JMIR Publications

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  RCTs - Protocols/Proposals (funded,...

  Oct 27, 2020

  A Mobile Health Intervention (LifeBuoy App) to Help Young People Manage Suicidal Thoughts: Protocol for a Mixed-Methods Randomized Controlled Trial

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  Authors List:

  • Jin Han  
  • Lauren McGillivray  
  • Quincy JJ Wong  
  • Aliza Werner-Seidler  
  • Iana Wong  
  • Alison Calear  
  • Helen Christensen  
  • Michelle Torok  

  Abstract:

  Background: Self-help smartphone apps offer a new opportunity to address youth suicide prevention by improving access to support and by providing potentially high fidelity and cost-effective treatment. However, there have been very few smartphone apps providing evidence-based support for suicide prevention in this population. To address this gap, we developed the LifeBuoy app, a self-help smartphone app informed by dialectical behavior therapy (DBT), to help young people manage suicidal thoughts in their daily life. Objective: This study describes the protocol for a randomized controlled trial to evaluate the efficacy of the LifeBuoy app for reducing suicidal thoughts and behaviors, depression, anxiety, and psychological distress, and improving general mental well-being in young adults aged 18 to 25 years. Methods: This is a randomized controlled trial recruiting 378 young adults aged between 18 and 25 years and comparing the LifeBuoy app with a matched attention control (a placebo app with the same display but no DBT components). The primary outcome is suicidal thoughts measured by the Suicidal Ideation Attributes Scale (SIDAS). The secondary outcomes are suicidal behavior, depression, anxiety, psychological distress, and general mental well-being. The changes in the levels of insomnia, rumination, suicide cognitions, distress tolerance, loneliness, and help seeking before and after using the app are evaluated in this study. The study also addresses risk factors and responses to the intervention. A series of items assessing COVID-19 experiences is included in the trial to capture the potential impact of the pandemic on this study. Assessments will occur on the following three occasions: baseline, postintervention, and follow-up at 3 months postintervention. A qualitative interview about user experience with the LifeBuoy app will take place within 4 weeks of the final assessment. Using linear mixed models, the primary analysis will compare the changes in suicidal thoughts in the intervention condition relative to the control condition. To minimize risks, participants will receive a call from the team clinical psychologist by clicking a help button in the app or responding to an automated email sent by the system when they are assessed with elevated suicide risks at the baseline, postintervention, and 3-month follow-up surveys. Results: The trial recruitment started in May 2020. Data collection is currently ongoing. Conclusions: This is the first trial examining the efficacy of a DBT-informed smartphone app delivered to community-living young adults reporting suicidal thoughts. This trial will extend knowledge about the efficacy and acceptability of app-based support for suicidal thoughts in young people. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001671156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378366.

  • JMIR Res Protoc 2020;9(10):e23655

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  RCTs - Protocols/Proposals (eHealth)

  Oct 27, 2020

  Repetitive Transcranial Magnetic Stimulation With and Without Internet-Delivered Cognitive-Behavioral Therapy for the Treatment of Resistant Depression:...

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  Authors List:

  • Rabab M Abou El-Magd  
  • Gloria Obuobi-Donkor  
  • Medard K Adu  
  • Christopher Lachowski  
  • Surekha Duddumpudi  
  • Mobolaji A Lawal  
  • Adegboyega O Sapara  
  • Michael Achor  
  • Maryam Kouzehgaran  
  • Roshan Hegde  
  • Corina Chew  
  • Mike Mach  
  • Shelley Daubert  
  • Liana Urichuk  
  • Mark Snaterse  
  • Shireen Surood  
  • Daniel Li  
  • Andrew Greenshaw  
  • Vincent Israel Opoku Agyapong  

  Abstract:

  Background: Major depression is a severe, disabling, and potentially lethal clinical disorder. Only about half of patients respond to an initial course of antidepressant pharmacotherapy. At least 15% of all patients with major depressive disorder (MDD) remain refractory to any treatment intervention. By the time that a patient has experienced 3 definitive treatment failures, the likelihood of achieving remission with the fourth treatment option offered is below 10%. Repetitive transcranial magnetic stimulation (rTMS) is considered a treatment option for patients with MDD who are refractory to antidepressant treatment. It is not currently known if the addition of internet-delivered cognitive-behavioral therapy (iCBT) enhances patients’ responses to rTMS treatments. Objective: This study will evaluate the initial comparative clinical effectiveness of rTMS with and without iCBT as an innovative patient-centered intervention for the treatment of participants diagnosed with treatment-resistant depression (TRD). Methods: This study is a prospective, two-arm randomized controlled trial. In total, 100 participants diagnosed with resistant depression at a psychiatric care clinic in Edmonton, Alberta, Canada, will be randomized to one of two conditions: (1) enrolment in rTMS sessions alone and (2) enrolment in the rTMS sessions plus iCBT. Participants in each group will complete evaluation measures (eg, recovery, general symptomatology, and functional outcomes) at baseline, 1 month, 3 months, and 6 months. The primary outcome measure will be the mean change to scores on the Hamilton Depression Rating Scale. Patient service utilization data and clinician-rated measures will also be used to gauge patient progress. Patient data will be analyzed with descriptive statistics, repeated measures, and correlational analyses. Results: We expect the results of the study to be available in 24 months. We hypothesize that participants enrolled in the study who receive rTMS plus iCBT will achieve superior outcomes in comparison to participants who receive rTMS alone. Conclusions: The concomitant application of psychotherapy with rTMS has not been investigated previously. We hope that this project will provide us with a concrete base of data to evaluate the practical application and efficacy of using a novel combination of these two treatment modalities (rTMS plus iCBT). Trial Registration: ClinicalTrials.gov NCT0423965; https://clinicaltrials.gov/ct2/show/NCT04239651

  • JMIR Res Protoc 2020;9(10):e18843

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  Non-Randomized Study Protocols and...

  Oct 27, 2020

  The Technical Feasibility of Integrating Primary Eye Care Into Primary Health Care Systems in Nigeria: Protocol for a Mixed Methods Cross-Sectional Study

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  Authors List:

  • Ada Aghaji  
  • Helen Burchett  
  • Shaffa Hameed  
  • Jayne Webster  
  • Clare Gilbert  

  Abstract:

  Background: Approximately 90% of the 253 million blind or visually impaired people worldwide live in low- and middle-income countries. Lack of access to eye care is why most people remain or become blind. The World Health Organization Regional Office for Africa (WHO-AFRO) recently launched a primary eye care (PEC) package for sub-Saharan Africa—the WHO-AFRO PEC package—for integration into the health system at the primary health care (PHC) level. This has the potential to increase access to eye care, but feasibility studies are needed to determine the extent to which the health system has the capacity to deliver the package in PHC facilities. Objective: Our objective is to assess the technical feasibility of integrating the WHO-AFRO PEC package in PHC facilities in Nigeria. Methods: This study has several components, which include (1) a literature review of PEC in sub-Saharan Africa, (2) a Delphi exercise to reach consensus among experts regarding the technical complexity of the WHO-AFRO PEC package and the capacities needed to deliver it in PHC facilities, (3) development of PEC technical capacity assessment tools, and (4) data collection, including facility surveys and semistructured interviews with PHC staff and their supervisors and village health workers to determine the capacities available to deliver PEC in PHC facilities. Analysis will identify opportunities and the capacity gaps that need to be addressed to deliver PEC. Results: Consensus was reached among experts regarding the technical complexity of the WHO-AFRO PEC package and the capacities needed to deliver it as part of PHC. Quantitative tools (ie, structured questionnaires, in-depth interviews, and observation checklists) and topic guides based on agreed-upon technical capacities have been developed and relevant stakeholders have been identified. Surveys in 48 PHC facilities and interviews with health professionals and supervisors have been undertaken. Capacity gaps are being analyzed. Conclusions: This study will determine the capacity of PHC centers to deliver the WHO-AFRO PEC package as an integral part of the health system in Nigeria, with identification of capacity gaps. Although capacity assessments have to be context specific, the tools and findings will assist policy makers and health planners in Nigeria and similar settings, who are considering implementing the package, in making informed choices.

