JMIR Publications

JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results

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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) publishes peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.

JMIR Res Protoc is a new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor 2015: 4.532)

JMIR Res Protoc publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions

JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central

Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort 

JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal

JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols

JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced

JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods

Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine

Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others)

 
 

Recent Articles:

  • Rehabilitation screen shot. Image Source: www.trakphysio.org.uk. 
Intellectual property of Cardiff University. Designed by Prof Irena Spasic and Dr Kate Button (author). Licensed:  Licensed under Creative Commons Attribution 2.0.

    Taxonomy for the Rehabilitation of Knee Conditions (TRAK), a Digital Intervention to Support the Self-Care Components of Anterior Cruciate Ligament...

    Abstract:

    Background: Rupture of the anterior cruciate ligament (ACL) is common, especially in the active population. In defining the problem of ACL rehabilitation, this study draws from the knowledge that improved self-care, strength, and fitness are associated with better outcomes. Traditional rehabilitation involves regular physiotherapy, but it is not clear what the optimal way for delivering rehabilitation is, and it varies widely across the world. Evidence for treatments are discussed in the literature, however standard length of rehabilitation and frequency of appointments are unknown. Additionally, current rehabilitation models in the National Health Service (NHS) struggle with catering to large volumes of patients and the lengthy time span over which rehabilitation is delivered. The use of eHealth (the Internet in health care) has been successful at delivering behavior change to a number of diverse patient groups. In physiotherapy, problems such as exercise compliance, exercise technique, and managing a broad program of rehabilitation and advice can be challenging. An eHealth intervention called Taxonomy for the Rehabilitation of Knee Conditions (TRAK) to support self-management and behavior change has been developed by patients and clinicians, and acceptability studies have yielded positive results. TRAK is not an exercise rehabilitation protocol; it is a tool to support ACL rehabilitation with personalized plans, prompts, and logs to help adherence and videos and instructions to improve quality and address queries. The patients have their own log-ins and can email their physiotherapist through the website. This novel platform is directly in line with current NHS England, National Institute for Health and Care Excellence, and NHS Improvement agendas that call for rehabilitation initiatives using both technology and supported self-management for patients. This study forms part of a research platform to identify a best practice model of ACL care from the literature and opinions of key stakeholders. Patients’ exercise programs and duration of treatment are still based on individual needs, but use of the website may offer improved self-management and function and reduced health resource use. Objective: This is a feasibility study to establish recruitment, retention, sample size estimates, and practicality of collecting outcome measures to inform a future trial comparing the TRAK intervention, which has been rigorously designed to address the challenges of ACL rehabilitation, to usual care. Methods: This is a feasibility study comparing 2 groups: standard care and standard care plus eHealth. It will use convergent parallel mixed methods where both qualitative and quantitative data are sought for a more thorough understanding of the objectives. Primary outcomes relate to feasibility, including recruitment, retention, and usage. Secondary outcomes relate to health resource use and patient-rated outcome measures. Results: This research expects to establish the feasibility of a full-scale randomized controlled trial to explore whether patients who use an eHealth intervention to support ACL rehabilitation have better outcomes plus improved self-efficacy and reduced health resource use than a usual care group. Conclusions: The study will provide essential information to support the development and powering of a future clinical trial of eHealth and physiotherapy for patients with ACL reconstruction in the NHS.

  • Spinal cord injury. Image sourced and copyright owned by authors.

    Spinal Cord Injury—Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN Study): Protocol of An Exploratory Study In Assessing the...

    Abstract:

    Background: Spinal cord injury (SCI) is a devastating condition with limited therapeutic options despite decades of research. Current treatment options include use of steroids, surgery, and rehabilitation. Nevertheless, many patients with SCI remain disabled. MLC601 (NeuroAiD), a combination of natural products, has been shown to be safe and to aid neurological recovery after brain injuries and may have a potential role in improving recovery after SCI. Objective: The aim of this study is to evaluate the safety and efficacy of NeuroAiD amongst people who sustain SCI in the study setting. Methods: Spinal Cord Injury—Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN) is a prospective cohort study of patients with moderately severe to severe SCI, defined as American Spinal Injury Association (ASIA) Impairment Scale (AIS) A and B. These patients will be treated with open-label NeuroAiD for 6 months in addition to standard care and followed for 24 months. Anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 and will include information on demographics; main diagnostics; and neurological and functional state assessed by the Spinal Cord Independence Measure, ASIA—International Standard for Neurological Classification Spinal Cord Injury, and Short Form (SF-8) Health Survey. In addition, NeuroAiD treatment, compliance, concomitant therapies, and side effects, if any, will be collected. Investigators will use a secured online system for data entry. The study is approved by the ethics committee of Hospital University Kebangsaan Malaysia. Results: The coprimary endpoints are safety, AIS grade, and improvement in ASIA motor score at 6 months. Secondary endpoints are AIS grade, ASIA motor scores and sensory scores, Spinal Cord Independence Measure (SCIM), SF-8 Health Survey, and compliance at other time points. Conclusions: SATURN investigates the promising role of NeuroAiD in SCI especially given its excellent safety profile. We described here the protocol and online data collection tool we will use for this prospective cohort study. The selection of moderately severe to severe SCI provides an opportunity to investigate the role of NeuroAiD in addition to standard rehabilitation in patients with poor prognosis. The results will provide important information on the feasibility of conducting larger controlled trials to improve long-term outcome of patients with SCI. Trial Registration: Clinicaltrials.gov NCT02537899; https://clinicaltrials.gov/ct2/show/NCT02537899 (Archived by WebCite at http://www.webcitation.org/6m2pncVTG)

