TY - JOUR AU - Lai, Byron AU - Chiu, Chia-Ying AU - Pounds, Emily AU - Tracy, Tracy AU - Mehta, Tapan AU - Young, Hui-Ju AU - Riser, Emily AU - Rimmer, James PY - 2020/7/3 TI - COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e18415 VL - 9 IS - 7 KW - multiple sclerosis KW - telerehabilitation KW - teletraining KW - physical activity KW - disability KW - tele-exercise KW - telehealth KW - COVID-19 N2 - Background: Access to comprehensive exercise and rehabilitation services for people with multiple sclerosis (MS) remains a major challenge, especially in rural, low-income areas. Hence, the Tele-Exercise and Multiple Sclerosis (TEAMS) study aims to provide patient-centered, coordinated care by implementing a 12-week complementary and alternative medicine (CAM) intervention for adults with MS. However, due to the societal impact of coronavirus disease (COVID-19) in mid-March 2020, the University of Alabama at Birmingham announced a limited business model halting all nonessential research requiring on-site visits, which includes the TEAMS study. Objective: In compliance with the shelter-in-place policy and quarantine guidance, a modified testing and training protocol was developed to allow participants to continue the study. Methods: The modified protocol, which replaces on-site data collection and training procedures, includes a teleassessment package (computer tablet, blood pressure cuff, hand dynamometer, mini disc cone, measuring tape, an 8? step, and a large-print 8? × 11? paper with ruler metrics and wall-safe tape) and a virtual meeting platform for synchronous interactive training between the therapist and the participant. The teleassessment measures include resting blood pressure and heart rate, grip strength, Five Times Sit to Stand, Timed Up & Go, and the Berg Balance Scale. The teletraining component includes 20 sessions of synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized for a range of functional levels. Teletraining lasts 12 weeks and participants are instructed to continue exercising for a posttraining period of 9 months. Results: The protocol modifications were supported with supplemental funding (from the Patient-Centered Outcomes Research Institute) and approved by the University Institutional Review Board for Human Use. At the time nonessential research visits were halted by the university, there were 759 people enrolled and baseline tested, accounting for 92.5% of our baseline testing completion target (N=820). Specifically, 325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments. A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in the presence of uncertainty and protocol deviations. Study results are projected to be published in 2021. Conclusions: This modified remote teleassessment/teletraining protocol will impact a large number of participants with MS who would otherwise have been discontinued from the study. Trial Registration: ClinicalTrials.gov NCT03117881; https://clinicaltrials.gov/ct2/show/NCT03117881 International Registered Report Identifier (IRRID): DERR1-10.2196/18415 UR - https://www.researchprotocols.org/2020/7/e18415 UR - http://dx.doi.org/10.2196/18415 UR - http://www.ncbi.nlm.nih.gov/pubmed/32540838 ID - info:doi/10.2196/18415 ER - TY - JOUR AU - Taylor Jr, A. Herman AU - Francis, Sherilyn AU - Evans, Ray Chad AU - Harvey, Marques AU - Newton, A. Brittney AU - Jones, P. Camara AU - Akintobi, Henry Tabia AU - Clifford, Gari PY - 2020/7/9 TI - Preventing Cardiovascular Disease Among Urban African Americans With a Mobile Health App (the MOYO App): Protocol for a Usability Study JO - JMIR Res Protoc SP - e16699 VL - 9 IS - 7 KW - African Americans KW - mHealth KW - community-based participatory research KW - agile design KW - cardiovascular N2 - Background: Cardiovascular disease (CVD) disparities are a particularly devastating manifestation of health inequity. Despite advancements in prevention and treatment, CVD is still the leading cause of death in the United States. Additionally, research indicates that African American (AA) and other ethnic-minority populations are affected by CVD at earlier ages than white Americans. Given that AAs are the fastest-growing population of smartphone owners and users, mobile health (mHealth) technologies offer the unparalleled potential to prevent or improve self-management of chronic disease among this population. Objective: To address the unmet need for culturally tailored primordial prevention CVD?focused mHealth interventions, the MOYO app was cocreated with the involvement of young people from this priority community. The overall project aims to develop and evaluate the effectiveness of a novel smartphone app designed to reduce CVD risk factors among urban-AAs, 18-29 years of age. Methods: The theoretical underpinning will combine the principles of community-based participatory research and the agile software development framework. The primary outcome goals of the study will be to determine the usability, acceptability, and functionality of the MOYO app, and to build a cloud-based data collection infrastructure suitable for digital epidemiology in a disparity population. Changes in health-related parameters over a 24-week period as determined by both passive (eg, physical activity levels, sleep duration, social networking) and active (eg, use of mood measures, surveys, uploading pictures of meals and blood pressure readings) measures will be the secondary outcome. Participants will be recruited from a majority AA ?large city? school district, 2 historically black colleges or universities, and 1 urban undergraduate college. Following baseline screening for inclusion (administered in person), participants will receive the beta version of the MOYO app. Participants will be monitored during a 24-week pilot period. Analyses of varying data including social network dynamics, standard metrics of activity, percentage of time away from a given radius of home, circadian rhythm metrics, and proxies for sleep will be performed. Together with external variables (eg, weather, pollution, and socioeconomic indicators such as food access), these metrics will be used to train machine-learning frameworks to regress them on the self-reported quality of life indicators. Results: This 5-year study (2015-2020) is currently in the implementation phase. We believe that MOYO can build upon findings of classical epidemiology and longitudinal studies like the Jackson Heart Study by adding greater granularity to our knowledge of the exposures and behaviors that affect health and disease, and creating a channel for outreach capable of launching interventions, clinical trials, and enhancements of health literacy. Conclusions: The results of this pilot will provide valuable information about community cocreation of mHealth programs, efficacious design features, and essential infrastructure for digital epidemiology among young AA adults. International Registered Report Identifier (IRRID): DERR1-10.2196/16699 UR - https://www.researchprotocols.org/2020/7/e16699 UR - http://dx.doi.org/10.2196/16699 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673258 ID - info:doi/10.2196/16699 ER - TY - JOUR AU - Chung, Alicia AU - Seixas, Azizi AU - Williams, Natasha AU - Senathirajah, Yalini AU - Robbins, Rebecca AU - Newsome Garcia, Valerie AU - Ravenell, Joseph AU - Jean-Louis, Girardin PY - 2020/7/14 TI - Development of ?Advancing People of Color in Clinical Trials Now!?: Web-Based Randomized Controlled Trial Protocol JO - JMIR Res Protoc SP - e17589 VL - 9 IS - 7 KW - health communication KW - health care disparities KW - eHealth N2 - Background: Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of ?Advancing People of Color in Clinical Trials Now!? (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color. Objective: This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color. Methods: ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed t test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention. Results: We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020. Conclusions: ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website. Trial Registration: ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401 International Registered Report Identifier (IRRID): DERR1-10.2196/17589 UR - https://www.researchprotocols.org/2020/7/e17589 UR - http://dx.doi.org/10.2196/17589 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673274 ID - info:doi/10.2196/17589 ER - TY - JOUR AU - Hides, Leanne AU - Baker, Amanda AU - Norberg, Melissa AU - Copeland, Jan AU - Quinn, Catherine AU - Walter, Zoe AU - Leung, Janni AU - Stoyanov, R. Stoyan AU - Kavanagh, David PY - 2020/7/29 TI - A Web-Based Program for Cannabis Use and Psychotic Experiences in Young People (Keep It Real): Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e15803 VL - 9 IS - 7 KW - cannabis KW - marijuana KW - substance use KW - psychotic KW - psychotic experiences KW - psychosis KW - digital intervention KW - web-based program KW - eHealth KW - adolescent KW - CBT KW - motivational interviewing KW - mindfulness KW - education KW - well-being N2 - Background: Young Australians (16-25 years) have the highest rates of past-month cannabis use in the world. Cannabis use increases the risk of alcohol and other drug disorders and depressive disorders, and has a robust dose-response association with psychotic experiences (PEs) and disorders. PEs are subthreshold positive psychotic symptoms, including delusions and hallucinations, which increase the risk of substance use, depressive or anxiety disorders, and psychotic disorders. Access to effective web-based early interventions targeting both cannabis use and PEs could reduce such risk in young people. Objective: The objective of this study is to determine the efficacy and cost-effectiveness of the Keep it Real web-based program compared to an information-only control website among young cannabis users (16-25 years) with PEs. Methods: Participants are recruited online, and consenting individuals meeting inclusion criteria (aged 16-25 years, who have used cannabis in the past month and experienced PEs in the past 3 months) are automatically randomized to either the Keep it Real web-based program (n=249) or an information-only control website (n=249). Both websites are self-guided (fully automated). The baseline and follow-up assessments at 3, 6, 9, and 12 months are self-completed online. Primary outcome measures are weekly cannabis use, PEs, and the relative cost-effectiveness for quality-adjusted life years. Secondary outcomes include other substance use and related problems, PE-related distress, cannabis intoxication experiences, severity of cannabis dependence, depression/anxiety symptoms, suicidality, and mental well-being and functioning. Results: Recruitment commenced in February 2019, and the results are expected to be submitted for publication in mid-2021. Conclusions: This study protocol describes a large randomized controlled trial of a new web-based program for young cannabis users experiencing PEs. If effective, the accessibility and scalability of Keep it Real could help reduce growing public health concerns about the significant social, economic, and health impacts of cannabis use. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618001107213; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374800 International Registered Report Identifier (IRRID): DERR1-10.2196/15803 UR - https://www.researchprotocols.org/2020/7/e15803 UR - http://dx.doi.org/10.2196/15803 UR - http://www.ncbi.nlm.nih.gov/pubmed/32723727 ID - info:doi/10.2196/15803 ER - TY - JOUR AU - Fontaine, Guillaume AU - Cossette, Sylvie AU - Gagnon, Marie-Pierre AU - Dubé, Véronique AU - Côté, José PY - 2020/7/31 TI - Effectiveness of a Theory- and Web-Based Adaptive Implementation Intervention on Nurses? and Nursing Students? Intentions to Provide Brief Counseling: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e18894 VL - 9 IS - 7 KW - brief counseling KW - implementation science KW - knowledge translation KW - eLearning KW - clinical practice improvement KW - nursing education N2 - Background: Brief counseling can motivate patients to initiate health behavior change. However, increasing the provision of brief counseling by nurses is difficult due to contextual and practitioner-level factors impeding nurses? motivation and intentions to provide brief counseling (eg, unfavorable attitude toward brief counseling, lack of perceived control linked to barriers). Theory-based implementation interventions could address these practitioner-level factors and support evidence-based practice in the context of brief counseling. Web-based, adaptive e-learning (electronic learning) programs are a novel type of implementation intervention that could address the limitations of current brief counseling training programs, such as accessibility and personalization. Objective: This paper presents a study protocol for evaluating the effectiveness of the E_MOTIVA implementation intervention?a theory- and web-based adaptive e-learning program?to increase nurses? and nursing students? intentions to provide brief counseling for smoking, an unbalanced diet, and medication nonadherence. Methods: A two-group, single-blind, randomized controlled trial will be conducted with nurses and nursing students enrolled in a Bachelor of Science in Nursing program in Quebec, Canada. Participants in the experimental group will be allocated to the E_MOTIVA intervention?a theory- and web-based adaptive e-learning program?while participants in the active control group will be allocated to the E_MOTIVB intervention, a knowledge- and web-based standardized e-learning program. The E_MOTIVA intervention was designed to influence the constructs of the Theory of Planned Behavior (eg, attitude, subjective norms, and perceived behavioral control) in the context of brief counseling. The Cognitive Load Index and User Engagement Scale will be used to assess participants? cognitive load and engagement related to e-learning. Participants will complete the Brief Counseling Nursing Practices Questionnaire?Abridged Version at baseline and follow-up. All study measures will be completed online. Results: The study is ongoing. The results of the study will provide answers to the primary hypothesis (H1) that experimental group participants will demonstrate a greater change in the score of intentions to provide brief counseling between baseline (?T1) and follow-up (T4). Secondary hypotheses include greater improvements in scores of attitude (H2), subjective norms (H3), perceived control (H4), behavioral beliefs (H5), normative beliefs (H6), and control beliefs (H7) regarding brief counseling in the experimental group between baseline and follow-up. We also anticipate lower intrinsic and extrinsic cognitive loads (H8, H9), higher germane cognitive load (H10), and higher engagement (H11, H12) in the experimental group. Conclusions: This study will be among the first in evaluating a novel type of implementation intervention, a theory- and web-based adaptive e-learning program, in nurses and nursing students. This type of intervention has the potential to support evidence-based practice through accessible, personalized training in wide-ranging domains in nursing. Trial Registration: ISRCTN Registry ISRCTN32603572; http://www.isrctn.com/ISRCTN32603572 International Registered Report Identifier (IRRID): PRR1-10.2196/18894 UR - https://www.researchprotocols.org/2020/7/e18894 UR - http://dx.doi.org/10.2196/18894 UR - http://www.ncbi.nlm.nih.gov/pubmed/32734932 ID - info:doi/10.2196/18894 ER - TY - JOUR AU - Mesman, Mathijs AU - Onrust, Simone AU - Verkerk, Renée AU - Hendriks, Hanneke AU - Van den Putte, Bas PY - 2020/7/8 TI - Effectiveness of the InCharge Prevention Program to Promote Healthier Lifestyles: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e17702 VL - 9 IS - 7 KW - school-based health intervention KW - adolescents KW - health behavior KW - healthy lifestyle KW - quality of life KW - behavior change N2 - Background: InCharge is a newly developed school-based health intervention aimed at older adolescents. It aims to promote a healthier lifestyle by increasing self-regulation skills. After the InCharge program?s effectiveness was previously investigated in a pilot study, the content of the program was adapted. Objective: This study describes the protocol of a cluster randomized controlled trial that aims to investigate the effectiveness of the InCharge program. Methods: A cluster randomized controlled trial including 70 classes with older adolescents (aged 16 years or older) in the Netherlands will be conducted to test the effectiveness of the InCharge program. After schools are recruited, randomization occurs at the class level. The trial consists of the following two conditions: an experimental condition and a control condition. Participants in the experimental condition will be given the InCharge intervention, consisting of four lessons of 50 minutes, with each lesson containing three assignments of approximately 15 minutes. While participants in the experimental condition will receive InCharge, participants in the control condition will receive regular academic school courses. Surveys are administered 1 week before the intervention (baseline), 1 week after the intervention (posttest), and 12 weeks after the intervention (follow-up). Variables of interest include, but are not limited to, self-regulation; predictors of snack intake, physical activity, and alcohol use; and interpersonal communication regarding these health behaviors. In addition to surveys, observations will be conducted during the first and fourth lessons, teachers will be interviewed, and focus groups will be held with a selection of students from the intervention condition. Results: Enrollment started in September 2017. As of June 2019, a total of 1216 participants were enrolled for this trial. Findings will be published in peer-reviewed journals and presented at conferences. The trial has been approved by the Ethics Review Board of the Faculty of Social and Behavioral Sciences of the University of Amsterdam (reference no.: 2017-PC-8244). Conclusions: In this study protocol, the design of a cluster randomized controlled trial is described, which assesses how effectively the school-based intervention InCharge stimulates healthier lifestyles in late adolescents. We hypothesize that participants in the experimental condition will consume less alcohol, eat fewer unhealthy snacks, and be more physically active compared with participants in the control condition. Trial Registration: Netherlands Trial Register (NL6654); https://www.trialregister.nl/trial/6654 International Registered Report Identifier (IRRID): RR1-10.2196/17702 UR - http://www.researchprotocols.org/2020/7/e17702/ UR - http://dx.doi.org/10.2196/17702 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673278 ID - info:doi/10.2196/17702 ER - TY - JOUR AU - Lu, Tianyi AU - Li, Hang AU - Mao, Xiang AU - Peng, Erlei AU - Gao, Yangyang AU - Chu, Zhenxing AU - Zhang, Jing AU - Dong, Willa AU - Jiang, Yongjun AU - Xu, Junjie PY - 2020/7/9 TI - HIV Self-Testing to Promote Serostatus Disclosure Among Men Who Have Sex With Men in China: Protocol for a Stepped Wedge Randomized Controlled Trial JO - JMIR Res Protoc SP - e17788 VL - 9 IS - 7 KW - HIV KW - HIV self-testing (HIVST), HIV serostatus disclosure KW - men who have sex with men (MSM) KW - stepped wedge randomized controlled trial KW - China N2 - Background: Disclosure of HIV serostatus is important for the prevention of HIV infection among men who have sex with men (MSM). However, knowledge of sexual partners? HIV status among MSM in China is low. As a complement to HIV testing services, HIV self-testing (HIVST) has considerable potential to promote serostatus disclosure. Objective: The primary objective of our