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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed- and (new!) Scopus-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.

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 (preliminary results from pilot studies, early results, and formative research should now be published in JMIR Formative Research).

While the original focus was on the design of medical and health-related research and technology innovations, JRP publishes research protocols, proposals, feasibility studies, methods and early results in all areas of medical and health research.

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

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

JMIR Res Protoc 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 proposals 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: Pexels; Copyright: Anna Shvets; URL: https://www.pexels.com/photo/person-holding-white-printer-paper-4226124/; License: Licensed by JMIR.
    Non-Randomized Study Protocols and...

    Oct 21, 2020

    Respiratory Health of Pacific Youth: An Observational Study of Associated Risk and Protective Factors Throughout Childhood

    Authors List:

    Abstract:

    Background: Respiratory disease is the third most common cause of death in New Zealand, with Pacific people living in New Zealand bearing the greatest burden of this type of disease. Although some epidemiological outcomes are known, we lack the specifics required to formulate targeted and effective public health interventions. The Pacific Islands Families (PIF) birth cohort study is a study that provides a unique source of data to assess lung function and current respiratory health among participants entering early adulthood and to examine associations with early life events during critical periods of growth. Objective: This paper aims to provide an overview of the design, methods, and scope of the Respiratory Health of Pacific Youth Study, which uses the overall PIF study cohort aged 18-19 years. Methods: From 2000-2019, the PIF study has followed, from birth, the growth, and the development of 1398 Pacific children born in Auckland, New Zealand. Participants were nested within the overall PIF study (at ages 18-19 years) from June 2018, and assessments were undertaken until mid-November 2019. The assessments included respiratory and general medical histories, a general physical examination, assessment of lung function (forced expiratory volume and forced vital capacity), self-completed questionnaires (St George’s Respiratory Questionnaire, European Quality of Life 5 Dimensions-3 Level, Epworth Sleepiness Scale for Children and Adolescents, and Leicester Cough Questionnaire), blood tests (eosinophils, Immunoglobulin E, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and C-reactive protein), and chest x-rays. Noninferential analyses will be carried out on dimensionally reduced risk and protective factors and confounders. Results: Data collection began in June 2018 and ended in November 2019, with a total of 466 participants recruited for submission of the paper. Collection and collation of chest x-ray data is still underway, and data analysis and expected results will be published by November 2020. Conclusions: This is the first longitudinal observational study to address the burden of respiratory disease among Pacific youth by determining factors in early life that impose long-term detriments in lung function and are associated with the presence of respiratory illness. Identifying risk factors and the magnitude of their effects will help in adopting preventative measures, establishing whether any avoidable risks can be modified by later resilient behaviors, and provide baseline measurements for the development of respiratory disease in later adult life. The study results can be translated into practice guidelines and inform health strategies with immediate national and international impact.

  • Source: Unsplash; Copyright: javier matheu; URL: https://unsplash.com/photos/9dwZY2kcKdA; License: Licensed by JMIR.
    Systematic Review Protocols (funded)

    Oct 21, 2020

    Comparing Conventional Chemotherapy to Chronomodulated Chemotherapy for Cancer Treatment: Protocol for a Systematic Review

    Authors List:

    Abstract:

    Background: Chronomodulated chemotherapy aims to achieve maximum drug safety and efficacy by adjusting the time of treatment to an optimal biological time as determined by the circadian clock. Although it is a promising alternative to conventional (non–time-stipulated) chemotherapy in several instances, the lack of scientific consensus and the increased logistical burden of timed administration limit the use of a chronomodulated administration protocol. Objective: With the goal to increase scientific consensus on this subject, we plan to conduct a systematic review of the current literature to compare the drug safety and efficacy of chronomodulated chemotherapy with those of conventional chemotherapy. Methods: This systematic review will comply with the PRISMA (Preferred Reporting Items for the Systematic Reviews and Meta-Analysis) guidelines. In order to identify relevant studies, we conducted a comprehensive search in PubMed and Embase on May 18, 2020. We included clinical studies that compare either the safety or efficacy of chronomodulated chemotherapy with that of conventional chemotherapy. Potential studies will be reviewed and screened by 2 independent reviewers. Quality assessment will be performed using the National Institutes of Health’s Study Quality Assessment Tool (Quality Assessment of Controlled Intervention Studies). Disagreements will be resolved by consulting a third independent reviewer. Results: This protocol has received funding, and the search for studies from databases commenced on May 18, 2020. The systematic review is planned to be completed by October 31, 2020. Conclusions: In this systematic review, we will compare drug safety and drug efficacy for cancer patients who were administered either chronomodulated chemotherapy or conventional chemotherapy. Moreover, we will highlight the outcomes and quality of the selected trials for this review. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020177878; https://tinyurl.com/y53w9nq6

  • Source: Burst; Copyright: Matthew Henry; URL: https://burst.shopify.com/photos/in-office-working-on-laptop?q=person+on+laptop; License: Licensed by JMIR.
    Non-Randomized Study Protocols and...

    Oct 21, 2020

    Standardized Protocol Items Recommendations for Observational Studies (SPIROS) for Observational Study Protocol Reporting Guidelines: Protocol for a Delphi...

