Showing papers in "JMIR Research Protocols in 2017"

Mobile Application to Promote Adherence to Oral Chemotherapy and Symptom Management: A Protocol for Design and Development.

Abstract: Background: Oral chemotherapy is increasingly used in place of traditional intravenous chemotherapy to treat patients with cancer. While oral chemotherapy includes benefits such as ease of administration, convenience, and minimization of invasive infusions, patients receive less oversight, support, and symptom monitoring from clinicians. Additionally, adherence is a well-documented challenge for patients with cancer prescribed oral chemotherapy regimens. With the ever-growing presence of smartphones and potential for efficacious behavioral intervention technology, we created a mobile health intervention for medication and symptom management. Objective: The objective of this study was to develop and evaluate the usability and acceptability of a smartphone app to support adherence to oral chemotherapy and symptom management in patients with cancer. Methods: We used a 5-step development model to create a comprehensive mobile app with theoretically informed content. The research and technical development team worked together to develop and iteratively test the app. In addition to the research team, key stakeholders including patients and family members, oncology clinicians, health care representatives, and practice administrators contributed to the content refinement of the intervention. Patient and family members also participated in alpha and beta testing of the final prototype to assess usability and acceptability before we began the randomized controlled trial. Results: We incorporated app components based on the stakeholder feedback we received in focus groups and alpha and beta testing. App components included medication reminders, self-reporting of medication adherence and symptoms, an education library including nutritional information, Fitbit integration, social networking resources, and individually tailored symptom management feedback. We are conducting a randomized controlled trial to determine the effectiveness of the app in improving adherence to oral chemotherapy, quality of life, and burden of symptoms and side effects. At every stage in this trial, we are engaging stakeholders to solicit feedback on our progress and next steps. Conclusions: To our knowledge, we are the first to describe the development of an app designed for people taking oral chemotherapy. The app addresses many concerns with oral chemotherapy, such as medication adherence and symptom management. Soliciting feedback from stakeholders with broad perspectives and expertise ensured that the app was acceptable and potentially beneficial for patients, caregivers, and clinicians. In our development process, we instantiated 7 of the 8 best practices proposed in a recent review of mobile health app development. Our process demonstrated the importance of effective communication between research groups and technical teams, as well as meticulous planning of technical specifications before development begins. Future efforts should consider incorporating other proven strategies in software, such as gamification, to bolster the impact of mobile health apps. Forthcoming results from our randomized controlled trial will provide key data on the effectiveness of this app in improving medication adherence and symptom management. Clinical Trial: ClinicalTrials.gov NCT02157519; https://clinicaltrials.gov/ct2/show/NCT02157519 (Archived by WebCite at http://www.webcitation.org/6prj3xfKA) [JMIR Res Protoc 2017;6(4):e62]

Opening the Black Box of Electronic Health: Collecting, Analyzing, and Interpreting Log Data.

Abstract: In electronic health (eHealth) research, limited insight has been obtained on process outcomes or how the use of technology has contributed to the users' ability to have a healthier life, improved well-being, or activate new attitudes in their daily tasks. As a result, eHealth is often perceived as a black box. To open this black box of eHealth, methodologies must extend beyond the classic effect evaluations. The analyses of log data (anonymous records of real-time actions performed by each user) can provide continuous and objective insights into the actual usage of the technology. However, the possibilities of log data in eHealth research have not been exploited to their fullest extent. The aim of this paper is to describe how log data can be used to improve the evaluation and understand the use of eHealth technology with a broader approach than only descriptive statistics. This paper serves as a starting point for using log data analysis in eHealth research. Here, we describe what log data is and provide an overview of research questions to evaluate the system, the context, the users of a technology, as well as the underpinning theoretical constructs. We also explain the requirements for log data, the starting points for the data preparation, and methods for data collection. Finally, we describe methods for data analysis and draw a conclusion regarding the importance of the results for both scientific and practical applications. The analysis of log data can be of great value for opening the black box of eHealth. A deliberate log data analysis can give new insights into how the usage of the technology contributes to found effects and can thereby help to improve the persuasiveness and effectiveness of eHealth technology and the underpinning behavioral models.

Home-Based HIV Testing and Counseling for Male Couples (Project Nexus): A Protocol for a Randomized Controlled Trial

Abstract: Background: HIV prevalence remains high among men who have sex with men (MSM) in the United States, yet the majority of research has focused on MSM as individuals, not as dyads, and has discussed HIV risks primarily in the context of casual sex Nexus is an online prevention program that combines home-based HIV testing and couples HIV testing and counseling (CHTC) It allows partners in dyadic MSM relationships to receive HIV testing and care in the comfort of their designated residence, via video-based chat By using video-based technologies (eg, VSee video chat), male couples receive counseling and support from a remote online counselor, while testing for HIV at home Objective: This randomized control trial (RCT) aims to examine the effects of video-based counseling combined with home-based HIV testing on couples’ management of HIV risk, formation and adherence to explicit sexual agreements, and sexual risk-taking Methods: The research implements a prospective RCT of 400 online-recruited male couples: 200 self-reported concordant-negative couples and 200 self-reported discordant couples Couples in the control arm will receive one or two home-based HIV self-testing kits and will be asked to report their results via the study’s website Couples in the experimental arm will receive one or two home-based HIV self-testing kits and will conduct these tests together under the facilitation of a remotely located counselor during a prescheduled VSee-based video CHTC session Study assessments are taken at baseline, as well as at 3- and 6-month follow-up sessions Results: Project Nexus was launched in April 2016 and is ongoing To date, 219 eligible couples have been enrolled and randomized Conclusions: Combining home-based HIV testing with video-based counseling creates an opportunity to expand CHTC to male couples who (1) live outside metro areas, (2) live in rural areas without access to testing services or LGBTQ resources, or (3) feel that current clinic-based testing is not for them (eg, due to fears of discrimination associated with HIV and/or sexuality) Clinical Trial: ClinicalTrialsgov NCT02335138; https://clinicaltrialsgov/ct2/show/NCT02335138 (Archived by WebCite at http://wwwwebcitationorg/6qHxtNIdW) [JMIR Res Protoc 2017;6(5):e101]

MyVoice National Text Message Survey of Youth Aged 14 to 24 Years: Study Protocol.

Abstract: Background: There has been little progress in adolescent health outcomes in recent decades. Researchers and youth-serving organizations struggle to accurately elicit youth voice and translate youth perspectives into health care policy. Objective: Our aim is to describe the protocol of the MyVoice Project, a longitudinal mixed methods study designed to engage youth, particularly those not typically included in research. Text messaging surveys are collected, analyzed, and disseminated in real time to leverage youth perspectives to impact policy. Methods: Youth aged 14 to 24 years are recruited to receive weekly text message surveys on a variety of policy and health topics. The research team, including academic researchers, methodologists, and youth, develop questions through an iterative writing and piloting process. Question topics are elicited from community organizations, researchers, and policy makers to inform salient policies. A youth-centered interactive platform has been developed that automatically sends confidential weekly surveys and incentives to participants. Parental consent is not required because the survey is of minimal risk to participants. Recruitment occurs online (eg, Facebook, Instagram, university health research website) and in person at community events. Weekly surveys collect both quantitative and qualitative data. Quantitative data are analyzed using descriptive statistics. Qualitative data are quickly analyzed using natural language processing and traditional qualitative methods. Mixed methods integration and analysis supports a more in-depth understanding of the research questions. Results: We are currently recruiting and enrolling participants through in-person and online strategies. Question development, weekly data collection, data analysis, and dissemination are in progress. Conclusions: MyVoice quickly ascertains the thoughts and opinions of youth in real time using a widespread, readily available technology—text messaging. Results are disseminated to researchers, policy makers, and youth-serving organizations through a variety of methods. Policy makers and organizations also share their priority areas with the research team to develop additional question sets to inform important policy decisions. Youth-serving organizations can use results to make decisions to promote youth well-being. [JMIR Res Protoc 2017;6(12):e247]

The Malaria System MicroApp: A New, Mobile Device-Based Tool for Malaria Diagnosis.

