JMIR Publications

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  RCTs - Protocols/Proposals (non-eHealth)

  Oct 21, 2019

  Targeting the Infant Gut Microbiota Through a Perinatal Educational Dietary Intervention: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Samantha L Dawson  
  • Jeffrey M Craig  
  • Gerard Clarke  
  • Mohammadreza Mohebbi  
  • Phillip Dawson  
  • Mimi LK Tang  
  • Felice N Jacka  

  Abstract:

  Background: The early life gut microbiota are an important regulator of the biological pathways contributing toward the pathogenesis of noncommunicable disease. It is unclear whether improvements to perinatal diet quality could alter the infant gut microbiota. Methods: The Healthy Parents, Healthy Kids randomized controlled trial aimed to recruit 90 pregnant women from Melbourne, VIC. At week 26 of gestation, women were randomized to receive dietary advice from their doctor (n=45), or additionally receive a dietary intervention (n=45). The intervention included an educational workshop and 2 support calls aiming to align participants’ diets with the Australian Dietary Guidelines and increase intakes of prebiotic and probiotic foods. The educational design focused on active learning and self-assessment. Behavior change techniques were used to support dietary adherence, and the target behavior was eating for the gut microbiota. Exclusion criteria were age under 18 years, diagnosed mental illnesses, obesity, diabetes mellitus, diagnosed bowel conditions, exclusion diets, illicit drug use, antibiotic use, prebiotic or probiotic supplementation, and those lacking dietary autonomy. The primary outcome measure is a between-group difference in alpha diversity in infant stool collected 4 weeks after birth. Secondary outcomes include evaluating the efficacy of the intervention in influencing infant and maternal stool microbial composition and short chain fatty acid concentrations, epigenetic profile, and markers of inflammation and stress, as well as changes in maternal dietary intake and well-being. The study and intervention feasibility and acceptance will also be evaluated as secondary outcomes. Results: The study results are yet to be written. The first participant was enrolled on July 28, 2016, and the final follow-up assessment was completed on October 11, 2017. Conclusions: Data from this study will provide new insights regarding the ability of interventions targeting the perinatal diet to alter the maternal and infant gut microbiota. If this intervention is proven, our findings will support larger studies aiming to guide the assembly of gut microbiota in early life.

  • JMIR Res Protoc 2019;8(10):e14771

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  RCTs - Protocols/Proposals (funded,...

  Oct 18, 2019

  Weight Loss After Stroke Through an Intensive Lifestyle Intervention (Group Lifestyle Balance-Cerebrovascular Accident): Protocol for a Randomized Controlled...

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  Authors List:

  • Simon Driver  
  • Chad Swank  
  • Katherine Froehlich-Grobe  
  • Evan McShan  
  • Stephanie Calhoun  
  • Monica Bennett  

  Abstract:

  • JMIR Res Protoc 2019;8(10):e14338

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  Non-randomized Protocols and Methods...

  Oct 18, 2019

  Health Research Using Facebook to Identify and Recruit Pregnant Women Who Use Electronic Cigarettes: Internet-Based Nonrandomized Pilot Study

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  Authors List:

  • Harold H Lee  
  • Yuli Patrick Hsieh  
  • Joe Murphy  
  • Jennifer W Tidey  
  • David A Savitz  

  Abstract:

  Background: Participant recruitment is often a challenge, particularly enrolling individuals with relatively rare characteristics. The wide reach of social media may provide a mechanism to overcome these challenges. Objective: This paper aimed to provide information to researchers who seek to recruit participants from rare populations using social media for studies with demanding protocols. We aimed to describe a pilot study protocol that identified and enrolled pregnant women (second or third trimester) who were exclusive users of electronic cigarettes (e-cigarettes). We have described the recruitment methods, time, and cost; examined advertisement types that were more or less successful; discussed participant retention and relationship management; and described the process of collecting biological data. Methods: In an open-access, nonrandomized pilot study, we placed Facebook advertisements that were selectively targeting women who were likely to be pregnant and interested in e-cigarettes or vaping. The advertisements invited individuals to complete a fully automated eligibility screener based on Qualtrics. Eligible participants were asked to (1) complete a Web-based survey that collected detailed information on the use of e-cigarettes, including the exact type of device and electronic liquid, (2) report the frequency and intensity of e-cigarette use for 3 months before pregnancy and during each trimester, and (3) provide a saliva specimen for a nicotine biomarker assay. We collected a photograph of each participant’s e-cigarette device, 8 weeks after the mother’s due date, to allow corroboration of the self-report and the baby’s birth weight and gestational age from the participant’s physician. Results: Participants were recruited between August 19 and October 26, 2017. We enrolled 20 participants in 2 months at a cost of US $3421.28. Baseline data were collected for all 20 participants. Of the 20 women enrolled, 16 provided a saliva sample, 4 provided a photo of the e-cigarette device, and 10 provided physician contact information. Of the 10 physicians contacted by mail, 6 responded with information on the participants and their babies. Conclusions: Study findings suggest that Facebook’s targeting criteria should focus on e-cigarette users to maximize advertisement exposure of potentially eligible women. In addition, saliva sample collection was feasible among pregnant women (second or third trimester) who were exclusive e-cigarette users, but obtaining photographs and physician reports was problematic and called for further refinement. These lessons are likely useful to others who are seeking to use social media to recruit participants from rare populations into studies with demanding protocols.

