The Karma system is currently undergoing maintenance (Monday, January 29, 2018).
The maintenance period has been extended to 8PM EST.

Karma Credits will not be available for redeeming during maintenance.
Advertisement

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: Pixabay; Copyright: rawpixel; URL: https://pixabay.com/en/document-paper-office-composition-3271743/; License: Public Domain (CC0).

    A Patient Registry for the Management of Uterine Fibroids in Canada: Protocol for a Multicenter, Prospective, Noninterventional Study

    Abstract:

    Background: Uterine fibroids are the most common benign tumor in women. Among those with fibroids, approximately 30% become symptomatic, with abnormal uterine bleeding, pelvic pain, and bulk symptoms. Despite the high prevalence of fibroids, little information is available regarding symptoms, treatment choices, and outcomes for patients. Objective: A Canada-wide patient registry was established to understand the real-world practice. This registry included patient presentation and treatment preferences, health care provider attitudes, and clinical outcomes in the management of symptomatic uterine fibroids. Methods: This study is a prospective, noninterventional, observational patient registry. It will include women diagnosed with uterine fibroids and being managed for symptoms. Participant inclusion criteria were (1) at least 18 years of age, (2) premenopausal with a confirmed diagnosis of uterine fibroids, and associated symptoms, and (3) initiating treatment (drug intervention, procedure intervention, or a combination of both) or watchful waiting. Patients (or legal representative) must understand the nature of the project and provide written informed consent before enrollment. Participant exclusion criteria were (1) they have known or suspected clinically significant pelvic pathology not associated with uterine fibroids, and (2) they are undergoing an emergency hysterectomy at the initial visit. Outcomes will be evaluated in the context of routine clinical practice. Results: Participant recruitment of this registry began in July 2015. This study currently has a total sample of 1500 patients. Conclusions: This registry, a first in Canada, will accumulate evidence on the risks and benefits of watchful waiting, and medical and procedural interventions. It will contribute to enhancing access to treatment options for patients. Trial Registration: ClinicalTrials.gov NCT02580578; https://clinicaltrials.gov/ct2/show/NCT02580578 (Archived by WebCite at http://www.webcitation.org/6yax4Hpvr) International Registered Report Identifier (IRRID): RR1-10.2196/10926

  • Mothers and babies group. Source: Mothers and Babies Program website (The Authors); Copyright: The Authors; URL: http://www.mothersandbabiesprogram.org/mothers-clients/; License: Licensed by JMIR.

    Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression via the Mothers and Babies Course: Protocol for...

    Abstract:

    Background: Postpartum depression is highly prevalent in low-income women and has significant health and mental health effects on mother and child. Home visiting (HV) programs provide services to large numbers of perinatal women in the United States and are a logical setting for delivering mental health services. Although there are interventions that reduce the risk of developing postpartum depression among low-income women, none have used nonhealth or nonmental health professionals as interventionists. Objective: This study aimed to outline the protocol of a cluster randomized trial funded by the Patient-Centered Outcomes Research Institute that evaluates whether the Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is more efficacious than usual care. It will also examine if MB, when led by home visitors, is not inferior to MB delivered by mental health professionals (MHPs). MB has previously demonstrated efficacy when delivered by MHPs, and pilot work indicated promising results using home visitors to deliver the intervention. Methods: A cluster randomized trial is being conducted with 38 HV programs. Sixteen HV programs will deliver MB using MHPs, 16 will deliver MB using paraprofessional home visitors, and 6 will deliver usual HV services. The study employs a modified covariate-constrained randomization design at the site level. We anticipate recruiting 933 women aged ≥16 years enrolled in HV programs, who are 33 or more weeks’ gestation and speak either English or Spanish. Women in the 2 intervention arms will receive the 6-session MB group intervention. Baseline, postintervention, 12-week postpartum, and 24-week postpartum assessments will be conducted to assess client outcomes. The primary outcome will be the change in Quick Inventory of Depressive Symptomatology Self-Report 16 scores from baseline to 24-week follow-up. Secondary outcomes associated with core MB content will also be examined. Semistructured interviews will be conducted with home visitors and MHPs who are group facilitators and 90 study participants to gain data on intervention successes and challenges. Analyses will proceed at the participant level. Primary analyses for depressive symptoms score at 24 weeks postpartum will involve a linear mixed model, controlling for baseline symptoms and other covariates, and random effects to account for clustering. Results: We have recruited 838 women through the end of August 2018. Recruitment will be completed at the end of September 2018. Conclusions: There is considerable potential to disseminate MB to HV programs throughout the United States. Should our results demonstrate home visitor efficacy when compared with usual care and/ noninferiority between home visitors and MHPs in improving mental health outcomes, no additional financial resources would be required for the existing HV staff to implement MB. Should this study determine that home visitors are less effective than MHPs, we will generate more wide-scale evidence on MB effectiveness when led by MHPs. Trial Registration: ClinicalTrials.gov NCT02979444; https://clinicaltrials.gov/ct2/show/NCT02979444 (Archived by Webcite at http://www.webcitation.org/archive.php) International Registered Report Identifier (IRRID): PRR1-10.2196/11624

  • Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) logo. Source: Study Logo; Copyright: Study Logo; URL: http://accessproject.org.au/; License: Licensed by JMIR.

