TECC): Protocol for a Prospective Longitudinal Cohort Study of Smartphone-Augmented Mental Health Treatment %A Rauseo-Ricupero,Natali %A Torous,John %+ Division of Digital Psychiatry, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Rabb Building, Boston, MA, 02446, United States, 1 617 667 6700, jtorous@bidmc.harvard.edu %K mental health care %K access %K multi-language %K smartphone %K app %K quality improvement %K protocol %K mental health %K treatment %K acceptability %K efficacy %K COVID-19 %D 2021 %7 14.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Even before COVID-19, there has been an urgent need to expand access to and quality of mental health care. This paper introduces an 8-week treatment protocol to realize that vision—Technology Enabled Clinical Care (TECC). TECC offers innovation in clinical assessment, monitoring, and interventions for mental health. TECC uses the mindLAMP app to enable digital phenotyping, clinical communication, and smartphone-based exercises that will augment in-person or telehealth virtual visits. TECC exposes participants to an array of evidence-based treatments (cognitive behavioral therapy, dialectical behavior therapy, acceptance and commitment therapy) introduced through clinical sessions and then practiced through interactive activities provided through a smartphone app called mindLAMP. Objective: TECC will test the feasibility of providing technology-enabled mental health care within an outpatient clinic; explore the practicality for providing this care to individuals with limited English proficiency; and track anxiety, depression, and mood symptoms for participants to measure the effectiveness of the TECC design. Methods: The TECC study will assess the acceptability and efficacy of this care model in 50 participants as compared to an age- and gender-matched cohort of patients presenting with similar clinical severity of depression, anxiety, or psychotic symptoms. Participants will be recruited from clinics in the Metro Boston area. Aspects of TECC will be conducted in both Spanish and English to ensure wide access to care for multiple populations. Results: The results of the TECC study will be used to support or adapt this model of care and create training resources to ensure its dissemination. The study results will be posted on ClinicalTrials.gov, with primary outcomes related to changes in mood, anxiety, and stress, and secondary outcomes related to engagement, alliance, and satisfaction. Conclusions: TECC combines new digital mental health technology with updated clinical protocols and workflows designed to ensure patients can benefit from innovation in digital mental health. Supporting multiple languages, TECC is designed to ensure digital health equity and highlights how mobile health can bridge, not expand, gaps in care for underserved populations. International Registered Report Identifier (IRRID): PRR1-10.2196/23771 %M 33296869 %R 10.2196/23771 %U https://www.researchprotocols.org/2021/1/e23771 %U https://doi.org/10.2196/23771 %U http://www.ncbi.nlm.nih.gov/pubmed/33296869 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e19073 %T Mobile Health Intervention in the Maternal Care Pathway: Protocol for the Impact Evaluation of hAPPyMamma %A Bonciani,Manila %A De Rosis,Sabina %A Vainieri,Milena %+ Management and Healthcare Laboratory, Institute of Management and Department EMbeDS, Sant’Anna School of Advanced Studies, Piazza Martiri della Libertà, 33, Pisa, 56127, Italy, 39 3462405234, m.bonciani@santannapisa.it %K mHealth %K maternal care pathway %K impact evaluation %K quasiexperimental study %D 2021 %7 19.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Mobile health (mHealth) has great potential to both improve the quality and efficiency of care and increase health literacy and empowerment of patient users. There are several studies related to the introduction of mHealth tools for supporting pregnancy and the postnatal period, with promising but not yet rigorously evaluated impacts. This article presents the protocol for evaluating an mHealth intervention (hAPPyMamma) applied in the maternal and child care pathway of a high-income country (in a pilot area of Tuscany Region, Italy). Objective: The protocol describes hAPPyMamma and the methods for evaluating its impact, including the points of view of women and practitioners. The research hypothesis is that the use of hAPPyMamma will facilitate a more appropriate use of available services, a better care experience for women, and an improvement in the maternal competencies of the women using the app compared to the control group. The protocol also includes analysis of the organizational impact of the introduction of hAPPyMamma in the maternal pathway. Methods: A pre-post quasiexperimental design with a control group is used to undertake difference-in-differences analysis for assessing the impact of the mHealth intervention from the mothers’ points of view. The outcome measures are improvement of maternal health literacy and empowerment as well as experience in the maternal care pathway of the control and intervention groups of sampled mothers. The organizational impact is evaluated through a quantitative and qualitative survey addressing professionals and managers of the maternal care pathway involved in the intervention. Results: Following study recruitment, 177 women were enrolled in the control group and 150 in the intervention group, with a participation rate of 97%-98%. The response rate was higher in the control group than in the intervention group (96% vs 67%), though the intervention group had less respondent loss at the postintervention survey (10% compared to 33% of the control group). Data collection from the women was completed in April 2018, while that from professionals and managers is underway. Conclusions: The study helps consolidate evidence of the utility of mHealth interventions for maternal and child care in developed countries. This paper presents a protocol for analyzing the potential role of hAPPyMamma as an effective mHealth tool for improving the maternal care pathway at individual and organizational levels and consequently helps to understand whether and how to scale up this intervention, with local, national, and international scopes of application. International Registered Report Identifier (IRRID): DERR1-10.2196/19073 %M 33464218 %R 10.2196/19073 %U http://www.researchprotocols.org/2021/1/e19073/ %U https://doi.org/10.2196/19073 %U http://www.ncbi.nlm.nih.gov/pubmed/33464218 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e21752 %T A Shared Cancer Follow-Up Model of Care Between General Practitioners and Radiation Oncologists for Patients With Breast, Prostate, and Colorectal Cancer: Protocol for a Mixed Methods Implementation Study %A Sandell,Tiffany %A Schütze,Heike %A Miller,Andrew %+ Wollongong Hospital, Loftus Street, Wollongong, 2500, Australia, 61 24222500, tiffany.sandell@health.nsw.gov.au %K radiation oncology %K general practice %K health technology %K communication %K cancer %K shared care %K follow-up %D 2021 %7 19.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The rising incidence of cancer and increasing numbers of cancer survivors have resulted in the need to find alternative models of care for cancer follow-up care. The acceptability for follow-up care in general practice is growing, and acceptance increases with shared-care models where oncologists continue to oversee the care. However, a major barrier to this model is the effective exchange of information in real time between oncologists and general practitioners. Improved communication technology plays an important role in the acceptability and feasibility of shared cancer follow-up care. Objective: The aim of this study is to evaluate the feasibility and acceptability of a shared cancer follow-up model of care between patients, general practitioners and radiation oncologists. Methods: This is a mixed methods, multisite implementation study exploring shared follow-up care for breast, colorectal, and prostate cancer patients treated with curative radiotherapy in New South Wales, Australia. This study uses web-based technology to support general practitioners in performing some aspects of routine radiotherapy follow-up care, while being overseen by a radiation oncologist in real time. The study has two phases: Phase 1 is designed to establish the level of agreement between general practitioners and radiation oncologists and Phase 2 is designed to implement shared follow-up care into practice and to evaluate this implementation. Results: Recruitment of radiation oncologists, patients, and general practitioners commenced in December 2020 and will continue until February 2021. Data collection will occur during 2021, and data will be ready for analysis by the end of 2021. Conclusions: Few studies have investigated the role of health technologies in supporting communication deficiencies for shared cancer follow-up care. The implementation and evaluation of models of care need to be conducted using a person-centered approach that is responsive to patients’ preferences and needs. Should the findings of the study be acceptable and feasible to radiation oncologists, general practitioners, and patients, it can be quickly implemented and expanded to other tumor groups or to medical oncology and hematology. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620001083987; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380057 International Registered Report Identifier (IRRID): PRR1-10.2196/21752 %M 33464209 %R 10.2196/21752 %U http://www.researchprotocols.org/2021/1/e21752/ %U https://doi.org/10.2196/21752 %U http://www.ncbi.nlm.nih.gov/pubmed/33464209 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e19244 %T Technology to Improve Autonomy and Inform Housing Decisions for Older Adults With Memory Problems Who Live at Home in Canada, Sweden, and the Netherlands: Protocol for a Multipronged Mixed Methods Study %A Sturge,Jodi %A Meijering,Louise %A Jones,C Allyson %A Garvelink,Mirjam %A Caron,Danielle %A Nordin,Susanna %A Elf,Marie %A Légaré,France %+ VITAM - Centre de recherche en santé durable, CIUSSS de la Capitale-Nationale, Department of Family Medicine and Emergency Medicine, Université Laval, Pavillon Landry-Poulin, door A-1-2, room A-4574, 2525, chemin de la Canardière, Quebec City, QC, G1J 0A4, Canada, 1 418 663 5713, France.Legare@fmed.ulaval.ca %K aging in place %K co-design %K cross-country comparison %K electronic decision support intervention %K housing decisions %K memory problems %K mixed methods %K mobility patterns %K shared decision making %K technology %D 2021 %7 21.