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  Non-Randomized Studies (funded,...

  Aug 7, 2020

  Lung Function Variability in Children and Adolescents With and Without Asthma (LUV Study): Protocol for a Prospective, Nonrandomized, Clinical Trial

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  Authors List:

  • Eirini-Sofia Frima  
  • Ilias Theodorakopoulos  
  • Dimos Gidaris  
  • Nikolaos Karantaglis  
  • Grigorios Chatziparasidis  
  • Panagiotis Plotas  
  • Michael Anthracopoulos  
  • Sotirios Fouzas  

  Abstract:

  Background: Variability analysis of peak expiratory flow (PEF) and forced expiratory volume at 1 second (FEV1) has been used in research to predict exacerbations in adults with asthma. However, there is a paucity of data regarding PEF and FEV1 variability in healthy children and adolescents and those with asthma. Objective: The objective of this study is the assessment of PEF and FEV1 variability in (1) healthy children and adolescents, to define the normal daily fluctuation of PEF and FEV1 and the parameters that may influence it, and (2) children and adolescents with asthma, to explore the differences from healthy subjects and reveal any specific variability changes prior to exacerbation. Methods: The study will include 100 healthy children and adolescents aged 6-18 years (assessment of normal PEF and FEV1 variability) and 100 children and adolescents of the same age with diagnosed asthma (assessment of PEF and FEV1 variability in subjects with asthma). PEF and FEV1 measurements will be performed using an ultraportable spirometer (Spirobank Smart; MIR Medical International Research) capable of smartphone connection. Measurements will be performed twice a day between 7 AM and 9 AM and between 7 PM and 9 PM and will be dispatched via email to a central database for a period of 3 months. PEF and FEV1 variability will be assessed by detrended fluctuation and sample entropy analysis, aiming to define the normal pattern (healthy controls) and to detect and quantify any deviations among individuals with asthma. The anticipated duration of the study is 24 months. Results: The study is funded by the “C. Caratheodory” Programme of the University of Patras, Greece (PN 47014/24.9.2018). It was approved by the Ethics Committee (decision 218/19-03-2019) and the Scientific Board (decision 329/02-04-2019) of the University Hospital of Patras, Greece. Patient recruitment started in January 2020, and as of June 2020, 100 healthy children have been enrolled (74 of them have completed the measurements). The anticipated duration of the study is 24 months. The first part of the study (assessment of lung function variability in healthy children and adolescents) will be completed in August 2020, and the results will be available for publication by October 2020. Conclusions: Healthy children and adolescents may present normal short- and long-term fluctuations in lung function; the pattern of this variability may be influenced by age, sex, and environmental conditions. Significant lung function variability may also be present in children and adolescents with asthma, but the patterns may differ from those observed in healthy children and adolescents. Such data would improve our understanding regarding the chronobiology of asthma and permit the development of integrated tools for assessing the level of control and risk of future exacerbations. Trial Registration: ClinicalTrials.gov NCT04163146; https://clinicaltrials.gov/ct2/show/NCT04163146

  • JMIR Res Protoc 2020;9(8):e20350

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  RCTs - Protocols/Proposals (eHealth)

  Aug 7, 2020

  Notifications to Improve Engagement With an Alcohol Reduction App: Protocol for a Micro-Randomized Trial

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  Authors List:

  • Lauren Bell  
  • Claire Garnett  
  • Tianchen Qian  
  • Olga Perski  
  • Henry W W Potts  
  • Elizabeth Williamson  

  Abstract:

  Background: Drink Less is a behavior change app that aims to help users in the general adult population reduce hazardous and harmful alcohol consumption. The app includes a daily push notification, delivered at 11 am, asking users to “Please complete your mood and drinking diaries.” Previous analysis of Drink Less engagement data suggests the current notification strongly influences how users engage with the app in the subsequent hour. To exploit a potential increase of vulnerability of excess drinking and opportunity to engage with the app in the evenings, we changed the delivery time from 11 am to 8 pm. We now aim to further optimise the content and sequence of notifications, testing 30 new evidence-informed notifications targeting the user’s perceived usefulness of the app. Objective: The primary objective is to assess whether sending a notification at 8 pm increases behavioral engagement (opening the app) in the subsequent hour. Secondary objectives include comparing the effect of the new bank of messages with the standard message and effect moderation over time. We also aim to more generally understand the role notifications have on the overall duration, depth, and frequency of engagement with Drink Less over the first 30 days after download. Methods: This is a protocol for a micro-randomized trial with two additional parallel arms. Inclusion criteria are Drink Less users who (1) consent to participate in the trial; (2) self-report a baseline Alcohol Use Disorders Identification Test score of 8 or above; (3) reside in the United Kingdom; (4) age ≥18 years and; (5) report interest in drinking less alcohol. In the micro-randomized trial, participants will be randomized daily at 8 pm to receive no notification, a notification with text from the new message bank, or the standard message. The primary outcome is the time-varying, binary outcome of “Did the user open the app in the hour from 8 pm to 9 pm?”. The primary analysis will estimate the marginal relative risk for the notifications using an estimator developed for micro-randomized trials with binary outcomes. Participants randomized to the parallel arms will receive no notifications (Secondary Arm A), or the standard notification delivered daily at 11 am (Secondary Arm B) over 30 days, allowing the comparison of overall engagement between different notification delivery strategies. Results: Approval was granted by the University College of London’s Departmental Research Ethics Committee (CEHP/2016/556) on October 11, 2019, and The London School of Hygiene and Tropical Medicine Interventions Research Ethics Committee (17929) on November 27, 2019. Recruitment began on January 2, 2020, and is ongoing. Conclusions: Understanding how push notifications may impact engagement with a behavior change app can lead to further improvements in engagement, and ultimately help users reduce their alcohol consumption. This understanding may also be generalizable to other apps that target a variety of behavior changes.

  • JMIR Res Protoc 2020;9(8):e18690

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  Non-Randomized Studies (funded,...

  Aug 7, 2020

  Individualized Apartment Accommodation for People With Intellectual Disability: Protocol for a Qualitative Study Examining the Well-Being and Support...

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  • Phillippa Carnemolla  

  Abstract:

  Background: Understanding the outcomes associated with both receiving and providing support to people with intellectual disability in specific settings can facilitate the alignment of health providers, community care providers, architects, and urban planners to strengthen levels of autonomy and community participation of people with intellectual disability living in the community. This study explores the impact of providing support (available 24 hours a day) for people with intellectual disability in a high-density apartment. It seeks the perspectives of people with intellectual disability who have moved into an apartment from a group home (where 4-6 people with disability live), their families, and support staff. It will enable comparison between two models of supported accommodation, group homes and individualized apartments, in a community setting. Objective: The aims of this study are to explore the impact of an individualized apartment model of supported accommodation in a high-density setting on the well-being, autonomy, and participation of people with intellectual disability living and receiving support; the experience of providing care or support; and how this setting impacts the logistics of how quality support is provided. Methods: Qualitative research methods were employed as the primary means of collecting and analyzing data. There are two main sources of data in this study: (1) semistructured interviews with participants in up to 3 waves (pre, post 1, and post 2) and (2) pre- and postoccupancy evaluation data on the design, layout, and location details of the built environments. Coded interview data will be paired with pre- and postoccupancy evaluations of the two accommodation settings. Results: As of May 2020, we have recruited 55 participants. There have been 96 interviews conducted in 2 waves with people who have moved into supported accommodation, families, and staff. Collected data are currently being analyzed. We expect the results of the trial to be published in a peer-reviewed journal in late 2020. Conclusions: This paper sets out a study of an alternative housing and support model for people with intellectual disability. It will capture personal experiences of people with intellectual disability receiving support in an apartment compared to their experiences in a group home. It will also capture the experiences of support staff working in the new setting and reveal how this differs from a group home setting. The inclusion of pre (group home) and post (apartment integrated into a community setting) measures addresses evaluative and comparative questions around the nature and impacts of the small-scale apartment and support model for both those who live and receive support, and those who support them.

  • JMIR Res Protoc 2020;9(8):e18248

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  RCTs - Protocols/Proposals (eHealth)

  Aug 7, 2020

  Evaluating the Effectiveness of an Intervention Integrating Technology and In-Person Sexual Health Education for Adolescents (In the Know): Protocol for a...