    Monitoring the Control of Sexually Transmissible Infections and Blood-Borne Viruses: Protocol for the Australian Collaboration for Coordinated Enhanced...

    Abstract:

    Background: New biomedical prevention interventions make the control or elimination of some blood-borne viruses (BBVs) and sexually transmissible infections (STIs) increasingly feasible. In response, the World Health Organization and governments around the world have established elimination targets and associated timelines. To monitor progress toward such targets, enhanced systems of data collection are required. This paper describes the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS). Objective: This study aims to establish a national surveillance network designed to monitor public health outcomes and evaluate the impact of strategies aimed at controlling BBVs and STIs. Methods: ACCESS is a sentinel surveillance system comprising health services (sexual health clinics, general practice clinics, drug and alcohol services, community-led testing services, and hospital outpatient clinics) and pathology laboratories in each of Australia’s 8 states and territories. Scoping was undertaken in each jurisdiction to identify sites that provide a significant volume of testing or management of BBVs or STIs or to see populations with particular risks for these infections (“priority populations”). Nationally, we identified 115 health services and 24 pathology laboratories as relevant to BBVs or STIs; purposive sampling was undertaken. As of March 2018, we had recruited 92.0% (104/113) of health services and 71% (17/24) of laboratories among those identified as relevant to ACCESS. ACCESS is based on the regular and automated extraction of deidentified patient data using specialized software called GRHANITE, which creates an anonymous unique identifier from patient details. This identifier allows anonymous linkage between and within participating sites, creating a national cohort to facilitate epidemiological monitoring and the evaluation of clinical and public health interventions. Results: Between 2009 and 2017, 1,171,658 individual patients attended a health service participating in ACCESS network comprising 7,992,241 consultations. Regarding those with unique BBV and STI-related health needs, ACCESS captured data on 366,441 young heterosexuals, 96,985 gay and bisexual men, and 21,598 people living with HIV. Conclusions: ACCESS is a unique system with the ability to track efforts to control STIs and BBVs—including through the calculation of powerful epidemiological indicators—by identifying response gaps and facilitating the evaluation of programs and interventions. By anonymously linking patients between and within services and over time, ACCESS has exciting potential as a research and evaluation platform. Establishing a national health surveillance system requires close partnerships across the research, government, community, health, and technology sectors. International Registered Report Identifier (IRRID): DERR1-10.2196/11028

  • Mother searching the internet. Source: FreeDigitalPhotos.net; Copyright: nalinratphi; URL: http://www.freedigitalphotos.net/images/woman-hands-using-laptop-and-wireless-mouse-photo-p538967; License: Licensed by JMIR.

    Assessing and Improving the Use of Online Information About Child Development, Education, Health, and Well-Being in Low-Education, Low-Income Parents:...

    Abstract:

    Background: This study is born from a partnership between Web editors of Naître et grandir (N&G) and AboutKidsHealth (AKH) and researchers who developed and validated the Information Assessment Method (IAM). N&G and AKH are popular Canadian websites with high-quality comprehensive information about child development, education, health, and well-being. IAM allows parents to assess online information and provide feedback to Web editors. High-quality online consumer health information improves knowledge, self-efficacy, and health. However, low-socioeconomic status (SES) parents underuse N&G and IAM, despite these parents being more likely to report decreased worries and increased confidence as outcomes from N&G information. Objective: The study is aimed to improve low-SES parents’ use of online child information and interaction with Web editors and explore subsequent health outcomes for parents and children. Methods: Multiphase mixed-methods design. Our general approach is centered on organizational participatory research. In phase 1, we will conduct a qualitative interpretive study to identify barriers and facilitators to using N&G information and to interacting with N&G editors via IAM; interview more than 10 low-SES parents about their experience with N&G and IAM and more than 10 nonusers of N&G and IAM; and use thematic analysis to identify main barriers and facilitators. In phase 2, we will integrate parents’ views (phase 1 findings) in N&G and IAM and implement a new version: IAM+N&G+. In phase 3, we will conduct a quantitative prospective longitudinal study (pre-/postimplementation monitoring of knowledge use and outcomes). We will compare the use of original (IAM and N&G) and new (IAM+ and N&G+) versions using Google Analytics variables, IAM variables, a material and social deprivation index, and demographics. We anticipate increased use post implementation (linear mixed modeling). In phase 4, we will conduct a qualitative descriptive study on outcomes of information use. We will interview more than 30 low-SES parents who receive and rate the N&G+ newsletter using IAM+ and analyze data in the form of life histories to describe how parents and children experience perceived outcomes. Results: The project was funded in 2017 by the Canadian Institutes of Health Research and received an ethics approval by the McGill University’s institutional review board. Data collection for phase 1 was completed in 2018. Phases 2 to 4 will be conducted until 2020. Findings from this study will also be used to develop a free toolkit, useful to all Web editors, with recommendations for improving health information for low-SES persons and interactions with them using IAM. Conclusions: The results of this study will provide a deep understanding of how low-SES parents use online child information and interact with Web editors. Following the implementation of IAM+N&G+, results will also elucidate subsequent health outcomes for low-SES parents and children after interaction with Web editors has been optimized. International Registered Report Identifier (IRRID): PRR1-10.2196/9996

  • Source: Pixabay; Copyright: oswaldoruiz; URL: https://pixabay.com/en/dentist-patient-1639683/; License: Public Domain (CC0).