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Understanding the mobility patterns and experiences of older adults with memory problems living at home has the potential to improve autonomy and inform shared decision making (SDM) about their housing options. Objective: We aim to (1) assess the mobility patterns and experiences of older adults with memory problems, (2) co-design an electronic decision support intervention (e-DSI) that integrates users’ mobility patterns and experiences, (3) explore their intention to use an e-DSI to support autonomy at home, and (4) inform future SDM processes about housing options. Methods: Informed by the Good Reporting of A Mixed Methods Study (GRAMMS) reporting guidelines, we will conduct a 3-year, multipronged mixed methods study in Canada, Sweden, and the Netherlands. For Phase 1, we will recruit a convenience sample of 20 older adults living at home with memory problems from clinical and community settings in each country, for a total of 60 participants. We will ask participants to record their mobility patterns outside their home for 14 days using a GPS tracker and a travel diary; in addition, we will conduct a walking interview and a final debrief interview after 14 days. For Phase 2, referring to results from the first phase, we will conduct one user-centered co-design process per country with older adults with memory issues, caregivers, health care professionals, and information technology representatives informed by the Double Diamond method. We will ask participants how personalized information about mobility patterns and experiences could be added to an existing e-DSI and how this information could inform SDM about housing options. For Phase 3, using online web-based surveys, we will invite 210 older adults with memory problems and/or their caregivers, split equally across the three countries, to use the e-DSI and provide feedback on its strengths and limitations. Finally, in Phase 4, we will triangulate and compare data from all phases and countries to inform a stakeholder meeting where an action plan will be developed. Results: The study opened for recruitment in the Netherlands in November 2018 and in Canada and Sweden in December 2019. Data collection will be completed by April 2021. Conclusions: This project will explore how e-DSIs can integrate the mobility patterns and mobility experiences of older adults with memory problems in three countries, improve older adults’ autonomy, and, ultimately, inform SDM about housing options. Trial Registration: ClinicalTrials.gov NCT04267484; https://clinicaltrials.gov/ct2/show/NCT04267484 International Registered Report Identifier (IRRID): DERR1-10.2196/19244 %M 33475512 %R 10.2196/19244 %U http://www.researchprotocols.org/2021/1/e19244/ %U https://doi.org/10.2196/19244 %U http://www.ncbi.nlm.nih.gov/pubmed/33475512 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e24826 %T Mapping, Infrastructure, and Data Analysis for the Brazilian Network of Rare Diseases: Protocol for the RARASnet Observational Cohort Study %A Alves,Domingos %A Yamada,Diego Bettiol %A Bernardi,Filipe Andrade %A Carvalho,Isabelle %A Filho,Márcio Eloi Colombo %A Neiva,Mariane Barros %A Lima,Vinícius Costa %A Félix,Têmis Maria %+ Department of Social Medicine, Ribeirão Preto Medical School, University of São Paulo, Av Bandeirantes, 3900, Ribeirão Preto, 14049-900, Brazil, 55 16996011595, quiron@fmrp.usp.br %K rare disease %K digital health %K health observatory %K data science %K health network %D 2021 %7 22.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: A rare disease is a medical condition with low prevalence in the general population, but these can collectively affect up to 10% of the population. Thus, rare diseases have a significant impact on the health care system, and health professionals must be familiar with their diagnosis, management, and treatment. Objective: This paper aims to provide health indicators regarding the rare diseases in Brazil and to create a network of reference centers with health professionals from different regions of the country. RARASnet proposes to map, analyze, and communicate all the data regarding the infrastructure of the centers and the patients’ progress or needs. The focus of the proposed study is to provide all the technical infrastructure and analysis, following the World Health Organization and the Brazilian Ministry of Health guidelines. Methods: To build this digitized system, we will provide a security framework to assure the privacy and protection of each patient when collecting data. Systems development life cycle methodologies will also be applied to align software development, infrastructure operation, and quality assurance. After data collection of all information designed by the specialists, the computational analysis, modeling, and results will be communicated in scientific research papers and a digital health observatory. Results: The project has several activities, and it is in an initial stage. Initially, a survey was given to all health care centers to understand the technical aspects of each network member, such as the existence of computers, technical support staff, and digitized systems. In this survey, we detected that 59% (23/39) of participating health units have electronic medical records, while 41% (16/39) have paper records. Therefore, we will have different strategies to access the data from each center in the data collection phase. Later, we will standardize and analyze the clinical and epidemiological data and use these data to develop a national network for monitoring rare diseases and a digital health observatory to make the information available. The project had its financing approved in December 2019. Retrospective data collection started in October 2020, and we expect to finish in January 2021. During the third quarter of 2020, we enrolled 40 health institutions from all regions of Brazil. Conclusions: The nature of rare disease diagnosis is complex and diverse, and many problems will be faced in the evolution of the project. However, decisions based on data analysis are the best option for the improvement of the rare disease network in Brazil. The creation of RARASnet, along with all the digitized infrastructure, can improve the accessibility of information and standardization of rare diseases in the country. International Registered Report Identifier (IRRID): DERR1-10.2196/24826 %M 33480849 %R 10.2196/24826 %U http://www.researchprotocols.org/2021/1/e24826/ %U https://doi.org/10.2196/24826 %U http://www.ncbi.nlm.nih.gov/pubmed/33480849 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e14326 %T Developing the Accuracy of Vital Sign Measurements Using the Lifelight Software Application in Comparison to Standard of Care Methods: Observational Study Protocol %A Jones,Thomas L %A Heiden,Emily %A Mitchell,Felicity %A Fogg,Carole %A McCready,Sharon %A Pearce,Laurence %A Kapoor,Melissa %A Bassett,Paul %A Chauhan,Anoop J %+ Portsmouth Hospitals NHS Trust, Southwick Hill Road, Portsmouth, United Kingdom, 1 02392286236 ext 77006236, anoop.chauhan@porthosp.nhs.uk %K health technology %K remote monitoring %K vital signs %K patient deterioration %D 2021 %7 28.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Vital sign measurements are an integral component of clinical care, but current challenges with the accuracy and timeliness of patient observations can impact appropriate clinical decision making. Advanced technologies using techniques such as photoplethysmography have the potential to automate noncontact physiological monitoring and recording, improving the quality and accessibility of this essential clinical information. Objective: In this study, we aim to develop the algorithm used in the Lifelight software application and improve the accuracy of its estimated heart rate, respiratory rate, oxygen saturation, and blood pressure measurements. Methods: This preliminary study will compare measurements predicted by the Lifelight software with standard of care measurements for an estimated population sample of 2000 inpatients, outpatients, and healthy people attending a large acute hospital. Both training datasets and validation datasets will be analyzed to assess the degree of correspondence between the vital sign measurements predicted by the Lifelight software and the direct physiological measurements taken using standard of care methods. Subgroup analyses will explore how the performance of the algorithm varies with particular patient characteristics, including age, sex, health condition, and medication. Results: Recruitment of participants to this study began in July 2018, and data collection will continue for a planned study period of 12 months. Conclusions: Digital health technology is a rapidly evolving area for health and social care. Following this initial exploratory study to develop and refine the Lifelight software application, subsequent work will evaluate its performance across a range of health characteristics, and extended validation trials will support its pathway to registration as a medical device. Innovations in health technology such as this may provide valuable opportunities for increasing the efficiency and accessibility of vital sign measurements and improve health care services on a large scale across multiple health and care settings. International Registered Report Identifier (IRRID): DERR1-10.2196/14326 %M 33507157 %R 10.2196/14326 %U http://www.researchprotocols.org/2021/1/e14326/ %U https://doi.org/10.2196/14326 %U http://www.ncbi.nlm.nih.gov/pubmed/33507157 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e25474 %T Awareness, Information-Seeking Behavior, and Information Preferences About Early Childhood Allergy Prevention Among Different Parent Groups: Protocol for a Mixed Methods Study %A Lander,Jonas %A Curbach,Janina %A von Sommoggy,Julia %A Bitzer,Eva Maria %A Dierks,Marie-Luise %+ Hanover Medical School, Carl-Neuberg-Str 1, Hanover, 30625, Germany, 49 5115324450, lander.jonas@mh-hannover.de %K health literacy %K allergy prevention %K children %K health information %K parents %D 2021 %7 20.1.2021 %9 Original Paper %J JMIR Res Protoc %G English %X Background: In early childhood allergy prevention (ECAP), parents act on behalf of their children. Parental health literacy and the availability of high-quality information, both online and offline, are crucial for effective ECAP. Recent research highlights three main points. First, parents need sufficient health literacy to discriminate between high-quality and low-quality information. Second, ECAP information behaviors may vary between phases of childhood development and according to individual circumstances. Third, to strengthen user-centeredness of available services, a better overview of parents’ information practices and needs and how they handle uncertainties is required. Objective: This study aims to explore why, how, and when parents search for and apply ECAP-specific health information and which individual (eg, understanding of advice) and organizational challenges (eg, information services, information complexity, and changing recommendations) they perceive and how they handle them. This study also aims to assess the needs and preferences that parents express for future information formats and contents. The findings should inform the practical design of ECAP information as well as formats and channels specific to different parent groups. Methods: The above-named issues will be explored with parents in four German cities as one element in our efforts to cover the spectrum of perspectives. Based on a mixed methods design, including qualitative and quantitative assessments, the first year serves to prepare focus groups, a piloted focus group guide, a short standardized survey adapted from the European Health Literacy Project, recruitment channels, and the recruitment of participants. After conducting 20 focus groups in the second year, data will be analyzed via a constant comparison method in the third year. Based on this, practice implications on channels (ie, Where?), formats (ie, How?), and contents (ie, What?) of ECAP-specific information will be derived and discussed with parents and associated project partners before its dissemination to relevant ECAP actors (eg, childcare institutions and pediatricians). Results: The study began with preselection of recruitment channels, drafting of recruitment and study information for potential participants, and agreement on a first full version of the guideline. Then, a detailed contact list was compiled of health professionals, administrative and social institutions, and relevant social media channels (N=386) to be approached for assistance in contacting parents. The recruitment was postponed due to COVID-19 and will start in January 2021. Conclusions: ECAP is a relevant example for assessing how users (ie, parents) handle not only health information but the various and continuous changes, uncertainties, and controversies attached to it. So far, it is unclear how parents implement the respective scientific recommendations and expert advice, which is why this study aims to inform those who communicate with parents about ECAP information. International Registered Report Identifier (IRRID): PRR1-10.2196/25474 %M 33470948 %R 10.2196/25474 %U http://www.researchprotocols.org/2021/1/e25474/ %U https://doi.org/10.2196/25474 %U http://www.ncbi.nlm.nih.gov/pubmed/33470948 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e21440 %T Morbidity and Complications of Diabetes Mellitus in Children and Adolescents in Ghana: Protocol for a Longitudinal Study %A Essuman,Vera Adobea %A Tagoe,Naa Naamuah %A Akpalu,Josephine %A Essuman,Akye %A Sackey,Adziri H %A Hayfron-Benjamin,CF %A Asare,George %A Abaidoo,Benjamin %A Amoah,AGB %A Ndanu,Thomas %A Ofori-Adjei,IDB %A Barnes,NA %A Appiah-Thompson,BL %A Amoaku,Winfried M %+ Ophthalmology and Visual Sciences (DCN), Faculty of Medicine and Health Sciences, School of Clinical Sciences, University Hospital, 'B' Floor, Eye and ENT Centre, Queen’s Medical Centre Campus, Nottingham, NG7 2UH, United Kingdom, 44 115 970 9796, wma@nottingham.ac.uk %K diabetes mellitus %K type 1 diabetes %K type 2 diabetes %K microvascular %K macrovascular complications %K quality of life %D 2021 %7 6.1.2021 %9 Proposal %J JMIR Res Protoc %G English %X Background: Diabetes is associated with premature morbidity and mortality from its many complications. There are limited data on the chronic complications of diabetes in children and adolescents in sub-Saharan Africa. Objective: The study aims to determine the (1) burden and related factors of chronic systemic complications of diabetes, including diabetic and nondiabetic ocular conditions in children and adolescents, and (2) quality of life (QoL) of participants compared to healthy controls. This manuscript describes the study methodology. Methods: Demographic information, medical history, anthropometric measurements, and laboratory characteristics were collected, and the participants were screened for microvascular and macrovascular complications as well as nondiabetic ocular disease. QoL questionnaires were administered to participants, their caregivers, and controls. Participants were followed up annually up to 3 years to determine the natural history of and trends in these conditions. SPSS Version 25.0 will be used for data analysis. Continuous and categorical data will be presented as mean (SD) and as percentages (%), respectively. t tests and analysis of variance will be used to compare means, and chi-square tests will be used to compare categorical data. Correlation, regression, and logistic regression analyses will be employed to establish linear associations and causal associations as appropriate. Relative risk and odds ratios will be used to estimate risk. QoL outcomes in Ghanaian children and adolescents with diabetes mellitus compared with caregivers and healthy controls will be assessed using the Pediatric Quality of Life inventory. Significance will be set at α=.05. Results: Institutional approval from the Ethical and Protocol Review Committee of the University of Ghana Medical School was received on August 22, 2014 (Protocol Identification Number: MS-Et/M.12-P4.5/2013-2014). Funding for the project was received from the University of Ghana Research Fund (#UGRF/9/LMG-013/2015-2016) in March 2016. Patient recruitment, clinical examination, and data collection commenced in August 2016 and was completed in September 2019. A total of 58 children and adolescents with diabetes mellitus have been recruited. Blood samples were stored at –80 °C for analysis, which was completed at the end of July 2020. Data analysis is ongoing and will be completed by the end of December 2020. Investigators plan to submit the results for publication by the end of February 2021. Conclusions: The prevalence, natural history, trends in diabetic complications and nondiabetic ocular disease, and QoL will be provided. Our data may inform policies and interventions to improve care given to children and adolescents with diabetes. International Registered Report Identifier (IRRID): DERR1-10.2196/21440 %M 33404517 %R 10.2196/21440 %U https://www.researchprotocols.org/2021/1/e21440 %U https://doi.org/10.2196/21440 %U http://www.ncbi.nlm.nih.gov/pubmed/33404517 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e25374 %T Reducing Ethnic and Geographic Inequities to Optimise New Zealand Stroke Care (REGIONS Care): Protocol for a Nationwide Observational Study %A Ranta,Annemarei %A Thompson,Stephanie %A Harwood,Matire Louise Ngarongoa %A Cadilhac,Dominique Ann-Michele %A Barber,Peter Alan %A Davis,Alan John %A Gommans,John Henry %A Fink,John Newton %A McNaughton,Harry Karel %A Denison,Hayley %A Corbin,Marine %A Feigin,Valery %A Abernethy,Virginia %A Levack,William %A Douwes,Jeroen %A Girvan,Jacqueline %A Wilson,Andrew %+ Department of Medicine, University of Otago, PO Box 7343, Wellington, 6242, New Zealand, 64 4 806 1031, anna.ranta@otago.ac.nz %K stroke %K protocols %K stroke units %K rehabilitation %K Māori %K Pacific people %K health inequities %K cost-efficacy %K rural %K observational study %D 2021 %7 12.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Stroke systems of care differ between larger urban and smaller rural settings and it is unclear to what extent this may impact on patient outcomes. Ethnicity influences stroke risk factors and care delivery as well as patient outcomes in nonstroke settings. Little is known about the impact of ethnicity on poststroke care, especially in Māori and Pacific populations. Objective: Our goal is to describe the protocol for the Reducing Ethnic and Geographic Inequities to Optimise New Zealand Stroke Care (REGIONS Care) study. Methods: This large, nationwide observational study assesses the impact of rurality and ethnicity on best practice stroke care access and outcomes involving all 28 New Zealand hospitals caring for stroke patients, by capturing every stroke patient admitted to hospital during the 2017-2018 study period. In addition, it explores current access barriers through consumer focus groups and consumer, carer, clinician, manager, and policy-maker surveys. It also assesses the economic impact of care provided at different types of hospitals and to patients of different ethnicities and explores the cost-efficacy of individual interventions and care bundles. Finally, it compares manual data collection to routine health administrative data and explores the feasibility of developing outcome models using only administrative data and the cost-efficacy of using additional manually collected registry data. Regarding sample size estimates, in Part 1, Study A, 2400 participants are needed to identify a 10% difference between up to four geographic subgroups at 90% power with an α value of .05 and 10% to 20% loss to follow-up. In Part 1, Study B, a sample of 7645 participants was expected to include an estimated 850 Māori and 419 Pacific patients and to provide over 90% and over 80% power, respectively. Regarding Part 2, 50% of the patient or carer surveys, 40 provider surveys, and 10 focus groups were needed to achieve saturation of themes. The main outcome is the modified Rankin Scale (mRS) score at 3 months. Secondary outcomes include mRS scores; EQ-5D-3L (5-dimension, 3-level EuroQol questionnaire) scores; stroke recurrence; vascular events; death; readmission at 3, 6, and 12 months; cost of care; and themes around access barriers. Results: The study is underway, with national and institutional ethics approvals in place. A total of 2379 patients have been recruited for Part 1, Study A; 6837 patients have been recruited for Part 1, Study B; 10 focus groups have been conducted and 70 surveys have been completed in Part 2. Data collection has essentially been completed, including follow-up assessment; however, primary and secondary analyses, data linkage, data validation, and health economics analysis are still underway. Conclusions: The methods of this study may provide the basis for future epidemiological studies that will guide care improvements in other countries and populations. International Registered Report Identifier (IRRID): DERR1-10.2196/25374 %M 33433396 %R 10.2196/25374 %U https://www.researchprotocols.org/2021/1/e25374 %U https://doi.org/10.2196/25374 %U http://www.ncbi.nlm.nih.gov/pubmed/33433396 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e21447 %T Self-Care Index and Post-Acute Care Discharge Score to Predict Discharge Destination of Adult Medical Inpatients: Protocol for a Multicenter Validation Study %A Conca,Antoinette %A Koch,Daniel %A Regez,Katharina %A Kutz,Alexander %A Bächli,Ciril %A Haubitz,Sebastian %A Schuetz,Philipp %A Mueller,Beat %A Spirig,Rebecca %A Petry,Heidi %+ Department of Nursing Science, University Witten/Herdecke, Stockumer Straße 12, Witten, 58453, Germany, 41 628384374, antoinette.conca@ksa.ch %K discharge planning %K forecasting %K logistic models %K patient transfer %K post-acute care discharge score %K protocol %K self-care index %K sensitivity %K specificity %K validation study %D 2021 %7 14.