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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed-indexed journal, publishing 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 journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (JMIR Impact Factor 2017: 4.671).

While the original focus was on eHealth studies, JMIR Res Protoc now 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.

JRP is compatible with the concept of "Registered Reports" and since May 2018, published protocols receive a Registered Report Identifier (What is a Registered Report Identifier?) and acceptance of the subsequent results paper is "in principle" guaranteed in any JMIR journal and partner journals - see What is a Registered Report?. 

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 provides a "dry-run" for peer-review of the final results paper, and allows feedback/critique of the methods, often while they still can be fixed.

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).

JMIR Res Protoc is also a unique crowdfunding platform, allowing backers to crowdfund carefully peer-reviewed projects that are not junk-science, and giving researchers additional small funding to conduct and publish their research results. Each article is published with a crowdfunding widget, allowing readers to make nominal donations to the project, which benefit the authors (currently in beta).

Need more reasons? Read the Knowledge Base article on "Why should I publish my protocol/grant proposal"!

 
 

Recent Articles:

  • Source: Flickr; Copyright: Daniel Soñé Photography, LLC; URL: https://www.flickr.com/photos/64860478@N05/38709125891/; License: Creative Commons Attribution (CC-BY).
    Non-Randomized Study Protocols and...

    Oct 19, 2018

    The Clinical and Cost-Effectiveness of 4 Enzyme-Linked Immunosorbent Assay Kits for Monitoring Infliximab in Crohn Disease Patients: Protocol for a...

    Authors List:

    Abstract:

    Background: Currently, treatment decisions for people with Crohn disease are based on clinical judgment and trial and error. Consequently, people may continue to receive high drug dosages and experience unnecessary toxicity when it is possible to reduce or discontinue without a detrimental effect on clinical outcomes. Therapeutic drug monitoring (TDM) involves regularly testing blood samples for drug and antibody levels that could help clinicians identify the optimal treatment strategy and pre-empt treatment failure. However, heterogeneity in the assays can lead to a discrepancy in results and difficulties in decision-making. Standardization of the kits, and therefore results, would allow clinicians to optimize the use of biologics. Currently, there is also a lack of evidence for the cost-effectiveness of TDM using commercial test kits. Objective: This study aims to analyze the clinical and cost-effectiveness of 4 commercial enzyme-linked immunosorbent assay (ELISA) kits (LISA TRACKER, IDKmonitor, Promonitor, and RIDASCREEN) to generate evidence which could support a recommendation for wider adoption in the National Health Service. Methods: We propose to carry out a prospective-retrospective predictive biomarker validation study using the blood samples and clinical/utilization data collected during the ongoing SPARE trial (NCT02177071). A total of 200 stored samples from people with Crohn's disease who respond to treatment with infliximab will be used along with clinical and cost data from the trial. We will investigate the relationship between the drug and antidrug antibody levels with the main clinical outcomes (relapse rate at 2 years and time spent in remission), as well as resource utilization and quality of life. Results: Funding is being sought to conduct this research. Conclusions: This is the first study to compare the 4 ELISA kits for monitoring infliximab in patients with Crohn disease. It aims to address the uncertainties in the potential benefits of using the technologies for TDM. International Registered Report Identifier (IRRID): PRR1-10.2196/11218

  • A community health worker teaches a study patient how to use the phone app used in the study. Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/10/e11083; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (funded,...

    Oct 19, 2018

    Hispanic Secondary Stroke Prevention Initiative Design: Study Protocol and Rationale for a Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: Hispanic-Latino populations face a disproportionate stroke burden and are less likely to have sufficient control over stroke risk factors in comparison with other ethnic populations. A promising approach to improving chronic health outcomes has been the use of community health workers (CHWs). Objective: The objective of this randomized controlled trial is to evaluate the effectiveness of a CHW intervention among Latino patients at risk of recurrent stroke. Methods: The Hispanic Secondary Stroke Prevention Initiative (HiSSPI) is a randomized clinical trial of 300 Latino participants from South Florida who have experienced a stroke within the last 5 years. Participants randomized into the CHW intervention arm receive health education and assistance with health care navigation and social services through home visits and phone calls. The intervention also includes a mHealth component in which participants also receive daily text messages (short message service). The primary outcome is change in systolic blood pressure at 12 months. Other secondary outcomes include changes in low-density lipoprotein, glycated hemoglobin, and medication adherence. Results: Study enrollment began in 2015 and will be completed by the end of 2018. The first results are expected to be submitted for publication in 2020. Conclusions: HiSSPI is one of the first randomized controlled trials to examine CHW-facilitated stroke prevention and will provide rigorous evidence on the impact of CHWs on secondary stroke risk factors among Latino individuals who have had a stroke. Trial Registration: ClinicalTrials.gov NCT02251834; https://clinicaltrials.gov/ct2/show/NCT02251834 (Archived by WebCite at http://www.webcitation.org/72DgMqftq) International Registered Report Identifier (IRRID): RR1-10.2196/11083

  • A participant performing a videoconference with the research team while doing in-home transcranial direct current stimulation. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/10/e10848/; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (funded,...