    Authors List:

    Abstract:

    Background: Approximately 90% of currently published clinical and public health research is in the form of observational studies. Having a detailed and registered study protocol prior to data collection is important in any empirical study. Without this, there is no reliable way to assess the occurrence of publication bias, outcome reporting bias, and other protocol deviations. However, there is currently no solid guidance available on the information that a protocol for an observational study should contain. Objective: The aim of this study is to formulate the Standardized Protocol Items Recommendations for Observational Studies (SPIROS) reporting guidelines, which focus on 3 main study designs of analytical epidemiology: cohort, case-control, and cross-sectional studies. Methods: A scoping review of published protocol papers of observational studies in epidemiology will identify candidate items for the SPIROS reporting guidelines. The list of items will be extended with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist items and recommendations from the SPIROS steering committee. This long list serves as the basis for a 2-round Delphi survey among experts to obtain consensus on which items to include. Each candidate item from the long list will be rated on a 5-point Likert scale to assess relevance for inclusion in the SPIROS reporting guidelines. Following the Delphi survey, an expert-driven consensus workshop will be convened to finalize the reporting guidelines. Results: A scoping review of published observational study protocols has been completed, with 59 candidate items identified for inclusion into the Delphi survey, itself launched in early 2020. Conclusions: This project aims to improve the timeliness, completeness, and clarity of study protocols of observational studies in analytical epidemiology by producing expert-based recommendations of items to be addressed. These reporting guidelines will facilitate and encourage researchers to prepare and register study protocols of sufficient quality prior to data collection in order to improve the transparency, reproducibility, and quality of observational studies.

  • The IDEA Study Logo. Source: Image commissioned by the authors through 99Designs; Copyright: Wayne State University; URL: http://www.researchprotocols.org/2020/10/e20191/; License: Licensed by the authors.
    RCTs - Protocols/Proposals (funded,...

    Oct 20, 2020

    Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy

    Authors List:

    Abstract:

    Background: Poor diabetes self-management in emerging adulthood (age 18-25 years) is associated with poorer diabetes health and diabetes complications. Emerging adults’ focus on individuation and independence underlies their poor diabetes outcomes, offering a lever for behavior change. Self-determination theory (SDT) suggests that interventions leveraging emerging adults’ innate developmental need for autonomy may offer a route to improving diabetes outcomes by increasing feelings of responsibility for and control over diabetes self-management activities. Objective: This research project will use the multiphase optimization strategy to test the efficacy of three autonomy-supportive intervention components to elicit a clinically significant improvement in metabolic control, assessed by a 0.5% improvement in hemoglobin A1c (HbA1c), among older adolescents and emerging adults (16-25 years) with poorly controlled type 1 diabetes (T1D; HbA1c≥9.0%). Methods: A question prompt list (QPL) is a tool to empower patients to assume a more active role during medical visits by asking questions and stating concerns. The motivation enhancement system (MES) is a brief counseling intervention that uses motivational interviewing communication strategies to build intrinsic motivation and self-efficacy for self-management. Text message reminders to complete diabetes care tasks may increase self-efficacy for diabetes self-management. After refining these intervention components for emerging adults, we will conduct a component selection experiment using an eight-arm full factorial design: 2 (QPL yes or no)×2 (MES yes or no)×2 (Text yes or no). Participants will complete 3 study visits: baseline, treatment end at 2 months, and a follow-up at 6 months. The primary outcome is metabolic control, which will be measured via HbA1c. Secondary outcomes include diabetes management and diabetes clinic attendance. SDT constructs of intrinsic motivation, self-efficacy, and the quality of the patient-provider relationship (ie, relatedness) are hypothesized mediators. Depression symptoms and emerging adults’ gender are hypothesized moderators. We will use the mixed-effects linear model for the analysis of variance of a factorial design to analyze continuous longitudinal experimental data; the generalized linear model will be used with categorical outcomes (eg, treatment attendance). The experiment was powered to detect the main effects of the intervention on the primary outcome. Results: A total of 20 participants have enrolled and completed a qualitative interview after reviewing one or more intervention components. Analysis of interview data are underway, with a report of these results anticipated in the fall of 2020. The clinical trial will be launched in the fall 2020, with participants enrolled through May 2023 and data collection continuing through November 2023. Conclusions: At the end of this experiment, we will have empirical evidence to support a large-scale, multisite effectiveness trial of an intervention package that has been optimized for older adolescents and emerging adults with poorly controlled T1D. Trial Registration: ClinicalTrials.gov NCT04066959; https://clinicaltrials.gov/ct2/show/NCT04066959

  • Source: Pexels; Copyright: Photo by VisionPic .net from Pexels; URL: https://www.pexels.com/photo/blue-jeans-3036405/; License: Licensed by JMIR.
    RCTs - Pilots/Feasibility Studies...