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  Authors List:

  • Martha J. Decker  
  • Abigail Gutmann-Gonzalez  
  • Melisa Price  
  • Julio Romero  
  • Bhupendra Sheoran  
  • Jennifer Yarger  

  Abstract:

  Background: Access to a smartphone is nearly universal among American adolescents, and most of them have used the internet to seek health information. Integrating digital technologies into health program delivery may expand opportunities for youth to receive important health information, yet there are few rigorous studies assessing the effectiveness of this type of intervention. Objective: The purpose of this study is to assess the effectiveness of In the Know (ITK), a program integrating in-person and technology-based sexual health education for underserved adolescents. Methods: Youth were engaged in the development of the intervention, including the design of the digital technology and the curriculum content. The intervention focuses on 3 main areas: sexual health and contraceptive use, healthy relationships, and educational and career success. It includes an in-person, classroom component, along with a web-based component to complement and reinforce key content. A cluster randomized controlled trial is in progress among adolescents aged 13-19 years living in Fresno County, California. It is designed to examine the differences in self-reported health and behavioral outcomes among youth in the intervention and control groups at 3 and 9 months. Primary outcomes are condom and contraceptive use or no sex in the past 3 months and use of any clinical health services in the past 3 months. Secondary outcomes include the number of sexual partners in the past 3 months and knowledge of local clinical sexual health services. We will use mixed-effects linear and logistic regression models to assess differences between the intervention and control groups. Results: Trial enrollment began in October 2017 and ended in March 2020 with a total of 1260 participants. The mean age of the participants is 15.73 (SD 1.83) years, and 69.98% (867/1239) of the participants report being Hispanic or Latino. Study results will be available in 2021. Conclusions: ITK has the potential to improve contraceptive and clinic use among underserved youth. This trial will inform future youth-focused health interventions that are considering incorporating technology.

  • JMIR Res Protoc 2020;9(8):e18060

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  RCTs - Protocols/Proposals (non-eHealth)

  Aug 7, 2020

  A Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection in Young Adults and Reduce HIV Transmission in Kenya: Protocol for a...

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  Authors List:

  • Susan M Graham  
  • Clara Agutu  
  • Elise van der Elst  
  • Amin S Hassan  
  • Evanson Gichuru  
  • Peter M Mugo  
  • Carey Farquhar  
  • Joseph B Babigumira  
  • Steven M Goodreau  
  • Deven T Hamilton  
  • Thumbi Ndung'u  
  • Martin Sirengo  
  • Wairimu Chege  
  • Eduard J Sanders  

  Abstract:

  Background: Detection and management of acute HIV infection (AHI) is a clinical and public health priority, and HIV infections diagnosed among young adults aged 18 to 39 years are usually recent. Young adults with recent HIV acquisition frequently seek care for symptoms and could potentially be diagnosed through the health care system. Early recognition of HIV infection provides considerable individual and public health benefits, including linkage to treatment as prevention, access to risk reduction counseling and treatment, and notification of partners in need of HIV testing. Objective: The Tambua Mapema Plus study aims to (1) test 1500 young adults (aged 18-39 years) identified by an AHI screening algorithm for acute and prevalent (ie, seropositive) HIV, linking all newly diagnosed HIV-infected patients to care and offering immediate treatment; (2) offer assisted HIV partner notification services to all patients with HIV, testing partners for acute and prevalent HIV infection and identifying local sexual networks; and (3) model the potential impact of these two interventions on the Kenyan HIV epidemic, estimating incremental costs per HIV infection averted, death averted, and disability-adjusted life year averted using data on study outcomes. Methods: A modified stepped-wedge design is evaluating the yield of this HIV testing intervention at 4 public and 2 private health facilities in coastal Kenya before and after intervention delivery. The intervention uses point-of-care HIV-1 RNA testing combined with standard rapid antibody tests to diagnose AHI and prevalent HIV among young adults presenting for care, employs HIV partner notification services to identify linked acute and prevalent infections, and follows all newly diagnosed patients and their partners for 12 months to ascertain clinical outcomes, including linkage to care, antiretroviral therapy (ART) initiation and virologic suppression in HIV-infected patients, and pre-exposure prophylaxis uptake in uninfected individuals in discordant partnerships. Results: Enrollment started in December 2017. As of April 2020, 1374 participants have been enrolled in the observation period and 1500 participants have been enrolled in the intervention period, with 13 new diagnoses (0.95%) in the observation period and 37 new diagnoses (2.47%), including 2 AHI diagnoses, in the intervention period. Analysis is ongoing and will include adjusted comparisons of the odds of the following outcomes in the observation and intervention periods: being tested for HIV infection, newly diagnosed with prevalent or acute HIV infection, linked to care, and starting ART by week 6 following HIV diagnosis. Participants newly diagnosed with acute or prevalent HIV infection in the intervention period are being followed for outcomes, including viral suppression by month 6 and month 12 following ART initiation and partner testing outcomes. Conclusions: The Tambua Mapema Plus study will provide foundational data on the potential of this novel combination HIV prevention intervention to reduce ongoing HIV transmission in Kenya and other high-prevalence African settings. Trial Registration: ClinicalTrials.gov NCT03508908; https://clinicaltrials.gov/ct2/show/NCT03508908