trial is to evaluate the effect of HIVST on improving serostatus disclosure to sexual partners. We hypothesize that MSM in an intervention condition will have a higher awareness of the HIV status of their sexual partners compared with MSM in the control condition. The secondary aims are to evaluate (i) changes in sexual behaviors after disclosure of HIV status by sexual partners, (ii) promotion of the frequency of HIV and syphilis testing on participants and their sexual partners, and (iii) factors that restrict the disclosure of HIV infection to sexual partners. We hypothesize that MSM in the intervention condition will exhibit safer sexual decision making and a higher rate of HIV testing uptake compared with MSM in the control condition. Methods: A stepped wedge randomized controlled trial will be conducted throughout China. Study recruitment of 800 MSM will be promoted through advertisements released on WeChat public accounts. Individuals who are born biologically male, aged ?18 years, HIV negative, and who have not undergone HIV testing in the past 3 months will be recruited. Eligible men will be randomly divided (1:1:1:1) into four groups and randomized. The group cluster will initiate the intervention so that participants will be provided with 2-4 free finger prick?based HIVST kits until trial completion. The intervention period for participants in each of the four groups will be initiated at 3-month intervals. Men in both groups will be required to complete a baseline and four follow-up surveys every 3 months. The primary intervention outcome will evaluate the effect of the distribution of HIVST kits on improvement in the disclosure of sexual partners? HIV status. The secondary outcomes will be changes in sexual behaviors after disclosure of HIV status from sexual partners, the promotion of the frequency of HIVST on participants and their sexual partners, and the factors that restrict disclosure of HIV status to sexual partners. Results: Subject recruitment began in August 2018. The first round of follow-up surveys post intervention is complete, with three rounds remaining to be done. Data analysis was scheduled for April 2020 and the results will be disseminated through conferences and peer-reviewed publications. Conclusions: Few studies have evaluated interventions to increase knowledge of sexual partners? HIV status among MSM. Our trial will provide information on the link between HIVST and HIV serostatus disclosure. The findings of this trial will facilitate the implementation of HIVST services to help control the spread of HIV among MSM in China. Trial Registration: Chinese Clinical Trial Registry ChiCTR1800019453; http://www.chictr.org.cn/showproj.aspx?proj=30158 International Registered Report Identifier (IRRID): DERR1-10.2196/17788 UR - https://www.researchprotocols.org/2020/7/e17788 UR - http://dx.doi.org/10.2196/17788 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673264 ID - info:doi/10.2196/17788 ER - TY - JOUR AU - Garcia-Suarez, Jessica AU - Garcia Fernandez, Javier AU - Sanz, Sergio AU - Martinez Lopez, Daniel AU - Reques, Leticia AU - Forteza Gil, Alberto PY - 2020/7/14 TI - Del Nido Cardioplegia Versus Cold Blood Cardioplegia in Adult Cardiac Surgery: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e17826 VL - 9 IS - 7 KW - del Nido cardioplegia KW - cardiac surgery KW - myocardial protection N2 - Background: The use of cardioplegia solutions as a myocardial protection technique is essential during cardiac surgery with cardiopulmonary bypass. The del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass. Its unique pharmacological features have created growing interest for adult cardiac surgery, especially for elderly patients or those with ventricular dysfunction who are more prone to ischemia-reperfusion injury. Ever since its implementation, several retrospective studies have been published to validate the efficacy, safety, and efficiency of DNS in adult patients undergoing coronary revascularization, valve replacement, or combined procedures. Recently, a meta-analysis based on nine retrospective studies was published claiming the noninferiority of DNS compared to other conventional cardioplegia solutions. Few prospective randomized studies have been conducted whose primary outcome was the assessment of DNS clinical efficacy compared to other solutions commonly used in adult patients. Objective: The aim of this randomized clinical trial is to assess the benefits of DNS compared to Cardi-Braun blood cardioplegia solution in clinical and biochemical terms regarding myocardial protection during adult cardiac surgery. Methods: This is the protocol of a controlled, randomized, single-center clinical trial carried out at the Puerta de Hierro Majadahonda University Hospital in Spain. A total of 474 participants over the age of 18 years undergoing elective cardiac surgery with cardiopulmonary bypass will be assigned to groups by simple randomization to receive either DNS or Cardi-Braun blood cardioplegia solution. The primary outcome will be the differences between groups in myocardial protection in biochemical terms (ie, perioperative troponin levels) and clinical terms (ie, presence of the composite variable acute cardiovascular event). The clinical trial will be carried out under conditions of respect for the fundamental rights of the person and the ethical principles that affect biomedical research with human beings, as well as in accordance with international recommendations contained in the Declaration of Helsinki and its subsequent revisions. Results: The inclusion process started in 2018. Data cleaning and analyses are expected to take place in the fall of 2020 and the results are expected in January 2021. Conclusions: This study is particularly relevant as it will be one of the first to analyze the clinical effects of del Nido cardioplegia on the basis of direct myocardial protection parameters. In light of published studies, carrying out prospective studies based on primary clinical objectives with a larger sample, high-risk patients, and longer cardiopulmonary bypass times continues to be necessary. We believe that our study addresses an important gap in the knowledge of del Nido cardioplegia in adult patient cardiac surgery and will be able to clarify the possible benefits of this method in a large population of patients undergoing these procedures. Trial Registration: European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) 2017-005144-14; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-005144-14+; ClinicalTrials.gov NCT04094168; https://clinicaltrials.gov/ct2/show/NCT04094168 International Registered Report Identifier (IRRID): DERR1-10.2196/17826 UR - https://www.researchprotocols.org/2020/7/e17826 UR - http://dx.doi.org/10.2196/17826 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673265 ID - info:doi/10.2196/17826 ER - TY - JOUR AU - Bientzle, Martina AU - Kimmerle, Joachim AU - Eggeling, Marie AU - Cebi, Idil AU - Weiss, Daniel AU - Gharabaghi, Alireza PY - 2020/7/14 TI - Evidence-Based Decision Aid for Patients With Parkinson Disease: Protocol for Interview Study, Online Survey, and Two Randomized Controlled Trials JO - JMIR Res Protoc SP - e17482 VL - 9 IS - 7 KW - decision aids KW - Parkinson disease KW - interview study KW - online survey KW - randomized controlled trial KW - patients N2 - Background: Shared decision making is particularly important in situations with different treatment alternatives. For the treatment of idiopathic Parkinson disease, both pharmacological and surgical approaches can be applied. Objective: In this research project, a series of studies will be conducted to investigate how decision aids for patients with idiopathic Parkinson disease should be designed in order to support the decision-making process. Methods: In Study 1a, qualitative interviews will be conducted to determine which needs frequently occur for patients with idiopathic Parkinson disease. In Study 1b, the identified needs will then be rated for personal relevance by an independent group of patients in an online survey. In Study 2, a randomized controlled trial will be used to pretest different decision aids in a sample group of people who do not have a medical background and who do not have Parkinson disease. In Study 3, a randomized controlled trial will be used to investigate the effect of the decision aids that had been evaluated as positive in Study 2 with patients who have idiopathic Parkinson disease. Results: This series of studies received ethical approval in January 2020. As of June 2020, data collection for Study 1a has started, and it is estimated that Studies 1a, 1b, 2, and 3 will take approximately 4, 4, 6, and 6 months to complete, respectively. It is planned to present the results and analyses at international conferences and to submit the results to peer-reviewed journals for publication, once the studies have been completed. The findings will also be shared with clinicians and patients through presentations at information events. Conclusions: This series of studies is intended to result in an evidence-based decision aid for patients with idiopathic Parkinson disease in order to support the informed and reflected shared decision-making process. We further intend to contribute to a deeper understanding of the individual preferences of patients with idiopathic Parkinson disease and the impact of those preferences on treatment decisions. UR - https://www.researchprotocols.org/2020/7/e17482 UR - http://dx.doi.org/10.2196/17482 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673261 ID - info:doi/10.2196/17482 ER - TY - JOUR AU - Merońo-Gallut, Javier Antonio AU - Cuesta-Barriuso, Rubén AU - Pérez-Llanes, Raúl AU - Donoso-Úbeda, Elena AU - López-Pina, José-Antonio PY - 2020/7/31 TI - Self-Myofascial Release Intervention and Mobile App in Patients With Hemophilic Ankle Arthropathy: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e15612 VL - 9 IS - 7 KW - Hemophilic arthropathy KW - ankle KW - self-myofascial release KW - joint pain KW - functionality KW - randomized clinical trial N2 - Background: Hemophilic ankle arthropathy is manifested by degenerative functional alterations and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain, and reduce tissue sensitivity. Objective: This study aims to evaluate the safety and efficacy of a protocol using self-myofascial release with a foam roller to be applied in patients with hemophilic ankle arthropathy. Methods: Patients with ankle arthropathy (N=70) will be recruited, enrolled, and assigned to one of two groups?experimental or control?in a 1:1 allocation ratio. Patients will be recruited from 5 centers in different regions of Spain. Patient data will be collected at baseline, posttreatment, and follow-up. The primary outcome will be frequency of ankle joint bleeding (self-reported). The secondary outcomes will be ankle range of motion (measured with a digital goniometer); joint pain (measured with a visual analog scale and an algometer); joint status (measured using the Hemophilia Joint Health Score); muscle strength (measured with a dynamometer); functionality of lower limbs (measured using the 6-minute walking test); activity (self-reported); and muscle flexibility (measured using the fingertip-to-floor test). The treatment program includes 11 exercises that must be administered bilaterally. A mobile app will be developed where each patient will be able to observe the exercises to be carried out. Each session will last 15 minutes with 5 physiotherapy sessions per week for a period of 3 months. It is expected that patients with hemophilia who receive the foam roller intervention will show improvement in mobility, pain, and status of the ankle joint; muscle strength; and function in the lower extremities. Results: The study has been approved by the institutional review board of the University of Murcia. Patient recruitment will begin in September 2020, and the intervention period will last until June 2021. Data collection will take place between September 2020 and October 2021. Conclusions: This protocol describes a randomized clinical trial to examine the safety and efficacy of a self-myofascial release intervention using a foam roller in patients with hemophilic ankle arthropathy. Trial Registration: ClinicalTrials.gov NCT03914287; http://clinicaltrials.gov/ct2/show/NCT03914287. International Registered Report Identifier (IRRID): PRR1-10.2196/15612 UR - https://www.researchprotocols.org/2020/7/e15612 UR - http://dx.doi.org/10.2196/15612 UR - http://www.ncbi.nlm.nih.gov/pubmed/32734929 ID - info:doi/10.2196/15612 ER - TY - JOUR AU - Ho, Yan Andy Hau AU - Dutta, Oindrila AU - Tan-Ho, Geraldine AU - Tan, Benny Toh Hsiang AU - Low, Casuarine Xinyi AU - Ganapathy, Sashikumar AU - Car, Josip AU - Ho, Moon-Ho Ringo AU - Miao, Yan Chun PY - 2020/7/5 TI - A Novel Narrative E-Writing Intervention for Parents of Children With Chronic Life-Threatening Illnesses: Protocol for a Pilot, Open-Label Randomized Controlled Trial JO - JMIR Res Protoc SP - e17561 VL - 9 IS - 7 KW - narrative therapy KW - psychotherapy KW - pediatric palliative care KW - end-of-life care KW - randomized controlled trial KW - cyber-counseling KW - mobile phone N2 - Background: A novel evidence-based Narrative e-Writing Intervention (NeW-I) has been developed and tested in Singapore to advance psychosociospiritual support for parents of children with chronic life-threatening illnesses. NeW-I is informed by an international systematic review and a Singapore-based qualitative inquiry on the lived experience of parental bereavement and supported by literature on anticipatory grief interventions for improving the holistic well-being of parent caregivers of seriously ill children. Objective: This study's aim was to provide an accessible platform, NeW-I?which is a strengths- and meaning-focused and therapist-facilitated mobile app and web-based counseling platform?that aims to enhance quality of life, spiritual well-being, hope, and perceived social support and reduce depressive symptoms, caregiver burden, and risk of complicated grief among parents of children with chronic life-threatening illnesses. Methods: The NeW-I therapist-facilitated web-based platform comprises a mobile app and a website (both of which have the same contentand functionality). NeW-I has been implemented in Singapore as a pilot open-label randomized controlled trial comprising intervention and control groups. Both primary and secondary outcomes will be self-reported by participants through questionnaires. In collaboration with leading pediatric palliative care providers in Singapore, the trial aims to enroll 36 participants in each group (N=72), so that when allowing for 30% attrition at follow-up, the sample size will be adequate to detect a small effect size of 0.2 in the primary outcome measure, with 90% power and two-sided significance level of at least .05. The potential effectiveness of NeW-I and the accessibility and feasibility of implementing and delivering the intervention will be assessed. Results: Funding support and institutional review board approval for this study have been secured. Data collection started in January 2019 and is ongoing. Conclusions: NeW-I aspires to enhance holistic pediatric palliative care services through a structured web-based counseling platform that is sensitive to the unique cultural needs of Asian family caregivers who are uncomfortable with expressing emotion even during times of loss and separation. The findings of this pilot study will inform the development of a full-scale NeW-I protocol and further research to evaluate the efficacy of NeW-I in Singapore and in other Asian communities around the world. Trial Registration: ClinicalTrials.gov NCT03684382; https://clinicaltrials.gov/ct2/show/NCT03684382 International Registered Report Identifier (IRRID): DERR1-10.2196/17561 UR - https://www.researchprotocols.org/2020/7/e17561 UR - http://dx.doi.org/10.2196/17561 UR - http://www.ncbi.nlm.nih.gov/pubmed/32623367 ID - info:doi/10.2196/17561 ER - TY - JOUR AU - Toupin April, Karine AU - Stinson, Jennifer AU - Cavallo, Sabrina AU - Proulx, Laurie AU - Wells, A. George AU - Duffy, M. Ciarán AU - ElHindi, Tania AU - Longmuir, E. Patricia AU - Brosseau, Lucie PY - 2020/7/6 TI - Yoga and Aerobic Dance for Pain Management in Juvenile Idiopathic Arthritis: Protocol for a Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e12823 VL - 9 IS - 7 KW - juvenile idiopathic arthritis KW - yoga KW - aerobic exercise KW - dance KW - pain management KW - pilot N2 - Background: Juvenile idiopathic arthritis (JIA) is one of the most common types of arthritis among children. According to JIA guidelines for physical activity (PA), structured PA interventions led to improved health outcomes. However, many PA programs, such as yoga and aerobic dance, have not been studied in this population despite being popular among youth. Web-based PA programs could provide patients with accessible and affordable interventions. Objective: The primary aims of the proposed pilot randomized controlled trial (RCT) are to examine (1) the feasibility of conducting a full-scale RCT to evaluate the effectiveness of two popular types of PA: a yoga training program and an aerobic dance training program, in female adolescents (aged 13-18 years) with JIA compared with an electronic pamphlet control group; and (2) the acceptability of these interventions. Methods: A three-arm prospective randomized open-label study with a parallel group design will be used. A total of 25 female adolescents with JIA who have pain will be randomized in a ratio of 2:2:1 to one of the 3 groups: (1) online yoga training program (group A: n=10); (2) online aerobic dance training program (group B: n=10); and (3) electronic pamphlet control group (group C: n=5). Participants in groups A and B will complete 3 individual 1-hour sessions per week using online exercise videos, as well as a 1-hour virtual group session per week using a videoconferencing platform for 12 weeks. Participants from all groups will have access to an electronic educational pamphlet on PA for arthritis developed by the Arthritis Society. All participants will also take part in weekly online consultations with a research coordinator and discussions on Facebook with participants from their own group. Feasibility (ie, recruitment rate, self-reported adherence to the interventions, dropout rates, and percentage of missing data), acceptability, and usability of Facebook and the videoconferencing platform will be assessed at the end of the program. Pain intensity, participation in general PA, morning stiffness, functional status, fatigue, self-efficacy, patient global assessment, disease activity, and adverse events will be assessed using self-administered electronic surveys at baseline and then weekly until the end of the 12-week program. Results: This pilot RCT has been funded by the Arthritis Health Professions Association. This protocol was approved by the Children?s Hospital of Eastern Ontario Research Ethics Board (#17/08X). As of May 11, 2020, recruitment and data collection have not started. Conclusions: To our knowledge, this is the first study to evaluate the effectiveness of yoga and aerobic dance as pain management interventions for female adolescents with JIA. The use of online programs to disseminate these 2 PA interventions may facilitate access to alternative methods of pain management. This study can lead to a full-scale RCT. International Registered Report Identifier (IRRID): PRR1-10.2196/12823 UR - https://www.researchprotocols.org/2020/7/e12823 UR - http://dx.doi.org/10.2196/12823 UR - http://www.ncbi.nlm.nih.gov/pubmed/32442139 ID - info:doi/10.2196/12823 ER - TY - JOUR AU - Kim, H. Andrew AU - Girgis, Afaf AU - Karimi, Neda AU - Sechi, J. Alexandra AU - Descallar, Joseph AU - Andrews, M. Jane