    Use of Dental Practices for the Identification of Adults With Undiagnosed Type 2 Diabetes Mellitus or Nondiabetic Hyperglycemia: Protocol for a Systematic...

    Abstract:

    Background: Type 2 diabetes mellitus (T2DM) is a growing global health burden and is expected to affect more than 590 million people by the year 2035. Evidence exists to demonstrate that dental settings have been used for risk assessment and identification of individuals who may be at high risk for T2DM or who may already unknowingly have the condition. Objective: This protocol aims to outline the methodology that will be undertaken to synthesize the literature relating to the use of primary care (nonhospital-based) dental services for the identification of undiagnosed T2DM or prediabetes—often termed nondiabetic hyperglycemia—in adult patients. Methods: This paper outlines the protocol that will be followed to conduct a systematic review and meta-analysis of the available literature. The protocol outlines the aims, objectives, search strategy, data extraction and data management methods, as well as the statistical analysis plan. The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines were followed in developing the protocol as were elements of the Cochrane handbook. Results: We expect the systematic review to be completed within 18 months of publication of this protocol and expect to see a high degree of heterogeneity in the existing literature. Conclusions: This review is of importance as it will synthesize the existing evidence base and inform future studies in the field. Following the publication of the protocol, the review will be registered on Prospective Register of Systematic Reviews. Following the completion of the review, results will be published in a suitable peer-reviewed journal. International Registered Report Identifier (IRRID): PRR1-10.2196/11843

  • Source: Flickr; Copyright: Brian Bilek; URL: https://www.flickr.com/photos/khelvan/5385037288; License: Creative Commons Attribution + ShareAlike (CC-BY-SA).

    A Smartphone Attention Bias Intervention for Individuals With Addictive Disorders: Protocol for a Feasibility Study

    Abstract:

    Background: Substance use disorders are highly prevalent globally. Relapse rates following conventional psychological interventions for substance use disorders remain high. Recent reviews have highlighted attentional and approach or avoidance biases to be responsible for multiple relapses. Other studies have reported the efficacy of interventions to modify biases. With advances in technologies, there are now mobile versions of conventional bias modification interventions. However, to date, no study has evaluated bias modification in a substance-using, non-Western sample. Existing evaluations of mobile technologies for the delivery of bias interventions are also limited to alcohol or tobacco use disorders. Objective: This study aims to examine the feasibility of mobile-based attention bias modification intervention among treatment-seeking individuals with substance use and alcohol use disorders. Methods: This is a feasibility study, in which inpatients who are in their rehabilitation phase of clinical management will be recruited. On each day that they are in the study, they will be required to complete a craving visual analogue scale and undertake both a visual probe-based assessment and and modification task in a smartphone app . Reaction time data will be collated for the computation of baseline attentional biases and to determine whether there is a reduction of attentional bias across the interventions. Feasibility will be determined by the number of participants recruited and participants’ adherence to the planned interventions up until the completion of their rehabilitation program and by the ability of the app in detecting baseline biases and changes in biases. Acceptability of the intervention will be assessed by a short questionnaire of users’ perceptions of the intervention. Statistical analyses will be performed using SPSS version 22.0, while qualitative analysis of the perspectives will be performed using NVivo version 10.0. Results: This study was approved by the National Healthcare Group Domain Specific Research Board, with approval number (2018/00316). Results will be disseminated by means of conferences and publications.Currently, we are in the process of recruitment for this study. Conclusions: To the best of our knowledge, this is the first study to evaluate the feasibility and acceptability of a mobile attention bias modification intervention for individuals with substance use disorders. The data pertaining to the feasibility and acceptability are undoubtedly crucial because they imply the potential use of mobile technologies in retraining attentional biases among inpatients admitted for medical-assisted detoxification and rehabilitation. Participants’ feedback pertaining to the ease of use, interactivity, and motivation to continue using the app is crucial because it will determine whether a codesign approach might be warranted to design an app that is acceptable for participants and that participants themselves would be motivated to use. International Registered Report Identifier (IRRID): PRR1-10.2196/11822

  • Tablet-based app to facilitate greater participation in and satisfaction with the consent process (montage). Source: The Authors / Placeit; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/11/e10360/; License: Creative Commons Attribution (CC-BY).

    A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Any study with human subjects must have a robust consent process to ensure that participants understand the study and can decide whether they want to be involved. Investigators must determine whether a potential study participant is able to make an informed decision and what modifications or supports are needed to maximize participation in decision making. A variety of approaches have been used to modify consent forms and the consent process to increase the research participants’ decisional capacity. This protocol describes a randomized controlled trial (RCT) of a digital health app to support decision making among individuals contemplating providing consent to participate in a clinical trial. Objective: The objective of this RCT will be to determine if the use of a tablet-based app facilitates greater participation in and satisfaction with the consent process compared with standard practice and identify which individual factors are associated with better response to the decision aid. We hypothesize that the tablet-based version of the consent process will promote more informed decision making, including decisions that are more consistent with individual preferences and values expressed during qualitative data collection. Methods: A two-arm RCT will be conducted in a sample of approximately 100 individuals with fragile X syndrome in their homes across the United States. Results: Data analysis will be completed by late 2018. Conclusions: By developing and testing a novel consent decision aid, we will have a better understanding of whether and how technological support can optimize the fit between the decisional capacity and the decisional process. Trial Registration: ClinicalTrials.gov NCT02465931; https://clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/72Q3xJQAw) International Registered Report Identifier (IRRID): PRR1-10.2196/10360

  • Dashboard for the TrueNTH Community of Wellness website (montage). Source: The Authors / Placeit; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/11/e11257/; License: Creative Commons Attribution (CC-BY).