  • JMIR Res Protoc 2020;9(10):e17263

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  Grant Proposals (eHealth, funded)

  Oct 26, 2020

  Video Consultations for Older Adults With Multimorbidity During the COVID-19 Pandemic: Protocol for an Exploratory Qualitative Study

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  Authors List:

  • Eng Sing Lee  
  • Poay Sian Sabrina Lee  
  • Evelyn Ai Ling Chew  
  • Gayathri Muthulingam  
  • Hui Li Koh  
  • Shu Yun Tan  
  • Yew Yoong Ding  

  Abstract:

  Background: Multimorbidity, the coexistence of multiple chronic conditions in an individual, is a growing public health challenge. Amidst the COVID-19 pandemic, physical distancing remains an indispensable measure to limit the spread of the virus. This pertains especially to those belonging to high-risk groups, namely older adults with multimorbidity. In-person visits are discouraged for this cohort; hence, there is a need for an alternative form of consultation such as video consultations to continue the provision of care. Objective: The potential of video consultations has been explored in several studies. However, the emergence of COVID-19 presents us with an unprecedented opportunity to explore the use of this technological innovation in a time when physical distancing is imperative. This study will evaluate the sustainability of video consultations on a micro-, meso-, and macro-level by assessing the views of patients, physicians, and organizational and national policymakers, respectively. Methods: The NASSS (nonadoption, abandonment, scale-up, spread, and sustainability) framework was designed as a guide for the development of health care technologies. In this study, the implementation of and experiences related to video consultations will be studied using the NASSS framework. Individual in-depth interviews or focus group discussions will be conducted with participants using the Zoom platform. Data will be analyzed by at least two investigators trained in qualitative methodology, organized thematically, and coded in two phases—an initial phase and a focused selective phase. All disagreements will be resolved by consulting the larger research team until consensus is reached. Results: This study was approved for funding from the Geriatric Education and Research Institute. Ethics approval was obtained from the National Healthcare Group Domain Specific Review Board (reference #2020/00760). Study recruitment commenced in July 2020. The results of the data analysis are expected to be available by the end of the year. Conclusions: This study aims to evaluate the adoption and sustainability of video consultations for older adults with multimorbidity during the pandemic as well as post COVID-19. The study will yield knowledge that will challenge the current paradigm on how care is being delivered for community-dwelling older adults with multimorbidity. Findings will be shared with administrators in the health care sector in order to enhance the safety and quality of these video consultations to improve patient care for this group of population.

  • JMIR Res Protoc 2020;9(10):e22679

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  Non-randomized Protocols and Methods...

  Oct 26, 2020

  A Biological Age Model Designed for Health Promotion Interventions: Protocol for an Interdisciplinary Study for Model Development

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  Authors List:

  • Karina Louise Skov Husted  
  • Mathilde Fogelstrøm  
  • Pernille Hulst  
  • Andreas Brink-Kjær  
  • Kaj-Åge Henneberg  
  • Helge Bjarup Dissing Sorensen  
  • Flemming Dela  
  • Jørn Wulff Helge  

  Abstract:

  Background: Actions to improve healthy aging and delay morbidity are crucial, given the global aging population. We believe that biological age estimation can help promote the health of the general population. Biological age reflects the heterogeneity in functional status and vulnerability to disease that chronological age cannot. Thus, biological age assessment is a tool that provides an intuitively meaningful outcome for the general population, and as such, facilitates our understanding of the extent to which lifestyle can increase health span. Objective: This interdisciplinary study intends to develop a biological age model and explore its usefulness. Methods: The model development comprised three consecutive phases: (1) conducting a cross-sectional study to gather candidate biomarkers from 100 individuals representing normal healthy aging people (the derivation cohort); (2) estimating the biological age using principal component analysis; and (3) testing the clinical use of the model in a validation cohort of overweight adults attending a lifestyle intervention course. Results: We completed the data collection and analysis of the cross-sectional study, and the initial results of the principal component analysis are ready. Interpretation and refinement of the model is ongoing. Recruitment to the validation cohort is forthcoming. We expect the results to be published by December 2021. Conclusions: We expect the biological age model to be a useful indicator of disease risk and metabolic risk, and further research should focus on validating the model on a larger scale. Trial Registration: ClinicalTrials.gov NCT03680768, https://clinicaltrials.gov/ct2/show/NCT03680768 (Phase 1 study); NCT04279366 https://clinicaltrials.gov/ct2/show/NCT04279366 (Phase 3 study).