Abstract: Background: Malaria is a public health problem that affects remote areas worldwide. Climate change has contributed to the problem by allowing for the survival of Anopheles in previously uninhabited areas. As such, several groups have made developing news systems for the automated diagnosis of malaria a priority. Objective: The objective of this study was to develop a new, automated, mobile device-based diagnostic system for malaria. The system uses Giemsa-stained peripheral blood samples combined with light microscopy to identify the Plasmodium falciparum species in the ring stage of development. Methods: The system uses image processing and artificial intelligence techniques as well as a known face detection algorithm to identify Plasmodium parasites. The algorithm is based on integral image and haar-like features concepts, and makes use of weak classifiers with adaptive boosting learning. The search scope of the learning algorithm is reduced in the preprocessing step by removing the background around blood cells. Results: As a proof of concept experiment, the tool was used on 555 malaria-positive and 777 malaria-negative previously-made slides. The accuracy of the system was, on average, 91%, meaning that for every 100 parasite-infected samples, 91 were identified correctly. Conclusions: Accessibility barriers of low-resource countries can be addressed with low-cost diagnostic tools. Our system, developed for mobile devices (mobile phones and tablets), addresses this by enabling access to health centers in remote communities, and importantly, not depending on extensive malaria expertise or expensive diagnostic detection equipment. [JMIR Res Protoc 2017;6(4):e70]

Rationale and Design of a Genetic Study on Cardiometabolic Risk Factors: Protocol for the Tehran Cardiometabolic Genetic Study (TCGS)

Abstract: Background: Cardiometabolic risk factors comprise cardiovascular diseases and/or diabetes, and need to be evaluated in different fields. Objective: The primary aim of the Tehran Cardiometabolic Genetic Study (TCGS) is to create a comprehensive genome-wide database of at least 16,000 Tehranians, who are participants of the ongoing Tehran Lipid and Glucose Study (TLGS) cohort. Methods: TCGS was designed in collaboration with the Research Institute for Endocrine Sciences and the genetic company deCODE. Participants had already been followed for over a 20-year period for major cardiometabolic-related health events including myocardial infarction, stroke, diabetes mellitus, hypertension, obesity, hyperlipidemia, and familial hypercholesterolemia. Results: The TCGS cohort described here comprises 17,186 (86.3%) of the 19,905 TLGS participants who provided a baseline blood sample that was adequate for plasma and deoxyribonucleic acid analysis. This study is comprised of 849 individuals and 3109 families with at least one member having genotype information. Finally, 5977 males and 7422 females with the total genotyping rate of 0.9854 were genotyped with HumanOmniExpress-24-v1-0 bead chips (containing 649,932 single-nucleotide polymorphism loci with an average mean distance of 4 kilobases). Conclusions: Investigations conducted within the TCGS will seek to identify relevant patterns of genetic polymorphisms that could be related to cardiometabolic risk factors in participants from Tehran. By linking genome-wide data to the existing databank of TLGS participants, which includes comprehensive behavioral, biochemical, and clinical data on each participant since cohort inception in 1999, the TCGS will also allow exploration of gene-gene and gene-environment interactions as they relate to disease status. [JMIR Res Protoc 2017;6(2):e28]

Automating Construction of Machine Learning Models With Clinical Big Data: Proposal Rationale and Methods

Abstract: Background: To improve health outcomes and cut health care costs, we often need to conduct prediction/classification using large clinical datasets (aka, clinical big data), for example, to identify high-risk patients for preventive interventions. Machine learning has been proposed as a key technology for doing this. Machine learning has won most data science competitions and could support many clinical activities, yet only 15% of hospitals use it for even limited purposes. Despite familiarity with data, health care researchers often lack machine learning expertise to directly use clinical big data, creating a hurdle in realizing value from their data. Health care researchers can work with data scientists with deep machine learning knowledge, but it takes time and effort for both parties to communicate effectively. Facing a shortage in the United States of data scientists and hiring competition from companies with deep pockets, health care systems have difficulty recruiting data scientists. Building and generalizing a machine learning model often requires hundreds to thousands of manual iterations by data scientists to select the following: (1) hyper-parameter values and complex algorithms that greatly affect model accuracy and (2) operators and periods for temporally aggregating clinical attributes (eg, whether a patient’s weight kept rising in the past year). This process becomes infeasible with limited budgets. Objective: This study’s goal is to enable health care researchers to directly use clinical big data, make machine learning feasible with limited budgets and data scientist resources, and realize value from data. Methods: This study will allow us to achieve the following: (1) finish developing the new software, Automated Machine Learning (Auto-ML), to automate model selection for machine learning with clinical big data and validate Auto-ML on seven benchmark modeling problems of clinical importance; (2) apply Auto-ML and novel methodology to two new modeling problems crucial for care management allocation and pilot one model with care managers; and (3) perform simulations to estimate the impact of adopting Auto-ML on US patient outcomes. Results: We are currently writing Auto-ML’s design document. We intend to finish our study by around the year 2022. Conclusions: Auto-ML will generalize to various clinical prediction/classification problems. With minimal help from data scientists, health care researchers can use Auto-ML to quickly build high-quality models. This will boost wider use of machine learning in health care and improve patient outcomes. [JMIR Res Protoc 2017;6(8):e175]

The National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study Cohort: Rationale, Methods, and Baseline Characteristics

Abstract: Background: Although bariatric procedures are commonly performed in clinical practice, long-term data on the comparative effectiveness and safety of different procedures on sustained weight loss, comorbidities, and adverse effects are limited, especially in important patient subgroups (eg, individuals with diabetes, older patients, adolescents, and minority patients). Objective: The objective of this study was to create a population-based cohort of patients who underwent 3 commonly performed bariatric procedures—adjustable gastric band (AGB), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG)—to examine the long-term comparative effectiveness and safety of these procedures in both adults and adolescents. Methods: We identified adults (20 to 79 years old) and adolescents (12 to 19 years old) who underwent a primary (first observed) AGB, RYGB, or SG procedure between January 1, 2005 and September 30, 2015 from 42 health systems participating in the Clinical Data Research Networks within the National Patient-Centered Clinical Research Network (PCORnet). We extracted information on patient demographics, encounters with healthcare providers, diagnoses recorded and procedures performed during these encounters, vital signs, and laboratory test results from patients’ electronic health records (EHRs). The outcomes of interest included weight change, incidence of major surgery-related adverse events, and diabetes remission and relapse, collected for up to 10 years after the initial bariatric procedure. Results: A total of 65,093 adults and 777 adolescents met the eligibility criteria of the study. The adult subcohort had a mean age of 45 years and was predominantly female (79.30%, 51,619/65,093). Among adult patients with non-missing race or ethnicity information, 72.08% (41,248/57,227) were White, 21.13% (12,094/57,227) were Black, and 20.58% (13,094/63,637) were Hispanic. The average highest body mass index (BMI) recorded in the year prior to surgery was 49 kg/m2. RYGB was the most common bariatric procedure among adults (49.48%, 32,208/65,093), followed by SG (45.62%, 29,693/65,093) and AGB (4.90%, 3192/65,093). The mean age of the adolescent subcohort was 17 years and 77.5% (602/777) were female. Among adolescent patients with known race or ethnicity information, 67.3% (473/703) were White, 22.6% (159/703) were Black, and 18.0% (124/689) were Hispanic. The average highest recorded BMI in the year preceding surgery was 53 kg/m2. The majority of the adolescent patients received SG (60.4%, 469/777), followed by RYGB (30.8%, 239/777) and AGB (8.9%, 69/777). A BMI measurement (proxy for follow-up) was available in 84.31% (44,978/53,351), 68.09% (20,783/30,521), and 68.56% (7159/10,442) of the eligible adult patients at 1, 3, and 5 years of follow-up, respectively. The corresponding proportion was 82.0% (524/639), 49.9% (174/349), and 38.8% (47/121) in the adolescent subcohort. Conclusions: Our study cohort is one of the largest cohorts of patients with bariatric procedures in the United States. Patients are geographically and demographically diverse, which improves the generalizability of the research findings and allows examination of treatment effect heterogeneity. Ongoing and planned investigations will provide real-world evidence on the long-term benefits and risks of these most commonly used bariatric procedures in current clinical practice.

