JMIR Publications

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  Non-randomized Protocols and Methods...

  Aug 15, 2018

  Virtual Medical Modality Implementation Strategies for Patient-Aligned Care Teams to Promote Veteran-Centered Care: Protocol for a Mixed-Methods Study

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  Authors List:

  • Jolie Haun  
  • Margeaux Chavez  
  • Wendy Hathaway  
  • Nicole Antinori  
  • Christine Melillo  
  • Bridget A Cotner  
  • Julie McMahon-Grenz  
  • Brian Zilka  
  • Shilpa Patel-Teague  
  • William Messina  
  • Kim Nazi  

  Abstract:

  Background: The Veterans Health Administration (VHA) is making system-wide efforts to increase integrated use of health information technology (HIT), including My HealtheVet (MHV), the Veterans Affairs (VA) electronic patient portal, Vet Link kiosks, telehealth, and mobile apps. Integrated use of HIT can increase individual and system efficiency, maximize resources, and enhance patient outcomes. Prior research indicates that provider endorsement and reinforcement are key determinants of patient adoption of HIT. HIT implementation strategies need to reflect providers’ perspectives to promote adoption and endorsement of these tools; however, providers often lack awareness or are unmotivated to incorporate HIT into clinical care with their patients. When these modalities are used by patients, the approach is often fragmented rather than integrated within and across care settings. Research is needed to identify effective implementation strategies for increasing patient-aligned care team (PACT) member (ie, the VHA’s Patient Centered Medical Home) awareness and motivation to use HIT in a proactive and integrated approach with patients. Objective: This paper describes the rationale, design, and methods of the PACT protocol to promote proactive integrated use of HIT. Methods: In Aim 1, focus groups (n=21) were conducted with PACT members (n=65) along with questionnaires and follow-up individual interviews (n=16). In Aim 2, the team collaborated with VA clinicians, electronic health researchers and operational partners to conduct individual expert interviews (n=13), and an environmental scan to collect current and emerging provider-focused implementation tools and resources. Based on Aim 1 findings, a gap analysis was conducted to determine what implementation strategies and content needed to be adapted or developed. Following the adaptation or development of resources, a PACT expert panel was convened to evaluate the resultant content. In Aim 3, a local implementation of PACT-focused strategies to promote integrated use of HIT was evaluated using pre- and postquestionnaire surveys, brief structured interviews, and secondary data analysis with PACT members (n=63). Results: Study enrollment for Aim 1 has been completed. Aims 1 and 2 data collection and analysis are underway. Aim 3 activities are scheduled for year 3. Conclusions: This work highlights the practical, technological, and participatory factors involved in facilitating implementation research designed to engage PACT clinical members in the proactive integrated use of HIT. These efforts are designed to support the integrated and proactive use of VA HIT to support clinical care coordination in ways that are directly aligned with PACT member preferences. This study evaluated integrated VA HIT use employing mixed-methods and multiple data sources. Deliverables included PACT-focused strategies to support integrated use of HIT in the ambulatory care setting that will also inform strategy development in other systems of care and support subsequent implementation efforts at regional and national levels. Registered Report Identifier: RR1-10.2196/11262

  • JMIR Res Protoc 2018;7(8):e11262

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  RCTs - Protocols/Proposals (funded,...

  Aug 15, 2018

  Intra-Arterial TheraSphere Yttrium-90 Glass Microspheres in the Treatment of Patients With Unresectable Hepatocellular Carcinoma: Protocol for the STOP-HCC...

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  Authors List:

  • Nikhil Chauhan  
  • Janet Bukovcan  
  • Eveline Boucher  
  • David Cosgrove  
  • Julien Edeline  
  • Bonnie Hamilton  
  • Laura Kulik  
  • Fayaz Master  
  • Riad Salem  

  Abstract:

  Background: Globally, hepatocellular carcinoma is the second most common cause of cancer deaths. It remains challenging to intensify cancer treatment without impairing liver function. Objective: The objective of the TheraSphere in the Treatment of Patients with Unresectable Hepatocellular Carcinoma (STOP-HCC) study is to examine the hypothesis that transarterial radioembolization (TheraSphere yttrium-90 glass microspheres) combined with standard first-line treatment with sorafenib will improve outcomes over treatment with sorafenib alone in unresectable hepatocellular carcinoma. The STOP-HCC study is the largest international, multicenter, prospective study of intra-arterial treatment in combination with sorafenib in unresectable hepatocellular carcinoma. Here we report the study design. Methods: STOP-HCC is a prospective, phase 3, open-label, randomized controlled study conducted across up to 105 sites in North America, Europe, and Asia. Eligible adults have unresectable hepatocellular carcinoma and a life expectancy of at least 12 weeks, 1 or more unidimensional measurable lesions, Child-Pugh score 7 points or less, and Eastern Cooperative Oncology Group Performance Status score 1 or lower, and are candidates for treatment with sorafenib. Presence of branch portal vein tumor thrombosis is permitted. Patients were randomly assigned in a 1:1 ratio to receive either sorafenib alone or transarterial radioembolization followed by sorafenib within 2 to 6 weeks. The primary outcome is overall survival. Secondary outcomes are time to progression, time to untreatable progression, time to symptomatic progression, tumor response, quality of life, and adverse event occurrence. The study is an adaptive trial, comprising a group-sequential design with 2 interim analyses with 520 patients, and an option to increase the sample size to 700 patients at the second interim analysis. The sample size of 520 patients allows for 417 deaths to give 80% power to detect an increase in median overall survival from 10.7 months for the sorafenib group (based on the Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol [SHARP] trial) to 14.2 months for the transarterial radioembolization+sorafenib group (hazard ratio 0.754) with 2-sided alpha of .05. The increased sample size of 700 patients allows for 564 deaths to give 80% power to detect a smaller difference in median overall survival from 10.7 months for the sorafenib group to 13.7 months for the transarterial radioembolization+sorafenib group (hazard ratio 0.781). Results: Enrollment for the study completed in September 2017. Results of the first and second interim analyses were reviewed by the Independent Data Monitoring Committee. The recommendation of the committee, at both interim analyses, was to continue the study without any changes. Conclusions: The STOP-HCC study will contribute toward the establishment of the role of combination therapy with transarterial radioembolization and sorafenib in the treatment of unresectable hepatocellular carcinoma with and without branch portal vein tumor thrombosis. Trial Registration: ClinicalTrials.gov NCT01556490; https://clinicaltrials.gov/ct2/show/NCT01556490 (Archived by WebCite at http://www.webcitation.org/7188iygKs). Registered Report Identifier: RR1-10.2196/11234

  • JMIR Res Protoc 2018;7(8):e11234

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  Non-randomized Protocols and Methods...

  Aug 13, 2018

  A Remote Intervention to Prevent or Delay Cognitive Impairment in Older Adults: Design, Recruitment, and Baseline Characteristics of the Virtual Cognitive...

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  Authors List:

  • Nicholas Bott  
  • Shefali Kumar  
  • Caitlyn Krebs  
  • Jordan M Glenn  
  • Erica N Madero  
  • Jessie L Juusola  

  Abstract:

  Background: A growing body of evidence supports the use of lifestyle interventions for preventing or delaying the onset of Alzheimer disease and other forms of dementia in at-risk individuals. The development of internet-delivered programs would increase the scalability and reach of these interventions, but requires validation to ensure similar effectiveness to brick-and-mortar options. Objective: We describe the study design, recruitment process, and baseline participant characteristics of the sample in the Virtual Cognitive Health (VC Health) study. Future analyses will assess the impact of the remotely delivered lifestyle intervention on (1) cognitive function, (2) depression and anxiety, and (3) various lifestyle behaviors, including diet, exercise, and sleep, in a cohort of older adults with subjective memory decline. Additional analyses will explore feasibility outcomes, as well as the participants’ engagement patterns with the program. Methods: Older adults (aged 60-75 years) with subjective memory decline as measured by the Subjective Cognitive Decline 9-item (SCD-9) questionnaire, and who reported feeling worried about their memory decline, were eligible to participate in this single-arm pre-post study. All participants enrolled in the yearlong digital intervention, which consists of health coach-guided lifestyle change for improving diet, exercise, sleep, stress, and cognition. All components of this study were conducted remotely, including the collection of data and the administration of the intervention. We assessed participants at baseline, 12 weeks, 24 weeks, and 52 weeks with online surveys and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) test. We will conduct intention-to-treat analysis on all outcomes. Results: A total of 85 participants enrolled in the intervention and 82 are included in the study sample (3 participants withdrew). The study cohort of 82 participants comprises 61 (74%) female, 72 (88%) white, and 64 (78%) overweight or obese participants, and 55 (67%) have at least a college degree. The average baseline RBANS score was 95.9 (SD 11.1), which is within age-adjusted norms. The average SCD-9 score was 6.0 (SD 2.0), indicating minor subjective cognitive impairment at the beginning of the study. The average baseline Generalized Anxiety Disorder 7-item scale score was 6.2 (SD 4.5), and the average Patient Health Questionnaire 9-item score was 8.5 (SD 4.9), indicating mild levels of anxiety and depression at baseline. Conclusions: Internet-delivered lifestyle interventions are a scalable solution for the prevention or delay of Alzheimer disease. The results of this study will provide the first evidence for the effectiveness of a fully remote intervention and lay the groundwork for future investigations. Trial Registration: ClinicalTrials.gov NCT02969460; http://clinicaltrials.gov/ct2/show/NCT02969460 (Archived by WebCite at http://www.webcitation.org/71LkYAkSh) Registered Report Identifier: RR1-10.2196/11368