  • JMIR Res Protoc 2020;9(10):e19209

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  RCTs - Protocols/Proposals (funded,...

  Oct 26, 2020

  The Effect of Multi-Parametric Magnetic Resonance Imaging in Standard of Care for Nonalcoholic Fatty Liver Disease: Protocol for a Randomized Control Trial

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  Authors List:

  • Dimitar Tonev  
  • Elizabeth Shumbayawonda  
  • Louise Ann Tetlow  
  • Laura Herdman  
  • Marika French  
  • Soubera Rymell  
  • Helena Thomaides-Brears  
  • Filipe Caseiro-Alves  
  • Miguel Castelo-Branco  
  • Carlos Ferreira  
  • Minneke Coenraad  
  • Hildo Lamb  
  • Meinrad Beer  
  • Matt Kelly  
  • Rajarshi Banerjee  
  • Matthias Dollinger  
  • RADIcAL1

  Abstract:

  Background: The rising prevalence of nonalcoholic fatty liver disease (NAFLD) and the more aggressive subtype, nonalcoholic steatohepatitis (NASH), is a global public health concern. Left untreated, NAFLD/NASH can lead to cirrhosis, liver failure, and death. The current standard for diagnosing and staging liver disease is a liver biopsy, which is costly, invasive, and carries risk for the patient. Therefore, there is a growing need for a reliable, feasible, and cost-effective, noninvasive diagnostic tool for these conditions. LiverMultiScan is one such promising tool that uses multi-parametric magnetic resonance imaging (mpMRI) to characterize liver tissue and to aid in the diagnosis and monitoring of liver diseases of various etiologies. Objective: The primary objective of this trial (RADIcAL1) is to evaluate the cost-effectiveness of the introduction of LiverMultiScan as a standardized diagnostic test for liver disease in comparison to standard care for NAFLD, in different EU territories. Methods: RADIcAL1 is a multi-center randomized control trial with 2 arms conducted in 4 European territories (13 sites, from across Germany, Netherlands, Portugal, and the United Kingdom). In total, 1072 adult patients with suspected fatty liver disease will be randomized to be treated according to the result of the mpMRI in the intervention arm, so that further diagnostic evaluation is recommended only when values for metrics of liver fat or fibro-inflammation are elevated. Patients in the control arm will be treated as per center guidelines for standard of care. The primary outcome for this trial is to compare the difference in the proportion of patients with suspected NAFLD incurring liver-related hospital consultations or liver biopsies between the study arms, from the date of randomization to the end of the study follow-up. Secondary outcomes include patient feedback from a patient satisfaction questionnaire, at baseline and all follow-up visits to the end of the study, and time, from randomization to diagnosis by the physician, as recorded at the final follow-up visit. Results: This trial is currently open for recruitment. The anticipated completion date for the study is December 2020. Conclusions: This randomized controlled trial will provide the evidence to accelerate decision making regarding the inclusion of mpMRI-based tools in existing NAFLD/NASH clinical care. RADIcAL1 is among the first and largest European health economic studies of imaging technologies for fatty liver disease. Strengths of the trial include a high-quality research design and an in-depth assessment of the implementation of the cost-effectiveness of the mpMRI diagnostic. If effective, the trial may highlight the health economic burden on tertiary-referral hepatology clinics imposed by unnecessary consultations and invasive diagnostic investigations, and demonstrate that including LiverMultiScan as a NAFLD diagnostic test may be cost-effective compared to liver-related hospital consultations or liver biopsies. Trial Registration: ClinicalTrials.gov NCT03289897 https://clinicaltrials.gov/ct2/show/NCT03289897

  • JMIR Res Protoc 2020;9(10):e19189

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  Non-Randomized Study Protocols and...