Project Stronger Together: Protocol to Test a Dyadic Intervention to Improve Engagement in HIV Care Among Sero-Discordant Male Couples in Three US Cities.

Abstract: Background: An estimated one- to-two-thirds of new human immunodeficiency virus (HIV) infections among US men who have sex with men (MSM) occur within the context of primary partnerships. Despite this fact, there remains a lack of prevention interventions that focus on male sero-discordant dyads. Interventions that provide male couples with skills to manage HIV risk, and to support each other towards active engagement in HIV prevention and care, are urgently needed. Objective: The objective of this paper is to describe the protocol for an innovative dyadic intervention (Stronger Together) that combines couples’ HIV testing and dyadic adherence counseling to improve treatment adherence and engagement in care among HIV sero-discordant male couples in the United States. Methods: The research activities involve a prospective randomized controlled trial (RCT) of approximately 165 venue- and clinic-recruited sero-discordant male couples (330 individuals: 165 HIV sero-negative and 165 HIV sero-positive). Couples randomized into the intervention arm receive couples’ HIV counseling and testing plus dyadic adherence counseling, while those randomized to the control arm receive individual HIV counseling and testing. The study takes place in three cities: Atlanta, GA (study site Emory University); Boston, MA (study site The Fenway Institute); and Chicago, IL (study site Ann & Robert H. Lurie Children’s Hospital of Chicago). Cohort recruitment began in 2015. Couples are followed prospectively for 24 months, with study assessments at baseline, 6, 12, 18, and 24 months. Results: Stronger Together was launched in August 2014. To date, 160 couples (97% of the target enrollment) have been enrolled and randomized. The average retention rate across the three sites is 95%. Relationship dissolution has been relatively low, with only 13 couples breaking up during the RCT. Of the 13 couples who have broken up, 10 of the 13 HIV-positive partners have been retained in the cohort; none of these HIV-positive partners have enrolled new partners into the RCT. Conclusions: The intervention offers a unique opportunity for sero-discordant couples to support each other towards common HIV management goals by facilitating their development of tailored prevention plans via couples-based HIV testing and counseling, as well as problem-solving skills in Partner Strategies to Enhance Problem-solving Skills (STEPS). Trial Registration: ClinicalTrials.gov NCT01772992; https://clinicaltrials.gov/ct2/show/NCT01772992 (Archived by WebCite at http://www.webcitation.org/6szFBVk1R) [JMIR Res Protoc 2017;6(8):e170]

Assessing the Efficacy and Safety of an 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017) in the Idiopathic Intracranial Hypertension Drug Trial, IIH:DT: Clinical Methods and Design for a Phase II Randomized Controlled Trial

Abstract: Background: Idiopathic intracranial hypertension (IIH) is a condition with few effective management options. So far, there have been no randomized controlled trials evaluating new treatments in IIH. Objectives: The purpose of this paper is to outline the trial design for the Idiopathic Intracranial Hypertension Drug Trial (IIH:DT), assessing an innovative medical treatment in IIH and the rationale for the chosen trial methodology. Methods: IIH:DT is a phase II double-blind randomized placebo-controlled trial recruiting 30 female participants with active IIH (intracranial pressure >25cm H2O and papilledema). Participants are randomized in a 1:1 ratio to 12 weeks of either AZD4017, an 11β-hydroxysteroid dehydrogenase type 1 inhibitor, or a matching placebo. They receive either 400 mg of AZD4017 or placebo twice daily. Participants are followed up at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16 postrandomization. The primary outcome is to examine the effect of AZD4017 on intracranial pressure, measured by lumbar puncture, over 12 weeks. Secondary outcome measures include IIH symptoms, visual function, papilledema, headache measures, safety, and tolerability. Cerebrospinal fluid, serum, plasma, urine, and adipose tissue are also taken for exploratory outcomes. Results: All participants were recruited between April 2014 and August 2016. Conclusions: IIH:DT is the first phase II double-blind randomized placebo-controlled trial assessing the efficacy and safety of the novel pharmacological intervention, AZD4017, for the treatment of IIH. Trial Registration: Clinicaltrials.gov NCT02017444; https://clinicaltrials.gov/ct2/show/NCT02017444 (Archived by WebCite at http://www.webcitation.org/6tVHesN6s) [JMIR Res Protoc 2017;6(9):e181]

Effectiveness of Adaptive E-Learning Environments on Knowledge, Competence, and Behavior in Health Professionals and Students: Protocol for a Systematic Review and Meta-Analysis

Abstract: Background: Adaptive e-learning environments (AEEs) can provide tailored instruction by adapting content, navigation, presentation, multimedia, and tools to each user’s navigation behavior, individual objectives, knowledge, and preferences. AEEs can have various levels of complexity, ranging from systems using a simple adaptive functionality to systems using artificial intelligence. While AEEs are promising, their effectiveness for the education of health professionals and health professions students remains unclear. Objective: The purpose of this systematic review is to assess the effectiveness of AEEs in improving knowledge, competence, and behavior in health professionals and students. Methods: We will follow the Cochrane Collaboration and the Effective Practice and Organisation of Care (EPOC) Group guidelines on systematic review methodology. A systematic search of the literature will be conducted in 6 bibliographic databases (CINAHL, EMBASE, ERIC, PsycINFO, PubMed, and Web of Science) using the concepts “adaptive e-learning environments,” “health professionals/students,” and “effects on knowledge/skills/behavior.” We will include randomized and nonrandomized controlled trials, in addition to controlled before-after, interrupted time series, and repeated measures studies published between 2005 and 2017. The title and the abstract of each study followed by a full-text assessment of potentially eligible studies will be independently screened by 2 review authors. Using the EPOC extraction form, 1 review author will conduct data extraction and a second author will validate the data extraction. The methodological quality of included studies will be independently assessed by 2 review authors using the EPOC risk of bias criteria. Included studies will be synthesized by a descriptive analysis. Where appropriate, data will be pooled using meta-analysis by applying the RevMan software version 5.1, considering the heterogeneity of studies. Results: The review is in progress. We plan to submit the results in the beginning of 2018. Conclusions: Providing tailored instruction to health professionals and students is a priority in order to optimize learning and clinical outcomes. This systematic review will synthesize the best available evidence regarding the effectiveness of AEEs in improving knowledge, competence, and behavior in health professionals and students. It will provide guidance to policy makers, hospital managers, and researchers in terms of AEE development, implementation, and evaluation in health care. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews: CRD42017065585; https://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42017065585 (Archived by WebCite® at http://www.webcitation.org/6rXGdDwf4)

Internet-Based HIV Prevention With At-Home Sexually Transmitted Infection Testing for Young Men Having Sex With Men: Study Protocol of a Randomized Controlled Trial of Keep It Up! 2.0.