    Oct 18, 2018

    Connectivity as a Predictor of Responsiveness to Transcranial Direct Current Stimulation in People with Stroke: Protocol for a Double-Blind Randomized...

    Authors List:

    Abstract:

    Background: Stroke can have devastating consequences for an individual’s quality of life. Interventions capable of enhancing response to therapy would be highly valuable to the field of neurological rehabilitation. One approach is to use noninvasive brain stimulation techniques, such as transcranial direct current stimulation, to induce a neuroplastic response. When delivered in combination with rehabilitation exercises, there is some evidence that transcranial direct current stimulation is beneficial. However, responses to stimulation are highly variable. Therefore biomarkers predictive of response to stimulation would be valuable to help select appropriate people for this potentially beneficial treatment. Objective: The objective of this study is to investigate connectivity of the stimulation target, the ipsilesional motor cortex, as a biomarker predictive of response to anodal transcranial direct current stimulation in people with stroke. Methods: This study is a double blind, randomized controlled trial (RCT), with two parallel groups. A total of 68 participants with first ever ischemic stroke with motor impairment will undertake a two week (14 session) treatment for upper limb function (Graded Repetitive Arm Supplementary Program; GRASP). Participants will be randomized 2:1 to active:sham treatment groups. Those in the active treatment group will receive anodal transcranial direct current stimulation to the ipsilesional motor cortex at the start of each GRASP session. Those allocated to the sham treatment group will receive sham transcranial direct current stimulation. Behavioural assessments of upper limb function will be performed at baseline, post treatment, 1 month follow-up and 3 months follow-up. Neurophysiological assessments will include magnetic resonance imaging (MRI), electroencephalography (EEG) and transcranial magnetic stimulation (TMS) and will be performed at baseline, post treatment, 1 month follow-up (EEG and TMS only) and 3 months follow-up (EEG and TMS only). Results: Participants will be recruited between March 2018 and December 2018, with experimental testing concluding in March 2019. Conclusions: Identifying a biomarker predictive of response to transcranial direct current stimulation would greatly assist clinical utility of this novel treatment approach. Trial Registration: Australia New Zealand Clinical Trials Registry ACTRN12618000443291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000443291 (Archived by WebCite at http://www.webcitation.org/737QOXXxt) Registered Report Identifier: RR1-10.2196/10848

  • The MATCH study logo. Source: Image created by the Authors; Copyright: The Authors; URL: https://www.researchprotocols.org/2018/10/e10826/; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (eHealth)

    Oct 18, 2018

    Varenicline and Bupropion for Long-Term Smoking Cessation (the MATCH Study): Protocol for a Real-World, Pragmatic, Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: Varenicline and bupropion are efficacious, prescription-only pharmacotherapies for smoking cessation; however, their real-world impact is limited by prescriber knowledge, affordability, and accessibility. Objective: The primary objective of the MATCH (Medication Aids for Tobacco Cessation Health) study was to evaluate the real-world, long-term effectiveness of mailed bupropion and varenicline in a sample of interested smokers with the utilization of Web-based recruitment and follow-up. In addition, the study aims to investigate the genotypic and phenotypic predictors of cessation. Methods: This is a two-group, parallel block, randomized (1:1) open-label clinical trial. This study will be conducted online with the baseline enrollment through the study’s website and follow-up by emails. In addition, medication prescriptions will be filled by the study contract pharmacy and couriered to participants. Individuals who smoke ≥10 cigarettes per day and intend to quit within the next 30 days will be recruited through Public Health Units and Tobacco Control Area Networks throughout Ontario by word-of-mouth and the internet. Eligible participants will receive an email with a prescription for 12-week assigned medication and a letter to take to their physician. The recruitment and randomization will continue until 500 participants per arm have received medication. All participants will receive weekly motivational emails during the treatment phase. The primary outcome measure is the smoking status after 6 months, biochemically confirmed by mailed-in salivary cotinine. Follow-ups will be conducted through emails after 4, 8, 12, 26, and 52 weeks of starting the treatment to assess the smoking prevalence and continuous smoking abstinence. In addition, mailed-in saliva samples will be used for genetic and nicotine metabolism analyses. Furthermore, personality characteristics will be assessed using the Big Five Aspect Scales. Results: The project was funded in 2014 and enrollment was completed in January 2017. Data analysis is currently underway. Conclusions: To the best of our knowledge, this is the first randomized controlled trial to mass distribute prescription medications for smoking cessation. We expect this method to be logistically feasible and cost effective with quit outcomes that are comparable to published clinical trials. Trial Registration: ClinicalTrials.gov NCT02146911; https://clinicaltrials.gov/ct2/show/NCT02146911 (Archived by WebCite at http://www.webcitation.org/72CZ6AvXZ) Registered Report Identifier: RR1-10.2196/10826