  Oct 26, 2020

  Safety and Biovigilance in Organ Donation (SAFEBOD): Protocol for a Population-Based Cohort Study

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  Authors List:

  • Brenda Rosales  
  • James Hedley  
  • Nicole De La Mata  
  • Claire M Vajdic  
  • Patrick Kelly  
  • Kate Wyburn  
  • Angela C Webster  
  • The SAFEBOD Study Group

  Abstract:

  Background: Tension lies between the need to increase access to organ transplantation and the equally urgent need to prevent inadvertent transmission of infectious diseases or cancer from organ donors. Biovigilance, or the evaluation of potential donors, is often time-pressured and may be based on incomplete information. Objective: The Safety and Biovigilance in Organ Donation (SAFEBOD) study aims to improve estimates of infection and cancer transmission risk and explore how real-time data access could support decision-making. Methods: We will link existing donor referral, actual donor, recipient, and health-outcome data sets from 2000-2015 in New South Wales. Organ donor data sets will include the Organ Donor Characterizing Risk-Profile of Donors Study, the National Organ Matching System, the Australian and New Zealand Organ Donor Register, and the Australian and New Zealand Living Donor Kidney Register. Recipient data sets will include the Australian and New Zealand Dialysis and Transplant Register, the Australian and New Zealand Cardiothoracic Register, the Australian and New Zealand Islet and Pancreas Register, and the Australian and New Zealand Liver Transplant Register. New South Wales health outcome data sets will include HIV and AIDS Notifications and Surveillance Data, the Notifiable Conditions Information Management System, Admitted Patient Data Collection, Emergency Department Data Collection, the Central Cancer Registry, and the Cause of Death Data Collection. We will link organ donors to transplant recipients and health outcomes data sets using probabilistic data-matching based on personal identifiers. Transmission and nontransmission events will be determined by comparing previous cases in donors and posttransplant cases in recipients. We will compare the perceived-risk at referral with the verified risk from linked health outcome data sets and the odds of cancer or contracting an infectious disease in organ recipients from donors based on their transmission-risk profile and estimate recipient survival by donor transmission risk group. Results: Data were requested from each of the listed registries in September 2018, and data collection is ongoing. Linked data from all listed data sets are expected to be complete in September 2020. Conclusions: The SAFEBOD study will overcome current limitations in organ donation by accessing comprehensive information on referred organ donors and recipients in existing data sets. The study will provide robust estimates of disease transmission and nontransmission events based on recent data. It will also describe the agreement between perceived risk estimated at the time of referral and verified risk when all health outcome data are accessible. The improved understanding of transmission and nontransmission events will inform clinical decisions and highlight where current policies can be revised to broaden the acceptance of deceased donors. Trial Registration:

  • JMIR Res Protoc 2020;9(10):e18282

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  RCTs - Pilots/Feasibility Studies...

  Oct 23, 2020

  Use of a Smartphone App to Increase Physical Activity Levels in Insufficiently Active Adults: Feasibility Sequential Multiple Assignment Randomized Trial...

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  Authors List:

  • Bárbara De Barros Gonze  
  • Ricardo Da Costa Padovani  
  • Maria Do Socorro Simoes  
  • Vinicius Lauria  
  • Neli Leite Proença  
  • Evandro Fornias Sperandio  
  • Thatiane Lopes Valentim Di Paschoale Ostolin  
  • Grace Angélica De Oliveira Gomes  
  • Paula Costa Castro  
  • Marcello Romiti  
  • Antonio Gagliardi  
  • Rodolfo Leite Arantes  
  • Victor Zuniga Dourado  

  Abstract:

  Background: The sequential multiple assignment randomized trial (SMART) design allows for changes in the intervention during the trial period. Despite its potential and feasibility for defining the best sequence of interventions, so far, it has not been utilized in a smartphone/gamified intervention for physical activity. Objective: We aimed to investigate the feasibility of the SMART design for assessing the effects of a smartphone app intervention to improve physical activity in adults. We also aimed to describe the participants’ perception regarding the protocol and the use of the app for physical activity qualitatively. Methods: We conducted a feasibility 24-week/two-stage SMART in which 18 insufficiently active participants (<10,000 steps/day) were first randomized to group 1 (smartphone app only), group 2 (smartphone app + tailored messages), and a control group (usual routine during the protocol). Participants were motivated to increase their step count by at least 2000 steps/day each week. Based on the 12-week intermediate outcome, responders continued the intervention and nonresponders were rerandomized to subsequent treatment, including a new group 3 (smartphone app + tailored messages + gamification) in which they were instructed to form groups to use several game elements available in the chosen app (Pacer). We considered responders as those with any positive slope in the linear relationship between weeks and steps per day at the end of the first stage of the intervention. We compared the accelerometer-based steps per day before and after the intervention, as well as the slopes of the app-based steps per day between the first and second stages of the intervention. Results: Twelve participants, including five controls, finished the intervention. We identified two responders in group 1. We did not observe relevant changes in the steps per day either throughout the intervention or compared with the control group. However, the rerandomization of five nonresponders led to a change in the slope of the steps per day (median −198 steps/day [IQR −279 to −103] to 20 steps/day [IQR −204 to 145]; P=.08). Finally, in three participants from group 2, we observed an increase in the number of steps per day up to the sixth week, followed by an inflection to baseline values or even lower (ie, a quadratic relationship). The qualitative analysis showed that participants’ reports could be classified into the following: (1) difficulty in managing the app and technology or problems with the device, (2) suitable response to the app, and (3) difficulties to achieve the goals. Conclusions: The SMART design was feasible and changed the behavior of steps per day after rerandomization. Rerandomization should be implemented earlier to take advantage of tailored messages. Additionally, difficulties with technology and realistic and individualized goals should be considered in interventions for physical activity using smartphones. Trial Registration: Brazilian Registry of Clinical Trials RBR-8xtc9c; http://www.ensaiosclinicos.gov.br/rg/RBR-8xtc9c/.

  • JMIR Res Protoc 2020;9(10):e14322

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  Systematic Review Protocols

  Oct 22, 2020

  Qualitative Evidence Synthesis on Self-Collection for Human Papillomavirus–Based Cervical Screening: Protocol for Systematic Review

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  Authors List:

  • Hawa Camara  
  • Ye Zhang  
  • Lise Lafferty  
  • Andrew Vallely  
  • Rebecca Guy  
  • Angela Kelly-Hanku  

  Abstract:

  Background: Cervical cancer is the fourth most common cancer affecting women worldwide. In the 1980s, it was found that the sexually transmitted disease human papillomavirus causes over 90% of all cervical cancer cases. Since that discovery, diagnostic technologies have been developed for the detection of human papillomavirus DNA in cervical samples. However, significant sociocultural and structural barriers remain. Considerable strides have taken place in recent years to address these barriers, such as the self-collection for human papillomavirus–based cervical screening method. Objective: The purpose of this review is to synthesize qualitative evidence around the self-collection method and identify strategies to increase acceptability and feasibility in different settings. This qualitative synthesis will be used to better understand how to conceptualize and implement more effective, accessible, and socially and culturally acceptable cervical screening programs and policies globally. Methods: A systematic search will be conducted in Global Health, Cochrane, CINAHL (Cumulative Index to Nursing and Allied Health Literature), ProQuest, ScienceDirect, EMBASE, EMCARE, Medline (OVID), Scopus, and Web of Science. Published and peer-reviewed articles will be included. Two reviewers will independently screen and assess the studies. The data will be coded and analyzed using a thematic synthesis process. The socioecological model will be used to organize emergent themes at the micro and macro levels. The results will be presented in narrative and tabular form. Results: The article search and data extraction were completed in May 2020. The data were analyzed in June 2020. The review will be submitted for publication in Fall 2020. Conclusions: This review will present the global evidence of the perspectives and experiences of various key stakeholders and how these perspectives and experiences impact their decision-making process to perform or accept self-collection for human papillomavirus–based cervical screening. The review will provide guidance to implementation researchers as well as implications for future research. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42019109073; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=109073

  • JMIR Res Protoc 2020;9(10):e21093

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  RCTs - Protocols/Proposals (funded,...