AU - Siegel, A. Corey AU - Connor, J. Susan PY - 2020/7/10 TI - A Web-Based Decision Aid (myAID) to Enhance Quality of Life, Empowerment, Decision Making, and Disease Control for Patients With Ulcerative Colitis: Protocol for a Cluster Randomized Controlled Trial JO - JMIR Res Protoc SP - e15994 VL - 9 IS - 7 KW - shared decision making KW - decision aid KW - ulcerative colitis N2 - Background: Patients with ulcerative colitis (UC) often face complex treatment decisions. Although shared decision making (SDM) is considered important, tools to facilitate this are currently lacking for UC. A recent pilot study of a novel Web-based decision aid (DA), my Actively Informed Decision (myAID), has suggested its acceptability and feasibility for informing treatment decisions and facilitating SDM in clinical practice. Objective: This paper describes the study protocol of the myAID study to assess the clinical impact of systematic implementation of myAID in routine UC management. Methods: The myAID study is a multicenter, cluster randomized controlled trial (CRCT) involving 22 Australian sites that will assess the clinical efficacy of routine use of myAID (intervention) against usual care without access to myAID (control) for UC patients. Participating sites (clusters) will be randomly allocated in a 1:1 ratio between the 2 arms. Patients making a new treatment decision beyond 5-aminosalicylate agents will be eligible to participate. Patients allocated to the intervention arm will view myAID at the time of recruitment and have free access to it throughout the study period. The effect of the myAID intervention will be assessed using the results of serial Web-based questionnaires and fecal calprotectin at baseline, 2 months, 6 months, and 12 months. A Web-based questionnaire within 2-4 weeks of referral will determine early change in quality of decision making and anxiety (both arms) and intervention acceptability (intervention arm only). Results: Study recruitment and funding began in October 2016, and recruitment will continue through 2020, for a minimum of 300 study participants at baseline at the current projection. The primary outcome will be health-related quality of life (Assessment of Quality of Life-8D), and secondary outcomes will include patient empowerment, quality of decision making, anxiety, work productivity and activity impairment, and disease activity. In addition, we aim to determine the predictors of UC treatment decisions and outcomes and the cost-effectiveness of implementing myAID in routine practice. Feedback obtained about myAID will be used to determine areas for improvement and barriers to its implementation. Completion of data collection and publication of study results are anticipated in 2021. Conclusions: myAID is a novel Web-based DA designed to facilitate SDM in UC management. The results of this CRCT will contribute new evidence to the literature in comparing outcomes between patients who routinely access such decision support intervention versus those who do not, across multiple large inflammatory bowel disease centers as well as community-based private practices in Australia. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12617001246370 http://anzctr.org.au/Trial/ Registration/TrialReview.aspx?ACTRN=12617001246370 International Registered Report Identifier (IRRID): DERR1-10.2196/15994 UR - https://www.researchprotocols.org/2020/7/e15994 UR - http://dx.doi.org/10.2196/15994 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673257 ID - info:doi/10.2196/15994 ER - TY - JOUR AU - Hankins, S. Jane AU - Shah, Nirmish AU - DiMartino, Lisa AU - Brambilla, Donald AU - Fernandez, E. Maria AU - Gibson, W. Robert AU - Gordeuk, R. Victor AU - Lottenberg, Richard AU - Kutlar, Abdullah AU - Melvin, Cathy AU - Simon, Jena AU - Wun, Ted AU - Treadwell, Marsha AU - Calhoun, Cecelia AU - Baumann, Ana AU - Potter, B. Michael AU - Klesges, Lisa AU - Bosworth, Hayden AU - PY - 2020/7/14 TI - Integration of Mobile Health Into Sickle Cell Disease Care to Increase Hydroxyurea Utilization: Protocol for an Efficacy and Implementation Study JO - JMIR Res Protoc SP - e16319 VL - 9 IS - 7 KW - sickle cell anemia KW - digital medicine KW - adherence KW - hydroxycarbamide KW - RE-AIM KW - implementation science KW - health innovation KW - mobile phone N2 - Background: Hydroxyurea prevents disease complications among patients with sickle cell disease (SCD). Although its efficacy has been endorsed by the National Health Lung and Blood Institute evidence-based guidelines, its adoption is low, both by patients with SCD and providers. Mobile health (mHealth) apps provide benefits in improving medication adherence and self-efficacy among patients with chronic diseases and have facilitated prescription among medical providers. However, mHealth has not been systematically tested as a tool to increase hydroxyurea adherence nor has the combination of mHealth been assessed at both patient and provider levels to increase hydroxyurea utilization. Objective: This study aims to increase hydroxyurea utilization through a combined two-level mHealth intervention for both patients with SCD and their providers with the goals of increasing adherence to hydroxyurea among patients and improve hydroxyurea prescribing behavior among providers. Methods: We will test the efficacy of 2 mHealth interventions to increase both patient and provider utilization and knowledge of hydroxyurea in 8 clinical sites of the NHLBI-funded Sickle Cell Disease Implementation Consortium (SCDIC). The patient mHealth intervention, InCharge Health, includes multiple components that address memory, motivation, and knowledge barriers to hydroxyurea use. The provider mHealth intervention, Hydroxyurea Toolbox (HU Toolbox), addresses the clinical knowledge barriers in prescribing and monitoring hydroxyurea. The primary hypothesis is that among adolescents and adults with SCD, adherence to hydroxyurea, as measured by the proportion of days covered (the ratio of the number of days the patient is covered by the medication to the number of days in the treatment period), will increase by at least 20% after 24 weeks of receiving the InCharge Health app, compared with their adherence at baseline. As secondary objectives, we will (1) examine the change in health-related quality of life, acute disease complications, perceived health literacy, and perceived self-efficacy in taking hydroxyurea among patients who use InCharge Health and (2) examine potential increases in the awareness of hydroxyurea benefits and risks, appropriate prescribing, and perceived self-efficacy to correctly administer hydroxyurea therapy among SCD providers between baseline and 9 months of using the HU Toolbox app. We will measure the reach, adoption, implementation, and maintenance of both the InCharge Health and the HU Toolbox apps using the reach, effectiveness, adoption, implementation, and maintenance framework and qualitatively evaluate the implementation of both mHealth interventions. Results: The study is currently enrolling study participants. Recruitment is anticipated to be completed by mid-2021. Conclusions: If this two-level intervention, that is, the combined use of InCharge Health and HU Toolbox apps, demonstrates efficacy in increasing adherence to hydroxyurea and prescribing behavior in patients with SCD and their providers, respectively, both apps will be offered to other institutions outside the SCDIC through a future large-scale implementation-effectiveness study. Trial Registration: ClinicalTrials.gov NCT04080167; https://clinicaltrials.gov/ct2/show/NCT04080167 International Registered Report Identifier (IRRID): DERR1-10.2196/16319 UR - https://www.researchprotocols.org/2020/7/e16319 UR - http://dx.doi.org/10.2196/16319 UR - http://www.ncbi.nlm.nih.gov/pubmed/32442144 ID - info:doi/10.2196/16319 ER - TY - JOUR AU - Proctor, Joanna AU - Naughton, Felix AU - Sloan, Melanie AU - Hopewell, Sarah AU - Brimicombe, James AU - Prevost, Toby A. AU - Wilson, F. Edward C. AU - Coleman, Tim AU - Sutton, Stephen PY - 2020/7/14 TI - Assessment of the Effectiveness and Cost-Effectiveness of Tailored Web- and Text-Based Smoking Cessation Support in Primary Care (iQuit in Practice II): Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e17160 VL - 9 IS - 7 KW - text messaging KW - smoking cessation KW - internet-based intervention KW - adults KW - smokers KW - tobacco KW - primary care N2 - Background: The prevalence of smoking is declining; however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to most smokers. However, this setting has one of the lowest success rates. The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates. iQuit has demonstrated feasibility, acceptability, and potential effectiveness. Objective: This definitive trial aims to determine the effectiveness and cost-effectiveness of iQuit when used as an adjunct to the usual support provided to patients who wish to quit smoking, compared with usual care alone. Methods: The iQuit in Practice II trial is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 individual allocation comparing usual care (ie, pharmacotherapy combined with multisession behavioral support)?the control?with usual care plus iQuit?the intervention. Participants were recruited through primary care clinics and talked to a smoking cessation advisor. Participants were randomized during the initial consultation, and those allocated to the intervention group received a tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients. Results: The primary outcome is self-reported prolonged abstinence biochemically verified using saliva cotinine at 6 months after the quit date. A sample size of 1700 participants, with 850 per arm, would yield 90% power to detect a 4.3% difference in validated quit rates between the groups at the two-sided 5% level of significance. The Cambridge East Research Ethics Committee approved the study in February 2016, and funding for the study was granted from May 2016. In total, 1671 participants were recruited between August 2016 and July 2019. Follow-up for all participants was completed in January 2020. Data analysis will begin in the summer of 2020. Conclusions: iQuit in Practice II is a definitive, pragmatic RCT assessing whether a digital intervention can augment the impact of routine smoking cessation support in primary care. Previous research has found good acceptability and feasibility for delivering iQuit among smoking cessation advisors working in primary care. If demonstrated to be cost-effective, iQuit could be delivered across primary care and other settings, such as community pharmacies. The potential benefit would likely be highest where less behavioral support is delivered. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 44559004; http://www.isrctn.com /ISRCTN44559004. International Registered Report Identifier (IRRID): DERR1-10.2196/17160 UR - https://www.researchprotocols.org/2020/7/e17160 UR - http://dx.doi.org/10.2196/17160 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673255 ID - info:doi/10.2196/17160 ER - TY - JOUR AU - Meinert, Edward AU - Rahman, Em AU - Potter, Alison AU - Lawrence, Wendy AU - Van Velthoven, Michelle PY - 2020/7/22 TI - Acceptability and Usability of the Mobile Digital Health App NoObesity for Families and Health Care Professionals: Protocol for a Feasibility Study JO - JMIR Res Protoc SP - e18068 VL - 9 IS - 7 KW - mHealth KW - mobile health KW - digital health KW - digital technology KW - weight loss KW - obesity KW - overweight KW - child health KW - cell phone KW - telecommunication N2 - Background: Almost a quarter or more than a fifth of children in the United Kingdom are overweight or obese by the time they start school. The UK Department of Health and Social Care?s national policy for combating childhood obesity has critical outcomes centered on sugar and caloric consumption reduction. Health Education England has developed two digital apps for families with children up to 15 years and for their associated health care professionals to provide a digital learning resource and tool aimed at encouraging healthy lifestyles to prevent obesity. Objective: This feasibility study assesses the usability and acceptability of Health Education England?s NoObesity app for undertaking activities to improve families? diet and physical activity. The purpose of the study is to evaluate the app?s influence on self-efficacy and goal setting and to determine what can be learnt to improve its design for future studies, if there is evidence of adoption and sustainability. Methods: The study population will include 20 to 40 families and their linked health care professionals. Considering issues related to digital access associated with socioeconomic status and the impact on information technology use, study recruitment will be regionally focused in a low socioeconomic status area. The study will last for 9 months (3-month intervention period and 6-month follow-up). The evaluations of feasibility, acceptability, and usability will be conducted using the following scales and theoretical frameworks: (1) system usability scale; (2) Reach Effectiveness Adoption Implementation Maintenance framework; (3) Bandura model of health promotion; and (4) Nonadoption, Abandonment, and Challenges to the Scale-up, Spread, and Suitability framework. App use will be captured and quantitatively analyzed for net use patterns (eg, number of screens viewed, number of logins, cumulative minutes using the app, number of plans made, and number of times goals met) and to triangulate qualitative feedback from study participants. Results: This study was funded in March 2019 by Health Education England and received University of Oxford Medical Sciences Interdivisional Research Ethics Committee approval on January 31, 2020 (R62092/RE001). At manuscript submission, study recruitment is pending, and expected results will be published in 2021. Conclusions: This study will provide evidence on the NoObesity app?s influence on self-efficacy and goal-setting and determine what can be learnt to improve its design for future studies, if there is evidence of adoption and sustainability. International Registered Report Identifier (IRRID): PRR1-10.2196/18068 UR - http://www.researchprotocols.org/2020/7/e18068/ UR - http://dx.doi.org/10.2196/18068 UR - http://www.ncbi.nlm.nih.gov/pubmed/32706703 ID - info:doi/10.2196/18068 ER - TY - JOUR AU - Hill, Jonathan AU - Garvin, Stefannie AU - Chen, Ying AU - Cooper, Vincent AU - Wathall, Simon AU - Bartlam, Bernadette AU - Saunders, Benjamin AU - Lewis, Martyn AU - Protheroe, Joanne AU - Chudyk, Adrian AU - Birkinshaw, Hollie AU - Dunn, M. Kate AU - Jowett, Sue AU - Oppong, Raymond AU - Hay, Elaine AU - van der Windt, Danielle AU - Mallen, Christian AU - Foster, E. Nadine PY - 2020/7/5 TI - Computer-Based Stratified Primary Care for Musculoskeletal Consultations Compared With Usual Care: Study Protocol for the STarT MSK Cluster Randomized Controlled Trial JO - JMIR Res Protoc SP - e17939 VL - 9 IS - 7 KW - musculoskeletal KW - primary health care KW - stratified care KW - randomized controlled trial KW - therapeutics KW - economics KW - outcome and process assessment, health care KW - prognosis KW - qualitative research KW - back pain KW - osteoarthritis N2 - Background: Musculoskeletal (MSK) pain is a major cause of pain and disability. We previously developed a prognostic tool (Start Back Tool) with demonstrated effectiveness in guiding primary care low back pain management by supporting decision making using matched treatments. A logical next step is to determine whether prognostic stratified care has benefits for a broader range of common MSK pain presentations. Objective: This study seeks to determine, in patients with 1 of the 5 most common MSK presentations (back, neck, knee, shoulder, and multisite pain), whether stratified care involving the use of the Keele Start MSK Tool to allocate individuals into low-, medium-, and high-risk subgroups, and matching these subgroups to recommended matched clinical management options, is clinical and cost-effective compared with usual nonstratified primary care. Methods: This is a pragmatic, two-arm parallel (stratified vs nonstratified care), cluster randomized controlled trial, with a health economic analysis and mixed methods process evaluation. The setting is UK primary care, involving 24 average-sized general practices randomized (stratified by practice size) in a 1:1 ratio (12 per arm) with blinding of trial statistician and outcome data collectors. Randomization units are general practices, and units of observation are adult MSK consulters without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records are tagged and individuals invited using a general practitioner (GP) point-of-consultation electronic medical record (EMR) template. The intervention is supported by an EMR template (computer-based) housing the Keele Start MSK Tool (to stratify into prognostic subgroups) and the recommended matched treatment options. The primary outcome using intention-to-treat analysis is pain intensity, measured monthly over 6 months. Secondary outcomes include physical function and quality of life, and an anonymized EMR audit to capture clinician decision making. The economic evaluation is focused on the estimation of incremental quality-adjusted life years and MSK pain?related health care costs. The process evaluation is exploring a range of potential factors influencing the intervention and understanding how it is perceived by patients and clinicians, with quantitative analyses focusing on a priori hypothesized intervention targets and qualitative approaches using focus groups and interviews. The target sample size is 1200 patients from 24 general practices, with >5000 MSK consultations available for anonymized medical record data comparisons. Results: Trial recruitment commenced on May 18, 2018, and ended on July 15, 2019, after a 14-month recruitment period in 24 GP practices. Follow-up and interview data collection was completed in February 2020. Conclusions: This trial is the first attempt, as far as we know, at testing a prognostic stratified care approach for primary care patients with MSK pain. The results of this trial should be available by the summer of 2020. Trial Registration: ISRCTN Registry ISRCTN15366334; http://www.isrctn.com/ISRCTN15366334. International Registered Report Identifier (IRRID): DERR1-10.2196/17939 UR - https://www.researchprotocols.org/2020/7/e17939 UR - http://dx.doi.org/10.2196/17939 UR - http://www.ncbi.nlm.nih.gov/pubmed/32442141 ID - info:doi/10.2196/17939 ER - TY - JOUR AU - Murat-Ringot, Audrey AU - Souquet, Jean Pierre AU - Chauvenet, Marion AU - Rentler, Charlotte AU - Subtil, Fabien AU - Schott, Anne-Marie AU - Preau, Marie AU - Piriou, Vincent PY - 2020/7/14 TI - The Effects of Foot Reflexology on Chemotherapy-Induced Nausea and Vomiting in Patients with Digestive System or Lung Cancer: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e17232 VL - 9 IS - 7 KW - cancer KW - randomized controlled trial KW - foot reflexology KW - nausea KW - vomiting KW - chemotherapy N2 - Background: The side effects of chemotherapy, specifically chemotherapy-induced nausea and vomiting, are a concern for patients. To relieve these side effects, antiemetic drugs are recommended. However, some patients report that these drugs are not sufficiently effective. Moreover, patients with chronic disease, including cancer, are increasingly interested in complementary and alternative medicines, and express the desire for nonpharmacological treatments to be used in hospitals. Foot reflexology is a holistic approach that is reported to significantly reduce the severity of chemotherapy-induced nausea and vomiting in patients with breast cancer. Some of the chemotherapy treatments for patients with lung and digestive system cancer are