  • Electronically signed informed consent document (montage). Source: The Authors / Placeit.net; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/10/e11239/; License: Creative Commons Attribution (CC-BY).
    Grant Proposals (eHealth, funded)

    Oct 17, 2018

    Facilitating the Informed Consent Process Using Teleconsent: Protocol for a Feasibility and Efficacy Study

    Authors List:

    Abstract:

    Background: Informed consent is among the biggest challenges in recruiting participants for clinical research studies. Researchers face many challenges in conducting clinical trials, some of which include budgetary restrictions, lack of trained personnel, and difficulty recruiting study participants—particularly minorities and participants from rural communities. Objective: The objective of this study is to utilize telemedicine to improve the informed consent process for clinical trials and studies. We aim to assess the feasibility and efficacy of the teleconsent intervention among residents in urban and rural settings. Methods: This study will be conducted separately yet concurrently at two institutions, the Medical University of South Carolina and the University of North Carolina at Chapel Hill, to compare results within and across institutions. Results: Enrollment for Phase 1 began in March of 2018 and concluded in May 2018. Data transcription and analysis will be conducted through June and September of 2018. Conclusions: In this paper, we present a novel approach for conducting informed consent using a new telemedicine modality, namely, teleconsent. Teleconsent presents the ability to conduct a live interaction among clinical research coordinators and potential participants while synchronously presenting the consent form on the screen and obtaining participant’s signature through doxy.me, the teleconsent system. Teleconsent provides potential to improve obtaining informed consent from potential clinical trial participants. Registered Report Identifier: RR1-10.2196/11239

  • Gamified attention bias modification task. Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/10/e10154; License: Licensed by JMIR.
    Systematic Review Protocols

    Oct 16, 2018

    Gamified Cognitive Bias Interventions for Psychiatric Disorders: Protocol of a Systematic Review

    Authors List:

    Abstract:

    Background: Cognitive bias modification has been increasingly studied in the past decade with reviews reporting the effectiveness of bias modification. Advances in electronic health and mobile health technologies have transformed how conventional cognitive bias modification is delivered. To date, gamification technologies and serious games have been widely evaluated in health care, and prior studies have reported the use of gamification for cognitive bias modification. However, no prior research, to date, has systematically evaluated the literature for gamified cognitive bias modification interventions. Objective: The proposed systematic review aims to review how gamification has been applied to cognitive bias modification interventions. Methods: A systematic review will be conducted. A search will be conducted on the respective databases till 2018. Selection of the studies will be determined by the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. Quality assessment of the included studies will be assessed using the Cochrane Risk of Bias Tool. In addition, a narrative synthesis will be conducted. Results: We expect that the review will be completed 12 months from the publication of this protocol. Conclusions: The findings that arise from this review will be crucial as they will inform future research that seeks to integrate gamification technologies into existing conventional bias modification interventions. Registered Report Identifier: RR1-10.2196/10154

  • Physician examining the electrocardiogram of a patient with atrial fibrillation (montage). Source: Wikimedia Commons / Placeit.net; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/10/e181/; License: Creative Commons Attribution + ShareAlike (CC-BY-SA).
    Non-randomized Protocols and Methods...

    Oct 15, 2018

    Design and Rationale of the National Tunisian Registry of Atrial Fibrillation: Protocol for a Prospective, Multicenter Trial

    Authors List:

    Abstract:

    Background: Atrial fibrillation (AF) is an important health problem in Tunisia. A significant change in the epidemiological pattern of heart disease has been seen in the last 3 decades; however, no large prospective multicenter trial reflecting national data has been published so far. Robust data on the contemporary epidemiological profile and management of AF patients in Tunisia are limited. Objective: The aim of this study is to analyze, follow, and evaluate patients with AF in a large multicenter nationwide trial. Methods: A total of 1800 consecutive patients with AF by electrocardiogram, reflecting all populations of all geographical regions of Tunisia, will be included in the study, with the objective of describing the epidemiological pattern of AF. Patients will be officially enrolled in the National Tunisian Registry of Atrial Fibrillation (NATURE-AF) only if an electrocardiogram diagnosis (12-lead, 24-hour Holter, or other electrocardiographic documentation) confirming AF is made. The qualifying episode of AF should have occurred within the last year, and patients do not need to be in AF at the time of enrollment. Patients will be followed for 1 year. Incidence of stroke or transient ischemic attack, thromboembolic events, and cardiovascular death will be recorded as the primary end point, and hemorrhagic accidents, measurement of international normalized ratio, and time in therapeutic range will be recorded as secondary end points. Results: Results will be available at the end of the study; the demographic profile and general risk profile of Tunisian AF patients, frequency of anticoagulation, frequency of effective treatment, and risks of thromboembolism and bleeding will be evaluated according to the current guidelines. Major adverse events will be determined. NATURE-AF will be the largest registry for North African AF patients. Conclusions: This study would add data and provide a valuable opportunity for real-world clinical epidemiology in North African AF patients with insights into the uptake of contemporary AF management in this developing region. Trial Registration: ClinicalTrials.gov NCT03085576; https://clinicaltrials.gov/ct2/show/NCT03085576 (Archived by WebCite at http://www.webcitation.org/6zN2DN2QX) Registered Report Identifier: RR1-10.2196/8523

