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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:

  • 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

  • Source: Military Health System (LA Shively); Copyright: US Air Force; URL: https://health.mil/News/Articles/2016/10/13/Army-Medicine-fights-cancer-with-advanced-treatments; License: Public Domain (CC0).
    RCTs - Protocols/Proposals (non-eHealth)

    Oct 1, 2018

    Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer: Protocol for a European Multicenter Prospective Cohort Study (MEDIRAD EARLY...

    Authors List:

    Abstract:

    Background: Breast cancer is the most common cancer among women, and radiotherapy plays a major role in its treatment. However, breast cancer radiotherapy can lead to incidental irradiation of the heart, resulting in an increased risk for a variety of heart diseases arising many years after radiotherapy. Therefore, identifying breast cancer patients at the highest risk for radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention, which may contribute to healthy aging. There is still a need for precise knowledge on the relationship between radiation dose to specific cardiac structures and early subclinical cardiac changes and their occurrence over time that could finally lead to cardiac complications. Objective: The MEDIRAD EARLY HEART study aims to identify and validate new cardiac imaging and circulating biomarkers of radiation-induced cardiovascular changes arising within first 2 years of breast cancer radiotherapy and to develop risk models integrating these biomarkers combined with precise dose metrics of cardiac structures based on three-dimensional dosimetry. Methods: The EARLY HEART study is a multicenter, prospective cohort study in which 250 women treated for breast cancer and followed for 2 years after radiotherapy will be included. Women treated with radiotherapy without chemotherapy for a unilateral breast cancer and aged 40-75 years meet the inclusion criteria. Baseline and follow-up data include cardiac measurements based on two-dimensional speckle-tracking echocardiography, computed tomography coronary angiography, cardiac magnetic resonance imaging, and a wide panel of circulating biomarkers of cardiac injury. The absorbed dose will be evaluated globally for the heart and different substructures. Furthermore, the dose-response relationship will allow modeling the radiation-induced occurrence and evolution of subclinical cardiac lesions and biomarkers to develop prediction models. Results: This study details the protocol of the MEDIRAD EARLY HEART study and presents the main limits and advantages of this international project. The inclusion of patients began in 2017. Preliminary results are expected to be published in 2019, and complete analysis should be published in 2021. Conclusions: The MEDIRAD EARLY HEART study will allow identifying the main cardiac imaging and blood-based determinants of radiation-induced cardiac injuries to better propose primary and secondary preventive measures in order to contribute to enhanced patient care and quality of life. Trial Registration: ClinicalTrials.gov NCT03297346; https://clinicaltrials.gov/ct2/show/NCT03297346 (Archived by WebCite at http://www.webcitation.org/72KS7MIUU) Registered Report Identifier: RR1-10.2196/9906

  • Woman in front of computer using social media. Source: Pixnio; Copyright: Walton LaVonda; URL: https://pixnio.com/people/female-women/girl-with-computer-emerging-technologies-social-media; License: Public Domain (CC0).
    NIH funded proposals with peer-review...

    Sep 25, 2018

    Monitoring Twitter Conversations for Targeted Recruitment in Cancer Trials in Los Angeles County: Protocol for a Mixed-Methods Pilot Study

    Authors List:

    Abstract:

    Background: Insufficient recruitment of participants remains a critical roadblock to successful clinical research, particularly clinical trials. Social media provide new ways for connecting potential participants with research opportunities. Researchers suggest that the social network Twitter may serve as a rich avenue for exploring how patients communicate about their health issues and increasing enrollment in cancer clinical trials. However, there is a lack of evidence that Twitter offers practical utility and impact. Objective: This pilot study aimed to examine the feasibility and impact of using Twitter monitoring data (ie, user activity and their conversations about cancer-related conditions and concerns expressed by Twitter users in Los Angeles County) as a tool for enhancing clinical trial recruitment at a comprehensive cancer center. Methods: We will conduct a mixed-methods interrupted time series study design with a before-and-after social media recruitment intervention. On the basis of a preliminary analysis of eligible trials, we plan to onboard at least 84 clinical trials across 6 disease categories: breast cancer, colon cancer, kidney cancer, lymphoma, non-small cell lung cancer, and prostate cancer that are open to accrual at the University of Southern California (USC) Norris Comprehensive Cancer Center. We will monitor messages about these 6 cancer conditions posted by Twitter users in Los Angeles County. Recruitment for the trials will occur through the Twitter account (@USCTrials). Primary study outcomes—feasibility and acceptance of the social media intervention among targeted Twitter users and the study teams of the onboarded trials—will be assessed using qualitative interviews and the 4-point Likert scale and by calculating the proportion of targeted Twitter users who engaged with outreach messages. Second, impact of the social media intervention will be measured by calculating the proportion of enrollees in trials. The enrollment rate will be compared between the active intervention period and the prior 10 months as historical control for each disease trial group. This study has been funded by the National Center for Advancing Translational Science through a Clinical and Translational Science Award. Study approval was obtained from the clinical investigations committee at USC Norris and the institutional review board at USC. Results: Recruitment on Twitter started in February 2018. Data collection will be completed in November 2018. Conclusions: This pilot project will provide preliminary data and practical insight into the application of publicly available Twitter data to identify and recruit clinical trial participants across 6 cancer disease types. We will shed light on the acceptance of the social media intervention among Twitter users and study team members of the onboarded trials. If successful, the findings will inform a multisite randomized controlled trial to determine the efficacy of the social media intervention across different locations and populations. Trial Registration: ClinicalTrials.gov NCT03408561; https://clinicaltrials.gov/ct2/show/NCT03408561 (Archived by WebCite at http://www.webcitation.org/72LihauzW) Registered Report Identifier: RR1-10.2196/9762

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  • 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.

  • Feasibility Of A Prospective Longitudinal Mechanistic Clinical Trial Aiming To Examine The Effects Of Gastric Bypass Surgery On Intestinal Metabolism

    Date Submitted: Oct 10, 2018

    Open Peer Review Period: Oct 14, 2018 - Oct 19, 2018

    Background: Current evidence shows that bariatric surgery and especially Roux-en-Y Gastric Bypass (RYGB) is the best treatment for obesity and its complications including type 2 diabetes (T2DM). Under...

    Background: Current evidence shows that bariatric surgery and especially Roux-en-Y Gastric Bypass (RYGB) is the best treatment for obesity and its complications including type 2 diabetes (T2DM). Understanding the specific mechanisms responsible for the beneficial metabolic effects will help to engineer ways to improve the procedure or produce these effects without surgery. Objective: The focus of this report is a translational study, designed to test a hypothesis for the mechanisms underlying the improvement in T2DM following gastric bypass that involves specific changes in the post-surgical, short- and long-term metabolism and morphology of the jejunum (Roux limb). Specifically to test whether the intestine enhances its metabolism and activity after gastric bypass and increases its fuel utilization, we designed a prospective, longitudinal study, which involved the recruitment of bariatric bypass surgery candidates with and without T2DM. We describe the tissue bank that we have generated and we discuss in detail our experience, hoping to further facilitate the performance of longitudinal mechanistic studies in human patients undergoing bariatric surgery and especially those involving methods examining the post-bypass intestinal biology. Methods: We designed and conducted a clinical trial (clinicaltrials.gov ID NCT02710370) aiming to characterize the effects of RYGB on intestinal metabolism. Intestinal tissue samples were collected from the jejunum at surgery, 1, 6, and 12 months post operatively for analysis of intestinal gene expression, metabolomic and morphologic changes. The target number of patients with completed at least the 6-month follow up was 26 and we included a 20% attrition rate increasing the total number to 32. Results: To enroll 26 patients, we had to approach 79 potential participants. 37 agreed to participate and started the study. 33 active participants completed their 1 month, 30 their 6 month and 26 their 12 month studies. Three participants withdrew and 30 participants are still active. Altruism and interest in research were the most common reasons for participation. Important factors for feasibility and successful retention included: 1) large volume case flow, 2) inclusion and exclusion criteria broad enough to capture a large segment of the patient population, but narrow enough to ensure completing study aims and protecting safety concerns, 3) accurate assessment of willingness and motivation to participate in a study, 4) seamless integration of the recruitment process into normal clinical flow, 5) financial reimbursement and non-financial rewards and gestures of appreciation and 6) non-burdensome follow-up visits and measures and reasonable time allotted. Conclusions: Human translational studies of the intestinal mechanisms of metabolic and weight change after bariatric surgery are both important and feasible. A tissue bank with unique samples has been established that could be used by investigators in many research fields further enabling mechanistic studies on the effects of bariatric surgery. Clinical Trial: Clinicaltrials.gov ID NCT02710370

  • 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.