    Effect of Increasing Levels of Web-Based Behavioral Support on Changes in Physical Activity, Diet, and Symptoms in Men With Prostate Cancer: Protocol for a...

    Abstract:

    Background: More than 3.1 million men in the United States are prostate cancer survivors. These men may improve their physical function, quality of life, and potentially their prognosis by adopting healthier lifestyle habits. The internet provides a scalable mechanism to deliver advice and support about improving physical activity and dietary habits, but the feasibility and acceptability of a Web-based lifestyle intervention and the dose of support necessary to improve health behaviors are not yet known. Objectives: The Community of Wellness is a Web-based intervention focused on supporting exercise and healthy dietary practices for men with prostate cancer. The objectives of this study were to determine the feasibility, acceptability, and preliminary efficacy of the Community of Wellness Web portal among prostate cancer survivors by conducting a randomized controlled trial (RCT) comparing 4 levels of additive Web-based content and interaction with participants: Level 1 (Teaching; Control), Level 2 (Teaching + Tailoring), Level 3 (Teaching + Tailoring + Technology), and Level 4 (Teaching + Tailoring + Technology + Touch). Methods: This is a single-blinded RCT comparing 3 levels of behavioral support within the Community of Wellness Web portal intervention (Levels 2 to 4) with each other and with the control condition (Level 1). The control condition receives general static Web-based educational information only on physical activity and dietary habits, self-efficacy for behavior change, motivation for physical activity, and changes in anxiety and treatment-related side effects. We will enroll and randomize 200 men with prostate cancer equally to 4 levels of the Community of Wellness Web-based intervention for 3 months (50 men per level). Surveys will be completed by self-report at baseline, 3 months (immediately postintervention), and 6 months (3 months postintervention). Feasibility and acceptability will be assessed by enrollment statistics, Web-based usage metrics, and surveys at the 3-month time point. We will also conduct focus groups after the postintervention follow-up assessment in a sample of enrolled participants to evaluate elements of usability and acceptability that cannot be obtained via surveys. Results: Enrollment is ongoing, with 124 enrolled. Study completion (6-month follow-up) is expected by July 2019. Conclusions: The goal of the study is to identify the level of support that is feasible, acceptable, promotes behavior change, and improves health in men with prostate cancer to inform future efforts to scale the program for broader reach. Trial Registration: ClinicalTrials.gov NCT03406013; https://clinicaltrials.gov/ct2/show/NCT03406013 (Archived by WebCite at http://www.webcitation.org/73YpDIoTX). International Registered Report Identifier (IRRID): PRR1-10.2196/11257

  • Electronic health–based implementation to facilitate the development of self-management skills among people with spinal cord injury (montage). Source: The Authors / Magic Mockups; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/11/e11069/; License: Creative Commons Attribution (CC-BY).

    Improving Self-Management Skills Among People With Spinal Cord Injury: Protocol for a Mixed-Methods Study

    Abstract:

    Background: Most people with spinal cord injury will develop secondary complications with potentially devastating consequences. Self-management is a key prevention strategy for averting the development of secondary complications and their recurrence. Several studies have shown that self-management programs improve self-management behaviors and health outcomes in individuals living with chronic conditions such as asthma, diabetes, hypertension, and arthritis. Given the burgeoning health care costs related to secondary complications, we developed an alternative electronic health–based implementation to facilitate the development of self-management skills among people with spinal cord injury. Objective: This study aims to evaluate the efficacy of a self-management app in spinal cord injury populations. The primary outcome is attainment of self-selected, self-management goals. Secondary outcomes include increases in general and self-management self-efficacy and reductions in self-reported health events, health care utilization, and secondary complications related to spinal cord injury. This study also aims to explore how the intervention was implemented and how the app was experienced by end users. Methods: This study will employ a mix of qualitative and quantitative methods. The quantitative portion of our study will involve a rater-blinded, randomized controlled trial with a stepped wedge design (ie, delayed intervention control group). The primary outcome is successful goal attainment, and secondary outcomes include increases in self-efficacy and reductions in self-reported health events, health care utilization, and secondary conditions related to spinal cord injury. The qualitative portion will consist of semistructured interviews with a subsample of the participants. Results: We expect that the mobile self-management app will help people with spinal cord injury to attain their self-management goals, improve their self-efficacy, reduce secondary complications, and decrease health care utilization. Conclusions: If the results are positive, this study will produce credible new knowledge describing multiple outcomes that people with spinal cord injury realize from an app-based self-management intervention and support its implementation in clinical practice. Trial Registration: ClinicalTrials.gov NCT03140501; http://clinicaltrials.gov/ct2/show/NCT03140501 (Archived by WebCite at http://www.webcitation.org/73Gw0ZlWZ) International Registered Report Identifier (IRRID): PRR1-10.2196/11069

  • Daily weight and shortness of breath self-monitoring. Source: The Authors; Copyright: Mahin Nomali; URL: http://www.researchprotocols.org/2018/11/e184/; License: Licensed by JMIR.