Abstract: Background: Human immunodeficiency virus (HIV) infections are increasing among young men who have sex with men (YMSM), yet few HIV prevention programs have studied this population. Keep It Up! (KIU!), an online HIV prevention program tailored to diverse YMSM, was developed to fill this gap. The KIU! 2.0 randomized controlled trial (RCT) was launched to establish intervention efficacy. Objective: The objective of the KIU! study is to advance scientific knowledge of technology-based behavioral HIV prevention, as well as improve public health by establishing the efficacy of an innovative electronic health (eHealth) prevention program for ethnically and racially diverse YMSM. The intervention is initiated upon receipt of a negative HIV test result, based on the theory that testing negative is a teachable moment for future prevention behaviors. Methods: This is a two-group, active-control RCT of the online KIU! intervention. The intervention condition includes modules that use videos, animation, games, and interactive exercises to address HIV knowledge, motivation for safer behaviors, self-efficacy, and behavioral skills. The control condition reflects HIV information that is readily available on many websites, with the aim to understand how the KIU! intervention improves upon information that is currently available online. Follow-up assessments are administered at 3, 6, and 12 months for each arm. Testing for urethral and rectal sexually transmitted infections (STIs) is completed at baseline and at 12-month follow-up for all participants, and at 3- and 6-month follow-ups for participants who test positive at baseline. The primary behavioral outcome is unprotected anal sex at all follow-up points, and the primary biomedical outcome is incident STIs at 12-month follow-up. Results: Consistent with study aims, the KIU! technology has been successfully integrated into a widely-used health technology platform. Baseline enrollment for the RCT was completed on December 30, 2015 (N=901), and assessment of intervention outcomes is ongoing at 3-, 6-, and 12-month time points. Upon collection of all data, and after the efficacy of the intervention has been evaluated, we will explore whether the KIU! intervention has differential efficacy across subgroups of YMSM based on ethnicity/race and relationship status. Conclusions: Our approach is innovative in linking an eHealth solution to HIV and STI home testing, as well as serving as a model for integrating scalable behavioral prevention into other biomedical prevention strategies. Trial Registration: Clinicaltrials.gov NCT01836445; https://clinicaltrials.gov/ct2/show/NCT01836445 (Archived by WebCite at http://www.webcitation.org/6myMFlxnC) [JMIR Res Protoc 2017;6(1):e1]

A Cloud-Based Virtual Reality App for a Novel Telemindfulness Service: Rationale, Design and Feasibility Evaluation.

Abstract: Background: Worldwide, there has been a marked increase in stress and anxiety, also among patients with traumatic brain injury (TBI) Access to psychology services is limited, with some estimates suggesting that over 50% of sufferers are not accessing the existing services available to them for reasons such as inconvenience, embarrassment, or stigmatization concerns around mental health Health service providers have increasingly been turning to drug-free therapies, such as mindfulness programs, as complementary treatments Objective: Virtual reality (VR) as a new delivery method for meditation-based stress and anxiety reduction therapy offers configurable environments and privacy protection Our objective was to design a serious learning-meditation environment and to test the feasibility of the developed telemindfulness approach based on cloud technologies Methods: We developed a cloud-based system, which consisted of a Web interface for the mindfulness instructor and remote clients, who had 3D VR headsets The mindfulness instructor could communicate over the Web interface with the participants using the headset Additionally, the Web app enabled group sessions in virtual rooms, 360-degree videos, and real interactions or standalone meditation The mindfulness program was designed as an 8-week Mindfulness-Based Stress Reduction course specifically for the developed virtual environments The program was tested with four employees and four patients with TBI The effects were measured with psychometric tests, the Mindful Attention Awareness Scale (MAAS) and the Satisfaction With Life Scale (SWLS) Patients also carried out the Mini-Mental State Examination (MMSE) An additional objective evaluation has also been carried out by tracking head motion Additionally, the power spectrum analyses of similar tasks between sessions were tested Results: The patients achieved a higher level of life satisfaction during the study (SWLS: mean 230, SD 18 vs mean 183, SD 39) and a slight increase of the MAAS score (mean 34, SD 06 vs mean 33, SD 04) Particular insight into the MAAS items revealed that one patient had a lower MAAS score (mean 23) Employees showed high MAAS scores (mean 43, SD 07) and although their SWLS dropped to mean 26, their SWLS was still high (mean 273, SD 28) The power spectrum showed that the employees had a considerable reduction in high-frequency movements less than 034 Hz, particularly with the 360-degree video As expected, the patients demonstrated a gradual decrease of high-frequency movements while sitting during the mindfulness practices in the virtual environment Conclusions: With such a small sample size, it is too early to make any specific conclusions, but the presented results may accelerate the use of innovative technologies and challenge new ideas in research and development in the field of mindfulness/telemindfulness [JMIR Res Protoc 2017;6(6):e108]

Providing Home-Based HIV Testing and Counseling for Transgender Youth (Project Moxie): Protocol for a Pilot Randomized Controlled Trial

Abstract: Background: Transgender and gender nonconforming people experience some of the highest human immunodeficiency virus (HIV) rates in the United States, and experience many structural and behavioral barriers that may limit their engagement in HIV testing, prevention, and care. Evidence suggests that transgender and gender nonconforming youth (TY) are especially vulnerable to acquiring HIV, yet there is little research on TY and few services are targeted towards HIV testing, prevention, and care for this population. Telehealth presents an opportunity to mitigate some structural barriers that TY experience in accessing HIV testing, allowing TY to engage in HIV testing and counseling in a safe and nonjudgmental space of their choosing. Project Moxie is an HIV prevention intervention that pairs the use of HIV self-testing with remote video-based counseling and support from a trained, gender-affirming counselor. This study aims to offer a more positive HIV testing and counseling experience, with the goal of improving HIV testing frequency. Objective: Project Moxie involves a pilot randomized controlled trial (RCT) of 200 TY aged 15-24 years, who are randomized on a 1:1 basis to control or intervention arms. The aim is to examine whether the addition of counseling provided via telehealth, coupled with home-based HIV testing, can create gains in routine HIV testing among TY over a six-month follow-up period. Methods: This study implements a prospective pilot RCT of 200 TY recruited online. Participants in the control arm will receive one HIV self-testing kit and will be asked to report their results via the study’s website. Participants in the experimental arm will receive one HIV self-testing kit and will test with a remotely-located counselor during a prescheduled video-counseling session. Participants are assessed at baseline, and at three and six months posttesting. Results: Project Moxie was launched in June 2017 and recruitment is ongoing. As of August 21, 2017, the study had enrolled 130 eligible participants. Conclusions: Combining home-based HIV testing and video-based counseling allows TY, an often stigmatized and marginalized population, to test for HIV in a safe and nonjudgmental setting of their choosing. This approach creates an opportunity to reduce the high rate of HIV among TY through engagement in care, support, and linkage to the HIV treatment cascade for those who test positive. Trial Registration: ClinicalTrials.gov NCT03185975; https://clinicaltrials.gov/ct2/show/NCT03185975 (Archived by WebCite at http://www.webcitation.org/6vIjHJ93s)

The Importance of Trust in the Adoption and Use of Intelligent Assistive Technology by Older Adults to Support Aging in Place: Scoping Review Protocol.