  • Randomised controlled trial evaluating the effectiveness of a self-regulation-based eHealth intervention targeting an active lifestyle in adults with type 2 diabetes: study protocol

    Date Submitted: Oct 4, 2018

    Open Peer Review Period: Oct 6, 2018 - Oct 20, 2018

    Background Adopting an active lifestyle plays an important role in the management of type 2 diabetes. Online interventions targeting lifestyle changes in adults with type 2 diabetes render mixed resu...

    Background Adopting an active lifestyle plays an important role in the management of type 2 diabetes. Online interventions targeting lifestyle changes in adults with type 2 diabetes render mixed results. Previous research highlights the importance of creating theory-based interventions adapted to the population’s specific needs. The online intervention ‘MyPlan 2.0’ targets physical activity and sedentary behaviour in adults with type 2 diabetes. ‘MyPlan 2.0’ is grounded in self-regulation theory and, by incorporating the feedback of users with type 2 diabetes, iteratively adapted to its target population. Objective The goal of this paper is to thoroughly describe ‘MyPlan 2.0’ and the study protocol that will be used to test the effectiveness of this intervention to alter patients’ levels of physical activity and sedentary behaviour. Methods A superiority two-arm randomized controlled trial will be performed. Physical activity and sedentary behaviour will be measured via accelerometers and questionnaires. Furthermore, via questionnaires and diaries patients’ stressors and personal determinants for change will be explored in-depth. To evaluate the primary outcomes of the intervention multilevel analyses will be conducted. Conclusions This study will increase our understanding about whether and how a theory-based online intervention can help adults with type 2 diabetes to increase their level of physical activity and decrease their sedentary time.

  • Explore Short Message Service (SMS) to Assess Depression and Related Conditions in Low-Income, Ethnically Diverse Patients with Diabetes: Design of a Randomized Study

    Date Submitted: Oct 2, 2018

    Open Peer Review Period: Oct 6, 2018 - Oct 20, 2018

    Background: Depression is an often under-diagnosed and therefore untreated comorbidity for low-income, racially or ethnically diverse patients with a chronic illness such as diabetes. Recent update of...

    Background: Depression is an often under-diagnosed and therefore untreated comorbidity for low-income, racially or ethnically diverse patients with a chronic illness such as diabetes. Recent update of the U.S. Preventive Services Task Force guideline in 2016 recommends assessing depression for every adult. Short Message Service (SMS) is an inexpensive, private, and scalable approach to provide depression screening and monitoring, and it can alleviate many barriers such as transportation, childcare, and clinical visit time faced by low-income population to receive depression diagnosis. Current evidence is inconsistent in comparing technology-mediated assessment vs. interviewer (INTW) assessment in collecting sensitive health information, as some studies suggest technology encourages self-disclosure while the other studies show the opposite effect. Objective: The proposed study will test using SMS to assess depression and its related conditions, including functional disability, pain, and anxiety, in low-income, culturally diverse safety-net primary care populations with diabetes. The study will examine the concordance between SMS and INTW assessments and evaluate test-retest reliability. Methods: The proposed study is a randomized trial with 200 patients with four study groups: SMS/INTW, INTW/SMS, SMS/SMS, INTW/INTW. The first two groups will be used to examine the concordance between SMS and INTW assessments. The third and fourth groups will be used to evaluate test-retest reliability. Participants of the study will be recruited from the participants of the prior Diabetes-depression Care-management Trial, a large comparative effectiveness research in collaboration with the Los Angeles County Department of Health Services (LAC-DHS). Concordance between SMS and INTW assessments will be evaluated by interclass correlation coefficient and Kappa statistic. Test-retest reliability will be measured by Cronbach’s alpha. Missing data patterns will be explored to understand whether participants are willing to self-disclose such information in SMS assessment. Results: Recruitment of participants was conducted from June, 2017 to November, 2017. A total of 206 participants were enrolled: 52 in SMS/INTW, 53 in SMS/SMS, 49 in INTW/SMS, 52 in INTW/INTW. Average age of the participants was 57.1. 57.8% (119/206) were female. 93.2% (192/206) were Latinos. And, 77.7% (160/206) chose Spanish as their preferred language. Test of the SMS assessment shows the cost of distributing the 16 questions is about $0.50 per person per time. Full results of the study will be reported elsewhere. Conclusions: The study is anticipated to establish feasibility of using SMS to assess depression and its related conditions in low-income, culturally diverse safety-net primary care populations with diabetes. We also expect to generate knowledge about whether patients in the targeted population are willing to reply and self-disclose the sensitive information about depression and its related conditions through SMS assessments.

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