    Self-Monitoring by Traffic Light Color Coding Versus Usual Care on Outcomes of Patients With Heart Failure Reduced Ejection Fraction: Protocol for a...

    Abstract:

    Background: Patients with heart failure (HF) reduced ejection fraction (HFrEF) have symptoms that are more severe and experience a higher rate of hospitalization compared with HF preserved ejection fraction (HFpEF) patients. However, symptom recognition cannot be made by patients based on current approaches. This problem is a barrier to effective self-care that needs to be improved by new self-monitoring instruments and strategies. Objective: This study describes a protocol for the self-monitoring daily diaries of weight and shortness of breath (SOB) based on the traffic light system (TLS). The primary objective is to compare the self-care between the intervention and control group. Comparison of HF knowledge, HF quality of life (HFQOL), and all-cause hospitalization between the 2 groups are the secondary objectives. Methods: A single-blind randomized controlled trial is being conducted at the HF clinic at Tehran Heart Center (Tehran, Iran). Sixty-eight adult patients of both genders will be enrolled during admission to HF clinic. Eligible subjects will be assigned to either the intervention or control group by a block balanced randomization method. Baseline surveys will be conducted before random allocation. Participants in the intervention group will receive an integrated package consisting of (1) HF self-care education by an Australian Heart Foundation booklet on HF, (2) regular home self-monitoring of weight and SOB, and (3) scheduled call follow-ups for 3 months. Patients in the control group will receive no intervention and they only complete monthly surveys. Results: This study is ongoing and is expected to be completed by the end of 2018. Conclusions: This is the first trial with new self-monitoring instruments in Iran as a low and middle-income country. If the findings show a positive effect, the package will be applied in different regions with the same health care status. Trial Registration: Iranian Registry of Clinical Trials IRCT2017021032476N1; https://en.irct.ir/trial/25296?revision=25296 (Archived by WebCite at http://www.webcitation.org/73DLICQL8) International Registered Report Identifier (IRRID): PRR1-10.2196/9209

  • A person with inflammatory bowel disease, experiencing symptom exacerbation (ie, abdominal pain). Source: Pixabay; Copyright: Martin Büdenbender; URL: https://pixabay.com/en/abdominal-pain-attack-medical-2493327/; License: Public Domain (CC0).

    Living With Inflammatory Bowel Disease: Protocol for a Longitudinal Study of Factors Associated With Symptom Exacerbations

    Abstract:

    Background: There has been limited longitudinal research that has comprehensively evaluated possible factors in the exacerbation of inflammatory bowel disease (IBD) symptoms with or without associated inflammation. Evolving Web-based technologies facilitate frequent monitoring of patients’ experiences and allow a fine-grained assessment of disease course. Objective: We aimed to prospectively identify factors associated with symptom exacerbation and inflammation in IBD including psychological functioning, diet, health behaviors, and medication adherence. Methods: Between June 2015 and May 2017, we enrolled adults with IBD, recruited from multiple sources, who had been symptomatically active at least once within the prior 2 years. They completed a Web-based survey every 2 weeks for 1 year and submitted a stool sample at baseline, 26 weeks, and 52 weeks. Any participant reporting a symptom exacerbation was matched to a control within the cohort, based on disease type, sex, age, and time of enrollment; both were sent a supplemental survey and stool collection kit. Biweekly surveys included validated measures of the disease course, psychological functioning, health comorbidities, and medication use. Intestinal inflammation was identified through fecal calprotectin (positive level >250 μg/g stool). Results: There were 155 participants enrolled with confirmed IBD, 66.5% (103/155) with Crohn disease and 33.5% (52/155) with ulcerative colitis, of whom 98.7% (153/155) completed the study. Over the 1-year period, 47.7% (74/155) participants experienced a symptom exacerbation. The results of analyses on risk factors for symptom exacerbations are pending. Conclusions: We recruited and retained a longitudinal IBD cohort that will allow the determination of risk factors for symptom exacerbation with and without inflammation. This will increase understanding of symptom exacerbations among persons with IBD. International Registered Report Identifier (IRRID): RR1-10.2196/11317

  • 3R study logo. Source: Leicester Diabetes Centre; Copyright: Leicester Diabetes Centre; URL: http://www.researchprotocols.org/2018/11/e11289/; License: Creative Commons Attribution (CC-BY).

    The Ready to Reduce Risk (3R) Study for a Group Educational Intervention With Telephone and Text Messaging Support to Improve Medication Adherence for the...