  • JMIR Res Protoc 2020;9(8):e16198

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  Non-randomized Protocols and Methods...

  Aug 5, 2020

  Using Machine Learning to Optimize the Quality of Survey Data: Protocol for a Use Case in India

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  Authors List:

  • Neha Shah  
  • Diwakar Mohan  
  • Jean Juste Harisson Bashingwa  
  • Osama Ummer  
  • Arpita Chakraborty  
  • Amnesty E. LeFevre  

  Abstract:

  Background: Data quality is vital for ensuring the accuracy, reliability, and validity of survey findings. Strategies for ensuring survey data quality have traditionally used quality assurance procedures. Data analytics is an increasingly vital part of survey quality assurance, particularly in light of the increasing use of tablets and other electronic tools, which enable rapid, if not real-time, data access. Routine data analytics are most often concerned with outlier analyses that monitor a series of data quality indicators, including response rates, missing data, and reliability of coefficients for test-retest interviews. Machine learning is emerging as a possible tool for enhancing real-time data monitoring by identifying trends in the data collection, which could compromise quality. Objective: This study aimed to describe methods for the quality assessment of a household survey using both traditional methods as well as machine learning analytics. Methods: In the Kilkari impact evaluation’s end-line survey amongst postpartum women (n=5095) in Madhya Pradesh, India, we plan to use both traditional and machine learning–based quality assurance procedures to improve the quality of survey data captured on maternal and child health knowledge, care-seeking, and practices. The quality assurance strategy aims to identify biases and other impediments to data quality and includes seven main components: (1) tool development, (2) enumerator recruitment and training, (3) field coordination, (4) field monitoring, (5) data analytics, (6) feedback loops for decision making, and (7) outcomes assessment. Analyses will include basic descriptive and outlier analyses using machine learning algorithms, which will involve creating features from time-stamps, “don’t know” rates, and skip rates. We will also obtain labeled data from self-filled surveys, and build models using k-folds cross-validation on a training data set using both supervised and unsupervised learning algorithms. Based on these models, results will be fed back to the field through various feedback loops. Results: Data collection began in late October 2019 and will span through March 2020. We expect to submit quality assurance results by August 2020. Conclusions: Machine learning is underutilized as a tool to improve survey data quality in low resource settings. Study findings are anticipated to improve the overall quality of Kilkari survey data and, in turn, enhance the robustness of the impact evaluation. More broadly, the proposed quality assurance approach has implications for data capture applications used for special surveys as well as in the routine collection of health information by health workers. Trial Registration:

  • JMIR Res Protoc 2020;9(8):e17619

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  RCTs - Protocols/Proposals (non-eHealth)

  Aug 5, 2020

  Effects of Alternative Offers of Screening Sigmoidoscopy and Colonoscopy on Utilization and Yield of Endoscopic Screening for Colorectal Neoplasms: Protocol...