  • JMIR Res Protoc 2018;7(8):e11368

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  Non-randomized Protocols and Methods...

  Aug 10, 2018

  Designing and Implementing a Home-Based Couple Management Guide for Couples Where One Partner has Dementia (DemPower): Protocol for a Nonrandomized...

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  Authors List:

  • Reena Lasrado  
  • Therése Bielsten  
  • Mark Hann  
  • Linda Davies  
  • James Schumm  
  • Siobhan Reilly  
  • Caroline Swarbrick  
  • John Keady  
  • Ingrid Hellström  

  Abstract:

  Background: The increasing rate of dementia and high health and social care costs call for effective measures to improve public health and enhance the wellbeing of people living with dementia and their relational networks. Most postdiagnostic services focus on the condition and the person with dementia with limited attention to the caring spouse or partner. The key focus of the study is to develop a guide for couples where one partner has a diagnosis of dementia. This couple management guide is delivered in the form of an app, DemPower. Objective: This study aims to investigate the feasibility and acceptability of DemPower and to assess the criteria for a full-integrated clinical and economic randomized control trial. DemPower couple management app will be introduced to couples wherein one partner has dementia. Methods: The study will recruit 25 couples in the United Kingdom and 25 couples in Sweden. Couples will be given 3 months to engage with the app, and the amount of time taken to complete the guide (can be <3 or >3 months) will be reviewed. A set of outcome measures will be obtained at baseline and postintervention stages. Results: The proposed study is at the recruitment phase. The DemPower app is being introduced to couples from consultation groups at a pretrial phase for identifying any bugs and exploring if any navigation challenges exist. The feasibility testing will begin in April 2018. Conclusions: The study will determine how much support couples need to engage with DemPower and whether or not they make use of it in their everyday lives. If there is support for app use, a future study will assess whether it is superior to “usual care.” Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 10122979; http://www.isrctn.com/ISRCTN10122979 (Archived by WebCite at http://www.webcitation.org/70rB1iWYI) Registered Report Identifier: RR1-10.2196/9087

  • JMIR Res Protoc 2018;7(8):e171

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  RCTs - Protocols/Proposals (eHealth)

  Aug 9, 2018

  The Use of Aspirin to Reduce the Risk of Thrombotic Events in Patients With End-Stage Renal Disease: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Tiago Lemos Cerqueira  
  • Armando Fartolino Guerrero  
  • Clara Krystal Pérez Fermin  
  • Ricardo Wang  
  • Evelin Elfriede Balbino  
  • Janis L Breeze  
  • Paola Gonzalez Mego  
  • Daniele Argentina Silva  
  • Walid Ezzeldin Omer  
  • Nathalie Monique Vandevelde  

  Abstract:

  Background: End-stage renal disease (ESRD) is the last stage of chronic kidney disease, mainly caused by type 2 diabetes mellitus and characterized by an increased mortality risk related to cardiovascular disease. Low-dose aspirin (acetylsalicylic acid or ASA) seems to effectively prevent cardiovascular events in patients with ESRD. However, the number of interventional studies in this population remains limited and the mechanisms of aspirin-related bleeding remain poorly understood. Aspirin’s efficacy and safety may be modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. Objective: The overall objective of this protocol is to (1) evaluate aspirin’s safety and efficacy in reducing the risk of thrombotic events in patients with ESRD on hemodialysis and (2) examine whether aspirin’s efficacy is modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. Specifically, the primary objective is to compare the 12-month rate of any thrombotic event (cardiac death, nonfatal myocardial infarction, nonfatal stroke, arteriovenous fistula thrombosis) and Thrombolysis in Myocardial Infarction (TIMI) major bleeding in patients treated with aspirin compared to those on placebo. Secondary objectives are to test for effect modification of treatment by the presence of type 2 diabetes mellitus or platelet hyperreactivity and compare the rate of TIMI minor bleeding between treatment groups. Methods: We developed a protocol for a phase 2 randomized, single-center, placebo-controlled, triple-blind, superiority clinical trial to assess the prophylactic efficacy and safety of aspirin in patients with ESRD and on hemodialysis. It follows the ethical principles of the Declaration of Helsinki of the World Medical Association. A total of 342 participants would be enrolled over 12 months at a large dialysis center. Patients will be randomized in a 1:1 ratio and stratified by presence of type 2 diabetes mellitus and platelet hyperreactivity to receive either oral aspirin (100 mg/d) or placebo for a treatment period of 12 months. An intention-to-treat statistical analysis will be performed. Results: The randomized clinical trial will be performed after approval by the ethical committee of the participating center and registration at ClinicalTrials.gov. Conclusions: We provide a protocol for a randomized controlled trial to evaluate the safety and efficacy of treatment with aspirin to reduce the risk of thrombotic events. In addition, such a study would further our understanding of the mechanism of aspirin-related bleeding and help identify subgroups of best-responders and patients with a higher risk of adverse events. Registered Report Identifier: RR1-10.2196/10516

  • JMIR Res Protoc 2018;7(8):e10516

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  Non-Randomized Study Protocols and...

  Aug 9, 2018

  Evaluating the Diagnostic Accuracy of Reflectance Confocal Microscopy to Diagnose Skin Cancer: Protocol for a Prospective, Multicenter Study

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  Authors List:

  • Naomi D. Herz  
  • Anastasia Chalkidou  
  • Fiona Reid  
  • Stephen F. Keevil  
  • Andrew Coleman  
  • Emma Craythorne  
  • Rakesh Patalay  

  Abstract:

  Background: In the United Kingdom, 350,000 patients per year are referred to hospital clinics with suspicious moles, and approximately half undergo a biopsy to identify the 5%-10% who require further treatment. If cancer cannot be ruled out clinically and on the basis of biopsy results, the lesion is surgically removed. One type of precancerous mole, called lentigo maligna, is particularly challenging to delineate and treat. Reflectance confocal microscopy (VivaScope, Caliber Imaging & Diagnostics) is an imaging technique that can supplement dermoscopy in identifying whether a clinically suspicious mole is malignant and can better assess lentigo maligna margins for excision. It allows clinicians to visualize the skin lesion to a depth of 200 microns with subcellular resolution, described as quasi-histological, and therefore better guide more accurate diagnoses. Objective: The aim of this paper is to describe a prospective, single blinded, multicenter study to examine patients with clinically suspicious moles or lentigo maligna to determine whether confocal microscopy can both reduce the number of unnecessary biopsies of moles and more accurately guide the surgical excision margins of lentigo maligna. Methods: This study will prospectively recruit adults into the following two cohorts: diagnostic accuracy and margin delineation. The diagnostic accuracy cohort will assess people with clinically suspicious lesions suspected of being diagnosed with melanoma and having an equivocal finding on dermoscopy or persistent clinical suspicion despite normal dermoscopy. Diagnostic accuracy will include the sensitivity and specificity of VivaScope in comparison with the histological diagnosis as the gold standard for patients. The margin delineation cohort will assess the ability of VivaScope to accurately delineate the margins of lentigo maligna compared with that of dermoscopy alone using margins taken during Mohs micrographic surgery as the gold standard. The primary study outcomes will be the diagnostic accuracy of VivaScope for the first cohort of patients and margin agreement between VivaScope and the final pathology report for the second cohort of patients. Results: Funding for this proposed research is being secured. Conclusions: The outcomes of the proposed study will indicate how many biopsies of nonmelanoma lesions, which are potentially unnecessary, could be prevented. This would reduce patient anxiety and cost to the National Health Service (NHS) in the United Kingdom. Improved margin delineation of lentigo maligna could also improve the surgical clearance rates and decrease overall cost. The results would demonstrate whether the adoption of VivaScope would potentially benefit patients and the NHS. Registered Report Identifier: RR1-10.2196/9296