  • A trained interviewer conducting face-to-face interview with one of the participants in Unguja Island, Zanzibar. Image sourced and copyright owned by authors.

    Design, Response Rates, and Population Characteristics of a Cross-Sectional Study in Zanzibar, Tanzania

    Abstract:

    Background: Data on nutritional status and correlates of noncommunicable diseases are scarce for resource-poor settings in sub-Saharan countries. With the scope of a project, “Access to Food and Nutrition Status of the Zanzibari Population,” data for investigating public health questions were collected using proven measurement and laboratory standards. Objective: The present study aims at providing a descriptive overview of recruitment approaches, standardization, quality control measures, and data collection, with special attention to the design, responses, and participant characteristics of the overall project. Methods: A cross-sectional study across 80 randomly selected Shehias (wards) was conducted in 2013 in Unguja Island, Zanzibar. Examinations included all members living in 1 household, face-to-face interviews and anthropometric measurements (weight, height, mid-upper arm circumference, waist and hip circumference, and body composition) were assessed for all household members, blood pressure was taken from participants older than 2 years, and biosamples (urine and blood) from eligible household members were collected. Data collected from the core sample included sociodemographic data, nutritional status, and medical history (hypertension). Physical activity data was collected from a subsample of children between 3 and 16 years of age. Results: A total of 1314 participants (mean age 23.6 ± 18.9 years, 54.54% female) completed all anthropometric measurements and were included in the analysis. Out of which, 98.40% (1293/1314) completed the household member’s questionnaire, 93.32% (1229/1314) participants older than 2 years completed blood pressure measurements, and 64.31% (845/1314) blood samples were collected from participants older than 5 years. Underweight prevalence for the total study population was 36.53% (480/1314) with the highest prevalence in children under 14 years. Overweight and obesity was highest among females with the prevalence of 7.61% (100/1314) and 6.62% (87/1314), respectively; obesity was rare among male participants. Conclusions: The study provides valuable data to investigate the interplay of socioeconomic, demographic, environmental, physiological, and behavioral factors in the development of diet-related disorders in a representative sample of the Zanzibari population.

  • Wearable Activity Tracker Impact. Image sourced and created by authors.

    Can a Free Wearable Activity Tracker Change Behavior? The Impact of Trackers on Adults in a Physician-Led Wellness Group

    Abstract:

    Background: Wearable activity trackers (trackers) are increasingly popular devices used to track step count and other health indicators. Trackers have the potential to benefit those in need of increased physical activity, such as adults who are older and face significant health challenges. These populations are least likely to purchase trackers and most likely to face challenges in using them, yet may derive educational, motivational, and health benefits from their use once these barriers are removed. Objective: The aim of this pilot research is to investigate the use of trackers by adults with chronic medical conditions who have never used trackers previously. Specifically, we aim to determine (1) if participants would accept and use trackers to increase their physical activity; (2) if there were barriers to use besides cost and training; (3) if trackers would educate participants on their baseline and ongoing activity levels and support behavior change; and (4) if clinical outcomes would show improvements in participants’ health. Methods: This study was conducted with patients (N=10) in a 12-week physician-led wellness group offered by Family Doctors, LLC. Patients were given trackers in the second week of The Wellness Group and were interviewed 2 to 4 weeks after it ended. The study investigators analyzed the interview notes to extract themes about the participants’ attitudes and behavior changes and collected and analyzed participants’ clinical data, including weight and low-density lipoprotein (LDL) cholesterol over the course of the study. Results: Over the 12 to 14 weeks of tracker use, improvements were seen in clinical outcomes, attitudes towards the trackers, and physical activity behaviors. Participants lost an average of 0.5 lbs per week (SD 0.4), with a mean total weight loss of 5.97 lbs (P=.004). Other short-term clinical outcomes included a 9.2% decrease in LDL levels (P=.038). All participants reported an increase in well-being and confidence in their ability to lead more active lives. We identified the following 6 major attitudinal themes from our qualitative analysis of the interview notes: (1) barriers to tracker purchase included cost, perceived value, and choice confusion; (2) attitudes towards the trackers shifted for many, from half of the participants expressing excitement and hope and half expressing hesitation or trepidation, to all participants feeling positive towards their tracker at the time of the interviews; (3) trackers served as educational tools for baseline activity levels; (4) trackers provided concrete feedback on physical activity, which motivated behavior change; (5) tracker use reinforced wellness group activities and goals; and (6) although commitment to tracker use did not waver, external circumstances influenced some participants’ ongoing use. Conclusions: Our findings suggest that adding trackers to wellness groups comprising primarily older adults with chronic medical conditions can support education and behavior change to be more physically active. The trackers increased participant self-efficacy by providing a tangible, visible reminder of a commitment to increasing activity and immediate feedback on step count and progress towards a daily step goal. While acceptance was high and attitudes ultimately positive, training and support are needed and short-term drop-off in participant use is to be expected. Future research will further consider the potential of trackers in older adults with chronic medical conditions who are unlikely to purchase them, and studies will use larger samples, continue over a longer period of time, and evaluate outcomes independent of a wellness group.