Abstract: Background: Intelligent assistive technologies that complement and extend human abilities have proliferated in recent years. Service robots, home automation equipment, and other digital assistant devices possessing artificial intelligence are forms of assistive technologies that have become popular in society. Older adults (>55 years of age) have been identified by industry, government, and researchers as a demographic who can benefit significantly from the use of intelligent assistive technology to support various activities of daily living. Objective: The purpose of this scoping review is to summarize the literature on the importance of the concept of “trust” in the adoption of intelligent assistive technologies to assist aging in place by older adults. Methods: Using a scoping review methodology, our search strategy will examine the following databases: ACM Digital Library, Allied and Complementary Medicine Database (AMED), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medline, PsycINFO, Scopus, and Web of Science. Two reviewers will independently screen the initial titles obtained from the search, and these results will be further inspected by other members of the research team for inclusion in the review. Results: This review will provide insights into how the concept of trust is actualized in the adoption of intelligent assistive technology by older adults. Preliminary sensitization to the literature suggests that the concept of trust is fluid, unstable, and intimately tied to the type of intelligent assistive technology being examined. Furthermore, a wide range of theoretical lenses that include elements of trust have been used to examine this concept. Conclusions: This review will describe the concept of trust in the adoption of intelligent assistive technology by older adults, and will provide insights for practitioners, policy makers, and technology vendors for future practice. [JMIR Res Protoc 2017;6(11):e218]

Vascular Cognitive Impairment in a Memory Clinic Population: Rationale and Design of the “Utrecht-Amsterdam Clinical Features and Prognosis in Vascular Cognitive Impairment” (TRACE-VCI) Study

Abstract: Background: Vascular Cognitive Impairment (VCI) refers to cognitive dysfunction due to vascular brain injury, as a single cause or in combination with other, often neurodegenerative, etiologies. VCI is a broad construct that captures a heterogeneous patient population both in terms of cognitive and noncognitive symptoms and in terms of etiology and prognosis. This provides a challenge when applying this construct in clinical practice. Objective: This paper presents the rationale and design of the TRACE-VCI study, which investigates the clinical features and prognosis of VCI in a memory clinic setting. Methods: The TRACE-VCI project is an observational, prospective cohort study of 861 consecutive memory clinic patients with possible VCI. Between 2009 and 2013, patients were recruited through the Amsterdam Dementia Cohort of the VU University Medical Centre (VUMC) (N=665) and the outpatient memory clinic and VCI cohort of the University Medical Centre Utrecht (UMCU) (N=196). We included all patients attending the clinics with magnetic resonance imaging (MRI) evidence of vascular brain injury. Patients with a primary etiology other than vascular brain injury or neurodegeneration were excluded. Patients underwent an extensive 1-day memory clinic evaluation including an interview, physical and neurological examination, assessment of biomarkers (including those for Alzheimer-type pathologies), extensive neuropsychological testing, and an MRI scan of the brain. For prognostic analyses, the composite primary outcome measure was defined as accelerated cognitive decline (change of clinical dementia rating ≥1 or institutionalization) or (recurrent) major vascular events or death over the course of 2 years. Results: The mean age at baseline was 67.7 (SD 8.5) years and 46.3% of patients (399/861) were female. At baseline, the median Clinical Dementia Rating was 0.5 (interquartile range [IQR] 0.5-1.0) and the median Mini-Mental State Examination score was 25 (IQR 22-28). The clinical diagnosis at baseline was dementia in 52.4% of patients (451/861), mild cognitive impairment in 24.6% (212/861), and no objective cognitive impairment in the remaining 23.0% (198/861). Conclusions: The TRACE-VCI study represents a large cohort of well-characterized patients with VCI in a memory clinic setting. Data processing and collection for follow-up are currently being completed. The TRACE-VCI study will provide insight into the clinical features of memory clinic patients that meet VCI criteria and establish key prognostic factors for further cognitive decline and (recurrent) major vascular events. [JMIR Res Protoc 2017;6(4):e60]

Data Collection for Mental Health Studies Through Digital Platforms: Requirements and Design of a Prototype

Abstract: Background: Mental and behavioral disorders are the main cause of disability worldwide. However, their diagnosis is challenging due to a lack of reliable biomarkers; current detection is based on structured clinical interviews which can be biased by the patient’s recall ability, affective state, changing in temporal frames, etc. While digital platforms have been introduced as a possible solution to this complex problem, there is little evidence on the extent of usability and usefulness of these platforms. Therefore, more studies where digital data is collected in larger scales are needed to collect scientific evidence on the capacities of these platforms. Most of the existing platforms for digital psychiatry studies are designed as monolithic systems for a certain type of study; publications from these studies focus on their results, rather than the design features of the data collection platform. Inevitably, more tools and platforms will emerge in the near future to fulfill the need for digital data collection for psychiatry. Currently little knowledge is available from existing digital platforms for future data collection platforms to build upon. Objective: The objective of this work was to identify the most important features for designing a digital platform for data collection for mental health studies, and to demonstrate a prototype platform that we built based on these design features. Methods: We worked closely in a multidisciplinary collaboration with psychiatrists, software developers, and data scientists and identified the key features which could guarantee short-term and long-term stability and usefulness of the platform from the designing stage to data collection and analysis of collected data. Results: The key design features that we identified were flexibility of access control, flexibility of data sources, and first-order privacy protection. We also designed the prototype platform Non-Intrusive Individual Monitoring Architecture (Niima), where we implemented these key design features. We described why each of these features are important for digital data collection for psychiatry, gave examples of projects where Niima was used or is going to be used in the future, and demonstrated how incorporating these design principles opens new possibilities for studies. Conclusions: The new methods of digital psychiatry are still immature and need further research. The design features we suggested are a first step to design platforms which can adapt to the upcoming requirements of digital psychiatry. [JMIR Res Protoc 2017;6(6):e110]

Influence of Information and Communication Technologies on the Resilience and Coping of Sexual and Gender Minority Youth in the United States and Canada (Project #Queery): Mixed Methods Survey.

Abstract: Background: Sexual and gender minority youth are a population in peril, exemplified by their disproportionate risk of negative experiences and outcomes. Sexual and gender minority youth may be particularly active users of information and communication technologies (ICTs), and it is important to identify the potential contributions of ICTs to their resilience and well-being. Objective: Our aim was to (1) investigate the use of ICTs by sexual and gender minority youth, (2) identify the ways that ICTs influence the resilience and coping of sexual and gender minority youth, focusing on promotion of well-being through self-guided support-seeking (particularly using mobile devices), (3) develop a contextually relevant theoretical conceptualization of resilience incorporating minority stress and ecological approaches, (4) generate best practices and materials that are accessible to multiple interested groups, and (5) identify whether video narratives are a viable alternative to collect qualitative responses in Web-based surveys for youth. Methods: Mixed methods, cross-sectional data (N=6309) were collected via a Web-based survey from across the United States and Canada from March-July 2016. The sample was generated using a multipronged, targeted recruitment approach using Web-based strategies and consists of self-identified English-speaking sexual and gender minority youth aged 14-29 with technological literacy sufficient to complete the Web-based survey. The survey was divided into eight sections: (1) essential demographics, (2) ICT usage, (3) health and mental health, (4) coping and resilience, (5) sexual and gender minority youth identities and engagement, (6) fandom communities, (7) nonessential demographics, and (8) a video submission (optional, n=108). The option of a 3-5 minute video submission represents a new research innovation in Web-based survey research. Results: Data collection is complete (N=6309), and analyses are ongoing. Proposed analyses include (1) structural equation modeling of quantitative data, (2) grounded theory analysis of qualitative data, and (3) an integrative, mixed methods analysis using a data transformation design. Theoretical and methodological triangulation of analyses integrates an interwoven pattern of results into a comprehensive picture of a phenomenon. Results will be reported in 2017 and 2018. Conclusions: This research study will provide critical insights into the emerging use of ICTs by sexual and gender minority youth and identify intervention strategies to improve their well-being and reduce risks encountered by this vulnerable population. Implications for practice, research, and knowledge translation are provided. [JMIR Res Protoc 2017;6(9):e189]

The Epital Care Model: A New Person-Centered Model of Technology-Enabled Integrated Care for People With Long Term Conditions