moderately or highly emetic. Objective: The primary objective of this study is to assess the benefits of foot reflexology, together with conventional treatments, on the severity and frequency of chemotherapy-induced nausea and vomiting in patients with lung or digestive system cancer. The secondary objectives to be assessed are quality of life, anxiety, and self-esteem. Methods: This study is an open-label randomized controlled trial conducted over 22 months (18 months intervention and 4 months follow-up). Eligible participants are patients with a lung or digestive system cancer with an indication for platinum-based chemotherapy. Participants are randomized into two groups: conventional care with foot reflexology and conventional care without foot reflexology. Foot reflexology sessions (30 minutes) are performed on an outpatient or inpatient basis. It was estimated that 40 participants per group will be required. The benefits of foot reflexology will be assessed by comparing the relative change in the severity of nausea and vomiting, as assessed by a visual analogue scale, and the frequency of these side effects between the two groups. The secondary objectives will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; Hospital and Anxiety Depression Scale; and Body Image Questionnaire. Results: This study was approved by the regional ethics committee (Île de France X CPP) on April 3, 2018 (No. ID RCB 2018-A00571-54). Enrollment started in June 2018. Data analysis will be performed during the second quarter of 2020 and results will be published in the last quarter of 2020. Conclusions: The lack of knowledge regarding the efficacy and safety of foot reflexology limits oncologists to recommend it for this use. This study will provide evidence of the benefits of foot reflexology. If efficacy is confirmed, foot reflexology may be a promising complement to conventional antiemetic drugs. Trial Registration: Clinicaltrials.gov NCT03508180; https://www.clinicaltrials.gov/ct2/show/NCT03508180. International Registered Report Identifier (IRRID): DERR1-10.2196/17232 UR - https://www.researchprotocols.org/2020/7/e17232 UR - http://dx.doi.org/10.2196/17232 UR - http://www.ncbi.nlm.nih.gov/pubmed/32449505 ID - info:doi/10.2196/17232 ER - TY - JOUR AU - Gurgel-Juarez, Nalia AU - Perrier, Marie-France AU - Hoffmann, Tammy AU - Lannin, Natasha AU - Jolliffe, Laura AU - Lee, Rachel AU - Brosseau, Lucie AU - Flowers, Heather PY - 2020/7/1 TI - Guideline Recommendations for Oral Care After Acquired Brain Injury: Protocol for a Systematic Review JO - JMIR Res Protoc SP - e17249 VL - 9 IS - 7 KW - practice guideline KW - evidence-based recommendations KW - brain injuries KW - oral health KW - oral hygiene KW - systematic review N2 - Background: Oral care is important to prevent buccal and systemic infections after an acquired brain injury (ABI). Despite recent advancements in the development of ABI clinical practice guidelines, recommendations for specific clinical processes and actions to attain adequate oral care often lack information. Objective: This systematic review will (1) identify relevant ABI clinical practice guidelines and (2) appraise the oral care recommendations existing in the selected guidelines. Methods: A search strategy was developed based on a recent systematic review of clinical practice guidelines for ABI. The protocol includes a search of MEDLINE, EMBASE, and DynaMed Plus databases, as well as organizational and best-practice websites and reference lists of accepted guidelines. Search terms will include medical subject headings and user-defined terms. Guideline appraisal will involve the Appraisal of Guidelines for Research and Evaluation II ratings, followed by a descriptive synopsis for oral care recommendations according to the National Health and Medical Research Council evidence levels. Results: This project started in April 2019, when we developed the search strategy. The preliminary search of databases and websites yielded 863 and 787 citations, respectively, for a total of 1650 citations. Data collection will start in August 2020 and we expect to begin disseminating the results in May 2021. Conclusions: Nursing staff may not have detailed recommendations on how to provide oral care for neurologically impaired patients. The findings of this review will explore the evidence for oral care in existing guidelines and improve outcomes for patients with ABI. We expect to provide adequate orientations to clinicians, inform policy and guidelines for best practices, and contribute to future directions for research in the ABI realm. International Registered Report Identifier (IRRID): PRR1-10.2196/17249 UR - https://www.researchprotocols.org/2020/7/e17249 UR - http://dx.doi.org/10.2196/17249 UR - http://www.ncbi.nlm.nih.gov/pubmed/32609090 ID - info:doi/10.2196/17249 ER - TY - JOUR AU - Shersher, Violetta AU - Haines, P. Terry AU - Williams, Cylie AU - Willoughby, Louisa AU - Sturgiss, Elizabeth AU - Weller, Carolina PY - 2020/7/14 TI - Developing a Taxonomy of Communication Techniques and Aids Used By Healthcare Providers During Patient Consultations: Protocol for a Systematic Review JO - JMIR Res Protoc SP - e16801 VL - 9 IS - 7 KW - communication KW - patient-provider communication, patient education, taxonomy N2 - Background: Currently, there is no available standardized taxonomy of defined communication techniques and aids used by healthcare providers during patient consultations. It is challenging to identify communication techniques that contribute to effective healthcare provider and patient consultations and to replicate communication interventions in research. Objective: The aim of this paper is to describe a protocol for the development and pilot of a taxonomy of communication techniques and aids used by healthcare providers during patient consultations. Methods: A systematic review will be completed to identify eligible studies. Extracted techniques and aids will be organized into a preliminary taxonomy by a multidisciplinary team. The preliminary taxonomy will be piloted by two groups: research assistants trained in taxonomy application and healthcare providers and healthcare professional students not trained in taxonomy use. The pilot will use custom developed video footage of health provider and patient interactions. Interrater validity and interview feedback will be used to inform a Delphi panel of multidisciplinary healthcare providers and patient experts when they convene to finalize the preliminary taxonomy. Results: This study was funded in November 2017 by the Monash University Interdisciplinary Research Seed Funding Scheme. Data collection commenced in March 2018, and data analysis is in progress. We expect the results to be published in 2021. Conclusions: This is the first known attempt to develop a defined and standardized taxonomy of communication techniques and aids used by healthcare providers in patient consultations. The findings will be used to inform future research by providing a detailed taxonomy of healthcare providers? communication techniques and standardized definitions. International Registered Report Identifier (IRRID): DERR1-10.2196/16801 UR - https://www.researchprotocols.org/2020/7/e16801 UR - http://dx.doi.org/10.2196/16801 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673277 ID - info:doi/10.2196/16801 ER - TY - JOUR AU - Odejimi, Opeyemi AU - Tadros, George AU - Sabry, Noha PY - 2020/7/24 TI - Prevalence of Mental Disorders, Cognitive Impairment, and Dementia Among Older Adults in Egypt: Protocol for a Systematic Review JO - JMIR Res Protoc SP - e14637 VL - 9 IS - 7 KW - mental disorders KW - cognitive impairment KW - dementia KW - older adults KW - Egypt KW - prevalence KW - socio-demographic factors KW - systematic review KW - protocol N2 - Background: In Egypt, the population of older adults is rapidly growing. The last census in 2017 indicated that older adults numbered 94.8 million, which is a 2.56% increase from the 2006 census. There is growing evidence that the older population is at greater risk for some forms of mental disorders such as depression, dementia, and many more. Objective: This study aims to review the current evidence regarding the prevalence of mental disorders among older adults in Egypt. This will be achieved by estimating the current prevalence of mental disorders and identifying any sociodemographic correlations with mental disorders. Methods: An electronic search of 5 key databases (MEDLINE, PsycINFO, EMBASE, AMED, and PubMed) from their date of inception was conducted. In addition, scans of reference lists and searches of key journals, citations, and relevant internet resources were conducted. Studies were included if they were published in English, point prevalence studies, conducted with older Egyptians aged ?60 years, and conducted using a validated diagnostic tool to ascertain mental disorders. Studies that did not meet any of these criteria were excluded. Results: This systematic review started in November 2018. The literature search of the 5 databases revealed 343 papers. After screening titles and abstracts, scanning citations and reference lists, and searching internet sources, a total of 38 full-text articles were accessed, of which 16 studies met the eligibility criteria and were included. We are currently in the process of data extraction and synthesis. Conclusions: This research will help bring the scale of mental disorders among older adults in Egypt to the forefront. This may help ensure evidence-based initiatives are established and that priority is given to resource allocation for geriatric mental health in Egypt. Trial Registration: PROSPERO International Prospective Register of Systematic Review CRD42018114831; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=114831 International Registered Report Identifier (IRRID): DERR1-10.2196/14637 UR - http://www.researchprotocols.org/2020/7/e14637/ UR - http://dx.doi.org/10.2196/14637 UR - http://www.ncbi.nlm.nih.gov/pubmed/32706699 ID - info:doi/10.2196/14637 ER - TY - JOUR AU - Debenham, Jennifer AU - Newton, Nicola AU - Birrell, Louise AU - Yücel, Murat AU - Lees, Briana AU - Champion, Katrina PY - 2020/7/27 TI - Cannabis and Illicit Drug Use During Neurodevelopment and the Associated Structural, Functional and Cognitive Outcomes: Protocol for a Systematic Review JO - JMIR Res Protoc SP - e18349 VL - 9 IS - 7 KW - cannabis KW - illicit drugs KW - neurodevelopment KW - longitudinal review KW - protocol KW - neurology KW - review N2 - Background: High rates of cannabis and illicit drug use are experienced by young people during the final stages of neurodevelopment (aged 15-24 years), a period characterized by high neuroplasticity. Frequent drug use during this time may interfere with neurophysiological and neuropsychological development pathways, potentially leading to ongoing unfavorable neuroadaptations. The dose-response relationship between illicit drug use, exposure, and individual neurodevelopmental variation is unknown but salient with global shifts in the legal landscape and increasingly liberal attitudes and perceptions of the harm caused by cannabis and illicit drugs. Objective: This systematic review aims to synthesize longitudinal studies that investigate the effects of illicit drug use on structural, functional, and cognitive brain domains in individuals under the neural age of adulthood (25 years). This protocol outlines prospective methods that will facilitate an exhaustive review of the literature exploring pre- and post-drug use brain abnormalities arising during neurodevelopment. Methods: Five electronic databases (Medline, Embase, PsycINFO, ProQuest Central, and Web of Science) will be systematically searched between 1990 and 2019. The search terms will be a combination of MeSH (Medical Subject Headings), with keywords adapted to each database. Study reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and if relevant, study quality will be assessed using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach. Eligible studies are those that sampled youth exposed to cannabis or illicit drugs and employed neurophysiological or neuropsychological assessment techniques. Studies will be excluded if participants had been clinically diagnosed with any psychiatric, neurological, or pharmacological condition. Results: This is an ongoing review. As of February 2020, papers are in full-text screening, with results predicted to be complete by July 2020. Conclusions: Integrating data collected on the three brain domains will enable an assessment of the links between structural, functional, and cognitive brain health across individuals and may support the early detection and prevention of neurodevelopmental harm. Trial Registration: PROSPERO CRD42020151442; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=151442 International Registered Report Identifier (IRRID): PRR1-10.2196/18349 UR - https://www.researchprotocols.org/2020/7/e18349 UR - http://dx.doi.org/10.2196/18349 UR - http://www.ncbi.nlm.nih.gov/pubmed/32716005 ID - info:doi/10.2196/18349 ER - TY - JOUR AU - Alturkistani, Abrar AU - Greenfield, Geva AU - Greaves, Felix AU - Aliabadi, Shirin AU - Jenkins, H. Rosemary AU - Costelloe, Ceire PY - 2020/7/31 TI - Patient Portal Functionalities and Uptake: Systematic Review Protocol JO - JMIR Res Protoc SP - e14975 VL - 9 IS - 7 KW - personal health record KW - patient portal KW - electronic health records KW - online access KW - patient records KW - systematic review N2 - Background: Patient portals are digital health tools adopted by health care organizations. The portals are generally connected to the electronic health record of the health care organization and offer patients functionalities such as access to the medical record, ability to order repeat prescriptions, make appointments, or message the health care provider. Patient portals may be beneficial for both patients and the health care system. Patient portals can widely differ from one context to another due to the differences in the portal functionalities and capabilities and it is anticipated that outcomes associated with the functionalities also differ. Current systematic reviews report outcomes associated with patient portal uptake but do not explicitly specify the patient portal functionalities. Objective: The aim of this systematic review is to synthesize the evidence on health and health care quality outcomes associated with patient portal use among adult (18 years or older) patients. The review research questions are as follows: What kind of health outcomes do tethered?patient portals and patient portal functionalities contribute to in adult patients (18 years or older)? and What kind of health care quality outcomes, including health care utilization outcomes, do tethered?patient portals and patient portal functionalities contribute to in adult patients (18 years or older)? Methods: The systematic review will be conducted by searching the MEDLINE, EMBASE, and Scopus databases for relevant literature. The review inclusion criteria will be studies about adult patients (18 years or older), studies only about tethered patient portals, and studies with or without a comparator. We will report patient portal?associated health and health care quality outcomes based on the patient portal functionalities. All quantitative primary study types will be included. Risk of bias of included studies will be assessed using the Cochrane Collaboration?s tool for assessing risk of bias in randomized trials and the National Heart, Lung, and Blood Institute?s quality assessment tools. Data will be synthesized using narrative synthesis and will be reported according to the patient portal functionalities, country, disease, and health care system model. Results: Searches will be conducted in September 2019, and the review is anticipated to be completed by the end of June 2020. Conclusions: This systematic review will provide an overview of health and health care quality outcomes associated with patient portal use among adult patients, providing detailed information about the functionalities of the portals and their associations with the outcomes. The review could potentially help patient portal evaluation studies by providing insights into outcomes associated with the different functionalities of patient portals. Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42019141131; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=141131 International Registered Report Identifier (IRRID): PRR1-10.2196/14975 UR - https://www.researchprotocols.org/2020/7/e14975 UR - http://dx.doi.org/10.2196/14975 UR - http://www.ncbi.nlm.nih.gov/pubmed/32734928 ID - info:doi/10.2196/14975 ER - TY - JOUR AU - Weiner, S. Lauren AU - Nagel, Stori AU - Su, Irene H. AU - Hurst, Samantha AU - Hartman, J. Sheri PY - 2020/7/8 TI - A Remotely Delivered, Peer-Led Physical Activity Intervention for Younger Breast Cancer Survivors (Pink Body Spirit): Protocol for a Feasibility Study and Mixed Methods Process Evaluation JO - JMIR Res Protoc SP - e18420 VL - 9 IS - 7 KW - physical activity KW - cancer survivors KW - peer mentors KW - quality of life KW - pilot study KW - breast cancer KW - fitness trackers KW - mobile phone N2 - Background: Younger breast cancer survivors consistently report a greater impact of their cancer experience on quality of life compared with older survivors, including higher rates of body image disturbances, sexual dysfunction, and fatigue. One potential strategy to improve quality of life is through physical activity, but this has been understudied in younger breast cancer survivors, who often decrease their activity during and after cancer treatment. Objective: The aim of this study is to explore the feasibility and acceptability of a technology-based, remotely delivered, peer-led physical activity intervention for younger breast cancer survivors. We will also assess the preliminary impact of the intervention on changes in physical activity and multiple aspects of quality of life. Methods: This study is a community-academic partnership between University of California, San Diego and Haus of Volta, a nonprofit organization that promotes positive self-image in younger breast cancer survivors. This ongoing pilot study aims to recruit 30 younger breast cancer survivors across the United States (<55 years old, >6 months post primary cancer treatment, self-report <60 min of moderate-to-vigorous-intensity physical activity [MVPA]) into a 3-month peer-delivered, fully remote exercise program. Participants will complete 6 biweekly video chat sessions with a trained peer mentor, a fellow younger breast cancer survivor. Participants will receive a Fitbit Charge 3; weekly feedback on Fitbit data from their peer mentor; and access to a private, in-app Fitbit Community to provide and receive support from other participants and all peer mentors. At baseline, 3 months, and 6 months, participants will complete quality of life questionnaires, and MVPA will be measured using the ActiGraph accelerometer. Feasibility and acceptability will be explored through a mixed methods approach (ie, quantitative questionnaires and qualitative interviews). Intervention delivery and adaptations by peer mentors will be tracked through peer mentor self-evaluations and reflections, review of video-recorded mentoring sessions, and monthly templated reflections by the research team. Results: Recruitment began in September 2019. As of February 2020, the physical activity intervention is ongoing. Final measures are expected to occur in summer 2020. Conclusions: This study explores the potential for physical activity to improve sexual function, body image, and fatigue, key quality of life issues in younger breast cancer survivors. Using peer mentors extends our reach into the young survivor community. The detailed process evaluation of intervention