  • TN health chat. Image sourced and copyright owned by authors.

    Engaging Moms on Teen Indoor Tanning Through Social Media: Protocol of a Randomized Controlled Trial

    Abstract:

    Background: Indoor tanning elevates the risk for melanoma, which is now the most common cancer in US women aged 25-29. Public policies restricting access to indoor tanning by minors to reduce melanoma morbidity and mortality in teens are emerging. In the United States, the most common policy restricting indoor tanning in minors involves parents providing either written or in person consent for the minor to purchase a tanning visit. The effectiveness of this policy relies on parents being properly educated about the harms of indoor tanning to their children. Objective: This randomized controlled trial will test the efficacy of a Facebook-delivered health communication intervention targeting mothers of teenage girls. The intervention will use health communication and behavioral modification strategies to reduce mothers’ permissiveness regarding their teenage daughters’ use of indoor tanning relative to an attention-control condition with the ultimate goal of reducing indoor tanning in both daughters and mothers. Methods: The study is a 12-month randomized controlled trial comparing 2 conditions: an attention control Facebook private group where content will be relevant to teen health with 25% focused on prescription drug abuse, a topic unrelated to tanning; and the intervention condition will enter participants into a Facebook private group where 25% of the teen health content will be focused on indoor tanning. A cohort of 2000 mother-teen daughter dyads will be recruited to participate in this study. Only mothers will participate in the Facebook groups. Both mothers and daughters will complete measures at baseline, end of intervention (1-year) and 6 months post-intervention. Primary outcomes include mothers’ permissiveness regarding their teenage daughters’ use of indoor tanning, teenage daughters’ perception of their mothers’ permissiveness, and indoor tanning by both mothers and daughters. Results: The first dyad was enrolled on March 31, 2016, and we anticipate completing this study by October 2019. Conclusions: This trial will deliver social media content grounded in theory and will test it in a randomized design with state-of-the-art measures. This will contribute much needed insights on how to employ social media for health behavior change and disease prevention both for indoor tanning and other health risk behaviors and inform future social media efforts by public health and health care organizations. ClinicalTrial: Clinicaltrials.gov NCT02835807; https://clinicaltrials.gov/ct2/show/NCT02835807 (Archived by WebCite at http://www.webcitation.org/6mDMICcCE).

  • Child using tablet. Image Source: https://pixabay.com/en/child-tablet-technology-computer-1183465/. Author: NadineDoerle. Copyright: Public domain.

    Quality of Mobile Phone and Tablet Mobile Apps for Speech Sound Disorders: Protocol for an Evidence-Based Appraisal

    Abstract:

    Background: Although mobile apps are readily available for speech sound disorders (SSD), their validity has not been systematically evaluated. This evidence-based appraisal will critically review and synthesize current evidence on available therapy apps for use by children with SSD. Objective: The main aims are to (1) identify the types of apps currently available for Android and iOS mobile phones and tablets, and (2) to critique their design features and content using a structured quality appraisal tool. Methods: This protocol paper presents and justifies the methods used for a systematic review of mobile apps that provide intervention for use by children with SSD. The primary outcomes of interest are (1) engagement, (2) functionality, (3) aesthetics, (4) information quality, (5) subjective quality, and (6) perceived impact. Quality will be assessed by 2 certified practicing speech-language pathologists using a structured quality appraisal tool. Two app stores will be searched from the 2 largest operating platforms, Android and iOS. Systematic methods of knowledge synthesis shall include searching the app stores using a defined procedure, data extraction, and quality analysis. Results: This search strategy shall enable us to determine how many SSD apps are available for Android and for iOS compatible mobile phones and tablets. It shall also identify the regions of the world responsible for the apps’ development, the content and the quality of offerings. Recommendations will be made for speech-language pathologists seeking to use mobile apps in their clinical practice. Conclusions: This protocol provides a structured process for locating apps and appraising the quality, as the basis for evaluating their use in speech pathology for children in English-speaking nations.

  • Electronic medical record. Image source: https://pixabay.com/en/ehr-emr-electronic-medical-record-1476525/. Author: mcmurryjulie. Copyright: CC0 Public Domain.