    Oct 20, 2020

    Intervention to Improve Preschool Children’s Fundamental Motor Skills: Protocol for a Parent-Focused, Mobile App–Based Comparative Effectiveness Trial

    Authors List:

    Abstract:

    Background: Preschool age is an important time to master fundamental motor skills (FMS) through structured physical activity, yet many young children lag behind in motor skill development. Objective: The Promoting Lifelong Activity in Youth (PLAY) study is a pilot comparative effectiveness trial to test the acceptability, feasibility, and preliminary effectiveness of a mobile app delivered to parents to promote FMS development in their preschool children (aged 3-5 years). Methods: We conducted a 2-arm, parallel-design, randomized comparative effectiveness trial in 72 parent-child dyads from the southeastern United States. Experts in motor development and developmental psychology developed an app designed to deliver a 12-week program to parents of preschoolers using 1 of 2 curricula: an FMS program (intervention) that involved peer modeling, parent engagement, and structured skills-based activities and an unstructured physical activity (comparator) curriculum that provided suggestions for child-led physical activity (ie, free play). Primary outcomes are feasibility and acceptability of the app and child’s FMS measured at end of intervention (week 12). Exploratory outcomes are child’s objective physical activity, perceived movement competence, and parent report of self-regulation at the end of treatment (week 12) and sustained outcomes at follow-up (week 24). Results: This project was funded in September 2018, with institutional review board approval in August 2018. Data collection took place from May 2019 through February 2020. To date, the project team has completed data collection on 69 preschool-age children, and results are expected to be published by 2021. Conclusions: The PLAY study examines the feasibility and preliminary effectiveness of a mobile app, parent-led curricula to promote FMS proficiency for preschool children. If found to be effective, the app has the potential for wide-scale dissemination to parents of preschoolers and to provide a model for the utilization of mobile apps to promote young children’s motor skill development. Trial Registration: ClinicalTrials.gov NCT03901300; https://clinicaltrials.gov/ct2/show/NCT03901300

  • Source: freepik; Copyright: Paper photo created by jcomp; URL: https://www.freepik.com/free-photo/close-up-physiotherapist-working-with-patient-clinic_5218093.htm#page=1&query=physiotherapy&position=9; License: Licensed by JMIR.
    Systematic Review Protocols

    Oct 20, 2020

    Mapping Evidence on Community-Based Clinical Education Models for Undergraduate Physiotherapy Students: Protocol for a Scoping Review

    Authors List:

    Abstract:

    Background: Community-based clinical training has been advocated as an excellent approach to transformation in clinical education. Clinical education for undergraduate physiotherapy students is a hands-on practical experience that aims to provide a student with the skills necessary to enable them to be fit to practice independently. However, in many countries, including South Africa, this training has been conducted only in large urban academic hospitals. Such hospitals are not a true reflection of the environment that these students will most likely be facing as practicing health care professionals. Objective: The objective of this scoping review is to map out existing evidence on community-based clinical education models for undergraduate physiotherapy students globally. Methods: A systematic scoping review will be based on the 2005 Arksey and O’Malley framework. Studies involving students and stakeholders in clinical education will be included. This review will not be limited by time of publication. An electronic search of relevant literature, including peer-reviewed primary studies and grey literature, will be conducted from the PubMed, Google Scholar, Medline, CINAHL, and Cochrane Library databases. The search strategy will include keywords such as “education,” “physiotherapy,” “undergraduate,” “community-based,” “training,” “decentralized,” and “distributed.” Boolean logic will be used for each search string. Two independent reviewers will conduct screening of titles, abstracts, and full text before extracting articles. A predesigned data-charting table will supplement the extraction of data. Version 12 NVIVO software will aide in the thematic analysis of data. Results: Data collection will commence after publication of this protocol, and the results are expected to be obtained in the following 5 months. Conclusions: The evidence obtained from the extracted data is expected to assist in the development of a model of community-based clinical education for undergraduate physiotherapy students in South Africa, and serve as a basis for future research. The discussion of this evidence will be guided by the research question utilizing a critical narrative approach to explore emerging themes. The enablers and barriers identified from the reviewed studies can guide the development of a community-based clinical education model.

  • Source: freepik; Copyright: freepik; URL: https://www.freepik.com/free-photo/close-up-doctor-filling-medical-form-with-patient_3894250.htm#page=1&query=doctors%20talking%20with%20patient&position=1; License: Licensed by JMIR.
    Grant Proposals (funded, non-ehealth)

    Oct 20, 2020

    Determinants of Medical Practice Variation Among Primary Care Physicians: Protocol for a Three Phase Study

    Authors List:

    Abstract:

    Background: One of the greatest challenges of modern health systems is the choice and use of resources needed to diagnose and treat patients. Medical practice variation (MPV) is a broad term which entails the differences between health care providers inclusive of both the overuse and underuse. In this paper, we describe a 3-phase research protocol examining MPV in primary care. Objective: We aim to identify the potential targets for behavioral modification interventions to reduce the variation in practice patterns and thus improve health care, decrease costs, and prevent disparities in care. Methods: The first phase will delineate the variation in primary care practice over a wide range of services and long follow-up period (2003-2017), the second will examine the 3 determinants of variation (ie, patient, physician, and clinic characteristics), and attempt to derive the unexplained variance. In the third phase, we will assess a novel component that might contribute to the previously unexplained variance - the physicians’ personal behavioral characteristics (such as risk aversion, fear of malpractice, stress from uncertainty, empathy, and burnout). Results: This work was supported by the research grant from Israel National Institute for Health Policy Research (Grant No. 2014/134). Soroka University Medical Center Institutional Ethics Committee has approved the updated version of the study protocol (SOR-14-0063) in February 2019. All relevant data for phases 1 and 2, including patient, physician, and clinic, were collected from the Clalit Health Services data set in 2019 and are currently being analyzed. The evaluation of the individual physician characteristics (eg, risk aversion) by the face-to-face questionnaires was started on 2018 and remains in progress. We intend to publish the results during 2020-2021. Conclusions: Based on the results of our study, we aim to propose a list of potential targets for focused behavioral intervention. Identifying new targets for such an intervention can potentially lead to a decrease in the unwarranted variation in the medical practice. We suggest that such an intervention will result in optimization of the health system, improvement of health outcomes, reduction of disparities in care and savings in cost.