delivery and adaptations by mentors could inform a future hybrid-effectiveness implementation trial. Finally, remote delivery with commercially available technology could promote broader dissemination. Trial Registration: ClinicalTrials.gov NCT04064892; https://clinicaltrials.gov/ct2/show/NCT04064892 International Registered Report Identifier (IRRID): DERR1-10.2196/18420 UR - https://www.researchprotocols.org/2020/7/e18420 UR - http://dx.doi.org/10.2196/18420 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673270 ID - info:doi/10.2196/18420 ER - TY - JOUR AU - Kelly, J. Peter AU - Beck, K. Alison AU - Baker, L. Amanda AU - Deane, P. Frank AU - Hides, Leanne AU - Manning, Victoria AU - Shakeshaft, Anthony AU - Larance, Briony AU - Neale, Joanne AU - Kelly, John AU - Oldmeadow, Christopher AU - Searles, Andrew AU - Treloar, Carla AU - Gray, M. Rebecca AU - Argent, Angela AU - McGlaughlin, Ryan PY - 2020/7/9 TI - Feasibility of a Mobile Health App for Routine Outcome Monitoring and Feedback in Mutual Support Groups Coordinated by SMART Recovery Australia: Protocol for a Pilot Study JO - JMIR Res Protoc SP - e15113 VL - 9 IS - 7 KW - SMART Recovery KW - mutual support group KW - mutual aid KW - routine outcome monitoring KW - treatment progress feedback KW - mHealth KW - addiction KW - mobile phone N2 - Background: Despite the importance and popularity of mutual support groups, there have been no systematic attempts toimplement and evaluate routine outcome monitoring (ROM) in these settings. Unlike other mutual support groups for addiction,trained facilitators lead all Self-Management and Recovery Training (SMART Recovery) groups, thereby providing an opportunityto implement ROM as a routine component of SMART Recovery groups. Objective: This study protocol aims to describe a stage 1 pilot study designed to explore the feasibility and acceptability of anovel, purpose-built mobile health (mHealth) ROM and feedback app (Smart Track) in SMART Recovery groups coordinated by SMART Recovery Australia (SRAU) The secondary objectives are to describe Smart Track usage patterns, explore psychometric properties of the ROM items (ie, internal reliability and convergent and divergent validity), and provide preliminary evidence for participant reported outcomes (such as alcohol and other drug use, self-reported recovery, and mental health). Methods: Participants (n=100) from the SMART Recovery groups across New South Wales, Australia, will be recruited to a nonrandomized, prospective, single-arm trial of the Smart Track app. There are 4 modes of data collection: (1) ROM data collected from group participants via the Smart Track app, (2) data analytics summarizing user interactions with Smart Track, (3) quantitative interview and survey data of group participants (baseline, 2-week follow-up, and 2-month follow-up), and (4) qualitative interviews with group participants (n=20) and facilitators (n=10). Feasibility and acceptability (primary objectives) will be analyzed using descriptive statistics, a cost analysis, and a qualitative evaluation. Results: At the time of submission, 13 sites (25 groups per week) had agreed to be involved. Funding was awarded on August 14, 2017, and ethics approval was granted on April 26, 2018 (HREC/18/WGONG/34; 2018/099). Enrollment is due to commence in July 2019. Data collection is due to be finalized in October 2019. Conclusions: To the best of our knowledge, this study is the first to use ROM and tailored feedback within a mutual support group setting for addictive behaviors. Our study design will provide an opportunity to identify the acceptability of a novel mHealth ROM and feedback app within this setting and provide detailed information on what factors promote or hinder ROM usage within this context. This project aims to offer a new tool, should Smart Track prove feasible and acceptable, that service providers, policy makers, and researchers could use in the future to understand the impact of SMART Recovery groups. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12619000686101; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377336. International Registered Report Identifier (IRRID): PRR1-10.2196/15113 UR - https://www.researchprotocols.org/2020/7/e15113 UR - http://dx.doi.org/10.2196/15113 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673272 ID - info:doi/10.2196/15113 ER - TY - JOUR AU - Oreglia, Elisa AU - Ly, Sokhey AU - Tijamo, Camille AU - Ou, Amra AU - Free, Caroline AU - Smith, Chris PY - 2020/7/10 TI - Development of an Intervention to Support the Reproductive Health of Cambodian Women Who Seek Medical Abortion: Research Protocol JO - JMIR Res Protoc SP - e17779 VL - 9 IS - 7 KW - reproductive health KW - abortion KW - Cambodia KW - mHealth KW - mobile phone N2 - Background: In Cambodia, abortion has been legally permitted on request during the first trimester of pregnancy since 1997. However, although there has been an increase in the percentage of women having induced abortion and medical abortion, there has also been a decrease in the percentage of women who say they received help from a health worker with their abortion. These data point toward the demedicalization of abortion, and although medical abortion has been shown to be safe, there are concerns about safety, given the variety of available products and counseling provided. These concerns are particularly relevant for female factory workers, who typically come from rural areas where access to good health care and information about reproductive health care is limited. Objective: This study aims to understand the reproductive health needs of female Cambodian garment factory workers after medical abortion from a multidisciplinary and mixed-methods perspective, focusing on how they seek and share medical abortion- and health-related information; how they use their mobile phones for this and other purposes; what cultural challenges exist around reproductive health; and how they might be magnified or mitigated by mobile phones, linguistic challenges around health care, and mobile phone use. The main purpose of this study is to combine multidisciplinary methods, theories, and expertise to gain new, culturally grounded insights into family planning and medical abortion in Cambodia, but the findings could help inform the development of a relevant intervention to support comprehensive postabortion care. Methods: The methods proposed are interviews and participant observation among factory workers, health providers, and mobile phone providers; a linguistic analysis of relevant data (interview transcripts, web-based sources, and other fieldwork materials); and digital methods to understand what kind of information about medical abortion exists on the web in Cambodia and how it is accessed by the targeted population. Results: The data collection part of the project will end on December 31, 2020. The team conducted 67 semistructured interviews with female factory workers, women who sought a medical abortion, health providers, and mobile phone providers; participant observation with factory workers and health providers; and an analysis of YouTube and Facebook to understand what kind of information is available, who creates it, and how it is used. The team is currently performing data analysis, and the findings are clustered around (1) the use of mobile phones and digital resources for health-related and medical abortion-related information, (2) the experience of medical abortion care, and (3) the development of an intervention through edutainment videos. Conclusions: The project highlights both the widely untapped potential of using digital platforms (especially YouTube and Facebook) to distribute accurate information on medical abortion and the challenges in providing individual information via mobile phones while respecting individuals? privacy. International Registered Report Identifier (IRRID): DERR1-10.2196/17779 UR - https://www.researchprotocols.org/2020/7/e17779 UR - http://dx.doi.org/10.2196/17779 UR - http://www.ncbi.nlm.nih.gov/pubmed/32423893 ID - info:doi/10.2196/17779 ER - TY - JOUR AU - Kasaeyan Naeini, Emad AU - Jiang, Mingzhe AU - Syrjälä, Elise AU - Calderon, Michael-David AU - Mieronkoski, Riitta AU - Zheng, Kai AU - Dutt, Nikil AU - Liljeberg, Pasi AU - Salanterä, Sanna AU - Nelson, M. Ariana AU - Rahmani, M. Amir PY - 2020/7/1 TI - Prospective Study Evaluating a Pain Assessment Tool in a Postoperative Environment: Protocol for Algorithm Testing and Enhancement JO - JMIR Res Protoc SP - e17783 VL - 9 IS - 7 KW - pain measurement KW - pain, postoperative KW - acute pain KW - health monitoring KW - wearable electronic devices KW - machine learning KW - multimodal biosignals N2 - Background: Assessment of pain is critical to its optimal treatment. There is a high demand for accurate objective pain assessment for effectively optimizing pain management interventions. However, pain is a multivalent, dynamic, and ambiguous phenomenon that is difficult to quantify, particularly when the patient?s ability to communicate is limited. The criterion standard of pain intensity assessment is self-reporting. However, this unidimensional model is disparaged for its oversimplification and limited applicability in several vulnerable patient populations. Researchers have attempted to develop objective pain assessment tools through analysis of physiological pain indicators, such as electrocardiography, electromyography, photoplethysmography, and electrodermal activity. However, pain assessment by using only these signals can be unreliable, as various other factors alter these vital signs and the adaptation of vital signs to pain stimulation varies from person to person. Objective pain assessment using behavioral signs such as facial expressions has recently gained attention. Objective: Our objective is to further the development and research of a pain assessment tool for use with patients who are likely experiencing mild to moderate pain. We will collect observational data through wearable technologies, measuring facial electromyography, electrocardiography, photoplethysmography, and electrodermal activity. Methods: This protocol focuses on the second phase of a larger study of multimodal signal acquisition through facial muscle electrical activity, cardiac electrical activity, and electrodermal activity as indicators of pain and for building predictive models. We used state-of-the-art standard sensors to measure bioelectrical electromyographic signals and changes in heart rate, respiratory rate, and oxygen saturation. Based on the results, we further developed the pain assessment tool and reconstituted it with modern wearable sensors, devices, and algorithms. In this second phase, we will test the smart pain assessment tool in communicative patients after elective surgery in the recovery room. Results: Our human research protections application for institutional review board review was approved for this part of the study. We expect to have the pain assessment tool developed and available for further research in early 2021. Preliminary results will be ready for publication during fall 2020. Conclusions: This study will help to further the development of and research on an objective pain assessment tool for monitoring patients likely experiencing mild to moderate pain. International Registered Report Identifier (IRRID): DERR1-10.2196/17783 UR - https://www.researchprotocols.org/2020/7/e17783 UR - http://dx.doi.org/10.2196/17783 UR - http://www.ncbi.nlm.nih.gov/pubmed/32609091 ID - info:doi/10.2196/17783 ER - TY - JOUR AU - Marshall, M. Jamie AU - Dunstan, A. Debra AU - Bartik, Warren PY - 2020/7/5 TI - Effectiveness of Using Mental Health Mobile Apps as Digital Antidepressants for Reducing Anxiety and Depression: Protocol for a Multiple Baseline Across-Individuals Design JO - JMIR Res Protoc SP - e17159 VL - 9 IS - 7 KW - mHealth KW - eHealth KW - mobile apps KW - mobile phone KW - anxiety KW - depression KW - single-case study N2 - Background: The use of mental health mobile apps to treat anxiety and depression is widespread and growing. Several reviews have found that most of these apps do not have published evidence for their effectiveness, and existing research has primarily been undertaken by individuals and institutions that have an association with the app being tested. Another reason for the lack of research is that the execution of the traditional randomized controlled trial is time prohibitive in this profit-driven industry. Consequently, there have been calls for different methodologies to be considered. One such methodology is the single-case design, of which, to the best of our knowledge, no peer-reviewed published example with mental health apps for anxiety and/or depression could be located. Objective: The aim of this study is to examine the effectiveness of 5 apps (Destressify, MoodMission, Smiling Mind, MindShift, and SuperBetter) in reducing symptoms of anxiety and/or depression. These apps were selected because they are publicly available, free to download, and have published evidence of efficacy. Methods: A multiple baseline across-individuals design will be employed. A total of 50 participants will be recruited (10 for each app) who will provide baseline data for 20 days. The sequential introduction of an intervention phase will commence once baseline readings have indicated stability in the measures of participants? mental health and will proceed for 10 weeks. Postintervention measurements will continue for a further 20 days. Participants will be required to provide daily subjective units of distress (SUDS) ratings via SMS text messages and will complete other measures at 5 different time points, including at 6-month follow-up. SUDS data will be examined via a time series analysis across the experimental phases. Individual analyses of outcome measures will be conducted to detect clinically significant changes in symptoms using the statistical approach proposed by Jacobson and Truax. Participants will rate their app on several domains at the end of the intervention. Results: Participant recruitment commenced in January 2020. The postintervention phase will be completed by June 2020. Data analysis will commence after this. A write-up for publication is expected to be completed after the follow-up phase is finalized in January 2021. Conclusions: If the apps prove to be effective as hypothesized, this will provide collateral evidence of their efficacy. It could also provide the benefits of (1) improved access to mental health services for people in rural areas, lower socioeconomic groups, and children and adolescents and (2) improved capacity to enhance face-to-face therapy through digital homework tasks that can be shared instantly with a therapist. It is also anticipated that this methodology could be used for other mental health apps to bolster the independent evidence base for this mode of treatment. International Registered Report Identifier (IRRID): PRR1-10.2196/17159 UR - https://www.researchprotocols.org/2020/7/e17159 UR - http://dx.doi.org/10.2196/17159 UR - http://www.ncbi.nlm.nih.gov/pubmed/32623368 ID - info:doi/10.2196/17159 ER - TY - JOUR AU - Burns, David AU - Razmjou, Helen AU - Shaw, James AU - Richards, Robin AU - McLachlin, Stewart AU - Hardisty, Michael AU - Henry, Patrick AU - Whyne, Cari PY - 2020/7/5 TI - Adherence Tracking With Smart Watches for Shoulder Physiotherapy in Rotator Cuff Pathology: Protocol for a Longitudinal Cohort Study JO - JMIR Res Protoc SP - e17841 VL - 9 IS - 7 KW - rehabilitation KW - treatment adherence and compliance KW - wearable electronic devices KW - machine learning KW - rotator cuff N2 - Background: Physiotherapy is essential for the successful rehabilitation of common shoulder injuries and following shoulder surgery. Patients may receive some training and supervision for shoulder physiotherapy through private pay or private insurance, but they are typically responsible for performing most of their physiotherapy independently at home. It is unknown how often patients perform their home exercises and if these exercises are performed correctly without supervision. There are no established tools for measuring this. It is, therefore, unclear if the full benefit of shoulder physiotherapy treatments is being realized. Objective: The proposed research will (1) validate a smartwatch and machine learning (ML) approach for evaluating adherence to shoulder exercise participation and technique in a clinical patient population with rotator cuff pathology; (2) quantify the rate of home physiotherapy adherence, determine the effects of adherence on recovery, and identify barriers to successful adherence; and (3) develop and pilot test an ethically conscious adherence-driven rehabilitation program that individualizes patient care based on their capacity to effectively participate in their home physiotherapy. Methods: This research will be conducted in 2 phases. The first phase is a prospective longitudinal cohort study, involving 120 patients undergoing physiotherapy for rotator cuff pathology. Patients will be issued a smartwatch that will record 9-axis inertial sensor data while they perform physiotherapy exercises both in the clinic and in the home setting. The data collected in the clinic under supervision will be used to train and validate our ML algorithms that classify shoulder physiotherapy exercise. The validated algorithms will then be used to assess home physiotherapy adherence from the inertial data collected at home. Validated outcome measures, including the Disabilities of the Arm, Shoulder, and Hand questionnaire; Numeric Pain Rating Scale; range of motion; shoulder strength; and work status, will be collected pretreatment, monthly through treatment, and at a final follow-up of 12 months. We will then relate improvement in patient outcomes to measured physiotherapy adherence and patient baseline variables in univariate and multivariate analyses. The second phase of this research will involve the evaluation of a novel rehabilitation program in a cohort of 20 patients. The program will promote patient physiotherapy engagement via the developed technology and support adherence-driven care decisions. Results: As of December 2019, 71 patients were screened for enrollment in the noninterventional validation phase of this study; 65 patients met the inclusion and exclusion criteria. Of these, 46 patients consented and 19 declined to participate in the study. Only 2 patients de-enrolled from the study and data collection is ongoing for the remaining 44. Conclusions: This study will provide new and important insights into shoulder physiotherapy adherence, the relationship between adherence and recovery, barriers to better adherence, and methods for addressing them. International Registered Report Identifier (IRRID): DERR1-10.2196/17841 UR - https://www.researchprotocols.org/2020/7/e17841 UR - http://dx.doi.org/10.2196/17841 UR - http://www.ncbi.nlm.nih.gov/pubmed/32623366 ID - info:doi/10.2196/17841 ER - TY - JOUR AU - Kim, Hee AU - Ganslandt, Thomas AU - Miethke, Thomas AU - Neumaier, Michael AU - Kittel, Maximilian PY - 2020/7/13 TI - Deep Learning Frameworks for Rapid Gram Stain Image Data Interpretation: Protocol for a Retrospective Data Analysis JO - JMIR Res Protoc SP - e16843 VL - 9 IS - 7 KW - high performance computing KW - rapid Gram stain classification KW - image data analysis KW - deep learning KW - convolutional neural network N2 - Background: In recent years, remarkable progress has been made in deep learning technology and successful use cases have been introduced in the medical domain. However, not many studies have considered high-performance computing to fully appreciate the capability of deep learning technology. Objective: This paper aims to design a solution to accelerate an automated Gram stain image interpretation by means of a