  • JMIR Res Protoc 2019;8(10):e12444

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  Non-Randomized Studies (funded,...

  Oct 17, 2019

  Development of a Patient-Reported Outcome Instrument for Patients With Severe Lower Extremity Trauma (LIMB-Q): Protocol for a Multiphase Mixed Methods Study

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  Authors List:

  • Lily R Mundy  
  • Anne Klassen  
  • Jordan Grier  
  • Matthew J Carty  
  • Andrea L Pusic  
  • Scott T Hollenbeck  
  • Mark J Gage  

  Abstract:

  Background: A current limitation in the care of patients with severe lower extremity traumatic injuries is the lack of a rigorously developed patient-reported outcome (PRO) instrument specific to lower extremity trauma patients. Methods: The phase I study follows an interpretive description approach. Development of the PRO instrument begins with identifying the concepts that are important to patients, after which a preliminary conceptual framework is devised from a systematic literature review and used to generate an interview guide. Patients aged 18 years or above with limb-threatening lower extremity traumatic injuries resulting in reconstruction, amputation, or amputation after failed reconstruction will be recruited. The subjects will participate in semistructured, in-depth qualitative interviews to identify all important concepts of interest. The qualitative interview data will be coded with top-level domains, themes, and subthemes. The codes will then be utilized to refine the conceptual framework and generate preliminary items and a set of scales. The preliminary scales will be further refined via a process of conducting cognitive debriefing interviews with lower extremity trauma patients and soliciting expert opinion. Phase III will include a large-scale field test, using Rasch measurement theory to analyze the psychometric properties of the instrument; shortening and finalizing the scales; and determining the reliability, validity, and responsiveness of the instrument. Results: Phases I and II of this study have been funded. Phase I of this study has been completed, and phase II began in winter 2019 and is expected to be completed in fall 2019. Phase III will begin following the completion of phase II. Conclusions: This protocol describes the initial phases of development of a novel PRO instrument for use in lower extremity trauma patients.

  • JMIR Res Protoc 2019;8(10):e14397

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  Personal Narratives and Viewpoints on...

  Oct 14, 2019

  Writing a Systematic Review for Publication in a Health-Related Degree Program

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  Authors List:

  • Clemens Scott Kruse  

  Abstract:

  Background: The protocol in this manuscript was designed to help graduate students publish, which resulted from a challenge from our provost in 2013. I developed this protocol over the last 6 years and have exercised the protocol for the last 5 years. The current version of the protocol has remained mostly static for the last 2 years—only small changes have been made to the process. Objective: The objective of this protocol is to enable students to learn a valuable skill of conducting a systematic review and to write the review in a way that can be published. I have designed the protocol to fit into the schedule of a traditional semester, but also used it in compressed semesters. Methods: An image map was created in HTML 5.0 and imported into a learning management system. It augments traditional instruction by providing references to published articles, examples, and previously recorded instructional videos. Students use the image map outside the classroom after traditional instruction. The image map helps students create manuscripts that follow established practice and are reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), and whose authorship follows guidelines by the International Committee of Medical Journal Editors. Results: Since its inception, this protocol has helped 77 students publish 27 systematic reviews in nine journals worldwide. Some manuscripts take multiple years to progress through multiple review processes at multiple journals submitted in sequence. Two other professors in the School of Health Administration have used this protocol in their classes. Conclusions: So far, this method has helped 51% of graduate students who used it in my graduate courses publish articles (with more manuscripts under consideration whose numbers have remained uncounted in this sum). I wish success to others who might use this protocol.