Abstract: Background: There is worldwide recognition that the future provision of health care requires a reorganization of provision of care, with increased empowerment and engagement of patients, along with skilled health professionals delivering services that are coordinated across sectors and organizations that provide health care. Technology may be a way to enable the creation of a coherent, cocreative, person-centered method to provide health care for individuals with one or more long-term conditions (LTCs). It remains to be determined how a new care model can be introduced that supports the intentions of the World Health Organization (WHO) to have integrated people-centered care. Objective: To design, pilot, and test feasibility of a model of health care for people with LTCs based on a cocreative, iterative, and stepwise process in a way that recognizes the need for person-centered care, and embraces the use of digital technology. Methods: The overall research method was inspired by action research and used an agile, iterative approach. In 2012, a living lab was established in a Danish municipality which allowed for the freedom of redesigning health care processes. As the first step, a wide group of stakeholders was gathered to create a layout for the reorganization of services and development of technology, based on established principles for innovative management of people with chronic conditions. The next three steps were (1) a proof of concept in 2012, (2) a pilot study, and (3) a feasibility study from 2013 to 2015, in which a total of 93 chronic obstructive pulmonary disease (COPD) patients were enrolled. Citizens were provided a tablet-based solution for remote follow-up and communication purposes, and access to a 24/7 response and coordination center that coordinated both virtual and face-to-face support for COPD management. In step five the initial model was extended with elements that support continuity of care. Beginning in the autumn of 2013, 1102 frail elderly individuals were included and offered two additional services: an outgoing acute medical team and a local subacute bed function. Results: Based on the findings from the iterative process, and evolving technology and workflow solutions, we propose a robust and feasible model that can provide a framework for developing solutions to support an active life with one or more LTCs. The resulting Epital Care Model (ECM) consists of six stages, and serves as a template for how a digitally-enhanced health service can be provided based on patients’ medical needs. The model is designed to be a proactive, preventive, and monitoring health care system that involves individuals in the management of their own health conditions. Conclusions: The ECM is in accordance with WHO’s framework for integrated people-centered health services, and may serve as a framework for the development of new technologies and provide a template for future reorganization. [JMIR Res Protoc 2017;6(1):e6]

Comparing Crowdsourcing and Friendsourcing: A Social Media-Based Feasibility Study to Support Alzheimer Disease Caregivers

Abstract: Background: In the United States, over 15 million informal caregivers provide unpaid care to people with Alzheimer disease (AD). Compared with others in their age group, AD caregivers have higher rates of stress, and medical and psychiatric illnesses. Psychosocial interventions improve the health of caregivers. However, constraints of time, distance, and availability inhibit the use of these services. Newer online technologies, such as social media, online groups, friendsourcing, and crowdsourcing, present alternative methods of delivering support. However, limited work has been done in this area with caregivers. Objective: The primary aims of this study were to determine (1) the feasibility of innovating peer support group work delivered through social media with friendsourcing, (2) whether the intervention provides an acceptable method for AD caregivers to obtain support, and (3) whether caregiver outcomes were affected by the intervention. A Facebook app provided support to AD caregivers through collecting friendsourced answers to caregiver questions from participants’ social networks. The study’s secondary aim was to descriptively compare friendsourced answers versus crowdsourced answers. Methods: We recruited AD caregivers online to participate in a 6-week-long asynchronous, online, closed group on Facebook, where caregivers received support through moderator prompts, group member interactions, and friendsourced answers to caregiver questions. We surveyed and interviewed participants before and after the online group to assess their needs, views on technology, and experience with the intervention. Caregiver questions were pushed automatically to the participants’ Facebook News Feed, allowing participants’ Facebook friends to see and post answers to the caregiver questions (Friendsourced answers). Of these caregiver questions, 2 were pushed to crowdsource workers through the Amazon Mechanical Turk platform. We descriptively compared characteristics of these crowdsourced answers with the friendsourced answers. Results: In total, 6 AD caregivers completed the initial online survey and semistructured telephone interview. Of these, 4 AD caregivers agreed to participate in the online Facebook closed group activity portion of the study. Friendsourcing and crowdsourcing answers to caregiver questions had similar rates of acceptability as rated by content experts: 90% (27/30) and 100% (45/45), respectively. Rates of emotional support and informational support for both groups of answers appeared to trend with the type of support emphasized in the caregiver question (emotional vs informational support question). Friendsourced answers included more shared experiences (20/30, 67%) than did crowdsourced answers (4/45, 9%). Conclusions: We found an asynchronous, online, closed group on Facebook to be generally acceptable as a means to deliver support to caregivers of people with AD. This pilot is too small to make judgments on effectiveness; however, results trended toward an improvement in caregivers’ self-efficacy, sense of support, and perceived stress, but these results were not statistically significant. Both friendsourced and crowdsourced answers may be an acceptable way to provide informational and emotional support to caregivers of people with AD. [JMIR Res Protoc 2017;6(4):e56]

Examining Factors of Engagement With Digital Interventions for Weight Management: Rapid Review

Abstract: Background: Digital interventions for weight management provide a unique opportunity to target daily lifestyle choices and eating behaviors over a sustained period of time. However, recent evidence has demonstrated a lack of user engagement with digital health interventions, impacting on the levels of intervention effectiveness. Thus, it is critical to identify the factors that may facilitate user engagement with digital health interventions to encourage behavior change and weight management. Objective: The aim of this study was to identify and synthesize the available evidence to gain insights about users’ perspectives on factors that affect engagement with digital interventions for weight management. Methods: A rapid review methodology was adopted. The search strategy was executed in the following databases: Web of Science, PsycINFO, and PubMed. Studies were eligible for inclusion if they investigated users’ engagement with a digital weight management intervention and were published from 2000 onwards. A narrative synthesis of data was performed on all included studies. Results: A total of 11 studies were included in the review. The studies were qualitative, mixed-methods, or randomized controlled trials. Some of the studies explored features influencing engagement when using a Web-based digital intervention, others specifically explored engagement when accessing a mobile phone app, and some looked at engagement after text message (short message service, SMS) reminders. Factors influencing engagement with digital weight management interventions were found to be both user-related (eg, perceived health benefits) and digital intervention–related (eg, ease of use and the provision of personalized information). Conclusions: The findings highlight the importance of incorporating user perspectives during the digital intervention development process to encourage engagement. The review contributes to our understanding of what facilitates user engagement and points toward a coproduction approach for developing digital interventions for weight management. Particularly, it highlights the importance of thinking about user-related and digital tool–related factors from the very early stages of the intervention development process. [JMIR Res Protoc 2017;6(10):e205]

Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial

Abstract: Background: Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors. Objective: This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention and will inform development of a full-scale pragmatic RCT. Methods: We will enroll 107 physically inactive breast cancer survivors and randomly assign them to intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto, Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than 55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week. Both intervention and control groups receive the 12-week physical activity program with weekly group sessions and an individualized, progressive, home-based exercise program. The intervention group will additionally receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3) supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting device linked to a smartphone program. Results: We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews; and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The primary clinical outcome will be directly measured peak oxygen consumption. Secondary clinical outcomes include health-related quality of life and anthropometric measures. All outcome measures are administered at baseline, after exercise program (month 3), and 6 months after program (month 9). Conclusions: This pilot RCT will inform full-scale RCT planning. We will assess pilot procedures and interventions and collect preliminary effect estimates. Clinical Trial: ClinicalTrials.gov NCT02620735; https://clinicaltrials.gov/ct2/show/NCT02620735 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02620735) [JMIR Res Protoc 2017;6(8):e165]

Health Information National Trends Survey in American Sign Language (HINTS-ASL): Protocol for the Cultural Adaptation and Linguistic Validation of a National Survey.