deep learning framework without additional hardware resources. Methods: We will apply and evaluate 3 methodologies, namely fine-tuning, an integer arithmetic?only framework, and hyperparameter tuning. Results: The choice of pretrained models and the ideal setting for layer tuning and hyperparameter tuning will be determined. These results will provide an empirical yet reproducible guideline for those who consider a rapid deep learning solution for Gram stain image interpretation. The results are planned to be announced in the first quarter of 2021. Conclusions: Making a balanced decision between modeling performance and computational performance is the key for a successful deep learning solution. Otherwise, highly accurate but slow deep learning solutions can add value to routine care. International Registered Report Identifier (IRRID): DERR1-10.2196/16843 UR - http://www.researchprotocols.org/2020/7/e16843/ UR - http://dx.doi.org/10.2196/16843 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673276 ID - info:doi/10.2196/16843 ER - TY - JOUR AU - Reis, Zilma AU - Vitral, Gabriela AU - Guimarăes, Rodney AU - Gaspar, Juliano AU - Colosimo, Enrico AU - Taunde, Sergio AU - Mussagy, Nilza AU - Rosado Santos, Rita AU - Ayres-De-Campos, Diogo AU - Romanelli, Roberta PY - 2020/7/14 TI - Premature or Small for Gestational Age Discrimination: International Multicenter Trial Protocol for Classification of the Low-Birth-Weight Newborn Through the Optical Properties of the Skin JO - JMIR Res Protoc SP - e16477 VL - 9 IS - 7 KW - prematurity KW - fetal growth restriction KW - childbirth KW - skin physiological phenomena KW - photomedicine KW - equipment and supplies N2 - Background: A low birth weight is an independent risk factor for adverse infant outcomes and a predictor of chronic disease in adulthood. In these situations, differentiating between prematurity and small for gestational age (SGA) or simultaneous conditions is essential to ensuring adequate care. Such diagnoses, however, depend on reliable pregnancy dating, which can be challenging in developing countries. A new medical optoelectronic device was developed to estimate gestational age (GA) at birth based on newborn skin reflection. Objective: This study will aim to evaluate the device?s ability to detect prematurity or SGA, or both conditions simultaneously as well as predict short-term pulmonary complications in a cohort of low-birth-weight newborns. Methods: This study protocol was designed for a multicenter cohort including referral hospitals in Brazil and Mozambique. Newborns weighing 500-2500 g will be eligible for inclusion with the best GA available, considering the limited resources of low-income countries. Comparator-GA is based on reliable last menstrual period dating or ultrasound assessment before 24 weeks? gestation. Estimated GA at birth (Test-GA) will be calculated by applying a novel optoelectronic device to the newborn?s skin over the sole. The average difference between Test-GA and Comparator-GA will be analyzed, as will the percentage of newborns who are correctly diagnosed as preterm or SGA. In addition, in a nested case?control study, the accuracy of skin reflection in the prediction of prematurity-related respiratory problems will be evaluated. The estimated required sample size is 298 newborns. Results: Teams of health professionals were trained, and standard operating procedures were developed following the good practice guidelines for the clinical investigation of medical devices for human participants. The first recruitment started in March 2019 in Brazil. Data collection is planned to end in December 2020, and the results should be available in March 2021. Conclusions: The results of this clinical study have the potential to validate a new device to easily assess postnatal GA, supporting SGA identification when pregnancy dating is unreliable or unknown. Trial Registration: ReBec: RBR-33rnjf; http://www.ensaiosclinicos.gov.br/rg/RBR-33rnjf/ International Registered Report Identifier (IRRID): DERR1-10.2196/16477 UR - https://www.researchprotocols.org/2020/7/e16477 UR - http://dx.doi.org/10.2196/16477 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673275 ID - info:doi/10.2196/16477 ER - TY - JOUR AU - Forsström, David AU - Sundström, Christopher AU - Berman, H. Anne AU - Sundqvist, Kristina PY - 2020/7/15 TI - Internet-Delivered Cognitive Behavioral Therapy for Problematic Alcohol Use in a Workplace Setting: Protocol for Quantitative and Qualitative Evaluation of Feasibility and Outcomes JO - JMIR Res Protoc SP - e18693 VL - 9 IS - 7 KW - workplace setting KW - ICBT KW - alcohol KW - protocol KW - mental health KW - feasibility KW - CBT KW - cognitive behavioral therapy KW - intervention KW - workplace N2 - Background: Internet-based cognitive behavioral therapy (ICBT) for mental health issues has been successfully implemented in routine health care settings, and research indicates that ICBT can also be applied to decrease problematic alcohol use in workplace settings. However, studies investigating the feasibility of implementing ICBT in a workplace setting have been lacking. Objective: The current study aims to investigate the feasibility of delivering ICBT for problematic alcohol use within an employee assistance program (EAP). Methods: The study has a quantitative naturalistic design, quantitively comparing ICBT and face-to-face treatment, and allowing for qualitative interviews with employees and employers. Recruitment of participants follows a five-session in-person psychological assessment at an EAP regarding an employee?s presumed problematic alcohol consumption. All assessed employees referred to ICBT or face-to-face treatment will be offered participation in the study. Interviews will be held with employees and their employer representatives following ICBT to elucidate both stakeholders? experience and perception of ICBT and its context. Outcome comparisons between ICBT and face-to-face treatment will be assessed quantitatively using a Reliable Change Index and analysis of variance. Thematic analysis and Grounded Theory will be used to analyze the interview material. Results: The study is set to begin in April 2020 and to end in September 2021. The aim is to recruit up to 150 participants to the quantitative part of the study and 45 participants (15 employees and 30 employer representatives) to the qualitative part of the study. Conclusions: The current study will provide knowledge that is lacking and urgently needed on how to implement ICBT for problematic alcohol use in a workplace setting. International Registered Report Identifier (IRRID): PRR1-10.2196/18693 UR - https://www.researchprotocols.org/2020/7/e18693 UR - http://dx.doi.org/10.2196/18693 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673266 ID - info:doi/10.2196/18693 ER - TY - JOUR AU - Jones, T. Matthew AU - Heiden, Emily AU - Fogg, Carole AU - Meredith, Paul AU - Smith, Gary AU - Sayer, Nicola AU - Toft, Lisa AU - Williams, Emma AU - Williams, Matthew AU - Brown, Thomas AU - Gates, Jessica AU - Lodge, David AU - Bassett, Paul AU - Amos, Mark AU - Chauhan, Milan AU - Begum, Selina AU - Rason, Madeleine AU - Winter, Jonathan AU - Longstaff, Jayne AU - Chauhan, J. Anoop PY - 2020/7/20 TI - An Evaluation of Agreement of Breathing Rates Measured by a Novel Device, Manual Counting, and Other Techniques Used in Clinical Practice: Protocol for the Observational VENTILATE Study JO - JMIR Res Protoc SP - e15437 VL - 9 IS - 7 KW - respiratory KW - monitoring KW - device KW - medical KW - piezoelectric KW - respiration KW - vital signs KW - telemetry KW - respiratory function tests KW - tachypnoea KW - bradypnoea N2 - Background: Respiratory rate (RR) is the most sensitive physiological observation to predict clinical deterioration on hospital wards, and poor clinical monitoring has been highlighted as a primary contributor to avoidable mortality. Patients in intensive care have their RR monitored continuously, but this equipment is rarely available on general hospital wards. Objective: The primary objective is to assess the accuracy of the RespiraSense device in comparison with other methods currently used in clinical practice. The secondary objective is to assess the accuracy of the RespiraSense device in participants in different positions and when reading aloud. Methods: A single-center, prospective observational study will investigate the agreement of the RespiraSense device as compared with other device measurements (capnography, electrocardiogram) and the current standard measurement of RR (manual counting by a trained health care professional). The different methods will be employed concurrently on the same participant as part of a single study visit. Results: Recruitment to this study has not yet started as funding decisions are still pending. Therefore, results are not available at this stage. It is anticipated that the data required could be collected within 2 months of first recruitment to the study and data analysis completed within 6 months of the study start date. Conclusions: The Evaluation of Agreement of Breathing Rates Measured by a Novel Device, Manual Counting, and Other Techniques Used in Clinical Practice (VENTILATE) study will provide further validation of the use of the RespiraSense device in subjects with abnormal respiratory rates. International Registered Report Identifier (IRRID): PRR1-10.2196/15437 UR - https://www.researchprotocols.org/2020/7/e15437 UR - http://dx.doi.org/10.2196/15437 UR - http://www.ncbi.nlm.nih.gov/pubmed/32706740 ID - info:doi/10.2196/15437 ER - TY - JOUR AU - Etingen, Bella AU - Patrianakos, Jamie AU - Wirth, Marissa AU - Hogan, P. Timothy AU - Smith, M. Bridget AU - Tarlov, Elizabeth AU - Stroupe, T. Kevin AU - Kartje, Rebecca AU - Weaver, M. Frances PY - 2020/7/20 TI - TeleWound Practice Within the Veterans Health Administration: Protocol for a Mixed Methods Program Evaluation JO - JMIR Res Protoc SP - e20139 VL - 9 IS - 7 KW - implementation KW - telehealth KW - wound care KW - veteran KW - protocol KW - wound KW - outcome N2 - Background: Chronic wounds, such as pressure injuries and diabetic foot ulcers, are a significant predictor of mortality. Veterans who reside in rural areas often have difficulty accessing care for their wounds. TeleWound Practice (TWP), a coordinated effort to incorporate telehealth into the provision of specialty care for patients with skin wounds, has the potential to increase access to wound care by allowing veterans to receive this care at nearby outpatient clinics or in their homes. The Veterans Health Administration (VA) is championing the rollout of the TWP, starting with regional implementation. Objective: This paper aims to describe the protocol for a mixed-methods program evaluation to assess the implementation and outcomes of TWP in VA. Methods: We are conducting a mixed-methods evaluation of 4 VA medical centers and their community-based outpatient clinics that are participating in the initial implementation of the TWP. Data will be collected from veterans, VA health care team members, and other key stakeholders (eg, clinical leadership). We will use qualitative methods (ie, semistructured interviews), site visits, and quantitative methods (ie, surveys, national VA administrative databases) to assess the process and reach of TWP implementation and its impact on veterans? clinical outcomes and travel burdens and costs. Results: This program evaluation was funded in October 2019 as a Partnered Evaluation Initiative by the US Department of Veterans Affairs, Diffusion of Excellence Office, and Office of Research and Development, Health Services Research and Development Service, Quality Enhancement Research Initiative Program (PEC 19-310). Conclusions: Evaluation of the TWP will identify barriers and solutions to TeleWound implementation in a small number of sites that can be used to inform successful rollout of the TWP nationally. Our evaluation work will inform future efforts to scale up the TWP across VA and optimize reach of the program to veterans across the nation. International Registered Report Identifier (IRRID): DERR1-10.2196/20139 UR - http://www.researchprotocols.org/2020/7/e20139/ UR - http://dx.doi.org/10.2196/20139 UR - http://www.ncbi.nlm.nih.gov/pubmed/32706742 ID - info:doi/10.2196/20139 ER - TY - JOUR AU - Willemse, Cornelis Bastiaan Johannes Paulus AU - Kaptein, Clemens Maurits AU - Hasaart, Fleur PY - 2020/7/31 TI - Developing Effective Methods for Electronic Health Personalization: Protocol for Health Telescope, a Prospective Interventional Study JO - JMIR Res Protoc SP - e16471 VL - 9 IS - 7 KW - eHealth KW - mHealth KW - personalization KW - longitudinal study KW - wearables KW - panel study KW - persuasive technology KW - gdpr N2 - Background: Existing evaluations of the effects of mobile apps to encourage physical activity have been criticized owing to their common lack of external validity, their short duration, and their inability to explain the drivers of the observed effects. This protocol describes the setup of Health Telescope, a longitudinal panel study in which the long-term effects of mobile electronic health (eHealth) apps are investigated. By setting up Health Telescope, we aim to (1) understand more about the long-term use of eHealth apps in an externally valid setting, (2) understand the relationships between short-term and long-term outcomes of the usage of eHealth apps, and (3) test different ways in which eHealth app allocation can be personalized. Objective: The objectives of this paper are to (1) demonstrate and motivate the validity of the many choices that we made in setting up an intensive longitudinal study, (2) provide a resource for researchers interested in using data generated by our study, and (3) act as a guideline for researchers interested in setting up their own longitudinal data collection using wearable devices. For the third objective, we explicitly discuss the General Data Protection Regulation and ethical requirements that need to be addressed. Methods: In this 4-month study, a group of approximately 450 participants will have their daily step count measured and will be asked daily about their mood using experience sampling. Once per month, participants will receive an intervention containing a recommendation to download an app that focuses on increasing physical activity. The mechanism for assigning recommendations to participants will be personalized over time, using contextual data obtained from previous interventions. Results: The data collection software has been developed, and all the legal and ethical checks are in place. Recruitment will start in Q4 of 2020. The initial results will be published in 2021. Conclusions: The aim of Health Telescope is to investigate how different individuals respond to different ways of being encouraged to increase their physical activity. In this paper, we detail the setup, methods, and analysis plan that will enable us to reach this aim. International Registered Report Identifier (IRRID): PRR1-10.2196/16471 UR - http://www.researchprotocols.org/2020/7/e16471/ UR - http://dx.doi.org/10.2196/16471 UR - http://www.ncbi.nlm.nih.gov/pubmed/32734930 ID - info:doi/10.2196/16471 ER - TY - JOUR AU - Schrage, Theresa AU - Görlach, Mirja AU - Betz, Stephan Christian AU - Bokemeyer, Carsten AU - Kröger, Nicolaus AU - Mueller, Volkmar AU - Petersen, Cordula AU - Krüll, Andreas AU - Schulz, Holger AU - Bleich, Christiane PY - 2020/7/29 TI - Development of a Short Instrument for Measuring Health-Related Quality of Life in Oncological Patients for Clinical Use: Protocol for an Observational Study JO - JMIR Res Protoc SP - e17854 VL - 9 IS - 7 KW - patient-reported outcomes KW - health-related quality of life KW - oncology KW - psychometric validation KW - mixed methods study N2 - Background: Cancer patients often suffer from the physical and psychological burden of their disease and its treatment. This is frequently insufficiently identified and addressed in clinical practice. In the context of improving patient-centered care in oncological patients, patient-reported outcomes (PROs) represent an important addition to current routine care. So far, available PRO questionnaires for cancer patients are unsuitable for routine procedures due to their length and complexity. Objective: This study aimed to develop and psychometrically test a short questionnaire to measure health-related quality of life (HrQoL) in cancer patients for use in routine care. Methods: This observational study consists of two parts: (1) a qualitative study to develop a short questionnaire measuring HrQoL and (2) a quantitative study to psychometrically test this questionnaire in five oncological departments of a comprehensive cancer center. In part 1 of the study, semistructured interviews with 28 cancer patients, as well as five focus groups with 22 clinicians and nurses, were conducted to identify clinically relevant dimensions of HrQoL. The identified dimensions were complemented with related dimensions from empirical studies and reviewed via expert discussion. Based on this, a short instrument was developed. In part 2 of the study, the developed questionnaire was tested in cancer in- and outpatients at five participating oncological clinics using additional standardized questionnaires assessing HrQoL and other important PROs. The questionnaire was presented to more than 770 patients twice during treatment. Results: The project started in May 2017 with recruitment for study phase I beginning in December 2017. Recruitment for study phases I and II ended in April 2018 and February 2019, respectively. After study phase II and psychometrical analyses, the newly developed questionnaire measuring the HrQoL of all cancer entities in routine care was finalized. Conclusions: With five to six dimensions and one item per dimension, the developed questionnaire is short enough to not disrupt routine procedures during treatment and is profound enough to inform clinicians about the patient?s HrQoL impairments and status. Trial Registration: Open Science Framework Registries 10.17605/OSF.IO/Y7XCE; https://osf.io/y7xce/ International Registered Report Identifier (IRRID): RR1-10.2196/17854 UR - https://www.researchprotocols.org/2020/7/e17854 UR - http://dx.doi.org/10.2196/17854 UR - http://www.ncbi.nlm.nih.gov/pubmed/32726289 ID - info:doi/10.2196/17854 ER - TY - JOUR AU - Draper, Louise Bridget AU - Pedrana, Alisa AU - Howell, Jessica AU - Yee, Lei Win AU - Htay, Hla AU - Aung, Sanda Khin AU - Shilton, Sonjelle AU - Kyi, Pyone Khin AU - Naing, Win AU - Hellard, Margaret PY - 2020/7/14 TI - Decentralized, Community-Based Hepatitis C Point-of-Care Testing and Direct-Acting Antiviral Treatment for People Who Inject Drugs and the General Population in Myanmar: Protocol for a Feasibility Study JO - JMIR Res Protoc SP - e16863 VL - 9 IS - 7 KW - hepatitis C KW - primary health care KW - community health services KW - delivery of health care KW - point-of-care testing KW - retention in care KW - Asia, Southeastern N2 - Background: The advent of direct-acting antivirals (DAAs) and point-of-care (POC) testing platforms for hepatitis C allow for the decentralization of care to primary care settings. In many countries, access to DAAs is generally limited to tertiary hospitals, with limited published research documenting decentralized models of care in low-and middle-income settings. Objective: This study aims to assess the feasibility, acceptability, effectiveness, and cost-effectiveness of decentralized community-based POC testing and DAA therapy for hepatitis C among people who inject drugs and the general population in Yangon, Myanmar. Methods: Rapid diagnostic tests for anti-hepatitis C antibodies were carried out on-site and, if reactive, were followed by POC GeneXpert hepatitis C RNA polymerase chain reaction tests. External