  • JMIR Res Protoc 2018;7(8):e170

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  Systematic Review Protocols

  Aug 7, 2018

  Web-Based Cognitive Bias Intervention for Psychiatric Disorders: Protocol for a Systematic Review

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  Authors List:

  • Melvyn Zhang  
  • Jiangbo Ying  
  • Guo Song  
  • Daniel SS Fung  
  • Helen Smith  

  Abstract:

  Background: Traditional psychological therapies focus mainly on modification of individuals’ conscious decision-making process. Unconscious processes, such as cognitive biases, have been found accountable for various psychiatric psychopathologies, and advances in technologies have transformed how bias modification programs are being delivered. Objective: The primary aim of this review is to synthesize evidence of Web-based cognitive bias modification intervention for bias reduction. The secondary aim is to determine the change in symptoms for individual psychiatric disorders following bias modification. Methods: A systematic review will be conducted including only randomized trials. There will be no restrictions on participants included in the study. A search will be conducted on the respective databases until 2017. Selection of studies will be by the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA-P) guidelines. Quality assessment of included studies will be conducted using the Cochrane Risk of Bias tool. A narrative synthesis of identified articles will then be conducted. A meta-analysis will be considered only if there are sufficient articles in a domain for statistical analysis. Ethical approval for this protocol and the planned systematic review was not required. Results: We expect that the review will be completed 12 months from publication of this protocol. Conclusions: This review is of importance given how technology has transformed delivery of conventional therapies. Findings from this review will guide future research involving technology and cognitive bias modification interventions. Trial Registration: International Prospective Register for Systematic Reviews (PROSPERO): 2017 CRD42017074754; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=74754 (Archived by WebCite at http://www.webcitation.org/ 71AvSgZGn) Registered Report Identifier: RR1-10.2196/10427

  • JMIR Res Protoc 2018;7(8):e10427

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  RCTs - Protocols/Proposals (funded,...

  Aug 7, 2018

  Technologies for Innovative Monitoring to Reduce Blood Pressure and Change Lifestyle Using Mobile Phones in Adult and Elderly Populations (TIM Study):...

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  Authors List:

  • Sandra C Fuchs  
  • Erno Harzheim  
  • Cirano Iochpe  
  • Caroline N De David  
  • Marcelo R Gonçalves  
  • Guilhermo P Sesin  
  • Cassio M Costa  
  • Leila B Moreira  
  • Flavio D Fuchs  

  Abstract:

  Background: Hypertension is a growing problem worldwide, markedly in low- and middle-income countries, where the rate of control slightly decreased. The overall prevalence of hypertension in Brazil is 28.7% among adult individuals and 68.9% in the population aged 60 years and older, and less than a third of patients have controlled blood pressure (BP). The use of technologies—mobile phones and the internet—to implement interventions to reduce blood pressure can minimize costs and diminish cardiovascular risk. Interventions through text messaging and electronic BP monitoring present divergent results. Objective: This trial evaluates the effectiveness of interventions—personalized messages and telemonitoring of BP—to reduce systolic BP and improve lifestyle compared to the usual care of patients with hypertension (control group). Methods: This factorial randomized controlled trial enrolls individuals aged 30 to 75 years who have a mobile phone and internet access with the diagnosis of hypertension under drug treatment with up to 2 medications and uncontrolled BP. Eligible participants should have both increased office BP and 24-hour BP with ambulatory BP monitoring. Participants with severe hypertension (systolic BP ≥180 or diastolic BP ≥110 mm Hg), life threatening conditions, low life expectancy, recent major cardiovascular event (last 6 months), other indications for the use of antihypertensive medication, diagnosis of secondary hypertension, pregnant or lactating women, or those unable to understand the interventions are excluded. Participants are randomly allocate to 1 of 4 experimental arms: (1) Telemonitoring of blood pressure (TELEM) group: receives an automatic oscillometric device to measure BP, (2) telemonitoring by text message (TELEMEV) group: receives personalized, standardized text messages to stimulate lifestyle changes and adhere with BP-lowering medication, (3) TELEM-TELEMEV group: receives both interventions, and (4) control group: receives usual clinical treatment (UCT). Data collection is performed in a clinical research center located in a referent hospital. The primary outcomes are reduction of systolic BP assessed by 24-hour ambulatory BP monitoring (primary outcome) and change of lifestyle (based on dietary approaches to stop hypertension (DASH)-type diet, sodium restriction, weight loss or control, increase of physical activity). Results: This study was funded by two Brazilian agencies: the National Council for Scientific and Technological Development and Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul. Enrollment was completed at the end of 2017 (N=231), the follow-up is ongoing, and data analysis is expected to begin in early 2019. A reduction of 24-hour systolic BP of approximately 8.8 [SD 13.1] mm Hg for participants in the BP monitoring group versus 3.4 [SD 11.6] mm Hg in the UCT group is expected. A similar reduction in the text messaging group is expected. Conclusions: The use of mobile technologies connected to the internet through mobile phones promotes time optimization, cost reduction, and better use of public health resources. However, it has not been established whether simple interventions such as text messaging are superior to electronic BP monitoring and whether both outperform conventional counseling. Trial Registration: ClinicalTrials.gov NCT03005470; https://clinicaltrials.gov/ct2/show/NCT03005470 (Archived by WebCite at http://www.webcitation.org/70AoANESu). Plataforma Brasil CAAE 31423214.0.0000.5327. Registered Report Identifier: RR1-10.2196/9619

  • JMIR Res Protoc 2018;7(8):e169

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  Theme Issue (2018): Adolescent...

  Aug 3, 2018

  University of North Carolina/Emory Center for Innovative Technology (iTech) for Addressing the HIV Epidemic Among Adolescents and Young Adults in the United...

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  Authors List:

  • Lisa B Hightow-Weidman  
  • Kathryn Muessig  
  • Eli Rosenberg  
  • Travis Sanchez  
  • Sara LeGrand  
  • Laura Gravens  
  • Patrick S Sullivan  

  Abstract:

  Background: Over a fifth of all new HIV infections in the United States occur among persons aged 13 24 years, with most of these diagnoses occurring among gay and bisexual males (81%). While the epidemic of HIV in the United States has leveled off for many age groups, the annual number of new HIV diagnoses among young men who have sex with men (YMSM; 13-24 years old) remains high. Traditional approaches to continuum improvement for youth have been insufficient, and targeted interventions are urgently needed for young people at risk for or infected with HIV. Interventions delivered through mobile health technology represent a promising approach for improving outcomes in this population. Mobile phones have nearly reached saturation among youth, making mobile technology a particularly promising tool for reaching this population. Objective: The University of North Carolina/Emory Center for Innovative Technology (iTech) is a National Institutes of Health cooperative agreement as part of the Adolescent Medicine Trials Network for HIV/AIDS Interventions. iTech aims to impact the HIV epidemic by conducting innovative, interdisciplinary research on technology-based interventions across the HIV prevention and care continuum for adolescents and young adults in the United States, particularly YMSM, by providing the following: (1) evaluation of novel approaches to identifying youth with undiagnosed HIV infections; (2) evaluation of multilevel, combination prevention approaches, particularly relevant to gender- and sexual-minority youth facing co-occurring health risks; (3) evaluation of uptake of and adherence to biomedical prevention modalities; and 4) evaluation of interventions designed to promote or optimize engagement in care and antiretroviral therapy adherence in HIV-positive youth, to optimize viral load suppression. Methods: iTech brings together multidisciplinary experts in the fields of adolescent HIV treatment and prevention, development and evaluation of technology-based interventions, HIV surveillance and epidemiology, and intervention design and evaluation. This initiative will support 8 efficacy trials and 2 exploratory projects, each led by 2 principal investigators. Taken together, the studies address all of the key steps of the HIV prevention and care continuum for youth in the United States. Each proposal uses technology in a scientifically rigorous and innovative way to access, engage, and impact at-risk or infected youth. Nine iTech subject recruitment venues are spread across 8 US cities. Three cores (management, analytic, and technology) support all iTech activities and form the research network’s infrastructure, facilitating all aspects of study implementation and evaluation. Results: Formative work has already begun on many of the above-mentioned iTech trials. We expect the first randomized controlled trials to begin in mid-2018. Additional details can be found in the individual intervention protocol papers in this issue. Conclusions: Through its comprehensive research portfolio, iTech aims to effectively advance HIV prevention and care for youth through technology-based, youth-relevant interventions that maximize adaptability and sustainability. Registered Report Identifier: RR1-10.2196/10365