    High Touch and High Tech (HT2) Proposal: Transforming Patient Engagement Throughout the Continuum of Care by Engaging Patients with Portal Technology at the...

    Abstract:

    Background: For patients with complex care needs, engagement in disease management activities is critical. Chronic illnesses touch almost every person in the United States. The costs are real, personal, and pervasive. In response, patients often seek tools to help them manage their health. Patient portals, personal health records tethered to an electronic health record, show promise as tools that patients value and that can improve health. Although patient portals currently focus on the outpatient experience, the Ohio State University Wexner Medical Center (OSUWMC) has deployed a portal designed specifically for the inpatient experience that is connected to the ambulatory patient portal available after discharge. While this inpatient technology is in active use at only one other hospital in the United States, health care facilities are currently investing in infrastructure necessary to support large-scale deployment. Times of acute crisis such as hospitalization may increase a patient’s focus on his/her health. During this time, patients may be more engaged with their care and especially interested in using tools to manage their health after discharge. Evidence shows that enhanced patient self-management can lead to better control of chronic illness. Patient portals may serve as a mechanism to facilitate increased engagement. Objective: The specific aims of our study are (1) to investigate the independent effects of providing both High Tech and High Touch interventions on patient-reported outcomes at discharge, including patients’ self-efficacy for managing chronic conditions and satisfaction with care; and (2) to conduct a mixed-methods analysis to determine how providing patients with access to MyChart Bedside (MCB, High Tech) and training/education on patient portals, and MyChart Ambulatory (MCA, High Touch) will influence engagement with the patient portal and relate to longer-term outcomes. Methods: Our proposed 4-year study uses a mixed-methods research (MMR) approach to evaluate a randomized controlled trial studying the effectiveness of a High Tech intervention (MCB, the inpatient portal), and an accompanying High Touch intervention (training patients to use the portal to manage their care and conditions) in a sample of hospitalized patients with two or more chronic conditions. This study measures how access to a patient portal tailored to the inpatient stay can improve patient experience and increase patient engagement by (1) improving patients’ perceptions of the process of care while in the hospital; (2) increasing patients’ self-efficacy for managing chronic conditions; and (3) facilitating continued use of a patient portal for care management after discharge. In addition, we aim to enhance patients’ use of the portal available to outpatients (MCA) once they are discharged. Results: This study has been funded by the Agency for Healthcare Research and Quality (AHRQ). Research is ongoing and expected to conclude in August 2019. Conclusions: Providing patients real-time access to health information can be a positive force for change in the way care is provided. Meaningful use policies require minimum demonstrated use of patient portal technology, most often in the ambulatory setting. However, as the technology matures to bridge the care transition, there is a greater need to understand how patient portals transform care delivery. By working in concert with patients to address and extend current technologies, our study aims to advance efforts to increase patients’ engagement in their care and develop a template for how other hospitals might integrate similar technologies.

  • Nitrogen balance. Image sourced and copyright owned by authors.

    Effect on Nitrogen Balance, Thermogenesis, Body Composition, Satiety, and Circulating Branched Chain Amino Acid Levels up to One Year after Surgery: Protocol...

    Abstract:

    Background: Bariatric surgery (BS), the most effective treatment for severe obesity, typically results in 40-50 kg weight loss in the year following the surgery. Beyond its action on protein metabolism, dietary protein intake (PI) affects satiety, thermogenesis, energy efficiency, and body composition (BC). However, the required amount of PI after surgical weight loss is not known. The current daily PI recommendation for diet-induced weight loss is 0.8 g/kg ideal body weight (IBW) per day, but whether this amount is sufficient to preserve fat-free mass during active surgical weight loss is unknown. Objective: To evaluate the effect of a 3-month dietary protein supplementation (PS) on nitrogen balance (NB), BC, energy expenditure, and satiety in women undergoing either gastric bypass or vertical sleeve gastrectomy. Methods: In this randomized prospective study, participants will be randomized to a high protein supplementation group (1.2 g/kg IBW per day) or standard protein supplementation group (0.8 g/kg IBW per day) based on current guidelines. Outcome measures including NB, BC, circulating branched chain amino acids, and satiety, which will be assessed presurgery, and at 3-months and 12-months postsurgery. Results: To date, no studies have examined the effect of dietary PS after BS. Current guidelines for PI after surgery are based on weak evidence. Conclusions: The results of this study will contribute to the development of evidence-based data regarding the safe and optimal dietary PI and supplementation after BS. Trial Registration: Clinicaltrials.gov NCT02269410; http://clinicaltrials.gov/ct2/show/NCT02269410 (Archived by WebCite at http://www.webcitation.org/6m2f2QLeg).

  • Predictors of cognitive impairment in stroke patients and healthy older adults in a Middle Eastern population. Image sourced and copyright owned by authors.