laboratory blood tests to exclude other major health issues were undertaken. Results were given to participants at their next appointment, with the participants commencing DAA therapy that day if a specialist review was not required. Standard clinical data were collected, and the participants completed behavioral questionnaires. The primary outcome measures are the proportion of participants receiving GeneXpert hepatitis C RNA test, the proportion of participants commencing DAA therapy, the proportion of participants completing DAA therapy, and the proportion of participants achieving sustained virological response 12 weeks after completing DAA therapy. Results: Recruitment was completed on September 30, 2019. Monitoring visits and treatment outcome visits are scheduled to continue until June 2020. Conclusions: This feasibility study in Myanmar contributes to the evidence gap for community-based hepatitis C care in low- and middle-income settings. Evidence from this study will inform the scale-up of hepatitis C treatment programs in Myanmar and globally. UR - https://www.researchprotocols.org/2020/7/e16863 UR - http://dx.doi.org/10.2196/16863 UR - http://www.ncbi.nlm.nih.gov/pubmed/32673260 ID - info:doi/10.2196/16863 ER - TY - JOUR AU - Niks, MW Irene AU - van Drongelen, Alwin AU - de Korte, M. Elsbeth PY - 2020/7/14 TI - Promoting Employees? Recovery During Shift Work: Protocol for a Workplace Intervention Study JO - JMIR Res Protoc SP - e17368 VL - 9 IS - 7 KW - shift work KW - recovery during work KW - fatigue KW - intervention study KW - participatory action research KW - ecological momentary assessment KW - mobile phone N2 - Background: Shift work can be demanding owing to disturbances in the biological and social rhythms. This can cause short-term negative effects in employees, such as increased fatigue and reduced alertness. A potential way to counteract these negative effects is to enhance employees? recovery from work during working hours. Objective: The aim of this study is to develop and implement an intervention that focuses on promoting ?on-job? recovery of shift workers. Methods: This study is performed in 2 department units with shift workers at a multinational company in the steel industry. For each department, an intervention will be developed and implemented through an iterative process of user-centered design and evaluation. This approach consists of various sessions in which employees and a project group (ie, researchers, line managers, human resource managers, and occupational health experts) provide input on the intervention content and implementation. Intervention effects will be evaluated using pretest and posttest web-based surveys. Digital ecological momentary assessment will be performed to gain insight into the link between the intervention and daily within-person processes. The intervention process and participants? perception of the interventions will be assessed through a process evaluation. Intervention results will be analyzed by performing mixed model repeated measures analyses and multilevel analyses. Results: This study is supported by the Netherlands Organization for Applied Scientific Research Work and Health Research Program, which is funded by the Ministry of Economic Affairs and supported by the Dutch Ministry of Social Affairs and Employment, program number 19.204.1-3. This study was approved by the institutional review board on February 7, 2019. From June to August 2019, baseline data were collected, and from November to December 2019, the first follow-up data were collected. The second follow-up data collection and data analysis are planned for the first two quarters of 2020. Dissemination of the results is planned for the last two quarters of 2020. Conclusions: A strength of this study design is the participatory action approach to enhance the stakeholder commitments, intervention adherence, and compliance. Moreover, since the target group will be participating in the development and implementation of the intervention, the proposed impact will be high. In addition, the short-term as well as the long-term effects will be evaluated. Finally, this study uses a unique combination of quantitative and qualitative evaluation methods. A limitation of this study is that it is impossible to randomly assign participants to an intervention or control group. Furthermore, the follow-up period (6 months) might be too short to establish health-related effects. Lastly, the results of this study might be specific to the department, organization, or sector, which limits the generalizability of the findings. However, as workplace intervention research for shift workers is scarce, this study might serve as a starting point for future research on shift work interventions. UR - https://www.researchprotocols.org/2020/7/e17368 UR - http://dx.doi.org/10.2196/17368 UR - http://www.ncbi.nlm.nih.gov/pubmed/32459635 ID - info:doi/10.2196/17368 ER - TY - JOUR AU - Jakobsson, Sofie AU - Olsson, S. Daniel AU - Andersson, Eva AU - Hallén, Tobias AU - Krabbe, David AU - Olofsson, Ann-Charlotte AU - Ragnarsson, Oskar AU - Skoglund, Thomas AU - Johannsson, Gudmundur AU - Jakobsson Ung, Eva PY - 2020/7/21 TI - Extended Support Within a Person-Centered Practice After Surgery for Patients With Pituitary Tumors: Protocol for a Quasiexperimental Study JO - JMIR Res Protoc SP - e17697 VL - 9 IS - 7 KW - pituitary tumor KW - person-centered care KW - clinical pathway KW - intervention KW - quasiexperimental N2 - Background: Patients with pituitary tumors often live with lifelong consequences of their disease. Treatment options include surgery, radiotherapy, and medical therapy. Symptoms associated with the tumor or its treatment affect several areas of life. Patients need to adhere to long-term contact with both specialist and general health care providers due to the disease, complex treatments, and associated morbidity. The first year after pituitary surgery constitutes an important time period, with medical evaluations after surgery and decisions on hormonal substitution. The development and evaluation of extended patient support during this time are limited. Objective: The aim of this study is to evaluate whether support within a person-centered care practice increases wellbeing for patients with pituitary tumors. Our main hypothesis is that the extended support will result in increased psychological wellbeing compared with the support given within standard of care. Secondary objectives are to evaluate whether the extended support, compared with standard care, will result in (1) better health status, (2) less fatigue, (3) higher satisfaction with care, (4) higher self-efficacy, (5) increased person-centered content in care documentation, and (6) sustained patient safety. Methods: Within a quasiexperimental design, patients diagnosed with a pituitary tumor planned for neurosurgery are consecutively included in a pretest-posttest study performed at a specialist endocrine clinic. The control group receives standard of care after surgery, and the interventional group receives structured patient support for 1 year after surgery based on person-centeredness covering self-management support, accessibility, and continuity. A total of 90 patients are targeted for each group. Results: Recruitment into the control group was performed between Q3 2015 and Q4 2017. Recruitment into the intervention group started in Q4 2017 and is ongoing until Q4 2020. The study is conducted according to the Declaration of Helsinki, and the protocol has received approval from a regional ethical review board. Conclusions: This study entails an extensive intervention constructed in collaboration between clinicians, patients, and researchers that acknowledges accessibility, continuity, and self-management support within person-centeredness. The study has the potential to compare standard care to person-centered practice adapted specifically for patients with pituitary tumors and evaluated with a combination of patient-reported outcomes and patient-reported experience measures. Following the results, the person-centered practice may also become a useful model to further develop and explore person-centered care for patients with other rare, lifelong conditions. Trial Registration: Researchweb.org. https://www.researchweb.org/is/sverige/project/161671 International Registered Report Identifier (IRRID): DERR1-10.2196/17697 UR - https://www.researchprotocols.org/2020/7/e17697 UR - http://dx.doi.org/10.2196/17697 UR - http://www.ncbi.nlm.nih.gov/pubmed/32706741 ID - info:doi/10.2196/17697 ER - TY - JOUR AU - Hawley, L. Nicola AU - Pomer, Alysa AU - Rivara, C. Anna AU - Rosenthal, L. Samantha AU - Duckham, L. Rachel AU - Carlson, C. Jenna AU - Naseri, Take AU - Reupena, Sefuiva Muagututia AU - Selu, Melania AU - Lupematisila, Vaimoana AU - Unasa, Folla AU - Vesi, Lupesina AU - Fatu, Tracy AU - Unasa, Seipepa AU - Faasalele-Savusa, Kima AU - Wetzel, I. Abigail AU - Soti-Ulberg, Christina AU - Prescott, T. Angela AU - Siufaga, Gloria AU - Penaia, Corina AU - To, B. Sophie AU - LaMonica, C. Lauren AU - Lameko, Viali AU - Choy, C. Courtney AU - Crouter, E. Scott AU - Redline, Susan AU - Deka, Ranjan AU - Kershaw, E. Erin AU - Urban, Zsolt AU - Minster, L. Ryan AU - Weeks, E. Daniel AU - McGarvey, T. Stephen PY - 2020/7/23 TI - Exploring the Paradoxical Relationship of a Creb 3 Regulatory Factor Missense Variant With Body Mass Index and Diabetes Among Samoans: Protocol for the Soifua Manuia (Good Health) Observational Cohort Study JO - JMIR Res Protoc SP - e17329 VL - 9 IS - 7 KW - cohort studies KW - CREBRF KW - type 2 diabetes KW - obesity KW - Samoa N2 - Background: The prevalence of obesity and diabetes in Samoa, like many other Pacific Island nations, has reached epidemic proportions. Although the etiology of these conditions can be largely attributed to the rapidly changing economic and nutritional environment, a recently identified genetic variant, rs373863828 (CREB 3 regulatory factor, CREBRF: c.1370G>A p.[R457Q]) is associated with increased odds of obesity, but paradoxically, decreased odds of diabetes. Objective: The overarching goal of the Soifua Manuia (Good Health) study was to precisely characterize the association of the CREBRF variant with metabolic (body composition and glucose homeostasis) and behavioral traits (dietary intake, physical activity, sleep, and weight control behaviors) that influence energy homeostasis in 500 adults. Methods: A cohort of adult Samoans who participated in a genome-wide association study of adiposity in Samoa in 2010 was followed up, based on the presence or absence of the CREBRF variant, between August 2017 and March 2019. Over a period of 7-10 days, each participant completed the main study protocol, which consisted of anthropometric measurements (weight, height, circumferences, and skinfolds), body composition assessment (bioelectrical impedance and dual-energy x-ray absorptiometry), point-of-care glycated hemoglobin measurement, a fasting blood draw and oral glucose tolerance test, urine collection, blood pressure measurement, hand grip strength measurement, objective physical activity and sleep apnea monitoring, and questionnaire measures (eg, health interview, cigarette and alcohol use, food frequency questionnaire, socioeconomic position, stress, social support, food and water insecurity, sleep, body image, and dietary preferences). In January 2019, a subsample of the study participants (n=118) completed a buttock fat biopsy procedure to collect subcutaneous adipose tissue samples. Results: Enrollment of 519 participants was completed in March 2019. Data analyses are ongoing, with results expected in 2020 and 2021. Conclusions: While the genetic variant rs373863828, in CREBRF, has the largest known effect size of any identified common obesity gene, very little is currently understood about the mechanisms by which it confers increased odds of obesity but paradoxically lowered odds of type 2 diabetes. The results of this study will provide insights into how the gene functions on a whole-body level, which could provide novel targets to prevent or treat obesity, diabetes, and associated metabolic disorders. This study represents the human arm of a comprehensive and integrated approach involving humans as well as preclinical models that will provide novel insights into metabolic disease. International Registered Report Identifier (IRRID): RR1-10.2196/17329 UR - https://www.researchprotocols.org/2020/7/e17329 UR - http://dx.doi.org/10.2196/17329 UR - http://www.ncbi.nlm.nih.gov/pubmed/32706746 ID - info:doi/10.2196/17329 ER - TY - JOUR AU - Ziemssen, Tjalf AU - Hoffmann, Olaf AU - Klotz, Luisa AU - Schreiber, Herbert AU - Weber, S. Martin AU - Rauser, Benedict PY - 2020/7/24 TI - Gaining First Insights on Secondary Progressive Multiple Sclerosis Patients Treated With Siponimod in Clinical Routine: Protocol of the Noninterventional Study AMASIA JO - JMIR Res Protoc SP - e19598 VL - 9 IS - 7 KW - secondary progressive multiple sclerosis KW - siponimod (Mayzent) KW - S1P modulator KW - oral therapy KW - noninterventional study KW - clinical routine KW - real-world evidence KW - disability KW - cognition KW - multiple sclerosis KW - drug therapy KW - chronic disease N2 - Background: A high proportion of patients with relapsing remitting multiple sclerosis convert to secondary progressive multiple sclerosis (SPMS) characterized by irreversibly progressing disability and cognitive decline. Siponimod (Mayzent), a selective sphingosine-1-phosphate receptor modulator, was recently approved by the European Medicines Agency for the treatment of adult SPMS patients with active disease, as evidenced by relapses or magnetic resonance imaging features of ongoing inflammatory activity. Approval by the Food and Drug Administration covers a broader range of indications, comprising clinically isolated syndrome, relapsing remitting multiple sclerosis, and active SPMS. However, treatment effects of siponimod have not been assessed in a structured setting in clinical routine so far. Objective: The objectives of AMASIA (impAct of Mayzent [siponimod] on secondAry progressive multiple Sclerosis patients in a long-term non-Interventional study in GermAny), a prospective noninterventional study, are to assess the long-term effectiveness and safety of siponimod in clinical routine and to evaluate the impact of disease burden on quality of life and socioeconomic conditions. Here, we report the study design of AMASIA. Methods: Treatment effects of siponimod will be evaluated in 1500 SPMS patients during a 3-year observational phase. According to the genetic polymorphism of CYP2C9, the initial dose will be titrated to the maintenance dose of 1 mg (CYP2C9*1*3 and *2*3) or 2 mg (all other polymorphisms of CYP2C9 except *3*3, which is contraindicated) taken orally once daily. Primary endpoint is the 6-month confirmed disability progression, as assessed by a functional composite endpoint comprising the Expanded Disability Status Scale and symbol digit modalities test to take appropriate account of cognitive changes and increase sensitivity. Further measures including multiple sclerosis activity data; assessments of functional domains; questionnaires addressing the patients?, physicians?, and relatives? perspectives of disability progression; cognitive worsening; quality of life; and socioeconomic aspects will be documented using the multiple sclerosis documentation system MSDS3D. Results: AMASIA is being conducted between February 2020 and February 2025 in up to 250 neurological centers in Germany. Conclusions: AMASIA will complement the pivotal phase III?derived efficacy and safety profile of siponimod with real-world data and will further evaluate several individual treatment aspects such as quality of life and socioeconomic conditions of patients and caregivers. It might help to establish siponimod as a promising option for the treatment of SPMS patients in clinical routine. International Registered Report Identifier (IRRID): DERR1-10.2196/19598 UR - http://www.researchprotocols.org/2020/7/e19598/ UR - http://dx.doi.org/10.2196/19598 UR - http://www.ncbi.nlm.nih.gov/pubmed/32499214 ID - info:doi/10.2196/19598 ER - TY - JOUR AU - Chaudhary, Shikha AU - Saywell, Nicola AU - Kumar, Arun AU - Taylor, Denise PY - 2020/7/27 TI - Visual Fixations and Motion Sensitivity: Protocol for an Exploratory Study JO - JMIR Res Protoc SP - e16805 VL - 9 IS - 7 KW - motion sensitivity KW - vestibular disorder KW - complex environments KW - visual fixations KW - postural control KW - posture KW - kinematics KW - inner ear KW - visual N2 - Background: Motion sensitivity after vestibular disorders is associated with symptoms of nausea, dizziness, and imbalance in busy environments. Dizziness and imbalance are reported in places such as supermarkets and shopping malls which have unstable visual backgrounds; however, the mechanism of motion sensitivity is poorly understood. Objective: The main aim of this exploratory observational study is to investigate visual fixations and postural sway in response to increasingly complex visual environments in healthy adults and adults with motion sensitivity. Methods: A total of 20 healthy adults and 20 adults with motion sensitivity will be recruited for this study. Visual fixations, postural sway, and body kinematics will be measured with a mobile eye tracker device, force plate, and 3D motion capture system, respectively. Participants will be exposed to experimental tasks requiring visual fixation on letters, projected on a range of backgrounds on a large screen during quiet stance. Descriptive statistics (mean and standard deviation) will be calculated for each of the variables. One-way independent-measures analyses of variance will be performed to investigate the differences between groups for all variables. Results: Data collection was started in May 2019 and was completed by February 2020. It was approved by Health and Disability Ethics Committees, Ministry of Health, New Zealand on November 2, 2018 (Ethics ref: 18/CEN/193). We are currently processing the data and will begin data analysis in July 2020. We expect the results to be available for publication by the end of 2020. The trial was funded by the Neurology Special Interest Group, Physiotherapy New Zealand, and the Eisdell Moore Centre in November 2018. Conclusions: This study will provide a detailed investigation of visual fixations in response to increasingly complex visual environments. Investigating characteristics of visual fixations in healthy adults and those with motion sensitivity will provide insight into this disabling condition and may inform the development of new intervention strategies which explicitly cater to the needs of this population. Trial Registration: Australian New Zealand Clinical Trials Registry, ACTRN12619000254190; https://tinyurl.com/yxbn7nks International Registered Report Identifier (IRRID): PRR1-10.2196/16805 UR - http://www.researchprotocols.org/2020/7/e16805/ UR - http://dx.doi.org/10.2196/16805 UR - http://www.ncbi.nlm.nih.gov/pubmed/32716003 ID - info:doi/10.2196/16805 ER - TY - JOUR AU - van Pamelen, Jeske AU - van Olst, Lynn AU - Budding, E. Andries AU - AU - de Vries, E. Helga AU - Visser, H. Leo PY - 2020/7/29 TI - Alterations of Gut Microbiota and the Brain-Immune-Intestine Axis in Patients With Relapsing-Remitting Multiple Sclerosis After Treatment With Oral Cladribine: Protocol for a Prospective Observational Study JO - JMIR Res Protoc SP - e16162 VL - 9 IS - 7 KW - multiple sclerosis KW - cladribine KW - brain-immune-intestine axis KW - brain-gut axis KW - gut-brain axis KW - microbiota N2 - Background: Immunological factors are the key to the pathogenesis of multiple sclerosis (MS). Conjointly, environmental factors are known to affect MS disease onset and progression. Several studies have found