    Abstract:

    Background: Poor adherence to cardiovascular medications is associated with worse clinical outcomes. Evidence for effective education interventions that address medication adherence for the primary prevention of cardiovascular disease is lacking. The Ready to Reduce Risk (3R) study aims to investigate whether a complex intervention, involving group education plus telephone and text messaging follow-up support, can improve medication adherence and reduce cardiovascular risk. Objective: This protocol paper details the design and rationale for the development of the 3R intervention and the study methods used. Methods: This is an open and pragmatic randomized controlled trial with 12 months of follow-up. We recruited participants from primary care and randomly assigned them at a 1:1 frequency, stratified by sex and age, to either a control group (usual care from a general practitioner) or an intervention group involving 2 facilitated group education sessions with telephone and text messaging follow-up support, with a theoretical underpinning and using recognized behavioral change techniques. The primary outcome was medication adherence to statins. The primary measure was an objective, novel, urine-based biochemical measure of medication adherence. We also used the 8-item Morisky Medication Adherence Scale to assess medication adherence. Secondary outcomes were changes in total cholesterol, blood pressure, high-density lipoprotein, total cholesterol to high-density lipoprotein ratio, body mass index, waist to hip ratio, waist circumference, smoking behavior, physical activity, fruit and vegetable intake, patient activation level, quality of life, health status, health and medication beliefs, and overall cardiovascular disease risk score. We also considered process outcomes relating to acceptability and feasibility of the 3R intervention. Results: We recruited 212 participants between May 2015 and March 2017. The 12-month follow-up data collection clinics were completed in April 2018, and data analysis will commence once all study data have been collected and verified. Conclusions: This study will identify a potentially clinically useful and effective educational intervention for the primary prevention of cardiovascular disease. Medication adherence to statins is being assessed using a novel urine assay as an objective measure, in conjunction with other validated measures. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN16863160; http://www.isrctn.com/ISRCTN16863160 (Archived by WebCite at http://www.webcitation.org/734PqfdQw) International Registered Report Identifier (IRRID): DERR1-10.2196/11289

Citing this Article

Right click to copy or hit: ctrl+c (cmd+c on mac)

Latest Submissions Open for Peer-Review:

View All Open Peer Review Articles
  • Improving Nutrition and Activity Behaviors Using Digital Technology and Tailored Feedback: Protocol For the Livelighter Tailored Diet and Activity (ToDAy) Randomized Controlled Trial

    Date Submitted: Nov 15, 2018

    Open Peer Review Period: Nov 17, 2018 - Nov 23, 2018

    Background: Excess weight is a major risk factor for chronic diseases. In Australia over 60% of adults are now overweight or obese. The overconsumption of energy-dense nutrient poor (EDNP) foods and l...

    Background: Excess weight is a major risk factor for chronic diseases. In Australia over 60% of adults are now overweight or obese. The overconsumption of energy-dense nutrient poor (EDNP) foods and low physical activity (PA) levels are key factors contributing to population obesity. New cost-effective approaches to improve population diet and PA behaviors are needed. Objective: This 1-year randomized controlled trial (6-month intervention; 6-month follow-up) aims to investigate whether a tailored intervention using mobile technology can improve diet and PA behaviors leading to weight loss in adults (18-65 years) who are overweight or obesity, recruited through a social marketing campaign (LiveLighter®). Methods: All eligible participants will complete demographics and lifestyle behaviors online at baseline, 6- and 12-months. Using a two stage randomization they will be allocated into one of three groups: 1) tailored feedback (TF) delivered via email at seven time points informed by objective dietary (mobile food record application™) and activity (wearable activity monitor) assessment; 2) active control (AC) receiving no tailored feedback, but undergoing the same objective assessments as TF; and 3) online control (OC) receiving no tailored feedback or objective assessments. Primary outcome measures at 6- and 12-months are changes in body mass, EDNP foods and beverage consumption and daily moderate-to-vigorous PA (measured via accelerometery). Secondary outcomes include change in fruit and vegetable consumption, daily sedentary behaviors and cost-effectiveness. Results: Enrolment commenced in August 2017. Primary outcomes at 12-months will be available for analysis from September 2019. Conclusions: Tailored email feedback provided to individuals may provide a cost effective strategy to overcome existing barriers to improving diet and PA. If shown to be successful and cost-effective, upscaling this intervention for inclusion in larger-scale interventions is highly feasible. Clinical Trial: Australian New Zealand Clinical Trials Registry ACTRN12617000554369.

  • Identification of Motor Symptoms Related to Parkinson's Disease Using Motion Tracking Sensors at Home (KÄVELI)

    Date Submitted: Nov 13, 2018

    Open Peer Review Period: Nov 17, 2018 - Nov 21, 2018

    Background: Clinical motion characterization in patients with Parkinson’s disease (PD) is challenging: symptom progression, suitability of medication, and level of independence in the home environme...