  • Source: Pexels; Copyright: bongkarn thanyakij; URL: https://www.pexels.com/photo/photo-of-person-holding-tablet-3740170/; License: Licensed by JMIR.
    Non-randomized Protocols and Methods...

    Oct 19, 2020

    The Kidney Score Platform for Patient and Clinician Awareness, Communication, and Management of Kidney Disease: Protocol for a Mixed Methods Study

    Authors List:

    Abstract:

    Background: Patient awareness, clinician detection, and management of chronic kidney disease remain suboptimal, despite clinical practice guidelines and diverse education programs. Objective: This protocol describes a study to develop and investigate the impact of the National Kidney Foundation Kidney Score Platform on chronic kidney disease awareness, communication, and management, by leveraging the Behavior Change Wheel, an implementation science framework that helps identify behavioral intervention targets and functions that address barriers to behavior change. Methods: We interviewed 20 patients with chronic kidney disease and 11 clinicians to identify patient and clinician behaviors suitable for intervention and barriers to behavior change (eg, limited awareness of chronic kidney disease clinical practice guidelines within primary care settings, limited data analytics to highlight chronic kidney disease care gaps, asymptomatic nature of chronic kidney disease in conjunction with patient reliance on primary care clinicians to determine risk and order kidney testing). Leveraging the Behavior Change Wheel, the Kidney Score Platform was developed with a patient-facing online Risk Calculator and a clinician-facing Clinical Practice Toolkit. The Risk Calculator utilizes risk predictive analytics to provide interactive health information tailored to an individual’s chronic kidney disease risk and health status. The Clinical Practice Toolkit assists clinicians in discussing chronic kidney disease with individuals at risk for and with kidney disease and in managing their patient population with chronic kidney disease. The Kidney Score Platform will be tested in 2 Veterans Affairs primary health care settings using a pre–post study design. Outcomes will include changes in patient self-efficacy for chronic kidney disease management (primary outcome), quality of communication with clinicians about chronic kidney disease, and practitioners’ knowledge of chronic kidney disease guidelines. Process outcomes will identify usability and adoption of different elements of the Kidney Score Platform using qualitative and quantitative methods. Results: As of September 2020, usability studies are underway with veterans and clinicians to refine the patient-facing components of the Kidney Score Platform before study initiation. Results and subsequent changes to the Kidney Score Platform will be published at a later date. The study is expected to be completed by December 2021. Conclusions: Results of this study will be used to inform integration of the Kidney Score Platform within primary care settings so that it can serve as a central component of the National Kidney Foundation public awareness campaign to educate, engage, and empower individuals at risk for and living with chronic kidney disease.

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/10/e21377/; License: Creative Commons Attribution (CC-BY).
    Non-Randomized Study Protocols and...

    Oct 19, 2020

    The Diabetes Location, Environmental Attributes, and Disparities Network: Protocol for Nested Case Control and Cohort Studies, Rationale, and Baseline...

    Authors List:

    Abstract:

    Background: Diabetes prevalence and incidence vary by neighborhood socioeconomic environment (NSEE) and geographic region in the United States. Identifying modifiable community factors driving type 2 diabetes disparities is essential to inform policy interventions that reduce the risk of type 2 diabetes. Objective: This paper aims to describe the Diabetes Location, Environmental Attributes, and Disparities (LEAD) Network, a group funded by the Centers for Disease Control and Prevention to apply harmonized epidemiologic approaches across unique and geographically expansive data to identify community factors that contribute to type 2 diabetes risk. Methods: The Diabetes LEAD Network is a collaboration of 3 study sites and a data coordinating center (Drexel University). The Geisinger and Johns Hopkins University study population includes 578,485 individuals receiving primary care at Geisinger, a health system serving a population representative of 37 counties in Pennsylvania. The New York University School of Medicine study population is a baseline cohort of 6,082,146 veterans who do not have diabetes and are receiving primary care through Veterans Affairs from every US county. The University of Alabama at Birmingham study population includes 11,199 participants who did not have diabetes at baseline from the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study, a cohort study with oversampling of participants from the Stroke Belt region. Results: The Network has established a shared set of aims: evaluate mediation of the association of the NSEE with type 2 diabetes onset, evaluate effect modification of the association of NSEE with type 2 diabetes onset, assess the differential item functioning of community measures by geographic region and community type, and evaluate the impact of the spatial scale used to measure community factors. The Network has developed standardized approaches for measurement. Conclusions: The Network will provide insight into the community factors driving geographical disparities in type 2 diabetes risk and disseminate findings to stakeholders, providing guidance on policies to ameliorate geographic disparities in type 2 diabetes in the United States.