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Delays in patient discharge can not only lead to deterioration, especially among geriatric patients, but also incorporate unnecessary resources at the hospital level. Many of these delays and their negative impact may be preventable by early focused screening to identify patients at risk for transfer to a post-acute care facility. Early interprofessional discharge planning is crucial in order to fit the appropriate individual discharge destination. While prediction of discharge to a post-acute care facility using post-acute care discharge score, the self-care index, and a combination of both has been shown in a single-center pilot study, an external validation is still missing. Objective: This paper outlines the study protocol and methodology currently being used to replicate the previous pilot findings and determine whether the post-acute care discharge score, the self-care index, or the combination of both can reliably identify patients requiring transfer to post-acute care facilities. Methods: This study will use prospective data involving all phases of the quasi-experimental study “In-HospiTOOL” conducted at 7 Swiss hospitals in urban and rural areas. During an 18-month period, consecutive adult medical patients admitted to the hospitals through the emergency department will be included. We aim to include 6000 patients based on sample size calculation. These data will enable a prospective external validation of the prediction instruments. Results: We expect to gain more insight into the predictive capability of the above-mentioned prediction instruments. This approach will allow us to get important information about the generalizability of the three different models. The study was approved by the institutional review board on November 21, 2016, and funded in May 2020. Expected results are planned to be published in spring 2021. Conclusions: This study will provide evidence on prognostic properties, comparative performance, reliability of scoring, and suitability of the instruments for the screening purpose in order to be able to recommend application in clinical practice. International Registered Report Identifier (IRRID): DERR1-10.2196/21447 %M 33263553 %R 10.2196/21447 %U http://www.researchprotocols.org/2021/1/e21447/ %U https://doi.org/10.2196/21447 %U http://www.ncbi.nlm.nih.gov/pubmed/33263553 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e21832 %T Health Professional Student Placements and Workforce Location Outcomes: Protocol of an Observational Cohort Study %A Campbell,Narelle %A Farthing,Annie %A Witt,Susan %A Anderson,Jessie %A Lenthall,Sue %A Moore,Leigh %A Rissel,Chris %+ Flinders University, Northern Territory, Royal Darwin Hospital, Darwin, 0810, Australia, 61 0889200297, chris.rissel@flinders.edu.au %K remote health %K students %K training %K workforce retention %K workforce location %K workforce %K allied health %K allied health professionals %K Northern Territory of Australia %K rural %K nursing %K rural employment %D 2021 %7 14.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The successful recruitment and retention of health professionals to rural and remote areas of Australia is a health policy priority. Nursing or allied health professional students’ learning placements in the Northern Territory (NT) of Australia, most of which is considered remote, may influence rural or remote work location decisions. Objective: The aim of this study is to determine where allied health professionals and nurses who have had a student placement in the NT of Australia end up practicing. Methods: This research is an observational cohort study, with data collection occurring at baseline and then repeated annually over 10 years (ie, 2017-2018 to 2029). The baseline data collection includes a demographic profile of allied health and nursing students and their evaluations of their NT placements using a nationally consistent questionnaire (ie, the Student Satisfaction Survey). The Work Location Survey, which will be administered annually, will track work location and the influences on work location decisions. Results: This study will generate unique data on the remote and rural work locations of nursing and allied health professional students who had a placement in the NT of Australia. It will be able to determine what are the most important characteristics of those who take up remote and rural employment, even if outside of the NT, and to identify barriers to remote employment. Conclusions: This study will add knowledge to the literature regarding rates of allied health and nursing professionals working in remote or rural settings following remote or rural learning placements. The results will be of interest to government and remote health workforce planners. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000797976; https://www.anzctr.org.au/ACTRN12620000797976.aspx International Registered Report Identifier (IRRID): PRR1-10.2196/21832 %M 33443482 %R 10.2196/21832 %U http://www.researchprotocols.org/2021/1/e21832/ %U https://doi.org/10.2196/21832 %U http://www.ncbi.nlm.nih.gov/pubmed/33443482 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e24298 %T Mental Health and Burnout Syndrome Among Postgraduate Students in Medical and Multidisciplinary Residencies During the COVID-19 Pandemic in Brazil: Protocol for a Prospective Cohort Study %A Pinho,Rebeca Da Nóbrega Lucena %A Costa,Thais Ferreira %A Silva,Nayane Miranda %A Barros-Areal,Adriana F %A Salles,André De Mattos %A Oliveira,Andrea Pedrosa %A Rassi,Carlos %A Valero,Caroline Elizabeth Brero %A Gomes,Ciro Martins %A Mendonça-Silva,Dayde %A Oliveira,Fernando %A Jochims,Isadora %A Ranulfo,Ivan %A Neves,Juliana De Brito Seixas %A Oliveira,Lucas %A Dantas,Maria Nogueira %A Rosal,Marta %A Soares,Mayra %A Kurizky,Patrícia %A Peterle,Viviane Uliana %A Faro,Yasmin Furtado %A Gomides,Ana Paula %A da Mota,Licia %A Albuquerque,Cleandro %A Simaan,Cezar Kozak %A Amado,Veronica M %+ Programa de Pós-Graduação em Ciências Médicas FM-UnB, SGAN 605, Av. L2 Norte, Brasília, Brazil, 55 61 98343 6834, nlp.rebeca@gmail.com %K burnout syndrome %K medical residency %K multidisciplinary residency %K COVID-19 %K mental health %K burnout %K stress %K anxiety %K prospective %K cohort %K health care professional %K medical student %D 2021 %7 19.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The COVID-19 pandemic has led to high levels of physical, psychological, and social stress among health care professionals, including postgraduate students in medical and multidisciplinary residencies. This stress is associated with the intense fear of occupational exposure to SARS-CoV-2, the virus known to cause COVID-19. These professionals are at risk of developing physical and mental illnesses not only due to the infection but also due to prolonged exposure to multidimensional stress and continued work overload. Objective: This study aims to evaluate the prevalence of symptoms suggestive of mental disorders and burnout syndrome and determine the risk factors for burnout among postgraduate students in medical and multidisciplinary residencies in Brazil during the COVID-19 pandemic. Methods: For this prospective cohort study with parallel groups, participants were recruited between July and September 2020 to achieve a sample size of at least 1144 participants. Research instruments such as Depression, Anxiety, and Stress Scale; Patient Health Questionnaire; Brief Resilient Coping Scale; and Oldenburg Burnout Inventory will be used to collect data. Data will be collected in 2 waves: the first wave will include data related to sample characterization and psychosocial evaluation, and the second wave will be launched 12 weeks later and will include an evaluation of the incidence of burnout as well as correlations with the potential predictive factors collected in the first wave. Additionally, we will collect data regarding participants’ withdrawal from work. Results: The recruitment took place from July 29 to September 5, 2020. Data analyses for this phase is already in progress. The second phase of the study is also in progress. The final data collection began on December 1, 2020, and it will be completed by December 31, 2020. Conclusions: We believe the findings of this study will help evaluate the impact of the COVID-19 pandemic on the mental health conditions of health professionals in Brazil as well as contribute to the planning and implementation of appropriate measures that can alleviate these mental health challenges. International Registered Report Identifier (IRRID): DERR1-10.2196/24298 %M 33290246 %R 10.2196/24298 %U https://www.researchprotocols.org/2021/1/e24298 %U https://doi.org/10.2196/24298 %U http://www.ncbi.nlm.nih.gov/pubmed/33290246 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e17436 %T Effects of the Argus II Retinal Prosthesis System on the Quality of Life of Patients With Ultra-Low Vision Due to Retinitis Pigmentosa: Protocol for a Single-Arm, Mixed Methods Study %A White,Judith %A Knight,Laura %A da Cruz,Lyndon %A Stanga,Paulo E %A Patrick,Hannah %A Powell,Helen %A Berry,Lee %A Withers,Kathleen %A Carolan-Rees,Grace %A Jackson,Timothy L %+ Cedar, Cardiff & Vale University Health Board, Cardiff Medicentre, Heath Park, Cardiff, CF14 4UJ, United Kingdom, 44 02920744771, judith.white3@wales.nhs.uk %K patient-reported outcomes %K quality of life %K qualitative methods %K artificial vision %K visual function %K functional vision %K ultra-low vision %K low vision %K visual function questionnaire %D 2021 %7 20.