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  Authors List:

  • Petra Schrotz-King  
  • Michael Hoffmeister  
  • Peter Sauer  
  • Anja Schaible  
  • Hermann Brenner  

  Abstract:

  Background: Flexible sigmoidoscopy and colonoscopy are recommended screening options for colorectal cancer (CRC). Despite colonoscopy being offered for CRC screening in Germany, the uptake of this offer has been very limited. Objective: The objective of this study was to assess the potential for increasing use of endoscopic CRC screening and the detection of advanced colorectal neoplasms by offering the choice between use of flexible sigmoidoscopy and colonoscopy. Methods: The DARIO study includes a cross-sectional study (part I), followed by a prospective 2-arm randomized controlled intervention trial (part II) with an associated biobank study (part III). Participation is possible in part I of the DARIO study only, parts I and II, or all 3 study parts. After obtaining informed consent from the municipalities, 12,000 people, aged 50-54 years, from the Rhine-Neckar region in Germany were randomly selected from residential lists of the responsible population registries and invited to complete a standardized questionnaire to investigate the nature, frequency, timing, and results of previous CRC screening and eventual diagnostic colonoscopies. In study part II participants from study part I with no colonoscopy in the preceding 5 years are randomized into 2 arms: arm A offering screening colonoscopy only, and arm B offering both options, either screening colonoscopy or screening sigmoidoscopy. The primary endpoint is the proportion of participants in whom colorectal neoplasms >0.5 cm are detected and removed at screening endoscopy. The secondary endpoints are the detection rate of any neoplasm and use of any endoscopic screening. Part III of the study will use samples from participants in study part II to construct a liquid and tissue biobank for the evaluation of less invasive methods of early detection of colon cancer and for the more detailed characterization of the detected neoplasms. Blood, urine, stool, and saliva samples are taken before the endoscopy. Tissue samples are obtained from the neoplasms removed during endoscopy. Results: A total of 10,568 from 12,000 randomly selected women and men aged 50-54 years living in the Rhine-Neckar-Region of Germany have been invited for participation. The remaining 1432 (11.93%) could not be invited because they reached the age of 55 at the time of contact. Of those invited, 2785/10,568 (26.35%) participated in study part I; 53.60% (1493/2785) of these participants were female. Study parts II and III are ongoing. Conclusions: This study will answer the question if alternative offers of either screening sigmoidoscopy or screening colonoscopy will increase utilization and effectiveness of endoscopic CRC screening compared with an exclusive offer of screening colonoscopy. In addition, alternative noninvasive screening tests will be developed and validated. Trial Registration: German Clinical Trials Register DRKS00018932; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00018932

  • JMIR Res Protoc 2020;9(8):e17516

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  CIHR funded proposals with...

  Aug 5, 2020

  Learning Integrated Health System to Mobilize Context-Adapted Knowledge With a Wiki Platform to Improve the Transitions of Frail Seniors From Hospitals and...

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  Authors List:

  • Patrick Michel Archambault  
  • Josée Rivard  
  • Pascal Y Smith  
  • Samir Sinha  
  • Michèle Morin  
  • Annie LeBlanc  
  • Yves Couturier  
  • Isabelle Pelletier  
  • El Kebir Ghandour  
  • France Légaré  
  • Jean-Louis Denis  
  • Don Melady  
  • Daniel Paré  
  • Josée Chouinard  
  • Chantal Kroon  
  • Maxime Huot-Lavoie  
  • Laetitia Bert  
  • Holly O Witteman  
  • Audrey-Anne Brousseau  
  • Clémence Dallaire  
  • Marie-Josée Sirois  
  • Marcel Émond  
  • Richard Fleet  
  • Sam Chandavong  
  • Network Of Canadian Emergency Researchers

  Abstract:

  Background: Elderly patients discharged from hospital experience fragmented care, repeated and lengthy emergency department (ED) visits, relapse into their earlier condition, and rapid cognitive and functional decline. The Acute Care for Elders (ACE) program at Mount Sinai Hospital in Toronto, Canada uses innovative strategies, such as transition coaches, to improve the care transition experiences of frail elderly patients. The ACE program reduced the lengths of hospital stay and readmission for elderly patients, increased patient satisfaction, and saved the health care system over Can $4.2 million (US $2.6 million) in 2014. In 2016, a context-adapted ACE program was implemented at one hospital in the Centre intégré de santé et de services sociaux de Chaudière-Appalaches (CISSS-CA) with a focus on improving transitions between hospitals and the community. The quality improvement project used an intervention strategy based on iterative user-centered design prototyping and a “Wiki-suite” (free web-based database containing evidence-based knowledge tools) to engage multiple stakeholders. Objective: The objectives of this study are to (1) implement a context-adapted CISSS-CA ACE program in four hospitals in the CISSS-CA and measure its impact on patient-, caregiver-, clinical-, and hospital-level outcomes; (2) identify underlying mechanisms by which our context-adapted CISSS-CA ACE program improves care transitions for the elderly; and (3) identify underlying mechanisms by which the Wiki-suite contributes to context-adaptation and local uptake of knowledge tools. Methods: Objective 1 will involve staggered implementation of the context-adapted CISSS-CA ACE program across the four CISSS-CA sites and interrupted time series to measure the impact on hospital-, patient-, and caregiver-level outcomes. Objectives 2 and 3 will involve a parallel mixed-methods process evaluation study to understand the mechanisms by which our context-adapted CISSS-CA ACE program improves care transitions for the elderly and by which our Wiki-suite contributes to adaptation, implementation, and scaling up of geriatric knowledge tools. Results: Data collection started in January 2019. As of January 2020, we enrolled 1635 patients and 529 caregivers from the four participating hospitals. Data collection is projected to be completed in January 2022. Data analysis has not yet begun. Results are expected to be published in 2022. Expected results will be presented to different key internal stakeholders to better support the effort and resources deployed in the transition of seniors. Through key interventions focused on seniors, we are expecting to increase patient satisfaction and quality of care and reduce readmission and ED revisit. Conclusions: This study will provide evidence on effective knowledge translation strategies to adapt best practices to the local context in the transition of care for elderly people. The knowledge generated through this project will support future scale-up of the ACE program and our wiki methodology in other settings in Canada. Trial Registration: ClinicalTrials.gov NCT04093245; https://clinicaltrials.gov/ct2/show/NCT04093245.

  • JMIR Res Protoc 2020;9(8):e17363

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  RCTs - Protocols/Proposals (eHealth)

  Aug 4, 2020

  A Web-Based Positive Psychological Intervention to Improve Blood Pressure Control in Spanish-Speaking Hispanic/Latino Adults With Uncontrolled Hypertension:...

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  Authors List:

  • Rosalba Hernandez  
  • Michael Cohn  
  • Alison Hernandez  
  • Martha Daviglus  
  • Lizet Martinez  
  • Angela Martinez  
  • Itzel Martinez  
  • Ramon Durazo-Arvizu  
  • Judith Moskowitz  

  Abstract:

  Background: Growing evidence links psychological well-being and resilience with superior cardiac health, but there remains a critical scientific gap about whether (or how) interventions that aim to cultivate psychological well-being reduce cardiac risk. Hispanic/Latino people in the United States have high cardiovascular disease risk and poorly controlled blood pressure (BP) compared with their peers of European ancestry, and they represent a population in need of new and innovative therapeutic approaches. As such, a focused intervention to boost psychological well-being holds promise as a novel therapeutic target for hypertension in Hispanic/Latino adults; to date, however, no research has explored whether a causal link is evident. Objective: The aim of this paper is to detail the protocol for the ¡Alégrate! (Be Happy!) intervention, a Phase II randomized controlled trial testing initial efficacy in improving BP of a web-based positive psychological intervention designed to boost psychological well-being in Spanish-speaking Hispanic/Latino people with hypertension. Methods: A total of 70 Hispanic/Latino people aged ≥18 years, fluent in Spanish, and with elevated BP (≥140/90 mm Hg) will be recruited in person from a single Federally Qualified Health Center in Chicago. Enrollees will be randomly assigned to 1 of 2 trial arms: (1) web-based positive psychological intervention or (2) an active control condition (eg, 3 times weekly emotion reporting). Our 5-week Spanish-language ¡Alégrate! intervention is web-based and delivers curricular content via didactic instruction, journaling, and assigned at-home practice—all accessed via our website using investigator-purchased tablet computers, with a unique username and password assigned to each enrollee. Targeted skills include noting daily positive events, positive reappraisal of stressful events, effective expression of gratitude, performing acts of kindness, and regular practice of mindfulness and meditation. The primary outcome is improvement in BP, both sitting values and 24-hour ambulatory readings, as measured at baseline and 5 and 12 weeks from baseline. Secondary outcomes include psychological well-being, engagement in healthy behaviors, and circulating levels of inflammatory markers. The outcomes of interest are collected by trained research staff through in-person interviews using the REDCap software. Results: Activities of the ¡Alégrate! intervention were funded in August 2017, and data collection is ongoing. We expect to submit trial results for peer-reviewed publications in 2021, soon after recruitment has been concluded and statistical analyses are finalized. Conclusions: Findings will provide evidence on whether interventions to boost psychological well-being and resilience have downstream effects on BP control and cardiovascular health, particularly as they are deployed in the Spanish language with cultural tailoring and via a web-based platform. If effective, we will have an easily disseminatable application that can positively impact well-being profiles and BP control in Hispanic/Latino people, with the possibility of addressing health disparities of this US racial/ethnic minority group. Trial Registration: ClinicalTrials.gov NCT03892057; https://clinicaltrials.gov/ct2/show/NCT03892057