  • Source: The Authors / Placeit / Instagram; Copyright: The Authors / Placeit; URL: https://www.researchprotocols.org/2020/10/e20417; License: Licensed by JMIR.
    Non-randomized Protocols and Methods...

    Oct 19, 2020

    Comparing Web-Based Platforms for Promoting HIV Self-Testing and Pre-Exposure Prophylaxis Uptake in High-Risk Men Who Have Sex With Men: Protocol for a...

    Authors List:

    Abstract:

    Background: The majority of those living with HIV in the United States are men who have sex with men (MSM), and young, minority MSM account for more new HIV infections than any other group. HIV transmission can be reduced through detection and early treatment initiation or by starting pre-exposure prophylaxis (PrEP), but rates of testing are lower than recommended among MSM, and PrEP uptake has been slow. Although promoting HIV testing and PrEP uptake by placing advertisements on web-based platforms — such as social media websites and dating apps — is a promising approach for promoting HIV testing and PrEP, the relative effectiveness of HIV prevention advertising on common web-based platforms is underexamined. Objective: This study aims to evaluate the relative effectiveness of advertisements placed on 3 types of web-based platforms (social media websites, dating apps, and informational websites) for promoting HIV self-testing and PrEP uptake. Methods: Advertisements will be placed on social media websites (Facebook, Instagram, and Twitter), dating apps (Grindr, Jack’d, and Hornet), and informational search websites (Google, Yahoo, and Bing) to recruit approximately 400 young (18-30 years old), minority (Black or Latino) MSM at elevated risk of HIV exposure. Recruitment will occur in 3 waves, with each wave running advertisements on 1 website from each type of platform. The number of participants per platform is not prespecified, and recruitment in each wave will occur until approximately 133 HIV self-tests are ordered. Participants will complete a baseline survey assessing risk behavior, substance use, psychological readiness to test, and attitudes and then receive an electronic code to order a free home-based HIV self-test kit. Two follow-ups are planned to assess HIV self-test results and PrEP uptake. Results: Recruitment was completed in July 2020. Conclusions: Findings may improve our understanding of how the platform users’ receptivity to test for HIV differs across web-based platforms and thus may assist in facilitating web-based HIV prevention campaigns. Trial Registration: ClinicalTrials.gov NCT04155502; https://clinicaltrials.gov/ct2/show/NCT04155502

  • Source: Image created by the authors; Copyright: Shinsuke Sasada; URL: http://www.researchprotocols.org/2020/10/e17524/; License: Creative Commons Attribution (CC-BY).
    Non-randomized Protocols and Methods...

    Oct 19, 2020

    Microwave Breast Imaging Using Rotational Bistatic Impulse Radar for the Detection of Breast Cancer: Protocol for a Prospective Diagnostic Study

    Authors List:

    Abstract:

    Background: Mammography is the standard examination for breast cancer screening; however, it is associated with pain and exposure to ionizing radiation. Microwave breast imaging is a less invasive method for breast cancer surveillance. A bistatic impulse radar–based breast cancer detector has recently been developed. Objective: This study aims to present a protocol for evaluating the diagnostic accuracy of the novel microwave breast imaging device. Methods: This is a prospective diagnostic study. A total of 120 participants were recruited before treatment administration and divided into 2 cohorts: 100 patients diagnosed with breast cancer and 20 participants with benign breast tumors. The detector will be directly placed on each breast, while the participant is in supine position, without a coupling medium. Confocal images will be created based on the analyzed data, and the presence of breast tumors will be assessed. The primary endpoint will be the diagnostic accuracy, sensitivity, and specificity of the detector for breast cancer and benign tumors. The secondary endpoint will be the safety and detectability of each molecular subtype of breast cancer. For an exploratory endpoint, the influence of breast density and tumor size on tumor detection will be investigated. Results: Recruitment began in November 2018 and was completed by March 2020. We anticipate the preliminary results to be available by summer 2021. Conclusions: This study will provide insights on the diagnostic accuracy of microwave breast imaging using a rotational bistatic impulse radar. The collected data will improve the diagnostic algorithm of microwave imaging and lead to enhanced device performance. Trial Registration: Japan Registry of Clinical Trials jRCTs062180005; https://jrct.niph.go.jp/en-latest-detail/jRCTs062180005

  • Source: Unsplash; Copyright: Danielle Cerullo; URL: https://unsplash.com/photos/3ckWUnaCxzc; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (non-eHealth)

    Oct 16, 2020

    High-Intensity Interval Aerobic Resistance Training to Counteract Low Relative Appendicular Lean Soft Tissue Mass in Middle Age: Study Protocol for a...