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Retinitis pigmentosa is an incurable, degenerative retinal condition causing progressive sight loss, significantly affecting patients’ quality of life. The Argus II Retinal Prosthesis is a surgically implanted medical device that delivers electrical stimulation to the retina. It is intended to produce a form of artificial vision for blind people with severe-to-profound retinitis pigmentosa by stimulating the remaining viable retinal cells to induce visual perception. This study has been initiated by National Health Service England’s Commissioning through Evaluation program and funded through the National Institute of Health Research of the United Kingdom. Objective: The aim of this study was to assess the effect of the Argus II device on patient’s daily activities and quality of life. Methods: This protocol is a prospective, single-arm, open-label, mixed methods study on 10 consecutive participants receiving the Argus II device. The patient representatives played an integral role in the design of this study. Eligibility criteria include ultra-low vision in both eyes as a result of end-stage retinitis pigmentosa and a willingness and capacity to complete the postimplantation rehabilitation program. Participants will be interviewed by independent researchers at baseline and 12 months later by using a semistructured, in-depth approach, alongside validated questionnaires (Impact of Vision Impairment-Very Low Vision, 5-level EuroQoL-5 dimensions scale, EuroQoL-visual analog scale, and Hospital Anxiety and Depression Scale) and a bespoke device-related questionnaire, which includes questions about users’ experiences with the procedure, the device, and rehabilitation. The effect of the device on patients’ functional vision and activities of daily living will be assessed by vision rehabilitation specialists using a set of tests measured on an ordinal scale (eg, ability to locate objects and avoid obstacles). Clinical outcomes include full-field stimulus light threshold, square localization, direction of motion, grating visual acuity, Landolt-C, procedural success, and adverse events. Qualitative and quantitative outcomes will be linked in a single database to enable individual participant measures to be considered in toto, comparing baseline to the final review. Results: This study was approved by the local ethics committee on April 24, 2019 (London-Camberwell St. Giles Research Ethics Committee, reference 19/LO/0429). It has also been approved by the Health Research Authority and Health and Care Research Wales. At the time of protocol writing, Argus II was available for use in the United Kingdom; however, the manufacturer recently withdrew the Argus II device from sale in the United Kingdom. Therefore, the study is not going ahead at this time. Conclusions: The mixed methods approach provides a rich and in-depth assessment of the effect of the device on participants’ quality of life. Despite the work not going ahead, the publication of this publicly funded protocol is important for researchers planning similar work. International Registered Report Identifier (IRRID): PRR1-10.2196/17436 %M 33470946 %R 10.2196/17436 %U http://www.researchprotocols.org/2021/1/e17436/ %U https://doi.org/10.2196/17436 %U http://www.ncbi.nlm.nih.gov/pubmed/33470946 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e21851 %T Health-Related Quality of Life in European Childhood Cancer Survivors: Protocol for a Study Within PanCareLIFE %A Calaminus,Gabriele %A Baust,Katja %A Berger,Claire %A Byrne,Julianne %A Binder,Harald %A Casagranda,Leonie %A Grabow,Desiree %A Grootenhuis,Martha %A Kaatsch,Peter %A Kaiser,Melanie %A Kepak,Tomas %A Kepáková,Kateřina %A Kremer,Leontien C M %A Kruseova,Jarmila %A Luks,Ales %A Spix,Claudia %A van den Berg,Marleen %A van den Heuvel-Eibrink,Marry M M %A van Dulmen-den Broeder,Eline %A Kuonen,Rahel %A Sommer,Grit %A Kuehni,Claudia %+ Department of Paediatric Haematology and Oncology, University Hospital Bonn, Venusberg-Campus 1, Bonn, 53127, Germany, 49 228 287 ext 33389, gabriele.calaminus@ukbonn.de %K children %K adolescents %K neoplasms %K quality of life %K health status %K Europe %K epidemiology %K survivors of childhood cancer %D 2021 %7 25.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Survival after childhood cancer has improved to more than 80% during the last few years, leading to an increased number of childhood cancer survivors. Cancer itself, or its treatment, may cause chronic health conditions, including somatic and mental sequelae, which may affect survivors’ health-related quality of life (HRQoL). Objective: The project PanCareLIFE aims to establish a large database with comprehensive data on childhood cancer survivors from different European countries, including data on HRQoL. Within PanCareLIFE, this study aims to describe HRQoL in survivors, investigate predictors of HRQoL, and describe the association of HRQoL with hearing and female fertility impairment. This paper describes the design of the HRQoL study, the origin of data, strategies for data collection, and sampling characteristics of survivors from each contributing country. Methods: A total of 6 institutions from 5 European countries (the Czech Republic, France, Germany, the Netherlands, and Switzerland) provided data on HRQoL assessed with the Short Form 36 and on relevant predictors. The central PanCareLIFE data center aggregated the data and harmonized the variables between the institutions. Survivors were eligible if they received a diagnosis of cancer according to the 12 main groups of the International Classification of Childhood Cancer, 3rd edition, or Langerhans cell histiocytosis; were aged ≤18 years at the time of diagnosis; were residents of the respective country at the time of diagnosis; had survived ≥5 years after cancer diagnosis; were aged ≥18 years at the time of the questionnaire survey; and did not refuse to registration in the national or local childhood cancer cohort. Results: We identified 24,993 eligible survivors. Of those, 19,268 survivors received a questionnaire and 9871 survivors participated, resulting in response rates of 9871/24,993 (39.50%) of eligible survivors and of 9871/19,268 (51.23%) invited survivors. Most participants were diagnosed with cancer between the ages of 10 and 14 years (3448/9871, 34.93%) or <5 years (3201/9871, 32.43%). The median age was 8 years. Of the 9871 participants, 3157 (31.97%) were survivors of leukemia, 2075 (21.02%) lymphoma, and 1356 (13.7%) central nervous system (CNS) tumors. Most participants (9225/9871, 93.46%) had no history of a subsequent tumor; 77.45% (7645/9871) received chemotherapy with or without other treatments. More than half (5460/9871, 55.31%) were aged 25 to 34 years at the time of the HRQoL study. Participating survivors differed from nonparticipants; participants were more often women, survivors of leukemia or lymphoma, and less frequently, survivors of CNS tumors than nonparticipants. Conclusions: PanCareLIFE successfully assessed HRQoL and its predictors in 9871 European survivors of childhood cancer. This large population will permit detailed investigations of HRQoL after childhood cancer, particularly the impact of hearing and female fertility impairment on HRQoL. International Registered Report Identifier (IRRID): RR1-10.2196/21851 %M 33492237 %R 10.2196/21851 %U http://www.researchprotocols.org/2021/1/e21851/ %U https://doi.org/10.2196/21851 %U http://www.ncbi.nlm.nih.gov/pubmed/33492237 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e19384 %T Improving Treatment Adherence and Retention of HIV-Positive Women Through Behavioral Change Interventions Aimed at Their Male Partners: Protocol for a Prospective, Controlled Before-and-After Study %A Orlando,Stefano %A Palla,Ilaria %A Ciccacci,Fausto %A Triulzi,Isotta %A Thole,Darlington %A Sangaré,Hawa Mamary %A Marazzi,Maria Cristina %A Nielsen-Saines,Karin %A Turchetti,Giuseppe %A Palombi,Leonardo %+ Department of Biomedicine, University of Tor Vergata, Via Montpellier 1, Rome, 00133, Italy, 39 067259 ext 6798, stefano.orlando@uniroma2.it %K retention in care %K therapeutic adherence and compliance %K men's role %K acquired immunodeficiency syndrome %K AIDS %K HIV %K behavior %K intervention study %K health education %K community health education %K Malawi %K mother-to-child transmission %K health-related behavior %K social ecology %D 2021 %7 25.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: According to the World Health Organization, in 2018, 37.9 million people were living with HIV globally. More than two-thirds were residing in sub-Saharan Africa, where the HIV prevalence in the adult population (aged 15-49 years) was 3.9%. This population included 1.3 million pregnant women, of whom 82% had received antiretroviral therapy (ART) for the prevention of HIV mother-to-child transmission. In these countries, one challenge is an insufficient level of treatment adherence, particularly in HIV-positive pregnant women. Among the causes, the lack of involvement from a male partner is a significant contributor to the problem. This issue has strongly emerged in Malawi, one of the countries with the highest HIV prevalence in the world: 9.2% of its adult population were living with HIV in 2018. Objective: This study aims to assess 3 interventions that are aimed at improving ART adherence and retention among HIV-positive women through engagement with their male partners in 4 Malawian health care centers. Methods: The prospective, controlled before-and-after study is conducted in 3 phases (total duration: 24 months): preintervention, intervention, and postintervention analyses. The number of selected clusters (clinical centers) is limited to 4: one for each intervention, plus a cluster where no intervention is performed (control arm). The interventions are as follows: opening the facility on one Saturday per month only for men, defined as a special day; testing peer-to-peer counseling among men, male champions; and providing a noneconomic incentive to all women who are accompanied by their partners to the facility, nudge. The primary outcome of the study is to evaluate the differences in retention in care and adherence to therapeutic protocols among women; the intermediate outcome is the assessment of differences in male involvement. The level of male involvement in the health of their partners (intermediate outcome) will be evaluated through a dedicated questionnaire administered at baseline and in the postintervention phase. Data will be collected at the clinical centers and stored in 2 electronic databases managed using 2 different types of software. Results: The analysis of data collected in the 4 centers during the preintervention phase is ongoing, as enrollment ended on March 31, 2020. The total number of patients enrolled was 452 (Namandanje: 133; Kapeni: 78; Kapire: 75; and Balaka: 166). Meanwhile, several meetings have been conducted to organize the intervention phase. Conclusions: The study will identify the best intervention that enhances the involvement of male partners in women’s health, using an approach that considers a broad spectrum of behaviors. An important aspect is the use of educational tools focused on messages, thereby initiating a reflective discussion of stereotypes and false beliefs related to the idea of masculinity present in the Malawian culture. International Registered Report Identifier (IRRID): DERR1-10.2196/19384 %M 33492232 %R 10.2196/19384 %U http://www.researchprotocols.org/2021/1/e19384/ %U https://doi.org/10.2196/19384 %U http://www.ncbi.nlm.nih.gov/pubmed/33492232 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e14781 %T Development of an Evidence-Based Best Practice Model for Teams Managing Crisis in Dementia: Protocol for a Qualitative Study %A Stanyon,Miriam %A Streater,Amy %A Coleston-Shields,Donna Maria %A Yates,Jennifer %A Challis,David %A Dening,Tom %A Hoe,Juanita %A Lloyd-Evans,Brynmor %A Mitchell,Shirley %A Moniz-Cook,Esme %A Poland,Fiona %A Prothero,David %A Orrell,Martin %+ Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham, Institute of Mental Health, Triumph Road, Nottingham, NG7 2TU, United Kingdom, 44 0115 8230251 ext 30251, miriam.stanyon@nottingham.ac.uk %K dementia %K caregivers %K crisis %K mental health %K home management %D 2021 %7 27.