    Predictors of Vascular Cognitive Impairment Poststroke in a Middle Eastern (Bahrain) Cohort: A Proposed Case-Control Comparison

    Abstract:

    Background: Poststroke dementia and cognitive impairment are associated with poor long-term outcomes after stroke. The contribution of genetic factors such as the presence of apolipoprotein (ApoE) ɛ4 allele and its association with cognitive impairment poststroke remains inconclusive, particularly in Middle Eastern regions. Objective: The aim of this study is to examine all correlates and potential predictors of cognitive impairment including self-awareness and regulation deficits in stroke patients and compare these functions with healthy older adults from a Middle Eastern population. Methods: A prospective stroke sample of 200 patients (case group) and 100 healthy aging individuals (control group) will be recruited from the largest medical complex in Bahrain. A neuropsychological battery of cognitive assessments (global, executive, and metacognition) will be conducted on all participants. Participants will be categorized into 4 subgroups (nonvascular cognitive impairment, vascular cognitive impairment with no dementia, vascular dementia, and mixed dementia) using standardized cognitive assessment scores and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, dementia criteria. Biomarkers will include ApoE genotype, soluble form of receptor for advanced glycation end products, neprilysin, beta-secretase 1, biochemistry, and hematology measurements. Results: The primary study outcome is to determine early risk factors for cognitive impairment after stroke in a Bahraini cohort. The study has received full ethical approval from the Bahrain Ministry of Health and from the affiliated university. Conclusions: With increasing stroke incidence rates in the Middle East, this research study will provide useful biological and epidemiological data for future development and planning of health policies and guidelines for stroke care within the Gulf region.

  • PROMPT-Care Consultation. Image sourced and copyright owned by authors.

    Development and Feasibility Testing of PROMPT-Care, an eHealth System for Collection and Use of Patient-Reported Outcome Measures for Personalized Treatment...

    Abstract:

    Background: Patient-reported outcome (PRO) measures have been used widely to screen for depression, anxiety, and symptoms in cancer patients. Computer-based applications that collect patients’ responses and transfer them to the treating health professional in real time have the potential to improve patient well-being and cancer outcomes. Objective: This study will test the feasibility and acceptability of a newly developed eHealth system which facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. Methods: The eHealth system is being developed in consultation with 3 overarching content-specific expert advisory groups convened for this project: the clinical advisory group, technical advisory group, and evaluation advisory group. The following work has already been completed during this phase of the study: the Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) eHealth system was developed, patient-reported outcomes were selected (distress, symptoms, unmet needs), algorithms to inform intervention thresholds for clinical and self-management were determined, clinician PRO feedback summary and longitudinal reports were designed, and patient self-management resources were collated. PROsaiq, a custom information technology system, will transfer PRO data in real time into the hospital-based oncology information system to support clinical decision making. The PROMPT-Care system feasibility and acceptability will be assessed through patients completing PROMPT-Care assessments, participating in face-to-face cognitive interviews, and completing evaluation surveys and telephone interviews and oncology staff participating in telephone interviews. Results: Over the course of 3 months, the system will be pilot-tested with up to 50 patients receiving treatment or follow-up care and 6 oncology staff at 2 hospitals in New South Wales, Australia. Data will be collected to determine the accuracy and completeness of data transfer procedures, extent of missing data from participants’ assessments, acceptability of the eHealth system and usefulness of the self-management resources (via patient evaluation surveys and interviews), and acceptability and perceived usefulness of real-time PRO reporting (via oncology staff interviews) at the completion of the pilot phase. Conclusions: This research investigates implementation of evidence into real world clinical practice through development of an efficient and user-friendly eHealth system. This study of feasibility and acceptability of the newly developed eHealth system will inform the next stage of larger scale testing and future implementation of the system as part of routine care. ClinicalTrial: Australian New Zealand Clinical Trials Registry ACTRN1261500135294; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369299&isReview=true (Archived by WebCite at http://www.webcitation.org/6lzylG5A0)

  • Study about carotid disease in Brazil. Image sourced and copyright owned by authors.

    An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocol

    Abstract:

    Background: Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease. CEA has been considered the first-line treatment for carotid stenosis worldwide, and the safety and efficacy of CAS compared to CEA remains in question. Objective: The purpose of this study is to compare the practice and outcomes of CAS and CEA in a real-world setting within public university hospitals in Brazil. Methods: This study will be a prospective 5-year analysis of treatment for atherosclerotic carotid stenosis with CEA and CAS performed at 5 centers affiliated with the Vascular Study Group at public university hospitals in Brazil. The indications for the procedures will be determined by each surgeon’s individual discretion, in accordance with preoperative risk evaluation. The primary outcome measures will be (1) any in-hospital stroke or death, and (2) any per-procedural stroke, death, or myocardial infarction (MI). Patients undergoing CEA in conjunction with cardiac surgery will be excluded from the study. Multivariate logistic regression will be performed to identify predictors of stroke or death in patients undergoing CEA and CAS. All tests of significance will be performed at the .05 level. This study was approved by the Committee of Ethics in Research at the University Hospital of Ribeirao Preto Medical School, and in all other participating institutions linked to National Research System and National Board of Health in Brazil (Process 15695/2011). Results: This study is currently in the recruitment phase, and the final patient is expected to be enrolled by the end of 2018. We hope to recruit approximately 800 patients to the study. Analyses will focus on primary end points for patients that are allocated to each treatment group. During the per-procedural period, the occurrence of the primary end point components (stroke, MI, or death) for CAS and CEA will be analyzed for symptomatic or asymptomatic subjects. Conclusions: The analyses of the primary endpoints (and all others variables of the study) are expected to be published in 2019 in a peer reviewed journal, and results will be presented at scientific meetings, with summary results published online. This study will obtain new data related to the quality of treatment for carotid disease in Brazil at the primary training centers of future vascular surgeons, but the initial data that will be obtained and published (with the outcomes and complications) are restricted to the first 30 days postprocedure. This time restriction limits the comparison of the results that relate to the main goal of treatment, which is to decrease the risk of stroke over 5 years. The purpose of the study group is to continue the monitoring of patient records, and evaluate the follow-up data in the 5 years following the initial evaluation. This study protocol will contribute very significantly to improving the care of patients with carotid disease, in addition to qualifying the level of assistance provided in public university hospitals in the state of São Paulo, Brazil. Trial Registration: Clinicaltrials.gov NCT02538276; https://www.clinicaltrials.gov/ct2/show/NCT02538276 (Archived by WebCite at http://www.webcitation.org/6m7APnFLD)

  • SwaziYolo Trial. Image sourced and copyright owned by authors.

    Efficacy of Mobile Serious Games in Increasing HIV Risk Perception in Swaziland: A Randomized Control Trial (SGprev Trial) Research Protocol

    Abstract:

    Background: The human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) continue to be a major public health problem in Sub-Saharan Africa (SSA), particularly in Swaziland, which has the highest HIV prevalence in this region. A wide range of strategies and interventions have been used to promote behavior change, though almost all such interventions have involved mass media. Therefore, innovative behavior change strategies beyond mass media communication are urgently needed. Serious games have demonstrated effectiveness in advancing health in the developed world; however, no rigorous serious games interventions have been implemented in HIV prevention in SSA. Objective: We plan to test whether a serious game intervention delivered on mobile phones to increase HIV risk perception, increase intention to reduce sexual partnerships, and increase intention to know own and partners HIV status will be more effective compared with current prevention efforts. Methods: This is a two-arm randomized intervention trial. We will recruit 380 participants who meet the following eligibility criteria: 18-29 years of age, own a smartphone running an Android-based operating system, have the WhatsApp messaging app, live in Swaziland, and can adequately grant informed consent. Participants will be allocated into a smartphone interactive, educational story game, and a wait-list control group in a 1:1 allocation ratio. Subsequently, a self-administered Web-based questionnaire will be issued at baseline and after 4 weeks of exposure to the game. We hypothesize that the change in HIV risk perception between pre- and post-intervention assessment is greater in the intervention group compared with the change in the control group. Our primary hypothesis is based on the assumption that increased perceived risk of HIV provides cues to engage in protective behavior. Our primary outcome measure is HIV risk perceived mean change between pre- and post-intervention compared with the mean change in the wait-list control group at 4-weeks post-intervention. We will use standardized regression coefficients to calculate the effect of the intervention on our primary outcome with P values. We will conduct both intention to treat and as treated analysis. Results: This study is funded by Hayao Nakayama Foundation for Science & Technology and Culture; Grant number H26-A2-41. The research and development approval has been obtained from Kyoto University Graduate School and Faculty of Medicine Ethics Committee, Japan, and Swaziland’s Ministry of Health Ethics and Scientific committee. Results are expected in February 2017. Conclusions: This study will provide evidence on the efficiency of a mobile phone interactive game in increasing HIV risk perception in Swaziland. Our findings may also be generalizable to similar settings in SSA. Trial Registration: University Hospital Medical Information Network Clinical Trial Registry ID number (UMIN-CTR):UMIN000021781; URL:https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025103 (Archived by WebCite at http://www.webcitation.org/6hOphB11a).

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    Open Peer Review Period: Nov 30, 2016 - Dec 14, 2016

    Background: Background: Translation of knowledge and skills from classroom settings to clinical practice is a major challenge in health care training, especially for behavioral interventions. For exam...