    Authors List:

    Abstract:

    Background: Sarcopenia is the age-related loss of skeletal muscle mass and function and may exist in early middle age. Previous research in this area has focused on resistance training in older individuals; however, there is a lack of intervention trials in middle-aged adults with low relative appendicular lean soft tissue mass who may be at risk for sarcopenia in older age. Objective: This randomized controlled trial aims to determine the effects of a high-intensity interval aerobic resistance training intervention on appendicular lean soft tissue mass in middle-aged adults with low relative appendicular lean soft tissue mass. Methods: We will conduct a 40-week, single-blinded randomized controlled trial in 84 middle-aged adults with low appendicular lean soft tissue mass in the wider Dunedin area, New Zealand. We will randomly allocate participants to receive either a group-based, 20-week high-intensity interval aerobic resistance training intervention program or a single, 60-minute education session on current exercise recommendations. After the first 20 weeks, both groups will be given a 20-week home program. The study will assess primary and secondary outcome measures, including body composition (regional and whole-body lean soft tissue mass, fat mass, percentage body fat, measured by dual x-ray absorptiometry), blood biomarkers (cortisol, creatinine, C-reactive protein, lipid profile, hemoglobin), physical fitness (maximum oxygen consumption, blood pressure), physical activity (accelerometry), physical function (handgrip strength, sit-to-stand, gait speed, quadriceps strength), and self-reported questionnaires (health outcomes, self-efficacy, perceived enjoyment of physical activity, and multifactorial lifestyle), at baseline, 20 weeks, and 40 weeks. Physical function and self-reported questionnaires will also be measured at 10 weeks. We will assess the primary outcome measure, total body lean soft tissue mass, at baseline, 20 weeks, and 40 weeks. Analyses will be performed using intention-to-treat principles, comparing the outcomes resulting from the intervention, using linear mixed models. Results: We obtained ethical approval for this study from The University of Otago Human Ethics Committee on December 10, 2018. Participant recruitment started on February 11, 2019 and was completed on May 14, 2019. Data collection started on February 25, 2019 and was completed on February 28, 2020. We expect to publish the results in January 2021. Conclusions: High-intensity interval aerobic resistance training is a time-efficient form of exercise, enabling busy middle-aged adults to meet physical activity recommendations while maximizing training results. The findings can inform the development of future prevention-focused interventions aimed at counteracting the high prevalence of sarcopenia in the aging population. Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN12618001778279); https://tinyurl.com/y555z6fz.

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    Open Peer Review Period: Oct 16, 2020 - Dec 11, 2020

    Background: Globally, the prevalence of type 1 diabetes (T1DM) is rising. In 2020, 124,652 Australians had T1DM. Maintaining optimal glycemic control [HbA1c ≤7.0% (≤53 mmol/mol)] on a standard car...

    Background: Globally, the prevalence of type 1 diabetes (T1DM) is rising. In 2020, 124,652 Australians had T1DM. Maintaining optimal glycemic control [HbA1c ≤7.0% (≤53 mmol/mol)] on a standard carbohydrate diet can be a challenge for people living with T1DM. The Diabetes Complications and Control Trial established that macrovascular and microvascular complications could be reduced by improving glycemic control. Recent studies have found that a very low or low carbohydrate diet can improve glycemic control. However, the overall evidence relating to an association between a very low or low carbohydrate diet and glycemic control in people living with T1DM is both limited and mixed. In addition, research has suggested that poor quality of life (QoL) due to anxiety and depression adversely influences glycemic control. Despite a potential link between a very low or low carbohydrate diet and good glycemic control, no research to our knowledge has examined an association between a very low or low carbohydrate diet, QoL and glycemic control, making this study unique in its approach. Objective: The study aims to: 1) develop a validated diabetes specific quality of life questionnaire for use in Australian adults with T1DM and 2) determine if an association exists between a low carbohydrate diet, quality of life and glycemic control in Australian adults living with T1DM. Methods: This cross-sectional study will be conducted in a tertiary hospital outpatient setting and will consist of three phases. Phase 1, online Australian diabetes specific quality of life questionnaire development and piloting (n=25-30 T1DM adults); Phase 2, questionnaire validation (n=364 T1DM adults) and Phase 3, a 12-week dietary intervention to determine if an association exists between a low carbohydrate diet, QoL and glycemic control in adults with T1DM (n=16-23 T1DM adults). The validation of the study developed Australian diabetes specific quality of life questionnaire and change in HbA1c and QoL in adults with T1DM while undertaking a low carbohydrate diet over 12 weeks will be the primary outcomes of this study. Results: Results: Study phase 1 is currently open for recruitment. It is anticipated the first results will be submitted for publication in November 2021. Presently, no results are available. Conclusions: This study is the first of its kind and will firstly generate a new validated instrument, which could be used in evidence-based practice and research to understand T1DM adults QoL. Secondly, the low carbohydrate dietary intervention outcomes could be used to inform clinicians about an alternative approach to assist T1DM Australian adults to improve their QoL and glycemic control. Finally, this study could warrant the development of an evidence based low carbohydrate dietary guideline for adults living with T1DM with the potential to have a profound impact on this population. Clinical Trial: ClinicalTrials.gov NCT04213300; https://www.clinicaltrials.gov/ct2/show/NCT04213300

  • XatJove Anoia, as a tool to bring health services closer to teenagers: A quasi-experimental study

    Date Submitted: Oct 16, 2020

    Open Peer Review Period: Oct 16, 2020 - Dec 11, 2020

    Background: The Catalan Health and School program aims to improve the health of adolescents through health promotion measures, risk prevention and early care for problems related to mental health, emo...