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Teams working in the community to manage crisis in dementia currently exist, but with widely varying models of practice, it is difficult to determine the effectiveness of such teams. Objective: The aim of this study is to develop a “best practice model” for dementia services managing crisis, as well as a set of resources to help teams implement this model to measure and improve practice delivery. These will be the best practice tool and toolkit to be utilized by teams to improve the effectiveness of crisis teams working with older people with dementia and their caregivers. This paper describes the protocol for a prospective study using qualitative methods to establish an understanding of the current practice to develop a “best practice model.” Methods: Participants (people with dementia, caregivers, staff members, and stakeholders) from a variety of geographical areas, with a broad experience of crisis and noncrisis work, will be purposively selected to participate in qualitative approaches including interviews, focus groups, a consensus workshop, and development and field testing of both the best practice tool and toolkit. Results: Data were collected between October 2016 and August 2018. Thematic analysis will be utilized to establish the current working of teams managing crisis in dementia in order to draw together elements of the best practice. Conclusions: This is the first study to systematically explore the requirements needed to fulfill effective and appropriate home management for people with dementia and their caregivers at the time of mental health crisis, as delivered by teams managing crisis in dementia. This systematic approach to development will support greater acceptability and validity of the best practice tool and toolkit and lay the foundation for a large scale trial with teams managing crisis in dementia across England to investigate the effects on practice and impact on service provision, as well as the associated experiences of people with dementia and their caregivers. International Registered Report Identifier (IRRID): RR1-10.2196/14781 %M 33502333 %R 10.2196/14781 %U http://www.researchprotocols.org/2021/1/e14781/ %U https://doi.org/10.2196/14781 %U http://www.ncbi.nlm.nih.gov/pubmed/33502333 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e21256 %T Metabolic Syndrome Parameters, Determinants, and Biomarkers in Adult Survivors of Childhood Cancer: Protocol for the Dutch Childhood Cancer Survivor Study on Metabolic Syndrome (Dutch LATER METS) %A Pluimakers,Vincent %A Fiocco,Marta %A van Atteveld,Jenneke %A Hobbelink,Monique %A Bresters,Dorine %A Van Dulmen-den Broeder,Eline %A Van der Heiden-van der Loo,Margriet %A Janssens,Geert O %A Kremer,Leontien %A Loonen,Jacqueline %A Louwerens,Marloes %A Van der Pal,Helena %A Ronckers,Cécile %A Van Santen,Hanneke %A Versluys,Birgitta %A De Vries,Andrica %A Van den Heuvel-Eibrink,Marry %A Neggers,Sebastian %+ Princess Maxima Center for Pediatric Oncology, Heidelberglaan 25, Utrecht, 3584CS, Netherlands, 31 613348669, v.g.pluimakers@prinsesmaximacentrum.nl %K metabolic syndrome %K childhood cancer survivor %K Dutch Childhood Cancer Survivor Study %K methodology %K Dutch LATER METS %D 2021 %7 27.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Potential late effects of treatment for childhood cancer include adiposity, insulin resistance, dyslipidemia, and hypertension. These risk factors cluster together as metabolic syndrome and increase the risk for development of diabetes mellitus and cardio- and cerebrovascular disease. Knowledge on risk factors, timely diagnosis, and preventive strategies is of importance to prevent cardio- and cerebrovascular complications and improve quality of life. Currently, no national cohort studies on the prevalence and determinants of metabolic syndrome in childhood cancer survivors, including biomarkers and genetic predisposition, are available. Objective: The objectives of the Dutch LATER METS study are to assess 1) the prevalence and risk factors of metabolic syndrome and its separate components, and 2) the potential diagnostic and predictive value of additional biomarkers for surveillance of metabolic syndrome in the national cohort of adult long-term survivors of childhood cancer. Methods: This is a cross-sectional study based on recruitment of all survivors treated in the Netherlands between 1963 and 2002. Metabolic syndrome will be classified according to the definitions of the third Adult Treatment Panel Report of the National Cholesterol Education Program as well as the Joint Interim Statement and compared to reference data. Dual-energy x-ray absorptiometry scans were performed to assess body composition in more detail. The effect of patient characteristics, previous treatment, and genetic variation on the risk of metabolic syndrome will be assessed. The diagnostic and predictive value of novel biomarkers will be tested. Results: Patient accrual started in 2016 and lasted until April 2020. A total of 2380 survivors from 7 pediatric oncology hospitals have participated. From July 2020, biomarker testing, single nucleotide polymorphism analysis, and data analysis will be performed. Conclusions: The Dutch LATER METS study will provide knowledge on clinical and genetic determinants of metabolic syndrome and the diagnostic value of biomarkers in childhood cancer survivors. The results of this study will be used to optimize surveillance guidelines for metabolic syndrome in survivors based on enhanced risk stratification and screening strategies. This will improve diagnosis of metabolic syndrome and prevent complications. International Registered Report Identifier (IRRID): DERR1-10.2196/21256 %M 32750002 %R 10.2196/21256 %U https://www.researchprotocols.org/2021/1/e21256 %U https://doi.org/10.2196/21256 %U http://www.ncbi.nlm.nih.gov/pubmed/32750002 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e25265 %T Assessing COVID-19–Related Knowledge, Attitudes, and Practices Among Hispanic Primary Care Patients: Protocol for a Cross-sectional Survey Study %A Burger,Zoe C %A Mehta,Shivani N %A Ortiz,Dayanna %A Sor,Sekboppa %A Kothari,Jigna %A Lam,Yvonne %A Meka,Meena %A Meka,Ajay %A Rodwell,Timothy %+ School of Medicine, University of California San Diego, 9500 Gilman Dr #0039, La Jolla, CA, 92093, United States, 1 7146790080, s1mehta@ucsd.edu %K COVID-19 %K knowledge %K attitude %K practices %K Hispanic %K California %K protocol %K cross-sectional %K survey %D 2021 %7 27.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Recent epidemiological data indicate that minority groups, especially Hispanic communities, experience higher rates of infection, hospitalization, and death due to COVID-19. It is important to understand the nature of this health disparity and the socioeconomic or behavioral factors that are placing Hispanic communities and other minority populations at higher risk for morbidity and mortality. Objective: The purpose of this project is to assess current COVID-19–related knowledge, attitudes, and practices (KAP) among a predominantly Hispanic population from Orange County, California, and identify risk factors that may contribute to increased susceptibility and vulnerability to contracting SARS-CoV-2. Methods: Our Orange County–wide community survey consists of quantitative survey questions in four domains: demographic information, COVID-19 knowledge questions, COVID-19 attitude questions, and COVID-19 practices questions. The survey questions are adapted from recent global KAP studies. Participants are being recruited from Amistad Medical Clinic, a private primary health clinic group in Orange County that treats a predominantly Hispanic population. Patients recruited during telehealth visits are surveyed remotely by telephone, and those recruited during in-person clinic visits are surveyed in person. Surveys are conducted by trained members of the study team who are native to the community setting. Results: As of October 12, 2020, we had recruited and enrolled 327 participants. Data collection occurred June 26th to October 30th. Data analysis is ongoing. Conclusions: Very few current COVID-19 studies focus on the perspective and experience of minority populations. Because Hispanic communities are disproportionately affected by COVID-19, it is important to understand the factors the contribute to this disparity and the next steps that should be taken to reduce the COVID-19 burden in this population. We believe that our study model of partnering with a local clinic system that serves our study population can be expanded to other settings to compare COVID-19 KAP and associated factors within different minority communities. International Registered Report Identifier (IRRID): DERR1-10.2196/25265 %M 33406051 %R 10.2196/25265 %U http://www.researchprotocols.org/2021/1/e25265/ %U https://doi.org/10.2196/25265 %U http://www.ncbi.nlm.nih.gov/pubmed/33406051 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e26934 %T Correction: Predictors and Consequences of Veterans Affairs Mental Health Provider Burnout: Protocol for a Mixed Methods Study %A Zivin,Kara %A Kononowech,Jennifer %A Boden,Matthew %A Abraham,Kristen %A Harrod,Molly %A Sripada,Rebecca K %A Kales,Helen C %A Garcia,Hector A %A Pfeiffer,Paul %+ Center for Clinical Management Research, Department of Veterans Affairs, 2800 Plymouth Road, Building 16, Ann Arbor, MI, 48109, United States, 1 734 845 3429, kzivin@med.umich.edu %D 2021 %7 12.1.2021 %9 Corrigenda and Addenda %J JMIR Res Protoc %G English %X %M 33434142 %R 10.2196/26934 %U https://www.researchprotocols.org/2021/1/e26934 %U https://doi.org/10.2196/26934 %U http://www.ncbi.nlm.nih.gov/pubmed/33434142 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e18675 %T Effectiveness of an Electronic Communication Tool on Transitions in Care From the Intensive Care Unit: Protocol for a Cluster-Specific Pre-Post Trial %A Parsons Leigh,Jeanna %A Brundin-Mather,Rebecca %A Whalen-Browne,Liam %A Kashyap,Devika %A Sauro,Khara %A Soo,Andrea %A Petersen,Jennie %A Taljaard,Monica %A Stelfox,Henry T %+ School of Health Administration, Faculty of Health, Dalhousie University, Sir Charles Tupper Medical Building, 5850 College Street, Second Floor, 2A01, Office 2A08, Halifax, NS, B3H 4R2, Canada, 1 902 494 8881, J.ParsonsLeigh@dal.ca %K patient transfers %K interprovider communication %K transitions in care %K electronic charting %K clinical documentation %K discharge tools %K patient discharge summaries %K electronic transfer summaries %K intensive care unit %K electronic tool %K ICU %K protocol %K effective %K communication %K transfer %K patient %K transition %D 2021 %7 8.