  • JMIR Res Protoc 2019;8(10):e15490

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  Non-Randomized Study Protocols and...

  Oct 14, 2019

  Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts from Brain Dead Donors: Protocol for a Prospective Pilot Study

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  Authors List:

  • Franziska Alexandra Meister  
  • Zoltan Czigany  
  • Jan Bednarsch  
  • Jörg Böcker  
  • Iakovos Amygdalos  
  • Daniel Antonio Morales Santana  
  • Katharina Rietzler  
  • Marcus Moeller  
  • René Tolba  
  • Peter Boor  
  • Wilko Rohlfs  
  • Ulf Peter Neumann  
  • Georg Lurje  

  Abstract:

  Background: Kidney transplantation is the only curative treatment option for end-stage renal disease. The unavailability of adequate organs for transplantation has resulted in a substantial organ shortage. As such, kidney donor allografts that would have previously been deemed unsuitable for transplantation have become an essential organ pool of extended criteria donor allografts that are now routinely being transplanted on a global scale. However, these extended criteria donor allografts are associated with significant graft-related complications. As a result, hypothermic oxygenated machine perfusion (HOPE) has emerged as a powerful, novel technique in organ preservation, and it has recently been tested in preclinical trials in kidney transplantation. In addition, HOPE has already provided promising results in a few clinical series of liver transplantations where the liver was donated after cardiac death. Objective: The present trial is an investigator-initiated prospective pilot study on the effects of HOPE on extended criteria donor allografts donated after brain death and used in kidney transplantation. Methods: A total of 15 kidney allografts with defined inclusion/exclusion criteria will be submitted to two hours of HOPE via the renal artery before implantation, and are going to be compared to a case-matched group of 30 patients (1:2 matching) who had kidneys transplanted after conventional cold storage. Primary (posttransplant dialysis within 7 days) and secondary (postoperative complications, early graft function, duration of hospital and intensive care unit stay, and six-month graft survival) endpoints will be analyzed within a six-month follow-up period. The extent of ischemia-reperfusion injury will be assessed using kidney tissue, perfusate, and serum samples taken during the perioperative phase of kidney transplantation Results: The results of this trial are expected in the first quarter of 2020 and will be presented at national and international scientific meetings and published in international peer-reviewed medical journals. The trial was funded in the third quarter of 2017 and patient enrollment is currently ongoing. Conclusions: This prospective study is designed to explore the effects of HOPE on extended criteria donor kidney allografts donated after brain death. The present report represents the preresults phase. Clinical Trial: Clinicaltrials.gov NCT03378817; https://clinicaltrials.gov/ct2/show/NCT03378817

  • JMIR Res Protoc 2019;8(10):e14622

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  RCTs - Protocols/Proposals (non-eHealth)

  Oct 11, 2019

  Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol...

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  Authors List:

  • Hideo Tsurushima  
  • Masafumi Mizukami  
  • Kenichi Yoshikawa  
  • Tomoyuki Ueno  
  • Yasushi Hada  
  • Masahiko Gosho  
  • Yutaka Kohno  
  • Koichi Hashimoto  
  • Yuichi Iizumi  
  • Toshihiro Kikuchi  
  • Akira Matsumura  
  • Hit2016 Study Group

  Abstract:

  Background: Gait disturbance often occurs in stroke survivors. Recovery of walking function is challenging, as some gait disturbance due to hemiparesis often remains even after rehabilitation therapy, presenting a major obstacle towards regaining activities-of-daily-living performance and achieving social reintegration. Objective: This study aims to clarify the effectiveness of a walking program involving the wearable Hybrid Assistive Limb (HAL-TS01) robotic exoskeleton for improving walking ability in stroke patients with hemiparesis and stagnant recovery despite ongoing rehabilitation. Methods: This is a multicenter, randomized, parallel-group, controlled study (HAL group, n=27; control group, n=27). The study period includes preintervention observation (until stagnant recovery), intervention (HAL-based walking therapy or conventional rehabilitation; 5 weeks), and postintervention observation (2 weeks). Following provision of informed consent and primary registration, the patients undergo conventional rehabilitation for preintervention observation, during which the recovery of walking ability is monitored to identify patients with stagnant recovery (based on weekly assessments using the 10-meter maximum walking speed [MWS] test). Patients with an MWS of 30-60 m/minute and insufficient weekly improvement in MWS undergo secondary registration and are randomly assigned to undergo HAL-based walking therapy (HAL group) or conventional rehabilitation (control group). The primary outcome is the change in MWS from baseline to the end of the 5-week intervention. Results: This study began in November 2016 and is being conducted at 15 participating facilities in Japan. Conclusions: Assessments of walking ability vary greatly and it is difficult to define the threshold for significant differences. To reduce such variability, our study involves conducting conventional rehabilitation to the point of saturation before starting the intervention. Stagnation in the recovery of walking ability despite conventional rehabilitation highlights the limits of current medical care. The present study may bring evidence that HAL-based therapy can overcome such limitations and induce added recovery of walking ability, which would promote the use of HAL technology in the clinical setting. Clinical Trial: University Hospital Medical Information Network (UMIN) 000024805; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028545.

  • JMIR Res Protoc 2019;8(10):e14001

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  Non-randomized Protocols and Methods...

  Oct 10, 2019

  A Digital Intervention for Australian Adolescents Above a Healthy Weight (Health Online for Teens): Protocol for an Implementation and User Experience Study

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  Authors List:

  • Carly Jane Moores  
  • Anthony Maeder  
  • Jacqueline Miller  
  • Ivanka Prichard  
  • Lucy Kate Lewis  
  • Lucinda Kate Bell  
  • Aimee Macoustra  
  • Michelle D Miller  

  Abstract:

  Background: More than one-fourth of Australian adolescents are overweight or obese, with obesity in adolescents strongly persisting into adulthood. Recent evidence suggests that the mid-teen years present a final window of opportunity to prevent irreversible damage to the cardiovascular system. As lifestyle behaviors may change with increased autonomy during adolescence, this life stage is an ideal time to intervene and promote healthy eating and physical activity behaviors, well-being, and self-esteem. As teenagers are prolific users and innate adopters of new technologies, app-based programs may be suitable for the promotion of healthy lifestyle behaviors and goal setting training. Objective: This study aims to explore the reach, engagement, user experience, and satisfaction of the new app-based and Web-based Health Online for Teens (HOT) program in a sample of Australian adolescents above a healthy weight (ie, overweight or obese) and their parents. Methods: HOT is a 14-week program for adolescents and their parents. The program is delivered online through the Moodle app–based and website-based learning environment and aims to promote adolescents’ lifestyle behavior change in line with Australian Dietary Guidelines and Australia’s Physical Activity and Sedentary Behaviour Guidelines for Young People (aged 13-17 years). HOT aims to build parental and peer support during the program to support adolescents with healthy lifestyle behavior change. Results: Data collection for this study is ongoing. To date, 35 adolescents and their parents have participated in one of 3 groups. Conclusions: HOT is a new online-only program for Australian adolescents and their parents that aims to reduce cardiovascular disease risk factors. This protocol paper describes the HOT program in detail, along with the methods to measure reach, outcomes, engagement, user experiences, and program satisfaction. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618000465257; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374771 International Registered Report Identifier (IRRID): DERR1-10.2196/13340

  • JMIR Res Protoc 2019;8(10):e13340

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  Non-Randomized Study Protocols and...

  Oct 10, 2019

  Modern Innovative Solutions to Improve Outcomes in Severe Asthma: Protocol for a Mixed Methods Observational Comparison of Clinical Outcomes in MISSION...

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  Authors List:

  • Claire Roberts  
  • Eleanor Lanning  
  • Carole Fogg  
  • Paul Bassett  
  • Alison Hughes  
  • Anoop J Chauhan  

  Abstract:

  Background: Asthma that is poorly controlled and undertreated can progress to more severe disease that is associated with high levels of unscheduled care that requires high-cost therapy, leading to a significant health economic burden. The identification and appropriate referral to a specialist asthma service is also often delayed by several months or years because of poor recognition and understanding of symptom severity. Current severe asthma services may take several months to provide a comprehensive multidisciplinary assessment, often necessitating multiple hospital visits and costing up to £5000 per patient. Methods: Modern Innovative Solutions to Improve Outcomes in (MISSION) Severe Asthma is a novel service model developed by asthma specialists from Portsmouth and Southampton severe asthma services. MISSION Severe Asthma identified patients with poorly controlled disease from general practice databases who had not been under secondary outpatient care in the last 12 months or who were not known to secondary care. In 1- or 2-stop assessments, a thorough review of diagnosis, disease phenotype, and control is undertaken, and clinical outcomes collected at baseline. Results: This protocol outlines a mixed methods study to assess the impact on disease control, unscheduled health care usage, and quality of life in patients seen in the MISSION clinic compared with a closely matched cohort who declined to attend. A variety of clinical outcomes will be collected to assess the service model. Conclusions: The results will be reported in June 2019.