    Background: Clinical motion characterization in patients with Parkinson’s disease (PD) is challenging: symptom progression, suitability of medication, and level of independence in the home environment can vary across time and from patient to patient. Appointments at the neurological outpatient clinic provide a limited understanding of the overall situation. In order to follow up on variations in the state of PD and heterogenity of symptoms, longer-term measurements performed outside the clinic could help to optimize and personalize therapies. Several wearable sensors have been used and algorithms have been developed to estimate the severity of symptoms in PD; however, large volumes of longitudinal recordings are rare. Home recordings have the potential benefit of providing more thorough and objective follow-up about the disease, while providing more information about the possible need to change medications or consider invasive secondary treatments. Objective: The primary objective of this study is to detect PD-related changes in walking patterns at home. The movement data are collected continuously and remotely at home during the normal lives of patients with Parkinson’s disease, as well as controls. The secondary objective is to study whether the registered medication intake can be identified from the collected movement data. Methods: The study protocol measures the activity using three different devices: (1) a smartphone with a built-in accelerometer, gyroscope, and phone orientation sensor, (2) a Movesense® smart sensor to measure movement data from the wrist, and (3) a Forciot® smart insole to measure the temporal and spatial distributions of the forces applied on the feet. The measurements are first collected during the appointment at the clinic through background interviews, a comprehensive Unified Parkinson’s Disease Rating Scale (UPDRS) test, and a 20-step walking test conducted by a trained clinical physiotherapist. Next, the subjects are asked to wear the smartphone at home for three consecutive days, and the data are transferred from the smartphone to a personal computer (PC) securely. Results: Data collection began in March 2018. The subject recruitment and data collection continued until the end of December 2018. The intended sample was 150 subjects, 100 of which were diagnosed with PD and 50 of which were control subjects. Conclusions: This study aims to produce an extensive movement sensor dataset recorded from PD patients in various phases of the disease, as well as a group of control subjects for effective and impactful comparison studies. The study also aims to develop data analysis methods to monitor PD symptoms and the effects of medication intake during normal life and outside of the clinic. Further applications of these methods may include tools for healthcare professionals to better monitor PD remotely or apply the tool to other movement disorders. Clinical Trial: This study is registered under ClinicalTrials.gov (NCT03366558). https://clinicaltrials.gov/ct2/show/NCT03366558?term=k%C3%A4veli&rank=1. Accessed: 2018-08-29. Archived at: http://www.webcitation.org/721n3uIqR

  • Protocol for the 3PS randomized controlled trial to promote family routines and positive parenting for obesity prevention: a pilot study

    Date Submitted: Nov 11, 2018

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

    Background: Childhood obesity is a pervasive and challenging public health issue, with 30% of children aged 2-4 years classified as being overweight or obese in New Zealand. This is concerning, given...

    Background: Childhood obesity is a pervasive and challenging public health issue, with 30% of children aged 2-4 years classified as being overweight or obese in New Zealand. This is concerning, given that up to 90% of obese 3-year-old children are overweight or obese by the time they reach adolescence. Interventions that specifically target this age range often fail to demonstrate long-term effectiveness, and primarily focus on traditional weight-related behaviours, including diet, physical activity, and sedentary behaviour. However, recent research suggests that targeting non-traditional weight-related behaviours, such as sleep, screen time, and family meals, may be appropriate and more effective approach in this age group, given the immense challenges in changing traditional weight-related behaviours long-term. Objective: The aim of the proposed study was to develop and pilot the 3 Pillars Study (3PS), a 6-week program for parents of New Zealand toddlers and preschoolers aged 2-4 years to promote positive parent-child interactions during three family routines, specifically, adequate sleep, regular family meals, and restricted screen time. Methods: The effects of the program on screen time (primary endpoint), frequency of family meals, parent feeding practices, diet quality, and sleep duration will be piloted using a randomized controlled trial, with outcomes compared between the active intervention group and a wait-list control group at 6 weeks (at the end of the programme) and 12 weeks (at final follow-up). We aim to recruit 50 participants (25 per arm). Eligibility criteria include parents of children aged 2-4 years of age who are currently exceeding screen use recommendations (that is, greater than 1 hour of screen time per day). The 3PS program involves a half-day workshop, run by a community worker trained to deliver the program content, and 6-week access to a study website that contains in-depth information about the program. All participants will also receive a study pack, which includes resources to encourage engagement in the three family routines promoted by the program. Study data will be collected in REDCap. All statistical analyses will be performed using SAS version 9.4, and have been specified a priori in a statistical analysis plan prepared by the study statistician. Results: Trial recruitment opened in July 2018. Final follow-up is expected in December 2018, with trial findings expected to be available in early 2019. Conclusions: Findings from this pilot study will provide relevant data to inform the design of a larger effectiveness study of the 3PS program. Clinical Trial: Australia New Zealand Clinical Trials Register ACTRN12618000823279

  • Policies and programs for the prevention and control of breast cancer in Mexican and Central American women: protocol for a scoping review

    Date Submitted: Nov 10, 2018

    Open Peer Review Period: Nov 10, 2018 - Nov 24, 2018

    Background: Breast cancer has become one of the main public health problems all around the world, especially in Central America and Mexico. Self-exploration and early diagnosis are the best ways to lo...