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Transitions in care are vulnerable periods in health care that can expose patients to preventable errors due to incomplete or delayed communication between health care providers. Transitioning critically ill patients from intensive care units (ICUs) to other patient care units (PCUs) is particularly risky, due to the high acuity of the patients and the diversity of health care providers involved in their care. Instituting structured documentation to standardize written communication between health care providers during transitions has been identified as a promising means to reduce communication breakdowns. We developed an evidence-informed, computer-enabled, ICU-specific structured tool—an electronic transfer (e-transfer) tool—to facilitate and standardize the composition of written transfer summaries in the ICUs of one Canadian city. The tool consisted of 10 primary sections with a user interface combination of structured, automated, and free-text fields. Objective: Our overarching goal is to evaluate whether implementation of our e-transfer tool will improve the completeness and timeliness of transfer summaries and streamline communications between health care providers during high-risk transitions. Methods: This study is a cluster-specific pre-post trial, with randomized and staggered implementation of the e-transfer tool in four hospitals in Calgary, Alberta. Hospitals (ie, clusters) were allocated randomly to cross over every 2 months from control (ie, dictation only) to intervention (ie, e-transfer tool). Implementation at each site was facilitated with user education, point-of-care support, and audit and feedback. We will compare transfer summaries randomly sampled over 6 months postimplementation to summaries randomly sampled over 6 months preimplementation. The primary outcome will be a binary composite measure of the timeliness and completeness of transfer summaries. Secondary measures will include overall completeness, timeliness, and provider ratings of transfer summaries; hospital and ICU lengths of stay; and post-ICU patient outcomes, including ICU readmission, adverse events, cardiac arrest, rapid response team activation, and mortality. We will use descriptive statistics (ie, medians and means) to describe demographic characteristics. The primary outcome will be compared within each hospital pre- and postimplementation using separate logistic regression models for each hospital, with adjustment for patient characteristics. Results: Participating hospitals were cluster randomized to the intervention between July 2018 and January 2019. Preliminary extraction of ICU patient admission lists was completed in September 2019. We anticipate that evaluation data collection will be completed by early 2021, with first results ready for publication in spring or summer 2021. Conclusions: This study will report the impact of implementing an evidence-informed, computer-enabled, ICU-specific structured transfer tool on communication and preventable medical errors among patients transferred from the ICU to other hospital care units. Trial Registration: ClinicalTrials.gov NCT03590002; https://www.clinicaltrials.gov/ct2/show/NCT03590002 International Registered Report Identifier (IRRID): DERR1-10.2196/18675 %M 33416509 %R 10.2196/18675 %U https://www.researchprotocols.org/2021/1/e18675 %U https://doi.org/10.2196/18675 %U http://www.ncbi.nlm.nih.gov/pubmed/33416509 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e24736 %T Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-Management and Provider Engagement: Protocol for a Feasibility Trial %A Kidd,Sean %A McKenzie,Kwame %A Wang,Wei %A Agrawal,Sacha %A Voineskos,Aristotle %+ Department of Psychiatry, University of Toronto, CAMH, 1001 Queen Street West, 2-1, Toronto, ON, Canada, 1 647 239 1296, sean.kidd@camh.ca %K schizophrenia %K psychosis %K digital health %K mobile health %K smartphone %D 2021 %7 25.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: In schizophrenia spectrum populations, adherence to treatment is poor, community-based supports are limited, and efforts to foster illness self-management have had limited success. These challenges contribute to frequent, lengthy, and costly hospital readmissions and poor functional outcomes. Digital health strategies, in turn, hold considerable promise in the effort to address these problems. Objective: This feasibility trial will examine a digital health platform called App4Independence (A4i), which was designed to enhance illness self-management and treatment engagement for individuals with schizophrenia. Methods: Feasibility metrics in this single-blind, randomized trial include study recruitment and retention, rate of technology use, safety, and utility in clinical interactions. Other outcome metrics include symptomatology, treatment adherence, patient-provider alliance, and quality of life. In this trial, 160 study participants with schizophrenia spectrum diagnoses will be randomized to either treatment or control conditions, with pretest-posttest outcomes measured over a 6-month period. Results: This study was funded by the Canadian Institutes of Health Research in January 2020 and received Institutional Review Board approval on August 13, 2020. This study plans to begin recruiting in January 2021 and will be completed within 3 years. Data collection is projected to begin in January 2021. Conclusions: This research will provide critical information for the development of this new technology in the larger effort to address a key problem in the schizophrenia field—how to leverage technology to enhance illness self-management and care engagement in resource-limited service contexts. International Registered Report Identifier (IRRID): PRR1-10.2196/24736 %M 33492235 %R 10.2196/24736 %U http://www.researchprotocols.org/2021/1/e24736/ %U https://doi.org/10.2196/24736 %U http://www.ncbi.nlm.nih.gov/pubmed/33492235 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e22536 %T Novel Assessments of Technical and Nontechnical Cardiac Surgery Quality: Protocol for a Mixed Methods Study %A Likosky,Donald %A Yule,Steven J %A Mathis,Michael R %A Dias,Roger D %A Corso,Jason J %A Zhang,Min %A Krein,Sarah L %A Caldwell,Matthew D %A Louis,Nathan %A Janda,Allison M %A Shah,Nirav J %A Pagani,Francis D %A Stakich-Alpirez,Korana %A Manojlovich,Milisa M %+ Department of Cardiac Surgery, University of Michigan, 5346 CVC, Ann Arbor, MI, 48109, United States, 1 7342324216, likosky@umich.edu %K cardiac surgery %K quality %K protocol %K study %K coronary artery bypass grafting surgery %K complications %K patient risk %K variation %K intraoperative %K improvement %D 2021 %7 8.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Of the 150,000 patients annually undergoing coronary artery bypass grafting, 35% develop complications that increase mortality 5 fold and expenditure by 50%. Differences in patient risk and operative approach explain only 2% of hospital variations in some complications. The intraoperative phase remains understudied as a source of variation, despite its complexity and amenability to improvement. Objective: The objectives of this study are to (1) investigate the relationship between peer assessments of intraoperative technical skills and nontechnical practices with risk-adjusted complication rates and (2) evaluate the feasibility of using computer-based metrics to automate the assessment of important intraoperative technical skills and nontechnical practices. Methods: This multicenter study will use video recording, established peer assessment tools, electronic health record data, registry data, and a high-dimensional computer vision approach to (1) investigate the relationship between peer assessments of surgeon technical skills and variability in risk-adjusted patient adverse events; (2) investigate the relationship between peer assessments of intraoperative team-based nontechnical practices and variability in risk-adjusted patient adverse events; and (3) use quantitative and qualitative methods to explore the feasibility of using objective, data-driven, computer-based assessments to automate the measurement of important intraoperative determinants of risk-adjusted patient adverse events. Results: The project has been funded by the National Heart, Lung and Blood Institute in 2019 (R01HL146619). Preliminary Institutional Review Board review has been completed at the University of Michigan by the Institutional Review Boards of the University of Michigan Medical School. Conclusions: We anticipate that this project will substantially increase our ability to assess determinants of variation in complication rates by specifically studying a surgeon’s technical skills and operating room team member nontechnical practices. These findings may provide effective targets for future trials or quality improvement initiatives to enhance the quality and safety of cardiac surgical patient care. International Registered Report Identifier (IRRID): PRR1-10.2196/22536 %M 33416505 %R 10.2196/22536 %U https://www.researchprotocols.org/2021/1/e22536 %U https://doi.org/10.2196/22536 %U http://www.ncbi.nlm.nih.gov/pubmed/33416505 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e27092 %T Correction: Effectiveness of Educational Interventions to Increase Knowledge of Evidence-Based Practice Among Nurses and Physiotherapists in Primary Health Care: Protocol for a Systematic Review %A Verloo,Henk %A Melly,Pauline %A Hilfiker,Roger %A Pereira,Filipa %+ School of Health Sciences, HES-SO Valais-Wallis, 5, Chemin de l’Agasse, Sion, 1950, Switzerland, 41 0787698990, henk.verloo@hevs.ch %D 2021 %7 15.1.2021 %9 Corrigenda and Addenda %J JMIR Res Protoc %G English %X %M 33449910 %R 10.2196/27092 %U http://www.researchprotocols.org/2021/1/e27092/ %U https://doi.org/10.2196/27092 %U http://www.ncbi.nlm.nih.gov/pubmed/33449910 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e23207 %T Web-Based Interventions to Promote Healthy Lifestyles for Older Adults: Protocol for a Scoping Review %A Lavoie,Audrey %A Dubé,Véronique %+ Research Center, Centre hospitalier de l’Université de Montréal, 850 rue Saint-Denis, Bureau S03.620, Montreal, QC, H2X 0A9, Canada, 1 514 890 8000 ext 15925, audrey.lavoie.7@umontreal.ca %K Aged %K web-based intervention %K healthy lifestyle %K behavioral change %K components %K effects %D 2021 %7 4.