    Background: Background: Translation of knowledge and skills from classroom settings to clinical practice is a major challenge in health care training, especially for behavioral interventions. For example, screening, brief intervention, and referral to treatment (SBIRT) is a highly-promoted, evidence-based approach to identifying and treating individuals at risk for alcohol or drug problems, yet effective, routine use of SBIRT has lagged. Objective: Objective: To promote SBIRT skill translation and application, the study team developed and piloted a mobile app based on the theory of planned behavior (TPB). Methods: Methods: Intended for use after classroom training occurs, the mobile app has 3 primary functions designed to increase behavioral intent to deliver SBIRT: 1) review skills (i.e., addresses knowledge and beliefs about SBIRT), 2) apply skills with patients (i.e., builds confidence and perceived behavioral control), and 3) report performance data (i.e., increases accountability and social norms/influence). A randomized controlled trial is in progress among health and social service learners (N=200) recruited from three universities and six different training programs in nursing, social work, internal medicine, psychiatry, and psychology. Participants are randomized to SBIRT classroom instruction alone vs. classroom instruction plus app access prior to beginning their field placement rotations. TPB-based data are collected pre-post and SBIRT utilization data are collected weekly for 10 weeks. Key outcomes include the frequency of screening, brief interventions, referrals to treatment, and self-reported confidence in delivery of SBIRT. Results: Results: Beta testing with advanced practice nursing students (N=22) indicated that the app and its associated assessment tools were acceptable and useful. Enrollment of trial participants began in September 2016. Results are expected by December 2017. Conclusions: Conclusions: This report describes the process of TPB-based app development and testing, and the protocol for a randomized controlled trial to determine the effectiveness of the app in enhancing skill translation. If effective, this approach could improve SBIRT implementation, fidelity and clinical outcomes. Clinical Trial: The study is not registered with clinicaltrials.gov because the design does not include collection of clinical data or patient-level outcomes.

  • A protocol of a multicenter study looking for the association between workarounds and medication administration errors in bar code assisted medication administration

    Date Submitted: Nov 28, 2016

    Open Peer Review Period: Nov 29, 2016 - Dec 13, 2016

    Abstract Introduction: Information technology (IT) based methods such as bar code assisted medication administration systems (BCMA) have the potential to reduce Medication Administration Errors (MAE...

    Abstract Introduction: Information technology (IT) based methods such as bar code assisted medication administration systems (BCMA) have the potential to reduce Medication Administration Errors (MAE’s) in hospitalized patients. In practice however systems are often not used as intended and instructed, leading to workarounds. Workarounds may result in MAE’s which may cause patient harm. Aim: The primary aim is to study the association of workarounds with MAE’s in the BCMA process. Secondly we will determine the frequency and type of workarounds and MAE’s and explore the potential risk factors (determinants) for workarounds. Methods and analysis: A multicentre prospective study on internal medicine and surgical wards of four Dutch hospitals using BCMA to administer medication. A total of 6000 individual drug administrations will be included using direct observation as data collection method. Ethics: The regional medical ethics committee (‘Regionale Medisch Ethische Commissie Zorgpartners Friesland’) approved the study protocol. Study data are coded in order to guarantee privacy of the participants. Trial registration: Netherlands Trial Register NTR4355 (Dutch BCMA trial).

  • Rationale and Design of Cardiovascular Diseases (CVD) risk assessment and communication by nurses for primary and secondary prevention of CVDs in India

    Date Submitted: Nov 25, 2016

    Open Peer Review Period: Nov 26, 2016 - Dec 10, 2016

    Background: Background: Rising burden of CVDs is the biggest challenge of 21st century in India and has contributed enormously to the increased burden on health care services including human resourc...

    Background: Background: Rising burden of CVDs is the biggest challenge of 21st century in India and has contributed enormously to the increased burden on health care services including human resources. Innovative approaches are required to implement prevention programmes with limited human resource. One such approach is task shifting of CVD risk assessment and communication to nurses, as nurses are one of the key health care providers in all levels of health care. Objective: The present study has been designed to test the innovative approach of risk assessment and communication by nurses for primary and secondary prevention of CVDs in tertiary health care setting. Methods: Methods and analysis: -The study is quasi experimental in nature with one year follow up to determine the effect of CVD risk assessment and communication by nurses using risk communication package on primary and secondary prevention of CVDs. Nurses (n=16) working in the selected OPDs of the tertiary health care setting will be trained in CVD risk assessment and communication. A total of 900 patients (400 for primary prevention and 500 for secondary prevention) attending the medicine and allied along with cardiology out patient departments will be enrolled by trained nurses for the study. Primary outcome measures for primary and secondary prevention groups will be the cardiovascular risk modification and medication adherence respectively. Results: none Conclusions: The study will evaluate the innovative approach of CVD risk assessment and management by nurses for primary and secondary prevention CVDs in India. Clinical Trial: Trial registration acknowledgement no :- REF/2015/09/009742

  • What is the impact of using mobile applications on progress of Alcohol Use Disorder? A Systematic Review Protocol.

    Date Submitted: Nov 22, 2016

    Open Peer Review Period: Nov 22, 2016 - Dec 6, 2016

    Background: Alcohol use disorders (AUD) are among the most prevalent mental disorders worldwide and are associated with a diverse range of physical and psychological comorbidities. There are various...