  • JMIR Res Protoc 2018;7(8):e10365

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  Theme Issue (2018): Adolescent...

  Aug 2, 2018

  A Multilevel Tailored Web App–Based Intervention for Linking Young Men Who Have Sex With Men to Quality Care (Get Connected): Protocol for a Randomized...

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  Authors List:

  • José A. Bauermeister  
  • Jesse M Golinkoff  
  • Keith J Horvath  
  • Lisa B Hightow-Weidman  
  • Patrick S Sullivan  
  • Rob Stephenson  

  Abstract:

  Background: HIV epidemic among young men who have sex with men (YMSM) is characterized by strong racial disparities and concerns about the availability and access to culturally appropriate HIV prevention and care service delivery. Get Connected, a Web-based intervention that employs individual- and system-level tailoring technology to reduce barriers to HIV prevention care (eg, HIV or sexually transmitted infection [STI] testing, pre-exposure prophylaxis [PrEP]), was developed for YMSM (age 15-24 years). This protocol details the design and procedures of a 2-phase project that includes mystery shopping and a randomized controlled trial (RCT) to test the efficacy of Get Connected among YMSM in Philadelphia, Atlanta, and Houston. Objective: The objective of mystery shopping is to examine the quality of HIV test counseling and PrEP-related referrals for YMSM within local HIV or STI testing sites. The objective of the RCT is to test the efficacy of Get Connected for increasing HIV-negative or HIV-unknown YMSM’s successful uptake of HIV prevention services (eg, routine HIV or STI testing), PrEP awareness, and likelihood to start PrEP (PrEP willingness), compared with those in the control condition, over a 12-month period. Methods: For Phase 1, we will create a master list of HIV and STI testing sites in each city. We will enroll and train 10-15 mystery shoppers per city; each testing site will be separately visited and assessed by 2 mystery shoppers. After each site visit, the mystery shoppers will complete a site evaluation to record their perceptions of various measures including lesbian, gay, bisexual, transgender, queer visibility and inclusivity, privacy and confidentiality, provider-patient interactions, and clinic environment. For Phase 2, we will enroll 480 YMSM for 12 months across the 3 iTech cities into a 2-arm prospective RCT. Participants randomized to the control condition are directed to the AIDSVu.org testing site locator. Participants randomized to the intervention condition will be granted access to a Web app with content tailored to their specific demographic characteristics (eg, age, race or ethnicity, location, and relationship status), HIV and STI risk behaviors (eg, HIV and STI testing history, substance use, communication with partners regarding status) and sociocultural context (eg, homelessness, incarceration). Study assessments will occur at enrollment and at 1, 3, 6, 9, and 12 months postenrollment. Results: Get Connected research activities began in September 2016 and are ongoing. To date, institutional review board (IRB) submission is complete and IRB authorization agreements are pending at several other universities. Conclusions: The deployment of Get Connected through a mobile-optimized Web app seeks to optimize the intervention’s acceptability, accessibility, availability, and long-term affordability among YMSM. Trial Registration: ClinicalTrials.gov (NCT03132415); https://clinicaltrials.gov/ct2/show/NCT03132415 (Archived by WebCite at http://www.webcitation.org/70j4gSFbZ) Registered Report Identifier: RR1-10.2196/10444

  • JMIR Res Protoc 2018;7(8):e10444

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  Non-randomized Protocols and Methods...