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: With the aging of the population and rising rates of chronic diseases, older adults need support if they are to adopt healthy lifestyles. Web-based interventions should be considered for this purpose, since they are easily accessed and can foster healthy lifestyles among older adults. However, the literature on such interventions discusses a variety of components and effects and provides only 2 syntheses of knowledge on web-based interventions with older adults. These studies focus on populations aged 50 years and older, whereas the components and effects of interventions for a population of older adults (ie, 65 years and older) may differ. In addition, these 2 syntheses examined only quantitative studies, although other types of studies (ie, qualitative) are available and could help advance knowledge in this field. A scoping review is therefore relevant in order to explore the extent of the literature on this subject. Objective: The purpose of the study described by this protocol is to explore the extent of the literature (experimental, quasi-experimental, qualitative, systematic reviews, and grey literature) on the components and effects of web-based interventions as a way to promote healthy lifestyles among older adults. Methods: The databases MEDLINE, CINAHL, PsycInfo, Web of Science, Cochrane Database of Systematic Review and Joanna Briggs Library will be searched, in addition to the grey literature using Google Scholar and OpenGrey. Studies will be selected for the review by 2 researchers, working independently. The data will be synthesized based on the conceptualization of web-based interventions (ie, behavior change techniques, dispensation modes, and theories). A thematic analysis will be performed to summarize the components of the interventions studied. Results: The database search will begin in August 2020 and be completed in October 2020. Conclusions: This scoping review should highlight web-based interventions designed to promote healthy lifestyles, as well as their components and effects, among people aged 65 years and older. These results could provide important guidance for intervention developers and designers in identifying the components of web-based interventions relevant to older adults and lead to further studies on this topic. International Registered Report Identifier (IRRID): PRR1-10.2196/23207 %M 33393929 %R 10.2196/23207 %U https://www.researchprotocols.org/2021/1/e23207 %U https://doi.org/10.2196/23207 %U http://www.ncbi.nlm.nih.gov/pubmed/33393929 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e17765 %T Open and Distance Learning Programs for Nursing and Midwifery Education in East Africa: Protocol for a Scoping Review %A Isangula,Kahabi %A Edwards,Grace %A Mwansisya,Tumbwene %A Mbekenga,Columba %A Pallangyo,Eunice %A Sarki,Ahmed %A Ndirangu-Mugo,Eunice %+ School of Nursing and Midwifery, Aga Khan University, Salama House, 344 Urambo St, Dar Es Salaam, United Republic of Tanzania, 255 754030726 ext 255, kahabi.isangula@aku.edu %K open and distance %K learning %K health care %K nurses %K midwifery %K health %K East Africa %D 2021 %7 11.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: In the face of growing modernity and the coronavirus disease 2019 (COVID-19) pandemic, open and distance learning (ODL) is considered to play an important role in increasing access to education worldwide. There is a robust evidence base demonstrating its cost effectiveness in comparison with conventional class-based teaching; however, the transition to this new paradigm of learning for nursing and midwifery courses has been difficult in low-income countries. While there are notable efforts to increase internet and education access to health care professionals, not much is known about ODL for nurses and midwives in East African countries. Objective: The objective of this scoping review is to understand whether ODL programs for nursing and midwifery education exist, the drivers of their adoption, their implementation, the topics/courses covered, their acceptability, and their impacts in East African countries. Methods: The scoping review methodology employs the framework developed by Arksey and O’Malley. Using an exploratory approach, a two-stage screening process consisting of a title and abstract scan and a full-text review will be used to determine the eligibility of articles. To be included, articles must report on an existing ODL initiative for nurses and midwives in Uganda, Tanzania, and Kenya. All articles will be independently assessed for eligibility by pairs of reviewers, and all eligible articles will be abstracted and charted in duplicate using a standardized form. Results: Details of ODL for nursing and midwifery education initiatives and study outcomes will be summarized in a table. The extracted data will undergo exploratory descriptive analysis, and the results will be classified into learner and clinical outcomes. Conclusions: Evidence on ODL for nursing and midwifery education will inform the ongoing development and restructuring of health care professional education in East Africa amidst the COVID-19 pandemic. International Registered Report Identifier (IRRID): PRR1-10.2196/17765 %M 33427679 %R 10.2196/17765 %U http://www.researchprotocols.org/2021/1/e17765/ %U https://doi.org/10.2196/17765 %U http://www.ncbi.nlm.nih.gov/pubmed/33427679 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e24689 %T Community-Based Physical Activity Interventions for Individuals with Moderate to Severe Traumatic Brain Injury: Scoping Review Protocol %A Quilico,Enrico %A Swaine,Bonnie %A Alarie,Christophe %A Colantonio,Angela %+ Rehabilitation Sciences Institute, University of Toronto, 500 University Avenue, Suite 160, Toronto, ON, M5G 1J7, Canada, 1 416 978 0300, enrico.quilico@mail.utoronto.ca %K traumatic brain injury %K community %K physical activity %K exercise %K sex %K gender %D 2021 %7 13.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Long-term physical, cognitive, and psychosocial problems resulting from moderate to severe traumatic brain injury (TBI) can prevent individuals from returning to preinjury lifestyles because of significant challenges with employment, leisure, and relationships. While physical activity (PA) is proposed as a cost-effective method to alleviate problems after moderate to severe TBI, there is no review to date that synthesizes the evidence for PA in the community-based context. Further, although sex- and gender-based considerations in research are considered requisite to good science, there is no review on PA and TBI that has included this explicit focus. Objective: The purpose of this review is to map and synthesize the current evidence identified through a systematic search of community-based PA interventions for individuals of all ages with moderate to severe TBI and provide an overview of that evidence by asking the following research questions: (1) what are the characteristics of community-based PA programs for individuals with moderate to severe TBI, (2) what are the reported health-related outcomes and measurement tools used to evaluate them, and (3) what considerations have been given to sex and/or gender? Methods: Searches will be conducted of six academic databases for peer-reviewed articles. Two reviewers will independently screen the articles for inclusion and extract data for the analysis. The extracted data will be coded according to the Consensus on Exercise Reporting Template checklist and the Template for Intervention Description and Replication checklist to provide sufficient detail for replication. Results: The abstract screening was completed by two reviewers and the extracted data were analyzed. A qualitative synthesis and description of community-based PA interventions for individuals with moderate to severe TBI will be provided. Conclusions: This scoping review will generate new knowledge from published and publicly available literature. Dissemination of the results will include activities related to knowledge transfer for community-based PA after moderate to severe TBI for future research and practice. Evidence-based recommendations, future directions, potential limitations, use of online/digital components, and the possible need for a systematic review will be discussed as well. International Registered Report Identifier (IRRID): DERR1-10.2196/24689 %M 33439145 %R 10.2196/24689 %U http://www.researchprotocols.org/2021/1/e24689/ %U https://doi.org/10.2196/24689 %U http://www.ncbi.nlm.nih.gov/pubmed/33439145 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e22279 %T Research Priorities to End the Adolescent HIV Epidemic in the United States: Viewpoint %A Fernandez,M Isabel %A Harper,Gary W %A Hightow-Weidman,Lisa B %A Kapogiannis,Bill G %A Mayer,Kenneth H %A Parsons,Jeffrey T %A Rotheram-Borus,Mary Jane %A Seña,Arlene C %A Sullivan,Patrick S %+ Department of Psychiatry, University of California, Los Angeles, 10920 Wilshire Blvd, Suite 350, Los Angeles, CA, 90024-6521, United States, 1 310 794 8278, mrotheram@mednet.ucla.edu %K HIV/AIDS %K adolescents %D 2021 %7 4.1.2021 %9 Viewpoint %J JMIR Res Protoc %G English %X Youth represent 21% of new HIV diagnoses in the United States. Gay, bisexual, and transgender (GBT) youth, particularly those from communities of color, and youth who are homeless, incarcerated, in institutional settings, or engaging in transactional sex are most greatly impacted. Compared with adults, youth have lower levels of HIV serostatus awareness, uptake of antiretroviral therapy (ART), and adherence. Widespread availability of ART has revolutionized prevention and treatment for both youth at high risk for HIV acquisition and youth living with HIV, increasing the need to integrate behavioral interventions with biomedical strategies. The investigators of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) completed a research prioritization process in 2019, focusing on research gaps to be addressed to effectively control HIV spread among American youth. The investigators prioritized research in the following areas: (1) innovative interventions for youth to increase screening, uptake, engagement, and retention in HIV prevention (eg, pre-exposure prophylaxis) and treatment services; (2) structural changes in health systems to facilitate routine delivery of HIV services; (3) biomedical strategies to increase ART impact, prevent HIV transmission, and cure HIV; (4) mobile technologies to reduce implementation costs and increase acceptability of HIV interventions; and (5) data-informed policies to reduce HIV-related disparities and increase support and services for GBT youth and youth living with HIV. ATN’s research priorities provide a roadmap for addressing the HIV epidemic among youth. To reach this goal, researchers, policy makers, and health care providers must work together to develop, test, and disseminate novel biobehavioral interventions for youth. %M 33393918 %R 10.2196/22279 %U https://www.researchprotocols.org/2021/1/e22279 %U https://doi.org/10.2196/22279 %U http://www.ncbi.nlm.nih.gov/pubmed/33393918