    Background: Alcohol use disorders (AUD) are among the most prevalent mental disorders worldwide and are associated with a diverse range of physical and psychological comorbidities. There are various types of treatment; however, there are many barriers to accessing treatment (i.e., stigma, cost, accessibility of service etc.) Mobile applications (apps) have the potential to overcome the barriers and provide support to those who need it. Objective: The purpose of this systematic review is to assess the effectiveness of mobile apps in reducing alcohol consumption for those with AUD and understand the psychological outcomes of using the app (i.e., client empowerment, self-efficacy, etc.). Methods: The search strategy was applied to seven health sciences and interdisciplinary databases. Two reviewers independently assessed all titles and abstracts for relevance and full texts of relevant articles for eligibility. To be included, the article must be a quantitative evaluation of clinical outcomes of using the intervention. The intervention must be a consumer-facing app focused on supporting individuals with AUD. Two reviewers will independently extract data from all eligible articles using a standardized extraction worksheet and will independently assess the study quality. A meta-analysis will be conducted if appropriate. Depending on outcomes reported, this review will calculate and report pooled risk ratios or standardized mean differences. Results: The search strategy yielded 699 unique citations. Sixty-three (9.01%; 63/699) articles were assessed as relevant for full-text review. The full-text review was underway at the time of the submission of this abstract. This review is projected to be completed in the winter of 2016. Conclusions: There is potential for mobile apps to support individuals those with AUD to in reduceing their alcohol consumption. This review will be the first to assess the effectiveness of AUD mobile apps and client experiences of using it.

  • Cluster randomized control trial of ReZone: Helping young people to self-manage when feeling overwhelmed

    Date Submitted: Nov 18, 2016

    Open Peer Review Period: Nov 21, 2016 - Dec 5, 2016

    Background: The association between behavioural difficulties and academic attainment is well established. Recent policy has promoted the early identification of behavioural difficulties, which has bee...

    Background: The association between behavioural difficulties and academic attainment is well established. Recent policy has promoted the early identification of behavioural difficulties, which has been a particular focus for policy advising schools on managing behaviour. There is also increasing research into mHealth interventions to provide support for emotional and behavioural difficulties for young people. Objective: The primary aim of the proposed research is to examine the effectiveness of an mHealth intervention—ReZone—in reducing emotional and behavioural difficulties in young people. Methods: We report the protocol for a cluster trial of eight schools with a total N=60 students with classes randomized to ReZone or management as usual. Results: Multilevel modelling will be used to compare ReZone vs. management as usual accounting for classroom-level variation. Conclusions: The proposed research will provide evidence as to whether or not ReZone is effective at helping young people to self-manage when feeling overwhelmed. Clinical Trial: ISTCRN 13425994

  • Enhancing mHealth technology in the patient centered medical home environment to activate Type 2 diabetes patients: A multi-site feasibility study protocol

    Date Submitted: Nov 20, 2016

    Open Peer Review Period: Nov 21, 2016 - Dec 5, 2016

    Background: The potential of mobile health (mHealth) technologies in the care of patients with diabetes and other chronic conditions has captured the attention of clinicians and researchers. Efforts t...

    Background: The potential of mobile health (mHealth) technologies in the care of patients with diabetes and other chronic conditions has captured the attention of clinicians and researchers. Efforts to date have incorporated a variety of tools and techniques including web-based portals, SMS text messaging, remote collection of biometric data, electronic coaching, electronic-based health education, secure e-mail communication between visits, and electronic collection of lifestyle and quality of life surveys. Each of these tools, used alone or in combination, have demonstrated varying degrees of effectiveness. Some of the more promising results have been demonstrated using regular collection of biometric devices, SMS text messaging, secure e-mail communication with clinical teams, and regular reporting of quality of life variables. In this study, we seek to incorporate several of the most promising mHealth capabilities in a patient centered medical home (PCMH) workflow. Objective: We aim to address underlying technology need and gaps related to the use of mHealth technology and the activation of patients living with Type-2 diabetes. Stated differently, we enable supporting technologies while seeking to influence patient activation and self-care activities. Methods: This is a multi-site phased study, conducted within the Military Health System that includes a user-centered design phase and a PCMH-based feasibility trial. In phase I we will assess both patient and provider preferences regarding the enhancement of the enabling technology capabilities for Type 2 diabetes chronic care management. Phase II research is a single-blinded 12-month feasibility study that incorporates randomization principles. Primary outcome measure is the Patient Activation Measure™ scores. Secondary outcome measures in the study include Summary of Diabetes Self-care Activities Measure scores, clinical measures, co-morbid conditions, health services resource consumption, and technology system usage statistics. Results: Results of the research will be reported when Phase I and Phase II are completed. Conclusions: Expected benefits of this research to the scientific community and health care services include improved understanding of how to leverage mHealth technology to activate patients living with Type 2 diabetes in self-management behaviors. The research will shed light on implementation strategies in integrating mHealth into the clinical workflow of the PCMH setting. Clinical Trial: ClinicalTrials.gov - NCT02949037, Registered October 31, 2016

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