  • JMIR Res Protoc 2019;8(10):e9585

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  RCTs - Protocols/Proposals (funded,...

  Oct 10, 2019

  An Online Minimally Guided Intervention to Support Family and Other Unpaid Carers of People With Dementia: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Ángel C Pinto-Bruno  
  • Anne Margriet Pot  
  • Annet Kleiboer  
  • Rose-Marie Droes  
  • Annemieke van Straten  

  Abstract:

  Background: About three-quarters of people with dementia live in their own homes, with help from family members and/or other unpaid carers, such as friends or neighbors. Often, unpaid carers themselves experience negative consequences, such as stress, burden, and symptoms of depression or anxiety. Research has shown that these consequences can be alleviated by psychosocial and psychological interventions. Moreover, there are indications that those interventions can be effective when offered online. Objective: This paper describes the protocol of a randomized controlled trial (RCT) that will take place in the Netherlands to evaluate the effectiveness of iSupport, a minimally guided, Internet-based intervention to improve carers’ mental health and coping resources. Methods: A superiority two-arm RCT comparing the effects of the online support program with a waiting-list control condition will be carried out in the Netherlands. The iSupport intervention was developed by the World Health Organization and is based on cognitive behavioral therapy principles. It has five main themes divided into 23 lessons. Carers can pick and choose which lessons they want to complete. We aim to recruit 200 unpaid carers. The experimental group (n=100) will be provided with access to the intervention for 3 months following randomization; those in the waiting-list control group (n=100) will be granted access to the intervention after 3 months. Assessments will be conducted at baseline (T0), 3 months after baseline (post intervention, T1), and 6 months after baseline (follow-up, T2). The primary outcome is perceived stress, measured by the Perceived Stress Scale. Secondary outcomes are symptoms of depression and anxiety, caregiver burden, sense of competence, self-efficacy, mastery, and carers’ attitudes toward dementia and their person-centered approach (ie, to what extent carers tailor the provided care to the interest, needs, and history of the person with dementia). Results: Recruitment for the trial started in January 2019. As of July 2019, we have enrolled 120 participants. Data collection is expected to be completed by March 2020. Once all the data have been collected, we will conduct the data analyses between April and May 2020. We aim to publish our results in a manuscript by June 2020. Conclusions: Online interventions have shown promising results in improving the mental health of carers of people with dementia. Additionally, online interventions may overcome accessibility barriers. If successful, this intervention will have important potential for implementation as a public health intervention, since costs and support by trained staff are minimal. Clinical Trial: Netherlands Trial Register (NTL) NL6417; https://www.trialregister.nl/trial/6417

  • JMIR Res Protoc 2019;8(10):e14106

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  Proposals (eHealth)

  Oct 9, 2019

  Use of Human-Centered Design to Improve Implementation of Evidence-Based Psychotherapies in Low-Resource Communities: Protocol for Studies Applying a...

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  Authors List:

  • Aaron R Lyon  
  • Sean A Munson  
  • Brenna N Renn  
  • David C Atkins  
  • Michael D Pullmann  
  • Emily Friedman  
  • Patricia A Areán  

  Abstract:

  Background: This paper presents the protocol for the National Institute of Mental Health (NIMH)–funded University of Washington’s ALACRITY (Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness) Center, which uses human-centered design (HCD) methods to improve the implementation of evidence-based psychosocial interventions (EBPIs). We propose that usability—the degree to which interventions and implementation strategies can be used with ease, efficiency, effectiveness, and satisfaction—is a fundamental, yet poorly understood determinant of implementation. Objective: We present a novel Discover, Design/Build, and Test (DDBT) framework to study usability as an implementation determinant. DDBT will be applied across Center projects to develop scalable and efficient implementation strategies (eg, training tools), modify existing EBPIs to enhance usability, and create usable and nonburdensome decision support tools for quality delivery of EBPIs. Methods: Stakeholder participants will be implementation practitioners/intermediaries, mental health clinicians, and patients with mental illness in nonspecialty mental health settings in underresourced communities. Three preplanned projects and 12 pilot studies will employ the DDBT model to (1) identify usability challenges in implementing EBPIs in underresourced settings; (2) iteratively design solutions to overcome these challenges; and (3) compare the solution to the original version of the EPBI or implementation strategy on usability, quality of care, and patient-reported outcomes. The final products from the center will be a streamlined modification and redesign model that will improve the usability of EBPIs and implementation strategies (eg, tools to support EBPI education and decision making); a matrix of modification targets (ie, usability issues) that are both common and unique to EBPIs, strategies, settings, and patient populations; and a compilation of redesign strategies and the relative effectiveness of the redesigned solution compared to the original EBPI or strategy. Results: The UW ALACRITY Center received institutional review board approval for the three separate studies in March 2018 and was funded in May 2018. Conclusions: The outcomes from this center will inform the implementation of EBPIs by identifying cross-cutting features of EBPIs and implementation strategies that influence the use and acceptability of these interventions, actively involving stakeholder clinicians and implementation practitioners in the design of the EBPI modification or implementation strategy solution and identifying the impact of HCD-informed modifications and solutions on intervention effectiveness and quality. Clinical Trial: ClinicalTrials.gov NCT03515226 (https://clinicaltrials.gov/ct2/show/NCT03515226), NCT03514394 (https://clinicaltrials.gov/ct2/show/NCT03514394), and NCT03516513 (https://clinicaltrials.gov/ct2/show/NCT03516513).

  • JMIR Res Protoc 2019;8(10):e14990

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  Systematic Review Protocols (funded)

  Oct 9, 2019

  Deaf Adults’ Health Literacy and Access to Health Information: Protocol for a Multicenter Mixed Methods Study

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  Authors List:

  • Michael M McKee  
  • Peter C Hauser  
  • Sara Champlin  
  • Michael Paasche-Orlow  
  • Kelley Wyse  
  • Jessica Cuculick  
  • Lorraine R Buis  
  • Melissa Plegue  
  • Ananda Sen  
  • Michael D Fetters  

  Abstract:

  Background: Deaf American Sign Language (ASL) users often struggle with limited health literacy compared with their hearing peers. However, the mechanisms driving limited health literacy and how this may impact access to and understanding of health information for Deaf individuals have not been determined. Deaf individuals are more likely than hearing individuals to use the internet, yet they continue to report significant barriers to health information. This study presents an opportunity to identify key targets that impact information access for a largely marginalized population. Objective: This study aims to elucidate the role of information marginalization on health literacy in Deaf ASL users and to better understand the mechanisms of health literacy in this population for the purpose of identifying viable targets for future health literacy interventions. Methods: This is an exploratory mixed-methods study to identify predictors and moderators of health literacy in the Deaf population. These predictors of health literacy will be used to inform the second step that qualitatively explains the findings, including how Deaf individuals access and understand Web-based health information. Multiple interviewer- and computer-based instruments underwent translation and adaptation, from English to ASL, to make them accessible for the Deaf participants in our study. A planned sample of 450 Deaf ASL users and 450 hearing native English speakers, aged 18 to 70 years, will be recruited from 3 partnering sites: Rochester, NY; Flint, MI; and Chicago, IL. These individuals will participate in a single data collection visit. A subset of participants (approximately 30) with key characteristics of interest will be invited for a second data collection visit to observe and inquire more about their ability to directly access, navigate, and comprehend Web-based health information. The study will help assess how the ways health literacy and information are visualized may differ between Deaf individuals and hearing individuals. The study will also survey participants’ ownership and use of computer and mobile devices and their level of Web-based information use, including health information. Results: Adaptation and translation of protocols and instruments have been completed and are now in use for the study. Recruitment is underway and will continue until late 2020. Results from this study will be used to provide a guide on how to structure Web-based health information in a way that maximizes accessibility and improves health literacy for Deaf individuals. Conclusions: The results from this mixed-methods proposal will advance what is known about health literacy and health information accessibility for Deaf individuals. This innovative study will generate rich data on how to formulate health information and health literacy interventions more accurately to take advantage of visual learning skills.

  • JMIR Res Protoc 2019;8(10):e14889

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