  • A text message from project Debunk. Source: Image created by the authors.; Copyright: The Authors; License: Creative Commons Attribution + Noncommercial + ShareAlike (CC-BY-NC-SA).
    RCTs - Protocols/Proposals (funded,...

    Oct 15, 2018

    Mobile Phone Text Messaging for Tobacco Risk Communication Among Young Adult Community College Students: Protocol and Baseline Overview for a Randomized...

    Authors List:

    Abstract:

    Background: Community-college students are at high risk for tobacco use. Because the use of mobile phone text messaging is nearly ubiquitous today, short message service (SMS) may be an effective strategy for tobacco risk communication in this population. Little is known, however, concerning the message structure significantly influencing perceived tobacco risk. Objective: We aim to outline the rationale and design of Project Debunk, a randomized trial comparing the effects of different SMS text message structures. Methods: We conducted a 6-month randomized trial comparing 8 arms, based on the combination of the 3 message structures delivered to young adults in a 2×2×2 study design: framing (gain-framed or loss-framed), depth (simple or complex), and appeal (emotional or rational). Participants were invited to participate from 3 community colleges in Houston from September 2016 to July 2017. Participants were randomized to 1 arm and received text messages in 2 separate campaigns. Each campaign consisted of 2 text messages per day for 30 days. Perceived tobacco risk was assessed at baseline, 2 months after the first campaign, and 2 months after the second campaign. We assessed the perceived risk of using conventional products (eg, combustible cigarettes) and new and emerging products (eg, electronic cigarettes). The validity of message structures was assessed weekly for each campaign. A 1-week follow-up assessment was also conducted to understand immediate reactions from participants. Results: We completed data collection for the baseline survey on a rolling basis during this time and assessed the validity of the message structure after 1 week of SMS text messages. For the entire sample (N=636), the average age was 20.92 years (SD 2.52), about two-thirds were male (430/636, 67.6%), and most were black or African American (259/636, 40.7%) or white (236/636, 37.1%). After 1 week of receiving text messages, the following was noted: (a) loss-framed messages were more likely to be perceived as presenting a loss than gain-framed messages (F7,522=13.13, P<.001), (b) complex messages were perceived to be more complex than simple messages (F7,520=2.04, P=.05), and (c) emotional messages were perceived to be more emotionally involving than rational messages (F7,520=6.46, P<.001). Conclusions: This study confirms that the recruitment, randomization, and message composition have been successfully implemented. Further analyses will identify specific types of messages that are more effective than others in increasing the perceived risk of tobacco use. If our results suggest that any of the 8 specific message structures are more effective for helping young adults understand tobacco risk, this would provide evidence to include such messages as part of a larger technology-based campaign such as mobile phone apps, entertainment-based campaigns, and social media. Trial Registration: ClinicalTrials.gov NCT03457480; https://clinicaltrials.gov/ct2/show/NCT03457480 (Archived by WebCite at http://www.webcitation.org/6ykd4IIap) Registered Report Identifier: RR1-10.2196/10977

  • Circles of care. Source: New Health Foundation; Copyright: New Health Foundation; URL: https://drive.google.com/open?id=17gakmGAnLgKGIBE_TUbKnn3Zhj6Rn1Bg; License: Licensed by the authors.
    Non-Randomized Study Protocols and...

    Oct 12, 2018

    Development and Management of Networks of Care at the End of Life (the REDCUIDA Intervention): Protocol for a Nonrandomized Controlled Trial

    Authors List:

    Abstract:

    Background: End-of-life needs can be only partly met by formalized health and palliative care resources. This creates the opportunity for the social support network of family and community to play a crucial role in this stage of life. Compassionate communities can be the missing piece to a complete care model at the end of life. Objective: The main objective of this study is to evaluate the REDCUIDA (Redes de Cuidados or Network of Care) intervention for the development and management of networks of care around people with advanced disease or at the end of life. Methods: The study is a 2-year nonrandomized controlled trial using 2 parallel groups. For the intervention group, we will combine palliative care treatment with a community promoter intervention, compared with a control group without intervention. Participants will be patients under a community palliative care team’s supervision with and without intervention. The community promotor will deliver the intervention in 7 sessions at 2 levels: the patient and family level will identify unmet needs, and the community level will activate resources to develop social networks to satisfy patient and family needs. A sample size of 320 patients per group per 100,000 inhabitants will offer adequate information and will give the study 80% power to detect a 20% increase in unmet needs, decrease families’ burden, improve families’ satisfaction, and decrease the use of health system resources, the primary end point. Results will be based on patients’ baseline and final analysis (after 7 weeks of the intervention). We will carry out descriptive analyses of variables related to patients’ needs and of people involved in the social network. We will analyze pre- and postintervention data for each group, including measures of central tendency, confidence intervals for the 95% average, contingency tables, and a linear regression. For continuous variables, we will use Student t test to compare independent samples with normal distribution and Mann-Whitney U test for nonnormal distributions. For discrete variables, we will use Mann-Whitney U test. For dichotomous variables we will use Pearson chi-square test. All tests will be carried out with a significance level alpha=.05. Results: Ethical approval for this study was given by the Clinical Research Committee of Andalusian Health Service, Spain (CI 1020-N-17), in June 2018. The community promoter has been identified, received an expert community-based palliative care course, and will start making contacts in the community and the palliative care teams involved in the research project. Conclusions: The results of this study will provide evidence of the benefit of the REDCUIDA protocol on the development and assessment of networks of compassionate communities at the end of life. It will provide information about clinical and emotional improvements, satisfaction, proxy burden, and health care resource consumption regarding patients in palliative care. Registered Report Identifier: RR1-10.2196/10515

  • BaroTest kit. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/10/e180/; License: Creative Commons Attribution (CC-BY).
    Non-Randomized Study Protocols and...

    Oct 12, 2018

    Innovative Approach for Enhancing Testing of HIV, Hepatitis B, and Hepatitis C in the General Population: Protocol for an Acceptability and Feasibility Study...

    Authors List:

    Abstract:

    Background: Despite substantial screening for HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) infections in France, a great number of infected persons remain undiagnosed. In this context, Santé publique France experimented with a new screening approach for HBV, HCV, and HIV infection, based on home self-sampling using dried blood spot (DBS) for blood collection. Objective: The objectives of the BaroTest study were to assess the acceptability and feasibility of this approach and to update the prevalence estimates of HBV, HCV, and HIV infections in the general population. Methods: Participants were enrolled using the 2016 Health Barometer, a national cross-sectional telephone survey based on a large representative sample of the general population aged 15 to 75 years (N=15,000). Upon completion of the questionnaire, any participant in the Health Barometer aged 18 to 75 years, having medical health insurance, and not under guardianship was invited to receive a self-sampling kit delivered by standard postal mail and to return the DBS card to the laboratory. The laboratory was then responsible for reporting the results to the participants. Acceptability of the protocol was based on the percentage of eligible individuals agreeing to receive the self-sampling kit, on the proportion of people returning the DBS card, and on the proportion of participants out of the total eligible population. The feasibility of the approach was based on the number of participants with adequately filled blood spots and the number of participants with blood spots for which at least one virological analysis could be performed. A complex system of reminders was implemented to increase the participation rate. Accordingly, we assumed that 35.00% (4900/14,000) of eligible persons would accept and return their DBS card. As the highest expected prevalence was for HBV infection, estimated at 0.65% in 2004, 5000 persons would make it possible to estimate this prevalence with an accuracy of approximately 0.22%. All indicators can be analyzed according to the characteristics of the participants collected in the Health Barometer questionnaire. BaroTest was approved by the French Ethics Committee (November 11, 2015) and the Commission on Information Technology and Liberties (December 24, 2015). The study has been registered by the French medical authority under number 2015-A01252-47 on November 10, 2015. Results: The results on acceptability and feasibility are expected in the last quarter of 2018 and those on the prevalence estimates in the first semester of 2019. Conclusions: The BaroTest results will help to inform new strategies for HIV, HBV, and HCV screening, and the Health Barometer provides a reliable updated assessment of the burden of HBV, HCV, and HIV infections in the general population in France while reducing the costs typically associated with this type of research. Registered Report Identifier: RR1-10.2196/9797

  • GeMRC logo. Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/10/e179; License: Licensed by JMIR.
    Proposals (eHealth)

    Oct 9, 2018

    Using Social Media and Web-Based Networking in Collaborative Research: Protocol for the Geriatric Medicine Research Collaborative

    Authors List:

    Abstract:

    Background: Traditional pathways to promote research collaboration typically take years to expand beyond individual institutions. Social media and online networking provide an innovative approach to promote research collaboration. Objective: The objective of this paper is to present the formation of the Geriatric Medicine Research Collaborative, United Kingdom — a national trainee-led research collaborative. This collaborative aims to facilitate research projects that will directly benefit older patients, improve research skills of geriatric medicine trainees, and facilitate recommendations for health care policy for older adults. Methods: Our methods of collaboration comprised trainee-led meetings regionally and at national conferences, email communication, direct uploading of project material to our website, social media, and virtual meetings. Structured use of local, regional, and network leads has facilitated this collaboration. Having a clear virtual presence has been the key to the rapid development of the network. Results: The use of social media and online networking encouraged the involvement of multiple regions early in the development of the collaborative and allowed rapid dissemination of project ideas. This facilitated the collection of large datasets and enhanced scientific validity of project outcomes. Furthermore, this has the potential to transform geriatric medicine research, as older patients have been historically excluded from large commercial trials due to multimorbidity, frailty, and cognitive impairment. Conclusions: Perceived limitations to predominantly online or virtual collaboratives, including reduced accountability, and loss of interpersonal relationships are balanced by increased trainee engagement, high frequency of communication, and rapid access to a breadth of expertise. Utilization of virtual communication has the potential to lead to future interspecialty, interprofessional, and international collaboration, and to accelerate research that improves outcomes for older adults.

  • Female participant holding a phone with sample pMOTAR screen (montage). Source: The Authors / iStock by Getty Images; Copyright: The Authors / iStock by Getty Images; URL: http://www.researchprotocols.org/2018/9/e175/; License: Licensed by the authors.
    RCTs - Protocols/Proposals (eHealth)

    Oct 3, 2018

    Using Mobile Technology (pMOTAR) to Assess Reactogenicity: Protocol for a Pilot Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: Accurate safety monitoring in HIV vaccine trials is vital to eventual licensure and consequent uptake of products. Current practice in preventive vaccine trials, under the HIV Vaccine Trials Network (HVTN), is to capture related side effects in a hardcopy tool. The reconciliation of this tool, 2 weeks after vaccination at the safety visit, is time consuming, laborious, and fraught with error. Unstructured Supplementary Service Data (USSD), commonly used to purchase airtime, has been suggested for collection of safety data in vaccine trials. With saturated access to mobile phones in South Africa, this cheap, accessible tool may improve accuracy and completeness of collected data and prove feasible and acceptable over the hardcopy tool. Objective: The objective of our study is to develop and implement a USSD tool for real-time safety data collection that is feasible and acceptable to participants and staff, allowing for a comparison with the hardcopy tool in terms of completeness and accuracy. Methods: This feasibility study is being conducted at a single study site, the Centre for the AIDS Programme of Research in South Africa eThekwini Clinical Research site, in South Africa. The feasibility study is nested within a parent phase 1/2a preventive HIV vaccine trial (HVTN 108) as an open-label, randomized controlled trial, open to all consenting parent trial participants. Participants are randomly assigned in a 1:1 ratio to the hardcopy or USSD tool, with data collection targeted to the third and fourth injection time points in the parent trial. Online feasibility and acceptability surveys will be completed by staff and participants at the safety visit. We will itemize and compare error rates between the hardcopy tool and the USSD printout and associated source documentation. We hypothesize that the USSD tool will be shown to be feasible and acceptable to staff and participants and to have superior quality and completion rates to the hardcopy tool. Results: The study has received regulatory approval. We have designed and developed the USSD tool to include all the data fields required for reactogenicity reporting. Online feasibility and accessibility surveys in both English and isiZulu have been successfully installed on a tablet. Data collection is complete, but analysis is pending. Conclusions: Several HIV preventive vaccine trials are active in Southern Africa, making tools to improve efficiencies and minimize error necessary. Our results will help to determine whether the USSD tool can be used in future vaccine studies and can eventually be rolled out. Trial Registration: ClincalTrials.gov NCT02915016; https://clinicaltrials.gov/ct2/show/NCT02915016 (Archived by WebCite at http://www.webcitation.org/71h0cztDM) Registered Report Identifier: RR1-10.2196/9396

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    Date Submitted: Oct 17, 2018

    Open Peer Review Period: Oct 20, 2018 - Oct 30, 2018

    Background: Smoking is considered the main cause of preventable illness and premature deaths worldwide. The treatment usually prescribed to subjects who wish to quit smoking is a multidisciplinary int...