Abstract: Background: The Health Information National Trends Survey (HINTS) collects nationally representative data about the American’s public use of health-related information. This survey is available in English and Spanish, but not in American Sign Language (ASL). Thus, the exclusion of ASL users from these national health information survey studies has led to a significant gap in knowledge of Internet usage for health information access in this underserved and understudied population. Objective: The objectives of this study are (1) to culturally adapt and linguistically translate the HINTS items to ASL (HINTS-ASL); and (2) to gather information about deaf people’s health information seeking behaviors across technology-mediated platforms. Methods: We modified the standard procedures developed at the US National Center for Health Statistics Cognitive Survey Laboratory to culturally adapt and translate HINTS items to ASL. Cognitive interviews were conducted to assess clarity and delivery of these HINTS-ASL items. Final ASL video items were uploaded to a protected online survey website. The HINTS-ASL online survey has been administered to over 1350 deaf adults (ages 18 to 90 and up) who use ASL. Data collection is ongoing and includes deaf adult signers across the United States. Results: Some items from HINTS item bank required cultural adaptation for use with deaf people who use accessible services or technology. A separate item bank for deaf-related experiences was created, reflecting deaf-specific technology such as sharing health-related ASL videos through social network sites and using video remote interpreting services in health settings. After data collection is complete, we will conduct a series of analyses on deaf people’s health information seeking behaviors across technology-mediated platforms. Conclusions: HINTS-ASL is an accessible health information national trends survey, which includes a culturally appropriate set of items that are relevant to the experiences of deaf people who use ASL. The final HINTS-ASL product will be available for public use upon completion of this study. [JMIR Res Protoc 2017;6(9):e172]

Comparison of Ecological Momentary Assessment Versus Direct Measurement of E-Cigarette Use With a Bluetooth-Enabled E-Cigarette: A Pilot Study

Abstract: Background: Assessing the frequency and intensity of e-cigarette use presents special challenges beyond those posed by cigarette use Accurate measurement of e-cigarette consumption, puff duration, and the stability of these measures over time will be informative for estimating the behavioral and health effects of e-cigarette use Objective: The purpose of this pilot study was to compare the accuracy of self-reported e-cigarette puff counts collected via ecological momentary assessment (EMA) to objective puff count data collected by a Bluetooth-enabled e-cigarette device and to examine the feasibility and acceptability of using a second-generation e-cigarette among adult smokers Methods: A total of 5 adult smokers were enrolled in a longitudinal parent study assessing how e-cigarette use affects cigarette use among e-cigarette–naive smokers Using a text message–based EMA system, participants reported e-cigarette puffs for 2 weeks Participants were also given a Bluetooth-enabled e-cigarette (Smokio) that passively collected puff counts and puff duration Comparisons between mean reports of Smokio (device-report) and EMA (self-report) use were evaluated using paired t tests Correlation and agreement between device- and self-reports were evaluated using Pearson correlation and the concordance correlation coefficient (CCC), respectively A linear mixed effect model was used to determine the fixed effect of timing and Smokio-reported daily puffs on report accuracy We examined the relationship between time of day and reporting accuracy using Tukey's test for multiple pairwise comparisons Results: A total of 5 African American participants, 4 men and 1 woman, who ranged in age from 24 to 59 years completed the study, resulting in 5180 observations (device-report) of e-cigarette use At baseline, participants reported smoking for 5 to 25 years and consumed a mean of 7 to 13 cigarettes per day (CPD); 4 smoked within 30 minutes of waking At the 30-day follow-up, CPD range decreased to 1 to 3 cigarettes; 4 participants reported past 7-day e-cigarette use, and 1 participant reported no cigarette smoking in the past 7 days Over 2 weeks of e-cigarette use, participants took an average of 1074 e-cigarette (SD 7790) puffs per person as captured by the device reports Each participant took a mean of 750 (SD 588) puffs per day, with each puff lasting an average of 36 (SD 24) seconds Device reports captured an average of 333 (SD 478) more puffs per person per day than the self-reported e-cigarette puffs In 87% of days, participants underestimated the number of puffs they had taken on the Smokio There was significant moderate correlation (r=47, P<001) but poor agreement (pc=031, 95% CI 015-046) between the device- and self-reported data Reporting accuracy was affected by amount and timing of e-cigarette use Conclusions: Compared to self-reported e-cigarette use, the Bluetooth-enabled device captured significantly more e-cigarette use and allowed for examination of puff duration in addition to puff counts A Bluetooth-enabled e-cigarette is a powerful and feasible tool for objective collection of e-cigarette use behavior in the real world [JMIR Res Protoc 2017;6(5):e84]

The Use of Social Media to Recruit Participants With Rare Conditions: Lynch Syndrome as an Example

Abstract: Background: Social media is increasingly being used as a means of recruiting participants, particularly for investigators whose areas of interest involve rare conditions or hard-to-reach populations. However, much of the literature to date has focused on paid advertisement recruitment. Objective: We used Lynch syndrome (LS), a rare hereditary cancer syndrome, as a model to demonstrate the successful partnership between researchers and a Web-based patient education and advocacy organization to facilitate participant recruitment. Methods: Recruitment was undertaken in partnership with Lynch Syndrome International (LSI), an advocacy organization with a strong social media presence. After LSI published our study information, participants followed up via email or phone call. Following prescreening and consent, interested and eligible participants were then sent a secure survey link. Results: Within 36 hours of a single Facebook post by the site administrators for LSI, over 150 individuals responded via phone or email. Sixty-five individuals were sent the survey link and 57 individuals completed the survey (88% response rate). Of note, these 57 individuals were geographically diverse within the Unites States, representing LS patients from 26 different states. Conclusions: This approach has several advantages, including recruitment through a trusted source outside of a clinical setting, higher response rates, and cost-effectiveness with a small research team in a relatively short amount of time. Overall, social media recruitment with a trusted online partner can be highly effective in hard-to-reach clinical populations, such as patients with LS. However, this approach requires additional effort for eligibility screening. [JMIR Res Protoc 2017;6(1):e12]

The Association of Health Literacy and Electronic Health Literacy With Self-Efficacy, Coping, and Caregiving Perceptions Among Carers of People With Dementia: Research Protocol for a Descriptive Correlational Study.

Abstract: Background: In the last decade, electronic health (eHealth) literacy has attracted the attention of the scientific community, as it is associated with the self-management of patients with chronic diseases and the quality and cost of care. It is estimated that 80% of people with chronic diseases are cared for at home by a family member, friend, or relative. Informal carers are susceptible to physical and mental health problems, as well as social and financial hardships. Nevertheless, there seems to be a research gap in terms of carers’ needs, skills, and available resources in the age of new technologies, with the vital role of eHealth literacy of the carers remaining unexplored. Objective: The aim of this study was to investigate the level of eHealth literacy and health literacy of primary and secondary carers of people with dementia, to explore the association between health and eHealth literacy, as well as their association with the caregiving variables: self-efficacy, coping, and caring perceptions. Methods: A sample of 200 primary carers (the carer who supports the people with dementia in everyday living) and 200 secondary carers (family member, friend, or other person in the social network assisting the primary carer in their role) will be recruited from dementia day care centers and Alzheimer’s associations in Greece and Cyprus. The study will be a cross-sectional correlational descriptive study. Tools to be used include the eHealth Literacy Scale adapted for carers to measure eHealth literacy, European Health Literacy Survey Questionnaire 16 (HLS-EU-Q16), Single Item Literacy Screener, Revised Scale for Caregiving Self-Efficacy, Carers of Older People in Europe (COPE) index for caregiving perceptions, and COPE brief to measure selected coping strategies. Descriptive statistics will be reported, and correlations between different variables will be explored with parametric and nonparametric measures. Results: As a preliminary study, the HLS-EU-Q16 has been validated in 107 older people. The internal consistency of the scale as estimated using Cronbach alpha coefficient was .77, somewhat lower than other validation studies. Recruitment of pilot study participants started in May 2017. Conclusions: Carers’ eHealth literacy is a new field. Whereas previous studies have focused on the role and impact of low eHealth literacy and health literacy among older adults, the eHealth literacy of carers, and in fact carers of people with dementia, has not been explored. We hypothesize an association between eHealth literacy and health literacy level with carers’ perceptions about caregiving role, self-efficacy, and coping strategies. A possible moderator in these associations is the secondary carers’ eHealth and health literacy level, which will also be explored. By confirming the above hypotheses, tailored eHealth literacy interventions for carers of people with dementia and their families will be developed as a direct outcome of this research. [JMIR Res Protoc 2017;6(11):e221]