    Background: Breast cancer has become one of the main public health problems all around the world, especially in Central America and Mexico. Self-exploration and early diagnosis are the best ways to look after this type of cancer. In Mexico and Central America, as in many other countries, breast cancer prevention and control activities are performed permanently; but, there are no comprehensive public reports that could provide information on the policies that originated the programs, the number, type, and scope of these activities as well as the impact of the performed programs and actions. Objective: Therefore, this document’s goal is to present the design of a Scoping Review protocol about the policies and action programs for breast cancer care in Mexico and Central America, as well as its objectives and implementation plan. Methods: This Scoping Review protocol was developed on the basis of the methodological reference framework of Arksey and O’Malley (2005). A systematic search of the following electronic databases will be performed: MEDLINE (PubMed), MEDLINE (EbscoHost), CINAHL (EbscoHost), Academic Search Complete (EbscoHost), ERIC, ISI Web of Science (Science Citation Index) in English, Cochrane, and MEDES-MEDicina in Spanish. The time scope of the search will be from 2000 trough 2018. Results: Since the data will not be obtained from primary sources, the approval of an ethics and research committee is not necessary. Data will be analyzed and presented in descriptive statistics and qualitative content analyses with analysis matrixes and semantic networks. The intention is to present the results to health authorities, conferences and publish them in an indexed journal. Conclusions: According to this proposal, we present a protocol for a Scoping Review-type literature revision based on the Arksey and O’Malley (2005) methodology during the first semester of 2019. According to this five-stage methodology, we will identify the scientific publications that present or analyze first-level action policies and programs for Breast Cancer care in Mexican women, as well as their results, if any. The outcome of this review will be used to define the bases of a research project intended to design an educational intervention strategy for the general public in Mexico, in order to deal with this important public health problem.

  • Integrating PrEP into Family Planning Services at Title X Clinics in the Southeastern US – Phase 1 (ATN 155)

    Date Submitted: Nov 8, 2018

    Open Peer Review Period: Nov 9, 2018 - Nov 23, 2018

    Background: Black adolescent and young adult women (AYAW) in the Southern United States (US) are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individu...

    Background: Black adolescent and young adult women (AYAW) in the Southern United States (US) are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individual-controlled HIV prevention strategy that is grossly underutilized among women of all ages and requires innovative delivery approaches to optimize its benefit. Anchoring PrEP delivery to health services that AYAW already trust, access routinely, and deem useful for their sexual health offers an ideal opportunity to reach women at risk for HIV and to enhance their PrEP uptake and adherence. These services include those of family planning (FP) providers in high HIV incidence settings. However, PrEP has not been widely integrated into FP services, including Title X-funded FP clinics that provide safety net sources of care for AYAW. To overcome potential implementation challenges for AYAW, Title X clinics in the Southern US are uniquely positioned to be focal sites for conceptually-informed and thoroughly-evaluated PrEP implementation science studies. Objective: Assess inner and outer context factors (barriers and facilitators) that may influence the adoption of PrEP prescription and treatment services in Title X clinics serving AYAW in the Southern US. Methods: Phase 1 of Planning4PrEP is an explanatory sequential, mixed methods study consisting of a geographically-targeted online survey of Title X clinic administrators and providers in the Southern US, followed by key informant interviews (KIIs) among a purposively-selected subset of responders to more comprehensively access inner and outer context factors that may influence adoption and implementation of PrEP in Title X FP clinics in the South. Results: Phase 1 of Planning4PrEP research activities began in October 2017and are ongoing. To date, survey and KII administration is near completion with quantitative and qualitative data analysis scheduled to begin soon after data collection completion Conclusions: This study seeks to assess inner and outer contextual factors (barriers and facilitators) that may influence the adoption and integration of PrEP prescription and treatment services in Title X clinics serving AYAW in the Southern US.

  • Utilizing Biomarker Feedback Documenting Child Exposure to Tobacco Toxins to Promote Smoke-Free Homes: Study Protocol for a Randomized Clinical Trial

    Date Submitted: Oct 30, 2018

    Open Peer Review Period: Nov 3, 2018 - Dec 29, 2018

    Background: Background: Exposure to second-hand smoke (SHS) early in life increases the risk of SIDS, asthma and respiratory illnesses. Since children’s primary exposure to SHS occurs in the home,...

    Background: Background: Exposure to second-hand smoke (SHS) early in life increases the risk of SIDS, asthma and respiratory illnesses. Since children’s primary exposure to SHS occurs in the home, these most vulnerable members of our society are not fully protected by recent increases in the adoption of smoking bans in public spaces. Although exposure to SHS is a readily addressed cause of excess morbidity, few low-income homes strictly enforce smoking restrictions. Objective: Objective: To test a novel approach to motivate the adoption of home smoking restrictions (HSR) and to eliminate child SHS exposure by providing parents with objective, biomarker documentation of child exposure to tobacco toxins. Methods: Methods: From 2011 to 2013, 195 low-income, female smokers with children ≤ 10 years old, residing in their homes were recruited into a two-arm randomized clinical trial. Participants were assigned to one of two groups: Biomarker Feedback (n = 98) vs. Health Education, (n = 97). In-home assessments were administered at baseline, week 16 and week 26. Child urine nicotine, cotinine and NNAL (a metabolite of the known tobacco carcinogen, NNK), an objective measure of home SHS exposure (i.e., passive nicotine dosimeter) and a surface sample of residual (ie, third-hand) tobacco smoke were collected at all three time points. Primary outcome was dosimeter-verified, complete home smoking restrictions at 6-months post-randomization. Secondary outcomes included parental self report of smoking behavior change and child urine biomarker change. Results: Results : Data collection and analyses are complete and results are being interpreted. Conclusions: Discussion: The study protocol describes the development of a novel community-based controlled trial designed to examine the efficacy of biomarker feedback documenting a child’s exposure to enviornmental tobacco smoke on parental smoking behavior change. Clinical Trial: Trial Registration: ClinicalTrials.gov Identifier: NCT01574560

Advertisement