    Background: Smoking is considered the main cause of preventable illness and premature deaths worldwide. The treatment usually prescribed to subjects who wish to quit smoking is a multidisciplinary intervention, combining both psychological advice and pharmacological therapy, since the application of both strategies significantly increases the chance of success in a quit attempt. Objective: This paper presents a study protocol of a 12-month randomized open-label parallel-group trial which primary objective is to analyze the efficacy and efficiency of the usual psycho-pharmacological therapy plus Social-Local-Mobile app (intervention group) applied to the smoking cessation process compared to usual psycho-pharmacological therapy (control group). Methods: The target population consist of smokers attending the Smoking Cessation Unit at Virgen del Rocío University Hospital. Social-Local-Mobile is an innovative intervention based on mobile technologies and its capacity to trigger behavioral changes. The App is a complement to pharmacological therapies to quit smoking providing personalised motivational messages, physical activity monitoring, lifestyle advices and distractions (mini-games) to help pass the cravings. Usual pharmacological therapy consists of bupropion (Zyntabac® 150 mg) or varenicline (Champix® 0.5 mg or 1 mg). The main clinical outcome will be the smoking abstinence rate at 1 year measured by means of exhaled carbon monoxide and urinary cotinine tests. The result of cost-effectiveness analysis will be expressed in terms of incremental cost-effectiveness ratio. Secondary objectives are to analyze safety of pharmacological therapy; to analyze health-related quality of life of patients; and to monitor healthy lifestyle and physical exercise habits. Results: We identified 548 patients using the hospital’s electronic records system. From this initial selection, 308 patients were excluded: 188 declined to participate and 120 not meeting the inclusion criteria. A total of 240 patients were enrolled: the control group (n=120) will receive usual psycho-pharmacological therapy, while the intervention group (n=120) will receive usual psycho-pharmacological therapy plus the So-Lo-Mo app. Conclusions: Nowadays, social networks and mobile technologies influence our daily lives and, therefore, may influence our smoking habits as well. As part of the SmokeFreeBrain H2020 European Commission project (GA 681120), this study aims at elucidating the potential role of these technologies when used as an extra aid to quit smoking. Clinical Trial: ClinicalTrials.gov identifier: NCT03553173. Retrospectively registered, 12 June 2018.

  • Understanding the Effect of Adding Automated and Human Coaching to an mHealth Physical Activity App for Afghanistan and Iraq Veterans: Protocol for a Randomized Controlled Trial of the Stay Strong Intervention

    Date Submitted: Oct 17, 2018

    Open Peer Review Period: Oct 19, 2018 - Oct 25, 2018

    Background: While maintaining a healthy weight and physical conditioning are requirements of active military duty, many U.S. veterans rapidly gain weight and lose conditioning when they separate from...

    Background: While maintaining a healthy weight and physical conditioning are requirements of active military duty, many U.S. veterans rapidly gain weight and lose conditioning when they separate from active duty service. Mobile health (mHealth) interventions that incorporate wearables for activity monitoring have become common, but how to optimize engagement over time is unclear. Personalized health coaching, either through tailored automated messaging or by individual health coaches has the potential to increase the efficacy of mHealth programs. In an attempt to preserve conditioning and ward off weight gain we developed Stay Strong, a mobile app tailored to younger veterans that tracks physical activity monitored by Fitbit Charge 2 devices, and weight measured on a Bluetooth enabled scale. Objective: The goal of this study is to determine the effect of activity monitoring plus health coaching, compared to activity monitoring alone. Methods: In this randomized controlled trial, we sought to enroll 350 veterans who received an mHealth lifestyle intervention that combines the use of a wearable physical activity tracker and a Bluetooth enabled weight scale, with Stay Strong, a mobile app designed specifically for younger veterans. The Stay Strong app displays physical activity and weight data trends over time. Enrolled participants are randomized to receive either the Stay Strong app (active comparator arm) or Stay Strong app + Coaching, an enhanced version of the program that adds coaching features (automated tailored messaging with weekly physical activity goal, as well as up to three telephone calls with a health coach) (intervention arm), for one year. Our primary outcome is change at 12 months in physical activity, with weight, pain, patient activation, and depression serving as secondary outcome measures. All processes related to recruitment, eligibility screening, informed consent, HIPAA authorization, baseline assessment, randomization, the bulk of intervention delivery, and outcome assessment will be accomplished via the internet or smartphone app. Results: Study recruitment began in September 2017 and data collection is expected to conclude in 2019. A total of 465 participants consented to participate and 357 (77%) provided baseline levels of physical activity and were randomized to one of the two interventions. Conclusions: This novel randomized control trial will provide much-needed findings about whether the addition of telephone-based human coaching and other automated supportive coaching features will improve physical activity compared to using a smartphone app linked to a wearable device alone. Clinical Trial: Clinicaltrials.gov NCT02360293

  • Impact of Food Preparation Video Exposure on Online WIC Nutrition Education

    Date Submitted: Oct 16, 2018

    Open Peer Review Period: Oct 16, 2018 - Oct 24, 2018

    Background: The impact of integrating video into health education delivery has been extensively investigated, however the effect of integrating video on a learner’s subsequent performance in an onli...