Systematic Review Protocol to Assess the Effectiveness of Usability Questionnaires in mHealth App Studies

Abstract: Background: Usability questionnaires have a wide use in mobile health (mHealth) app usability studies. However, no systematic review has been conducted for assessing the effectiveness of these questionnaires. Objective: This paper describes a protocol for conducting a systematic review of published questionnaire-based mHealth app usability studies. Methods: In this systematic review, we will select recently published (2008-2017) articles from peer-reviewed journals and conferences that describe mHealth app usability studies and implement at least one usability questionnaire. The search strategy will include terms such as “mobile app” and “usability.” Multiple databases such as PubMed, CINAHL, IEEE Xplore, ACM Digital Library, and INSPEC will be searched. There will be 2 independent reviewers in charge of screening titles and abstracts as well as determining those articles that should be included for a full-text review. The third reviewer will act as a mediator between the other 2 reviewers. Moreover, a data extraction form will be created and used during the full article data analysis. Notably, the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines will be followed in reporting this protocol. Results: A preliminary search produced 1271 articles, 40 of which are duplicate records. The inclusion-exclusion criteria are being strictly followed in performing the ongoing study selection. Conclusions: Usability questionnaires are an important tool in mHealth app usability studies. This review will summarize the usability questionnaires used in published research articles while assessing the efficacy of these questionnaires in determining the usability of mHealth apps.

Phone-Based Interventions in Adolescent Psychiatry: A Perspective and Proof of Concept Pilot Study With a Focus on Depression and Autism

Abstract: Background: Telemedicine has emerged as an innovative platform to diagnose and treat psychiatric disorders in a cost-effective fashion. Previous studies have laid the functional framework for monitoring and treating child psychiatric disorders electronically using videoconferencing, mobile phones (smartphones), and Web-based apps. However, phone call and text message (short message service, SMS) interventions in adolescent psychiatry are less studied than other electronic platforms. Further investigations on the development of these interventions are needed. Objective: The aim of this paper was to explore the utility of text message interventions in adolescent psychiatry and describe a user feedback-driven iterative design process for text message systems. Methods: We developed automated text message interventions using a platform for both depression (EpxDepression) and autism spectrum disorder (ASD; EpxAutism) and conducted 2 pilot studies for each intervention (N=3 and N=6, respectively). The interventions were prescribed by and accessible to the patients’ healthcare providers. EpxDepression and EpxAutism utilized an automated system to triage patients into 1 of 3 risk categories based on their text responses and alerted providers directly via phone and an online interface when patients met provider-specified risk criteria. Rapid text-based feedback from participants and interviews with providers allowed for quick iterative cycles to improve interventions. Results: Patients using EpxDepression had high weekly response rates (100% over 2 to 4 months), but exhibited message fatigue with daily prompts with mean (SD) overall response rates of 66.3% (21.6%) and 64.7% (8.2%) for mood and sleep questionnaires, respectively. In contrast, parents using EpxAutism displayed both high weekly and overall response rates (100% and 85%, respectively, over 1 to 4 months) that did not decay significantly with time. Monthly participant feedback surveys for EpxDepression (7 surveys) and EpxAutism (18 surveys) preliminarily indicated that for both interventions, daily messages constituted the “perfect amount” of contact and that EpxAutism, but not EpxDepression, improved patient communication with providers. Notably, EpxDepression detected thoughts of self-harm in patients before their case managers or caregivers were aware of such ideation. Conclusions: Text-message interventions in adolescent psychiatry can provide a cost-effective and engaging method to track symptoms, behavior, and ideation over time. Following the collection of pilot data and feedback from providers and patients, larger studies are already underway to validate the clinical utility of EpxDepression and EpxAutism. Trial Registration: Clinicaltrials.gov NCT03002311; https://clinicaltrials.gov/ct2/show/NCT03002311 (Archived by WebCite at http://www.webcitation.org/6qQtlCIS0) [JMIR Res Protoc 2017;6(6):e114]

Development of a Web-Based Health Care Intervention for Patients With Heart Disease: Lessons Learned From a Participatory Design Study

Abstract: Background: The use of telemedicine technologies in health care has increased substantially, together with a growing interest in participatory design methods when developing telemedicine approaches. Objective: We present lessons learned from a case study involving patients with heart disease and health care professionals in the development of a personalized Web-based health care intervention. Methods: We used a participatory design approach inspired by the method for feasibility studies in software development. We collected qualitative data using multiple methods in 3 workshops and analyzed the data using thematic analysis. Participants were 7 patients with diagnosis of heart disease, 2 nurses, 1 physician, 2 systems architects, 3 moderators, and 3 observers. Results: We present findings in 2 parts. (1) Outcomes of the participatory design process: users gave valuable feedback on ease of use of the platforms’ tracking tools, platform design, terminology, and insights into patients’ monitoring needs, information and communication technologies skills, and preferences for self-management tools. (2) Experiences from the participatory design process: patients and health care professionals contributed different perspectives, with the patients using an experience-based approach and the health care professionals using a more attitude-based approach. Conclusions: The essential lessons learned concern planning and organization of workshops, including the finding that patients engaged actively and willingly in a participatory design process, whereas it was more challenging to include and engage health care professionals. [JMIR Res Protoc 2017;6(5):e75]

An eHealth Intervention to Promote Physical Activity and Social Network of Single, Chronically Impaired Older Adults: Adaptation of an Existing Intervention Using Intervention Mapping.

Abstract: Background: Especially for single older adults with chronic diseases, physical inactivity and a poor social network are regarded as serious threats to their health and independence. The Active Plus intervention is an automated computer-tailored eHealth intervention that has been proven effective to promote physical activity (PA) in the general population of adults older than 50 years. Objective: The aim of this study was to report on the methods and results of the systematic adaptation of Active Plus to the wishes and needs of the subgroup of single people older than 65 years who have one or more chronic diseases, as this specific target population may encounter specific challenges regarding PA and social network. Methods: The Intervention Mapping (IM) protocol was used to systematically adapt the existing intervention to optimally suit this specific target population. A literature study was performed, and quantitative as well as qualitative data were derived from health care professionals (by questionnaires, n=10) and the target population (by focus group interviews, n=14), which were then systematically integrated into the adapted intervention. Results: As the health problems and the targeted behavior are largely the same in the original and adapted intervention, the outcome of the needs assessment was that the performance objectives remained the same. As found in the literature study and in data derived from health professionals and focus groups, the relative importance and operationalization of the relevant psychosocial determinants related to these objectives are different from the original intervention, resulting in a refinement of the change objectives to optimally fit the specific target population. This refinement also resulted in changes in the practical applications, program components, intervention materials, and the evaluation and implementation strategy for the subgroup of single, chronically impaired older adults. Conclusions: This study demonstrates that the adaptation of an existing intervention is an intensive process in which adopting the IM protocol is an invaluable tool. The study provides a broad insight in adapting interventions aimed at single older adults with a chronic disease. It is concluded that even when the new target population is a sizable segment of the original target population, the adapted intervention still needs considerable changes to optimally fit the needs and situational differences of the narrower target population. [JMIR Res Protoc 2017;6(11):e230]