  • JMIR Res Protoc 2020;9(8):e17721

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  Non-randomized Protocols and Methods...

  Aug 4, 2020

  An Evaluation of Parents’ Experiences of Patient Engagement in Research to Develop a Digital Knowledge Translation Tool: Protocol for a Multi-Method Study

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  Authors List:

  • Alison P Thompson  
  • Shannon E MacDonald  
  • Eytan Wine  
  • Shannon D Scott  

  Abstract:

  Background: The last decade has seen increasing calls for patient and public involvement in health-related research due to an ideological shift toward more equitable methods of knowledge development and an effort to increase the usability and relevance of knowledge by improving outcomes in clinical practice. Patient engagement includes simply informing patients to offering complete decision-making autonomy to individuals, groups, communities, caregivers, friends, and families who have personal experience and knowledge of a health issue. Despite the use of patient engagement methods in research, evaluation has lagged, resulting in a knowledge gap that makes it difficult to foster capacity and sustainability for patients and researchers alike since little is known about how effective patient collaborations in research are built, maintained, or improved. This study centers on pediatric functional constipation, a common condition that affects children and families. Since parents play a pivotal role in treatment, they are an optimal group to engage in improving the resources and support available to them. Objective: This study aims to use patient-engagement methods to establish a research collaboration with parents to cocreate a digital knowledge translation tool for parents caring for a child with functional constipation and formally evaluate the patient engagement processes within this project to build the science of patient engagement in research. Methods: Members of the parent collaborator group will be recruited from previous participants who expressed interest in the development of a digital knowledge translation tool. The group will collaborate with the research team to create a tool to address patients’ support and information needs when caring for a child with functional constipation. The parent collaborator group will then be evaluated in a multimethod study design. Data will be digitally and anonymously collected from all members of the parent collaborator group, using the validated Public and Patient Engagement Evaluation Tool (PPEET) patient questionnaire. Descriptive statistics will be used to report group characteristics and question responses. Qualitative analysis will be used to understand open-ended question responses. Specifically, directed content analysis will be used to assess themes of the Patient Engagement in Research (PEIR) Framework with a combination of deductive and inductive analyses. Findings will be integrated into the discussion if there are sufficient commonalities and inter-relationships. The final manuscript will include reporting of each element as described by the Good Reporting of a Mixed Methods Study criteria. Results: Recruitment is planned for June 2020. Data collection for the evaluation of patient engagement processes will occur upon completion of the digital knowledge translation tool. The results of this study are expected to be published by the end of 2020. Conclusions: This study will provide valuable information about parents’ experiences participating in child-health research and is a fundamental step in building the science of patient engagement in research.

  • JMIR Res Protoc 2020;9(8):e19108

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  Scoping Review Protocols

  Aug 4, 2020

  Usability Methods and Attributes Reported in Usability Studies of Mobile Apps for Health Care Education: Protocol for a Scoping Review

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  Authors List:

  • Susanne Grødem Johnson  
  • Thomas Potrebny  
  • Lillebeth Larun  
  • Donna Ciliska  
  • Nina Rydland Olsen  

  Abstract:

  Background: E-learning technologies, including mobile apps, are used to a large extent in health care education. Mobile apps can provide extendable learning environments and motivate students for adaptive and collaborative learning outside the classroom context. Developers should design practical, effective, and easy-to-use mobile apps. Usability testing is an important part of app development in order to understand if apps meet the needs of users. Objective: The aim of this study is to perform a scoping review of usability methods and attributes reported in usability studies of mobile apps for health care education. Methods: The scoping review is guided by the methodological framework developed by Arksey & O’Malley and further developed by Levac et al and Kahlil et al. The stages we will follow are as follows: (1) identifying the research question; (2) identifying relevant studies; (3) selecting studies; (4) charting the data; and (5) summarizing and reporting the results. We have developed two research questions to meet the aim of the study, which are as follows: (1) What usability methods are used to evaluate the usability of mobile apps for health care education? and (2) What usability attributes are reported in the usability studies of mobile apps for health care education? We will apply a comprehensive search of the literature, including 10 databases, a reference search, and a search for grey literature. Two review authors will independently screen articles for eligibility. Results: The initial electronic database searches were completed in March 2019. The literature search identified 14,297 unique references. Following title and abstract screening, the full texts of 369 records were obtained. The scoping review is expected to be completed in spring 2021. Conclusions: We expect the overview of usability methods and attributes reported in usability studies of mobile apps for health care education to contribute to the knowledge base for researchers and developers. It will give an overview of the research field and provide researchers and developers with relevant and important information on the usability research area, including highlighting possible research gaps.

  • JMIR Res Protoc 2020;9(8):e19072

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  RCTs - Protocols/Proposals (eHealth)

  Aug 4, 2020

  Immediate and Long-Term Effects of an 8-Week Digital Mental Health Intervention on Adults With Poorly Managed Type 2 Diabetes: Protocol for a Randomized...

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  Authors List:

  • Eliane Boucher  
  • Judith T Moskowitz  
  • Gina M Kackloudis  
  • Julia L Stafford  
  • Ian Kwok  
  • Acacia C Parks  

  Abstract:

  Background: Diabetes is a leading cause of years of life lost and accounts for approximately one-fourth of health care dollars spent in the United States. Many of these costs are related to poor medication adherence and lack of self-care behaviors and are thus preventable. Depression, which is more prevalent among people with diabetes than in the general population, predicts poorer management of one’s diabetes, whereas positive affect predicts engaging in more positive health behaviors. Consequently, interventions that improve depression and positive affect may also improve diabetes-related outcomes among people with diabetes. Although preliminary research on the impact of such interventions among people with diabetes is promising, these studies focused primarily on in-person interventions, have had small samples, and lack long-term follow-up. Objective: This study aims to examine the short- and long-term effects of a digital therapeutic platform focused on mental health among adults with poorly managed type 2 diabetes and elevated levels of depression. Methods: This is a randomized controlled trial in which adults with a type 2 diabetes diagnosis, elevated hemoglobin A_1c (HbA_1c) levels (≧7), and moderate to severe depressive symptoms will be randomly assigned to a positive emotion regulation skills intervention group or a sham digital intervention with only psychoeducational content. The study will take place over 14 months, including the 8-week intervention (or control) delivered via a digital therapeutic platform (Happify Health) and follow-up assessments at 3, 6, and 12 months postintervention. Throughout the intervention and for 1 week at each postintervention follow-up, participants will complete daily assessments of diabetes-related distress, diabetes regimen adherence, and mood. Our primary outcome, HbA_1c, will be self-reported every 3 months throughout the study. Secondary and exploratory outcomes will be assessed at baseline; at 8 weeks; and at 3, 6, and 12 months postintervention. Results: Recruitment is expected to begin in June 2020. Participants will begin the study as they are recruited and will finish in waves. The final wave of data collection from the 8-week intervention is expected for winter 2020, with the completion of the 12-month follow-up in winter 2021. Conclusions: Although previous research suggests that in-person psychological interventions have promising effects on both psychological and physical outcomes among adults with diabetes, digital interventions can be advantageous because they are easily scalable and reduce many barriers that prevent people from seeking treatment. This trial will provide important information about the effects of a digital mental health intervention among adults with type 2 diabetes, assessing both short- and long-term effects of this intervention on HbA1c, depressive symptoms, and other diabetes-specific outcomes. If successful, this may introduce a scalable intervention that would help reduce some of the preventable costs associated with diabetes. Trial Registration: ClinicalTrials.gov NCT04068805; https://clinicaltrials.gov/ct2/show/NCT04068805.

  • JMIR Res Protoc 2020;9(8):e18578

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