  Aug 2, 2018

  Multifactorial Screening Tool for Determining Fall Risk in Community-Dwelling Adults Aged 50 Years or Over (FallSensing): Protocol for a Prospective Study

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  Authors List:

  • Anabela Correia Martins  
  • Juliana Moreira  
  • Catarina Silva  
  • Joana Silva  
  • Cláudia Tonelo  
  • Daniela Baltazar  
  • Clara Rocha  
  • Telmo Pereira  
  • Inês Sousa  

  Abstract:

  Background: Falls are a major health problem among older adults. The risk of falling can be increased by polypharmacy, vision impairment, high blood pressure, environmental home hazards, fear of falling, and changes in the function of musculoskeletal and sensory systems that are associated with aging. Moreover, individuals who experienced previous falls are at higher risk. Nevertheless, falls can be prevented by screening for known risk factors. Objective: The objective of our study was to develop a multifactorial, instrumented, screening tool for fall risk, according to the key risk factors for falls, among Portuguese community-dwelling adults aged 50 years or over and to prospectively validate a risk prediction model for the risk of falling. Methods: This prospective study, following a convenience sample method, will recruit community-dwelling adults aged 50 years or over, who stand and walk independently with or without walking aids in parish councils, physical therapy clinics, senior’s universities, and other facilities in different regions of continental Portugal. The FallSensing screening tool is a technological solution for fall risk screening that includes software, a pressure platform, and 2 inertial sensors. The screening includes questions about demographic and anthropometric data, health and lifestyle behaviors, a detailed explanation about procedures to accomplish 6 functional tests (grip strength, Timed Up and Go, 30 seconds sit to stand, step test, 4-Stage Balance test “modified,” and 10-meter walking speed), 3 questionnaires concerning environmental home hazards, and an activity and participation profile related to mobility and self-efficacy for exercise. Results: The enrollment began in June 2016 and we anticipate study completion by the end of 2018. Conclusions: The FallSensing screening tool is a multifactorial and evidence-based assessment which identifies factors that contribute to fall risk. Establishing a risk prediction model will allow preventive strategies to be implemented, potentially decreasing fall rate. Registered Report Identifier: RR1-10.2196/10304

  • JMIR Res Protoc 2018;7(8):e10304

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  Proposals (eHealth)

  Jul 31, 2018

  Technology-Enhanced Consultations in Diabetes, Cancer, and Heart Failure: Protocol for the Qualitative Analysis of Remote Consultations (QuARC) Project

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  Authors List:

  • Sara E Shaw  
  • Deborah Cameron  
  • Joseph Wherton  
  • Lucas M Seuren  
  • Shanti Vijayaraghavan  
  • Satyajit Bhattacharya  
  • Christine A’Court  
  • Joanne Morris  
  • Trisha Greenhalgh  

  Abstract:

  Background: Remote videoconsulting is promoted by policy makers as a way of delivering health care efficiently to an aging population with rising rates of chronic illness. As a radically new service model, it brings operational and interactional challenges in using digital technologies. In-depth research on this dynamic is needed before remote consultations are introduced more widely. Objective: The objective of this study will be to identify and analyze the communication strategies through which remote consultations are accomplished and to guide patients and clinicians to improve the communicative quality of remote consultations. Methods: In previous research, we collected and analyzed two separate datasets of remote consultations in a National Institute for Health Research–funded study of clinics in East London using Skype and a Wellcome Trust–funded study of specialist community heart failure teams in Oxford using Skype or FaceTime. The Qualitative Analysis of Remote Consultations (QuARC) study will combine datasets and undertake detailed interactional microanalysis of up to 40 remote consultations undertaken by senior and junior doctors and nurse specialists, including consultations with adults with diabetes, women who have diabetes during pregnancy, people consulting for postoperative cancer surgery and community-based patients having routine heart failure reviews along with up to 25 comparable face-to-face consultations. Drawing on established techniques (eg, conversation analysis), analysis will examine the contextual features in remote consultations (eg, restricted visual field) combined with close analysis of different modes of communication (eg, speech, gesture, and gaze). Results: Our findings will address the current gap in knowledge about how technology shapes the fine detail of communication in remote consultations. Alongside academic outputs, findings will inform the coproduction of information and guidance about communication strategies to support successful remote consultations. Conclusions: Identifying the communication strategies through which remote consultations are accomplished and producing guidance for patients and clinicians about how to use this kind of technology successfully in consultations is an important and timely goal because roll out of remote consultations is planned across the National Health Service. Registered Report Identifier: RR1-10.2196/10913

  • JMIR Res Protoc 2018;7(7):e10913

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