    Background: The impact of integrating video into health education delivery has been extensively investigated, however the effect of integrating video on a learner’s subsequent performance in an online educational setting is much less frequently reported. A lack of findings exists associated with the relationship learner online video viewing has on subsequent progression toward health behavior change in a self-directed online educational session. Objective: Determine relationship of viewing a Health eKitchen (HeK) online video with key engagement performance indicators associated with WIC online nutrition education. Methods: This study involved a retrospective cohort of users with groups defined based on whether HeK exposure occurred before or after completing a nutrition education lesson. A two-sample test for equality of proportions was performed to test the difference in the likelihood of progression between groups overall and stratified by lesson type as defined by whether it was food preparation focused. Welch’s two-sample t-tests were performed to test the difference in average link depth and duration of use between groups overall and stratified by lesson type. Logistic regression was conducted to validate the impact of a video view prior to lesson completion while controlling for lesson type and factors known to be associated with WIC KPIs. Results: Greater stage of change progression was observed for both food-preparation (2=12.6, p=0.0004) and non-food preparation (2=62.8, p<0.0001) lessons among early stage users who had a HeK video view prior to completing a lesson. Time spent viewing educational learning resource links within the lesson was also significantly longer for both food preparation (t=7.8, p<0.0001) and non-food preparation (t=2.5, p=0.0116) lessons when these groups where compared. Logistic regression corroborated these results while controlling for known confounding. Odds of user progression was nearly three times greater among those that viewed a HeK video prior to lesson completion (OR=2.61; 95%CI=2.08,3.29). Type of lesson (food vs. non-food preparation) was the strongest predictor of progression odds (OR=3.12; 95%CI=2.47,3.95). Conclusions: User access of a HeK video prior to completing an online educational session had a significant impact on achieving lesson goals, regardless of food preparation focus. This observation suggests the potential benefit of providing an application-oriented video at the onset of online nutrition education lessons.

  • A randomized controlled pilot study of a sleep self-management intervention in pregnancy using a personalized health-monitoring device: rationale and protocol

    Date Submitted: Oct 10, 2018

    Open Peer Review Period: Oct 12, 2018 - Oct 26, 2018

    BACKGROUND: Sleep disruptions are common during pregnancy, and associated with increased risk for adverse maternal outcomes such as pre-eclampsia, gestational diabetes, prolonged labor, and cesarean b...

    BACKGROUND: Sleep disruptions are common during pregnancy, and associated with increased risk for adverse maternal outcomes such as pre-eclampsia, gestational diabetes, prolonged labor, and cesarean birth. Given the morbidity associated with poor sleep, cost-effective approaches to improving sleep that can be disseminated in community or clinical settings are needed. Personal health monitoring (PHM) devices offer an opportunity to promote behavior change, but their acceptability and efficacy at improving sleep in pregnant women are unknown. OBJECTIVE: To describe the protocol for an ongoing pilot randomized controlled trial that aims to establish the feasibility, acceptability and preliminary efficacy of using a PHM device (Misfit Shine 2) to promote sleep during pregnancy. METHODS: The proposed pilot study is a 12-week, parallel arm, randomized controlled trial. Pregnant women, at 24 weeks gestation, will be randomized at 1:1 ratio into a 12-week sleep education plus PHM device or sleep education alone comparison group. The primary outcomes will be measures of feasibility (i.e., recruitment, enrollment, adherence) and acceptability (i.e., participant satisfaction). The secondary outcomes will be self-reported sleep quality and duration, excessive daytime sleepiness, fatigue, depressive symptoms, and birth outcomes (e.g., delivery methods). DISCUSSION: This study will be the first to apply a PHM device as a tool for promoting self-management of sleep among pregnant women. PHM devices have the potential to facilitate behavioral interventions as they include theory-driven, self-regulatory techniques such as behavioral self-monitoring. The results of the study will inform the development of a sleep health intervention for pregnant women.

  • Using text messaging to promote mental health among university students: Protocol for a Randomized Controlled Trial of a mobile-phone based intervention.

    Date Submitted: Oct 4, 2018

    Open Peer Review Period: Oct 8, 2018 - Oct 22, 2018

    Background: There is a growing understanding that wellbeing and mental illness are two separate dimensions of mental health. Positive mental health is associated with decreased risk of disease and men...

    Background: There is a growing understanding that wellbeing and mental illness are two separate dimensions of mental health. Positive mental health is associated with decreased risk of disease and mental illness and increased longevity. Objective: This randomized controlled trial aims to test the efficacy of a mobile phone based intervention on positive mental health. Methods: Two-armed randomized controlled trial of university students in Sweden. Recruitment will last for 6 months by digital advertising (e.g. university websites). Participants will be randomly allocated to either an intervention (fully automated mobile-phone based mental health intervention) or control group (treatment as usual). The Primary outcome will be self-assessed positive mental health (Mental Health Continuum Short Form, MHC-SF). Secondary outcomes will be self-assessed depression anxiety symptomatology (Hospital Anxiety Depression Scale), emotional well-being, psychological functioning and social well-being (MHC-SF). Outcomes will be investigated at baseline, at 3- 6- and 12 months follow-up. Mediators (positive emotions and cognitions) will be investigated at baseline, mid-intervention and at 3 months follow-up using two single face-valid items. Results: Recruitment of participants will begin in mid-October 2018. Discussion: This study will add knowledge to the efficacy of a fully automated positive psychology intervention. Strengths and limitations of the study are discussed.

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