    Background: The Catalan Health and School program aims to improve the health of adolescents through health promotion measures, risk prevention and early care for problems related to mental health, emotional and sexual health and the consumption of drugs, alcohol and tobacco. Adolescents are often reluctant to seek counseling and/or health treatment for “embarrassing” or stigmatized conditions. As an anonymous digital health intervention, XatJove has the potential to address this problem. In the current climate of a health crisis caused by the COVID-19 pandemic and in an attempt to reduce the risk of infection, it makes more sense than ever to try to avoid face-to-face consultations with nursing staff in schools and also visits by young people to Primary Care Centres using digital health interventions. Objective: The objective of this study is to demonstrate that the use of mobile phones and messaging apps increases the number of health consultations as part of the Health and School program in the Anoia region in Catalonia. Methods: A quasi-experimental study of adolescents aged between 12 and 16 from secondary schools, comparing the total number of consultations (face-to-face and via XatJove) as part of the Health and School program in the Anoia region during the 2020-2021 academic year with the number of face-to-face consultations as part of the same program in the Osona region. Students will be asked to participate in a follow up study involving a focus group to learn more about the usefulness of XatJove. Results: The study is projected to start at the beginning of November 2020 and its will finish in June 2021 when data analysis is expected to start. Conclusions: The results could be of help in the evaluation, development and planning of school health programs. Clinical Trial: NCT04562350 (Registration data September 24, 2020)

  • haMSter: a smartphone application for tracking patient reported outcomes in people with multiple sclerosis: protocol for a pilot study

    Date Submitted: Oct 15, 2020

    Open Peer Review Period: Oct 14, 2020 - Dec 9, 2020

    Background: Treatment and monitoring decisions in people with multiple sclerosis (MS) are based commonly on clinician reported outcomes (CROs). These reflect physical and radiological disease activity...

    Background: Treatment and monitoring decisions in people with multiple sclerosis (MS) are based commonly on clinician reported outcomes (CROs). These reflect physical and radiological disease activity and are the most relevant endpoints in clinical trials. Over the past few years, the number of studies evaluating so-called patient reported outcomes (PROs) has been increasing. PROs are reports from patients concerning their own health perception. They are typically obtained by means of questionnaires and aim to quantify symptoms such as fatigue, depression or sexual dysfunction. The emergence of PROs has made a tremendous contribution to understanding the individual impact of disease in people with MS (pwMS) and their health-related quality of life. However, the assessment of PROs consumes resources of time and personnel. Thus, useful ways to conveniently introduce PROs into clinical practice are needed. Objective: To provide a rationale and pilot study protocol for a mobile health solution named “haMSter” that allows for remote monitoring of PROs in pwMS. Methods: The core function of haMSter is to provide three scientifically validated PROs relevant to MS for patients to fill out at home once a month. Thereby, longitudinal and remote documentation of PROs is enabled. A scoring algorithm graphically plots PRO scores over time and makes them available at the next visit. Results: A pilot study is currently ongoing and will evaluate adherence to this mobile-health (m-health) solution in 50 patients using haMSter over a period of six months. Conclusions: haMSter is a novel m-health based solution to modern PRO research which may constitute a first step in achieving to integrate PROs in clinical practice. This allows for a more problem-oriented approach in monitoring visits that addresses the patient’s needs and, ultimately, saves time. Clinical Trial: ClinicalTrials.gov Identifier: NCT04555863.

  • Phototherapy using a Light Emitting Fabrics device (Bubolight® device) in the treatment of new-born jaundice: Protocol for an interventional efficacy and safety study.

    Date Submitted: Oct 13, 2020

    Open Peer Review Period: Oct 6, 2020 - Dec 1, 2020

    Background: Neonatal jaundice is a very common condition occurring in 60–80% of all healthy term and late preterm neonates. In the newborn and especially in premature infants, the liver, which is st...

    Background: Neonatal jaundice is a very common condition occurring in 60–80% of all healthy term and late preterm neonates. In the newborn and especially in premature infants, the liver, which is still immature, is unable to eliminate the full amount of bilirubin. In the majority of cases, neonatal jaundice resolves spontaneously and causes no harm; however, in some babies, significant hyperbilirubinemia can develop. Bilirubin then accumulates in the blood and when too high, it can then lead to a serious neurological disease: kernicterus jaundice. Phototherapy is an effective therapy for jaundice and ideal phototherapy device should have a broad light emission surface, in order to cover the maximum of the body surface in the horizontal plane, it should generate no or little heat and provide a wavelength and light intensity optimal (420-490nm and ≥ 30µw / cm²/nm) Objective: The aim of the study is to investigate the feasibility, safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy, BUBOLight®, to which luminous textile have been incorporated in a sleeping bag. BUBOLight® emits homogeneous and stable light with a wavelength of 445 nm, for an irradiance of 3.5 mW/cm². It is easy to use and allows to carry out the phototherapy in the arms of the parents, thus preserving the parent–infant bonding. The primary end point of the study is to evaluate the safety of the BUBOLight® phototherapy device as an alternative to conventional hospital phototherapy under the usual conditions for the management of newborns jaundice. Secondary end points are the incidence of side effects (diarrhea, dehydration, skin lesions, temperature) related to phototherapy, evolution of blood bilirubin rate, perceptions of the parents and health team with the use of the device and the impact of the device on parent-child interactions and child comfort. Methods: The trial is an interventional, exploratory, simple group, non-randomized and single center (Lille Hospital) study. Ten to fifteen newborns and their parents will be included to obtain evaluable data from 10 parent-newborn pairs. Newborns more than 2500g of birth weight and born at greater than or equal to 37 weeks of gestation that required phototherapy according to the guidelines of the National Institute For Health and Clinical Excellence will receive one session of 4 hours of illumination. Bilirubin seric and transcutaneous levels were taken at the start and 2 hours after the end of phototherapy. Axillary temperature, heart rate and oxygen saturation will be measured at the beginning and during phototherapy. Number of subjects is therefore not calculated on the basis of statistical assumptions. The objective is to obtain a minimum proportion of 90% of the newborns included (i.e. 9 out of 10) who have been able to undergo 4-hours phototherapy treatment without unacceptable and unexpected toxicities. We will calculate the mean, median, quartiles, minimum and maximum of the quantitative parameters and the frequency of the qualitative parameters. The rate of patients with no unacceptable and unexpected toxicities (primary endpoint) will be calculated. Results: First patient is expected to be included at the end of 2020 and clinical investigations are planned until June 2021. The final results of this study are expected to be available at the end of 2021 Conclusions: This trial aims to evaluate the safety and feasibility of a new phototherapy device based on light emitting fabrics for the treatment of newborn jaundice. The objective of this new system if, it is effective, to improve the humanization of newborn care avoiding the mother-and-child separation. Clinical Trial: ClinicalTrials.gov NCT04365998; https://clinicaltrials.gov/ct2/show/NCT04365998