that the intestinal microbiota in MS patients differs from that of control subjects. One study found a trend toward lower species richness in patients with active disease versus in patients in remission. The microbiota plays an important role in shaping the immune system. Recent studies suggest the presence of an association between the gut microbiota and inflammatory pathways in the central nervous system. However, the function of this brain-immune-intestine axis and its possible value for predicting treatment effect in MS patients is currently unknown. Objective: Our goal is to examine if the changes in gut and oral microbiota and simultaneous changes in the immune response are a predictor for the treatment response in subjects with active relapsing-remitting MS (RRMS) who are being treated with oral cladribine. Methods: This is a prospective, observational, multicenter study. Eligible subjects are patients with RRMS, between the ages of 18 and 55 years, who will start treatment with oral cladribine. Patients who used probiotics 1 month prior to the start of oral cladribine will be excluded. At baseline (ie, before start) and after 3, 12, and 24 months, the Expanded Disability Status Scale (EDSS) score will be assessed and fecal, oral, and blood samples will be collected. Also, subjects will be asked to register their food intake for 7 consecutive days following the visits. After 24 months, a magnetic resonance imaging (MRI) assessment of the brain will be performed. Responders are defined as subjects without relapses, without progression on the EDSS, and without radiological progression on MRI. Results: Inclusion started in January 2019. A total of 30 patients are included at the moment. The aim is to include 80 patients from 10 participating centers during a period of approximately 24 months. Final results are expected in 2024. Conclusions: The results of the BIA Study will contribute to precision medicine in patients with RRMS and will contribute to a better understanding of the brain-immune-intestine axis. International Registered Report Identifier (IRRID): DERR1-10.2196/16162 UR - http://www.researchprotocols.org/2020/7/e16162/ UR - http://dx.doi.org/10.2196/16162 UR - http://www.ncbi.nlm.nih.gov/pubmed/32723709 ID - info:doi/10.2196/16162 ER - TY - JOUR AU - Lecamwasam, R. Ashani AU - Mohebbi, Mohammadreza AU - Ekinci, I. Elif AU - Dwyer, M. Karen AU - Saffery, Richard PY - 2020/7/31 TI - Identification of Potential Biomarkers of Chronic Kidney Disease in Individuals with Diabetes: Protocol for a Cross-sectional Observational Study JO - JMIR Res Protoc SP - e16277 VL - 9 IS - 7 KW - epigenetics KW - metabolomics KW - gut microbiome KW - diabetes KW - chronic kidney disease N2 - Background: The importance of identifying people with diabetes and progressive kidney dysfunction relates to the excess morbidity and mortality of this group. Rates of cardiovascular disease are much higher in people with both diabetes and kidney dysfunction than in those with only one of these conditions. By the time these people are identified in current clinical practice, proteinuria and renal dysfunction are already established, limiting the effectiveness of therapeutic interventions. The identification of an epigenetic or blood metabolite signature or gut microbiome profile may identify those with diabetes at risk of progressive chronic kidney disease, in turn providing targeted intervention to improve patient outcomes. Objective: This study aims to identify potential biomarkers in people with diabetes and chronic kidney disease (CKD) associated with progressive renal injury and to distinguish between stages of chronic kidney disease. Three sources of biomarkers will be explored, including DNA methylation profiles in blood lymphocytes, the metabolomic profile of blood-derived plasma and urine, and the gut microbiome. Methods: The cross-sectional study recruited 121 people with diabetes and varying stages (stages 1-5) of chronic kidney disease. Single-point data collection included blood, urine, and fecal samples in addition to clinical data such as anthropometric measurements and biochemical parameters. Additional information obtained from medical records included patient demographics, medical comorbidities, and medications. Results: Data collection commenced in January 2018 and was completed in June 2018. At the time of submission, 121 patients had been recruited, and 119 samples remained after quality control. There were 83 participants in the early diabetes-associated CKD group with a mean estimated glomerular filtration rate (eGFR) of 61.2 mL/min/1.73 m2 (early CKD group consisting of stage 1, 2, and 3a CKD), and 36 participants in the late diabetic CKD group with a mean eGFR of 23.9 mL/min/1.73 m2 (late CKD group, consisting of stage 3b, 4, and 5), P<.001. We have successfully obtained DNA for methylation and microbiome analyses using the biospecimens collected via this protocol and are currently analyzing these results together with the metabolome of this cohort of individuals with diabetic CKD. Conclusions: Recent advances have improved our understanding of the epigenome, metabolomics, and the influence of the gut microbiome on the incidence of diseases such as cancers, particularly those related to environmental exposures. However, there is a paucity of literature surrounding these influencers in renal disease. This study will provide insight into the fundamental understanding of the pathophysiology of CKD in individuals with diabetes, especially in novel areas such as epigenetics, metabolomics, and the kidney-gut axis. International Registered Report Identifier (IRRID): DERR1-10.2196/16277 UR - http://www.researchprotocols.org/2020/7/e16277/ UR - http://dx.doi.org/10.2196/16277 UR - http://www.ncbi.nlm.nih.gov/pubmed/32734931 ID - info:doi/10.2196/16277 ER - TY - JOUR AU - Burchartz, Alexander AU - Manz, Kristin AU - Anedda, Bastian AU - Niessner, Claudia AU - Oriwol, Doris AU - Schmidt, CE Steffen AU - Woll, Alexander PY - 2020/7/14 TI - Measurement of Physical Activity and Sedentary Behavior by Accelerometry Among a Nationwide Sample from the KiGGS and MoMo Study: Study Protocol JO - JMIR Res Protoc SP - e14370 VL - 9 IS - 7 KW - processing criteria KW - wear time protocol KW - epoch length KW - sampling frequency KW - intensity classification KW - Motorik-Modul study N2 - Background: Currently, no nationwide objective physical activity data exists for children and adolescents living in Germany. The German Health Interview and Examination Survey for Children and Adolescents (KiGGS) and the Motorik-Modul study (MoMo) is a national cohort study that has incorporated accelerometers in its most recent data collection wave (wave 2, since 2014). This wave 2 marks the first nationwide collection of objective data on the physical activity of children and adolescents living in Germany. Objective: The purpose of this protocol is to describe the methods used in the KiGGS and MoMo study to capture the intensity, frequency, and duration of physical activity with accelerometers. Methods: Participants (N=11,003, aged 6 to 31 years) were instructed to wear an ActiGraph GT3X+ or wGT3X-BT accelerometer laterally on the right hip. Accelerometers were worn on consecutive days during waking hours, including at least 4 valid weekdays and 1 weekend day (wear time >8 hours) in the evaluation. A nonwear time protocol was also implemented. Results: Data collection was completed by October 2017. Data harmonization took place in 2018. The first accelerometer results from this wave were published in 2019, and detailed analyses are ready to be submitted in 2020. Conclusions: This study protocol provides an overview of technical details and basic choices when using accelerometers in large-scale epidemiological studies. At the same time, the restrictions imposed by the specified filters and the evaluation routines must be taken into account. International Registered Report Identifier (IRRID): DERR1-10.2196/14370 UR - https://www.researchprotocols.org/2020/7/e14370 UR - http://dx.doi.org/10.2196/14370 UR - http://www.ncbi.nlm.nih.gov/pubmed/32459648 ID - info:doi/10.2196/14370 ER - TY - JOUR AU - Zepecki, Anne AU - Guendelman, Sylvia AU - DeNero, John AU - Prata, Ndola PY - 2020/7/6 TI - Using Application Programming Interfaces to Access Google Data for Health Research: Protocol for a Methodological Framework JO - JMIR Res Protoc SP - e16543 VL - 9 IS - 7 KW - Google KW - search data KW - infodemiology KW - infoveillance KW - infodemic KW - reproductive health KW - abortion KW - birth control KW - Google Trends KW - APIs N2 - Background: Individuals are increasingly turning to search engines like Google to obtain health information and access resources. Analysis of Google search queries offers a novel approach, which is part of the methodological toolkit for infodemiology or infoveillance researchers, to understanding population health concerns and needs in real time or near-real time. While searches predominantly have been examined with the Google Trends website tool, newer application programming interfaces (APIs) are now available to academics to draw a richer landscape of searches. These APIs allow users to write code in languages like Python to retrieve sample data directly from Google servers. Objective: The purpose of this paper is to describe a novel protocol to determine the top queries, volume of queries, and the top sites reached by a population searching on the web for a specific health term. The protocol retrieves Google search data obtained from three Google APIs: Google Trends, Google Health Trends (also referred to as Flu Trends), and Google Custom Search. Methods: Our protocol consisted of four steps: (1) developing a master list of top search queries for an initial search term using Google Trends, (2) gathering information on relative search volume using Google Health Trends, (3) determining the most popular sites using Google Custom Search, and (4) calculating estimated total search volume. We tested the protocol following key procedures at each step and verified its usefulness by examining search traffic on birth control in 2017 in the United States. Two separate programmers working independently achieved similar results with insignificant variation due to sample variability. Results: We successfully tested the methodology on the initial search term birth control. We identified top search queries for birth control, of which birth control pill was the most popular and obtained the relative and estimated total search volume for the top queries: relative search volume was 0.54 for the pill, corresponding to an estimated 9.3-10.7 million searches. We used the estimates of the proportion of search activity for the top queries to arrive at a generated list of the most popular websites: for the pill, the Planned Parenthood website was the top site. Conclusions: The proposed methodological framework demonstrates how to retrieve Google query data from multiple Google APIs and provides thorough documentation required to systematically identify search queries and websites, as well as estimate relative and total search volume of queries in real time or near-real time in specific locations and time periods. Although the protocol needs further testing, it allows researchers to replicate the steps and shows promise in advancing our understanding of population-level health concerns. International Registered Report Identifier (IRRID): RR1-10.2196/16543 UR - https://www.researchprotocols.org/2020/7/e16543 UR - http://dx.doi.org/10.2196/16543 UR - http://www.ncbi.nlm.nih.gov/pubmed/32442159 ID - info:doi/10.2196/16543 ER - TY - JOUR AU - Eisenhut, Michael PY - 2020/7/17 TI - The Identification of Native Epitopes Eliciting a Protective High-Affinity Immunoglobulin Subclass Response to Blood Stages of Plasmodium falciparum: Protocol for Observational Studies JO - JMIR Res Protoc SP - e15690 VL - 9 IS - 7 KW - proteome KW - immunome KW - 2D electrophoresis KW - Plasmodium falciparum KW - immunoglobulin KW - affinity KW - avidity KW - western blot KW - conformational epitope KW - nonlinear epitope N2 - Background: Antibodies to blood stages protective against complications of Plasmodium falciparum infection were found to be of immunoglobulin G 1 (IgG1) and IgG3 subclasses and of high affinity to the target epitopes. These target epitopes cannot be characterized using recombinant antigens because of a lack of appropriate glycosylation, phosphorylation, methylation, and bisulfide bond formation, which determine the structure of conformational and nonlinear epitopes within the tertiary and quaternary structures of native P. falciparum antigens. Objective: This study aims to develop a method for the comprehensive detection of all P. falciparum schizont antigens, eliciting a protective immune response. Methods: Purified parasitophorous vacuole membrane?enclosed merozoite structures (PEMSs) containing native schizont antigens are initially generated, separated by two-dimensional (2D) gel electrophoresis and blotted onto nitrocellulose. Antigens eliciting a protective antibody response are visualized by incubation with sera from patients with clinical immunity. This is followed by the elution of low-affinity antibodies with urea and detection of protective antibody responses by incubation with anti-IgG1 and anti-IgG3 antibodies, which were conjugated to horseradish peroxidase. This is followed by visualization with a color reaction. Blot signals are normalized by relating to the intensity of blot staining with a reference antibody and housekeeping antigens. Results are corrected for intensity of exposure by the relation of antibody responses to global P. falciparum antibody titers. Antigens eliciting the protective responses are identified as immunorelevant from the comparison of spot positions, indicating high-affinity IgG1 or IgG3 responses on the western blot, which is unique to or consistently more intensive in clinically immune individuals compared with nonimmune individuals. The results obtained are validated by using affinity chromatography. Results: Another group previously applied 2D western blotting to analyze antibody responses to P. falciparum. The sera of patients allowed the detection of 42 antigenic spots on the 2D immunoblot. The spots detected were excised and subjected to mass spectrometry for identification. A total of 19 protein spots were successfully identified and corresponded to 13 distinct proteins. Another group used immunoaffinity chromatography to identify antigens bound by IgGs produced by mice with enhanced immunity to Plasmodium yoelii. Immunorelevant antigens were isolated and identified by immobilizing immunoglobulin from immune mice to a Sephadex column and then passing a blood-stage antigen mixture through the column followed by the elution of specific bound antigens with sodium deoxycholate and the identification of those antigens by western blotting with specific antibodies. Conclusions: 2D western blotting using native antigens has the potential to identify antibody responses selective for specific defined isomeric forms of the same protein, including isoforms (protein species) generated by posttranscriptional modifications such as phosphorylation, glycosylation, and methylation. The process involved in 2D western blotting enables highly sensitive detection, high resolution, and preservation of antibody responses during blotting. Validation by immunoaffinity chromatography can compensate for the antigen loss associated with the blotting process. It has the potential for indirect quantification of protective antibody responses by enabling quantification of the amount of eluted antibody bound antigens through mass spectrometry. International Registered Report Identifier (IRRID): PRR1-10.2196/15690 UR - https://www.researchprotocols.org/2020/7/e15690 UR - http://dx.doi.org/10.2196/15690 UR - http://www.ncbi.nlm.nih.gov/pubmed/32706743 ID - info:doi/10.2196/15690 ER - TY - JOUR AU - Marques, S. Sandra C. AU - Doetsch, Julia AU - Brřdsgaard, Anne AU - Cuttini, Marina AU - Draper, S. Elizabeth AU - Kajantie, Eero AU - Lebeer, Jo AU - van der Pal, Sylvia AU - Pedersen, Pernille AU - AU - Barros, Henrique PY - 2020/7/15 TI - Improving Understanding of Participation and Attrition Phenomena in European Cohort Studies: Protocol for a Multi-Situated Qualitative Study JO - JMIR Res Protoc SP - e14997 VL - 9 IS - 7 KW - European cohorts KW - VPT KW - VLBW KW - preterm KW - participation KW - attrition KW - multi-situated qualitative study KW - collaborative visual methods KW - triangulation N2 - Background: Cohort studies represent a strong methodology for increasing one?s understanding of human life-course development and etiological mechanisms. Retention of participants, especially during long follow-up periods, is, however, a major challenge. A better understanding of the motives for participation and attrition in cohort studies in diverse sociogeographic and cultural settings is needed, as this information is most useful in developing effective retention strategies. Objective: This study aims to improve our understanding of participation and attrition phenomena in a European cohort study of very preterm/very-low-birth-weight (VPT/VLBW) infants from various sociogeographic and cultural settings to better understand variability and ultimately contribute to developing novel and more ?in-context? strategies to improve retention. Methods: This study uses a triangulation of multisituated methods to collect data on various cohorts in the Research on European Children and Adults Born Preterm (RECAP) network, which include focus group discussions, individual semidriven interviews, and a collaborative, reflexive visual methodology (participant-generated VideoStories) with relevant key actors involved with these cohort studies such as adult participants, parents (caregivers), cohort staff, health care professionals, and academic researchers. The methodological strategy aims to provide a shared flexible framework of various qualitatively driven methods to collect data on VPT/VLBW adult and child cohorts, from which research partners may choose and combine those most pertinent to apply in their own specific contexts. Data from all sources and sites will be submitted to a triangulation of phenomenological thematic analysis with discourse analysis. Results: As of January 2020, in this study, we enrolled 92 participants variously involved with child and adult RECAP partnering cohorts from six countries. Multisite enrollment and data collection are expected to be completed in all seven study settings by June 2020. Findings will be reported in future publications. Conclusions: Qualitative research methods are a useful complement for enriching and illuminating quantitative results. We expect that opting for a multisituated study approach addressing the interplay of the lived experience of individuals in both researcher and researched stances of particular cohort study settings will contribute to filling some gaps in the understanding of participation variability and effectiveness of different implemented strategies in context. Moreover, health research subjects have traditionally been positioned as passive objects of study rather than active participants, even though they have the greatest stake in improving health care policies and practices. Including collaborative methods allows us to counteract the ?top-down? model by handing over some research control to the very people who are providing the data on which research findings will be based while also acknowledging the value of their involvement. International Registered Report Identifier (IRRID): DERR1-10.2196/14997 UR - https://www.researchprotocols.org/2020/7/e14997 UR - http://dx.doi.org/10.2196/14997 UR - http://www.ncbi.nlm.nih.gov/pubmed/32667901 ID - info:doi/10.2196/14997 ER -