  Oct 22, 2020

  A Telemonitoring and Hybrid Virtual Coaching Solution “CAir” for Patients with Chronic Obstructive Pulmonary Disease: Protocol for a Randomized...

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  Authors List:

  • Christoph Gross  
  • Dario Kohlbrenner  
  • Christian F Clarenbach  
  • Adam Ivankay  
  • Thomas Brunschwiler  
  • Yves Nordmann  
  • Florian v Wangenheim  

  Abstract:

  Background: Chronic obstructive pulmonary disease (COPD) is one of the most common disorders in the world. COPD is characterized by airflow obstruction, which is not fully reversible. Patients usually experience breathing-related symptoms with periods of acute worsening and a substantial decrease in the health-related quality-of-life. Active and comprehensive disease management can slow down the progressive course of the disease and improve patients’ disabilities. Technological progress and digitalization of medicine have the potential to make elaborate interventions easily accessible and applicable to a broad spectrum of patients with COPD without increasing the costs of the intervention. Objective: This study aims to develop a comprehensive telemonitoring and hybrid virtual coaching solution and to investigate its effects on the health-related quality of life of patients with COPD. Methods: A monocentric, assessor-blind, two-arm (intervention/control) randomized controlled trial will be performed. Participants randomized to the control group will receive usual care and a CAir Desk (custom-built home disease-monitoring device to telemonitor disease-relevant parameters) for 12 weeks, without feedback or scores of the telemonitoring efforts and virtual coaching. Participants randomized to the intervention group will receive a CAir Desk and a hybrid digital coaching intervention for 12 weeks. As a primary outcome, we will measure the delta in the health-related quality of life, which we will assess with the St. George Respiratory Questionnaire, from baseline to week 12 (the end of the intervention). Results: The development of the CAir Desk and virtual coach has been completed. Recruitment to the trial started in September 2020. We expect to start data collection by December 2020 and expect it to last for approximately 18 months, as we follow a multiwave approach. We expect to complete data collection by mid-2022 and plan the dissemination of the results subsequently. Conclusions: To our knowledge, this is the first study investigating a combination of telemonitoring and hybrid virtual coaching in patients with COPD. We will investigate the effectiveness, efficacy, and usability of the proposed intervention and provide evidence to further develop app-based and chatbot-based disease monitoring and interventions in COPD. Trial Registration: ClinicalTrials.gov identifier: NCT04373070; https://clinicaltrials.gov/ct2/show/NCT04373070

  • JMIR Res Protoc 2020;9(10):e20412

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  Non-randomized Protocols and Methods...

  Oct 22, 2020

  Understanding the Uptake of Big Data in Health Care: Protocol for a Multinational Mixed-Methods Study

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  Authors List:

  • Rik Wehrens  
  • Vikrant Sihag  
  • Sandra Sülz  
  • Hilco van Elten  
  • Erik van Raaij  
  • Antoinette de Bont  
  • Anne Marie Weggelaar-Jansen  

  Abstract:

  Background: Despite the high potential of big data, their applications in health care face many organizational, social, financial, and regulatory challenges. The societal dimensions of big data are underrepresented in much medical research. Little is known about integrating big data applications in the corporate routines of hospitals and other care providers. Equally little is understood about embedding big data applications in daily work practices and how they lead to actual improvements for health care actors, such as patients, care professionals, care providers, information technology companies, payers, and the society. Objective: This planned study aims to provide an integrated analysis of big data applications, focusing on the interrelations among concrete big data experiments, organizational routines, and relevant systemic and societal dimensions. To understand the similarities and differences between interactions in various contexts, the study covers 12 big data pilot projects in eight European countries, each with its own health care system. Workshops will be held with stakeholders to discuss the findings, our recommendations, and the implementation. Dissemination is supported by visual representations developed to share the knowledge gained. Methods: This study will utilize a mixed-methods approach that combines performance measurements, interviews, document analysis, and cocreation workshops. Analysis will be structured around the following four key dimensions: performance, embedding, legitimation, and value creation. Data and their interrelations across the dimensions will be synthesized per application and per country. Results: The study was funded in August 2017. Data collection started in April 2018 and will continue until September 2021. The multidisciplinary focus of this study enables us to combine insights from several social sciences (health policy analysis, business administration, innovation studies, organization studies, ethics, and health services research) to advance a holistic understanding of big data value realization. The multinational character enables comparative analysis across the following eight European countries: Austria, France, Germany, Ireland, the Netherlands, Spain, Sweden, and the United Kingdom. Given that national and organizational contexts change over time, it will not be possible to isolate the factors and actors that explain the implementation of big data applications. The visual representations developed for dissemination purposes will help to reduce complexity and clarify the relations between the various dimensions. Conclusions: This study will develop an integrated approach to big data applications that considers the interrelations among concrete big data experiments, organizational routines, and relevant systemic and societal dimensions.

  • JMIR Res Protoc 2020;9(10):e16779

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  Non-Randomized Study Protocols and...

  Oct 21, 2020

  Respiratory Health of Pacific Youth: An Observational Study of Associated Risk and Protective Factors Throughout Childhood

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  Authors List:

  • El-Shadan Tautolo  
  • Conroy Wong  
  • Alain Vandal  
  • Shabnam Jalili-Moghaddam  
  • Emily Griffiths  
  • Leon Iusitini  
  • Adrian Trenholme  
  • Catherine Byrnes  

  Abstract:

  Background: Respiratory disease is the third most common cause of death in New Zealand, with Pacific people living in New Zealand bearing the greatest burden of this type of disease. Although some epidemiological outcomes are known, we lack the specifics required to formulate targeted and effective public health interventions. The Pacific Islands Families (PIF) birth cohort study is a study that provides a unique source of data to assess lung function and current respiratory health among participants entering early adulthood and to examine associations with early life events during critical periods of growth. Objective: This paper aims to provide an overview of the design, methods, and scope of the Respiratory Health of Pacific Youth Study, which uses the overall PIF study cohort aged 18-19 years. Methods: From 2000-2019, the PIF study has followed, from birth, the growth, and the development of 1398 Pacific children born in Auckland, New Zealand. Participants were nested within the overall PIF study (at ages 18-19 years) from June 2018, and assessments were undertaken until mid-November 2019. The assessments included respiratory and general medical histories, a general physical examination, assessment of lung function (forced expiratory volume and forced vital capacity), self-completed questionnaires (St George’s Respiratory Questionnaire, European Quality of Life 5 Dimensions-3 Level, Epworth Sleepiness Scale for Children and Adolescents, and Leicester Cough Questionnaire), blood tests (eosinophils, Immunoglobulin E, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and C-reactive protein), and chest x-rays. Noninferential analyses will be carried out on dimensionally reduced risk and protective factors and confounders. Results: Data collection began in June 2018 and ended in November 2019, with a total of 466 participants recruited for submission of the paper. Collection and collation of chest x-ray data is still underway, and data analysis and expected results will be published by November 2020. Conclusions: This is the first longitudinal observational study to address the burden of respiratory disease among Pacific youth by determining factors in early life that impose long-term detriments in lung function and are associated with the presence of respiratory illness. Identifying risk factors and the magnitude of their effects will help in adopting preventative measures, establishing whether any avoidable risks can be modified by later resilient behaviors, and provide baseline measurements for the development of respiratory disease in later adult life. The study results can be translated into practice guidelines and inform health strategies with immediate national and international impact.

  • JMIR Res Protoc 2020;9(10):e18916

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