JMIR Publications

Recent Articles:

• 

  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

  View Authors View Abstract

  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

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Personal Narratives and Viewpoints on...

  Oct 14, 2019

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

  View Authors View Abstract

  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

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  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

  View Authors View Abstract

  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

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  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...

  View Authors View Abstract

  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

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  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

  View Authors View Abstract

  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

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  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...

  View Authors View Abstract

  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

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  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

  View Authors View Abstract

  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

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  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...

  View Authors View Abstract

  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

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Systematic Review Protocols (funded)

  Oct 9, 2019

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

  View Authors View Abstract

  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

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Grant Proposals (eHealth, funded)

  Oct 9, 2019

  Remotely Supervised Home-Based Intensive Exercise Intervention to Improve Balance, Functional Mobility, and Physical Activity in Survivors of Moderate or...

  View Authors View Abstract

  Authors List:

  • Jennifer O'Neil  
  • Mary Egan  
  • Shawn Marshall  
  • Martin Bilodeau  
  • Luc Pelletier  
  • Heidi Sveistrup  

  Abstract:

  Background: Traumatic brain injury (TBI) may impact an individual physically, cognitively, socially, and emotionally. Poor balance, reduced mobility, and low daily physical activity often will require ongoing physical rehabilitation intervention. However, face-to-face specialized physiotherapy is not always accessible for individuals living in rural settings. Objective: We will answer four questions: (1) What is the feasibility of a remotely supervised, home-based, intensive exercise intervention with survivors of moderate and severe TBI? (2) Does the frequency of remote supervision have an impact on the feasibility of completing a home-based intensive exercise program? (3) Does the frequency of remote supervision impact balance, functional mobility, and physical activity? (4) What is the lived experience of remote supervision for both survivors and caregivers? Methods: Four participants will complete two intensive, 4-week (five days per week) home-based exercise interventions remotely supervised via synchronous videoconference. Each exercise intervention will have a goal of 160 to 300 repetitions or 60 minutes of tailored exercises to promote neuroplasticity and be defined as an intensive home-based exercise intervention. An alternating single-subject design will allow for the comparison between two frequencies of remote supervision, once weekly and five times weekly. Daily repeated outcome measures, pre- and postintervention outcome measures, and 1-month follow-up outcome measures will be collected to explore the effect on feasibility and physical variables. Daily outcome measures include step count and Five Times Sit-to-Stand test. Pre-post measures include assessment of quiet stance and the Community Balance and Mobility Scale. A semistructured interview will be completed at the end of each intervention segment to document the lived experience of both survivors and their study partners. Finally, five questionnaires will be used to understand the overall experience: the Mayo-Portland Adaptability Inventory-4 Participation Index, Satisfaction With Life Scale, Fall Efficacy Scale-International, Interpersonal Behavior Questionnaire, and System Usability Scale. Data will be analyzed following traditional single-subject methods of analysis. Results: Ethics approval was received from both the Bruyère Research Institute and University of Ottawa review boards in March 2019. Recruitment is underway. Conclusions: The proposed intervention is complex in nature due to the involvement of multiple technology sources and the inclusion of a complex dyad (survivors and caregivers) in a community setting. This type of research is timely given that alternative methods of physical intervention delivery are needed to facilitate gains in balance, mobility, physical activity among TBI survivors with limited access to clinical care, and the quality of the patients’ experience.

  • JMIR Res Protoc 2019;8(10):e14867

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  Non-Randomized Studies (funded,...

  Oct 9, 2019

  Improving the Health of Individuals With Cerebral Palsy: Protocol for the Multidisciplinary Research Program MOVING ON WITH CP

  View Authors View Abstract

  Authors List:

  • Ann Alriksson-Schmidt  
  • Johan Jarl  
  • Elisabet Rodby-Bousquet  
  • Annika Lundkvist Josenby  
  • Lena Westbom  
  • Kate Himmelmann  
  • Kristine Stadskleiv  
  • Pia Ödman  
  • Ingrid Svensson  
  • Christian Antfolk  
  • Nebojsa Malesevic  
  • Ira Jeglinsky  
  • Sanjib Saha  
  • Gunnar Hägglund  

  Abstract:

  Background: Cerebral palsy (CP) is one of the most common early onset disabilities globally. The causative brain damage in CP is nonprogressive, yet secondary conditions develop and worsen over time. Individuals with CP in Sweden and most of the Nordic countries are systematically followed in the national registry and the Cerebral Palsy Follow-Up Program (CPUP). CPUP has improved certain aspects of health care for individuals with CP and strengthened collaboration among professionals. However, there are still issues to resolve regarding health care for this specific population. Objective: The overall objectives of the research program MOVING ON WITH CP are to (1) improve the health care processes and delivery models; (2) develop, implement, and evaluate real-life solutions for Swedish health care provision; and (3) evaluate existing health care and social insurance benefit programs and processes in the context of CP. Methods: MOVING ON WITH CP comprises 9 projects within 3 themes. Evaluation of Existing Health Care (Theme A) consists of registry studies where data from CPUP will be merged with national official health databases, complemented by survey and interview data. In Equality in Health Care and Social Insurance (Theme B), mixed-methods studies and registry studies will be complemented with focus group interviews to inform the development of new processes to apply for benefits. In New Solutions and Processes in Health Care Provision (Theme C), an eHealth procedure will be developed and tested to facilitate access to specialized health care, and equipment that improves the assessment of movement activity in individuals with CP will be developed. Results: The individual projects are currently being planned and will begin shortly. Feedback from users has being integrated. Ethics board approvals have been obtained. Conclusions: In this 6-year multidisciplinary program, professionals from the fields of medicine, social sciences, health sciences, and engineering, in collaboration with individuals with CP and their families, will evaluate existing health care, create conditions for a more equal health care, and develop new technologies to improve the health care management of people with CP.

  • JMIR Res Protoc 2019;8(10):e13883

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.

• 

  RCTs - Protocols/Proposals (non-eHealth)

  Oct 8, 2019

  Evaluation of a Custom-Developed Computer Game to Improve Executive Functioning in 4- to 6-Year-Old Children Exposed to Alcohol in Utero: Protocol for a...

  View Authors View Abstract

  Authors List:

  • Jacobus Gidion Louw  
  • Leana Olivier  
  • Sarah Skeen  
  • Alastair van Heerden  
  • Mark Tomlinson  

  Abstract:

  Background: Fetal alcohol spectrum disorder (FASD) is one of the most common causes of preventable intellectual disability, and the key associated deficits are in executive function (EF). Aspects of EF can be improved using cognitive training interventions. The highest prevalence of FASD globally (at a rate of 135.1 per 1000) has been found in a South African population in the Western Cape province. There is a shortage of specialized health service personnel, and there are limited remedial services. Computer-based cognitive training, if age and culturally appropriate, could be an effective way to provide the interventions with minimal need for skilled personnel and other resources. The Foundation for Alcohol Related Research has developed such a program for the South African context. Objective: This protocol aimed to evaluate whether it is feasible to use computerized cognitive training in a resource-poor context to improve cognitive function in children exposed to alcohol in utero. Methods: We are conducting a randomized controlled trial in the Saldanha Bay Municipal area, evaluating a custom-developed cognitive training program to improve the cognitive function of children aged between 4 and 6 years who were exposed to alcohol in the prenatal stage. Participants will be recruited from local Early Childhood Development centers. Community workers will interview biological mothers to identify alcohol-exposed pregnancies. Alcohol-exposed children will be randomized into an intervention or a control group of 40 participants each using block randomization. A group of 40 children not exposed to alcohol will be included in a normative group using individual randomization. The intervention group will play the game for 6 months (40 sessions). Normative and control groups will receive no intervention. Neurodevelopmental assessments will be done at baseline and upon completion of the study with all participants. Results: The intervention has started, and all baseline assessments have been done at the time of submission. Conclusions: This study will provide insight into whether computerized cognitive training is viable and effective in the South African context. It has the potential to provide a means of intervention globally and in other resource-poor context and expand the knowledge base regarding executive functioning and FASD. This paper presents the research protocol and intervention design of the study. Clinical Trial: International Standard Randomized Controlled Trial Number (ISRCTN): 17244156; http://www.isrctn.com/ISRCTN17244156.

  • JMIR Res Protoc 2019;8(10):e14489

  • Choose one of the following formats:

  • Share this article:

    Or, copy the article link to your clipboard:

    Article URL

  • Citation

    • END

      for: Endnote

    • BibTeX

      for: BibDesk and LaTeX

    • RIS

      for: RefMan, Procite, Endnote, RefWorks

    Add this article to your Mendeley library Add this article to your CiteULike library Copy Citation to Clipboard

  • Metrics

    Discover Social Media mentions by hovering over the donut. Click the 'details' link for a full report.