  • Using the Intervention Mapping Protocol to Develop an App-Based Parenting Program to Promote Healthy Energy Balance-Related Parenting Practices

    Date Submitted: Oct 6, 2020

    Open Peer Review Period: Oct 6, 2020 - Dec 1, 2020

    Background: The family environment plays an important role in the development of children’s energy-balance related behaviors (EBRBs). As a result, parents’ energy-balance parenting practices (EBRP...

    Background: The family environment plays an important role in the development of children’s energy-balance related behaviors (EBRBs). As a result, parents’ energy-balance parenting practices (EBRPPs) are eminent targets of preventive childhood obesity programs. Families with a lower socioeconomic position (SEP) may benefit from participating in such programs, but are generally less well reached than families with a higher SEP. Objective: This study describes the application of the Intervention Mapping Protocol (IMP) for the development of an app-based preventive intervention program to promote healthy EBRPPs among parents of children (0-4 years old) with a lower SEP. Methods: The six steps of the IMP were used as a theory- and evidence-based framework to guide the development of the app-based preventive intervention program. Results: In Step 1, behavioral outcomes for the app-based program (ie, children have a healthy dietary intake, sufficient sleep, and restricted screen time/sufficient physical activity) and socio-cognitive (ie, knowledge, attitudes, self-efficacy) and automatic (ie, habitual behaviors) determinants of energy-balance related parenting were identified through a needs assessment. In Step 2, the behavioral outcomes were translated into performance objectives. To influence these objectives, in Step 3 theory-based intervention methods were selected for each of the determinants. In Step 4, the knowledge derived from the previous steps allowed for the development of the app-based program Samen Happie! through a process of continuous co-creation with parents and health professionals. In Step 5, community health services were identified as potential adopters for the app. Lastly, in Step 6, two (randomized controlled) trials were designed to evaluate the process and effects of the app among Dutch parents of infants (Trial 1) and preschoolers (Trial 2). These trials were completed in November 2019 (Trial 1) and February 2020 (Trial 2). Conclusions: The IMP allowed for effective development of the app-based parenting program Samen Happie! to promote healthy EBRPPs among parents of infants and preschoolers. Through the integration of theory, empirical evidence, and data from the target population, as well as the process of continued co-creation, the program specifically addresses parents with a lower SEP. This increases the potential of the program to prevent the development of obesity in early childhood among families with a lower SEP in particular. Clinical Trial: Netherlands Trial Register (NTR) NL6727; https://www.trialregister.nl/trial/6727 Netherlands Trial Register (NTR) NL7371; https://www.trialregister.nl/trial/7371

  • An Individual Cognitive Stimulation Therapy Application (iCST app) for People With Dementia and Carers: Protocol for a Feasibility Randomized Controlled Trial.

    Date Submitted: Sep 28, 2020

    Open Peer Review Period: Sep 28, 2020 - Nov 23, 2020

    Background: There is a need for more resources to support the cognition and quality of life (QoL) of people with dementia. The individual Cognitive Stimulation Therapy application (iCST app) aims to p...

    Background: There is a need for more resources to support the cognition and quality of life (QoL) of people with dementia. The individual Cognitive Stimulation Therapy application (iCST app) aims to provide cognitive stimulation and social interaction to people with dementia and carers through interactive touch-screen technology. It has been developed according to the principles of CST and iCST which have previously shown to improve the cognition and QoL of people with dementia, and to benefit the relationship between the person with dementia and carer, while improving quality of the carer’s life. This study aims to evaluate the feasibility of conducting a full-scale, randomized controlled trial (RCT) with the iCST app. Objective: To evaluate the feasibility of conducting a full-scale RCT with the iCST app compared to a treatment as usual (TAU) control group. Methods: A multi-centre, pragmatic, single blind, feasibility RCT with a treatment as usual (TAU) control group. This study aims to recruit 60 people with mild to moderate dementia and their informal carers as dyads. Both parties must be able to provide informed consent and participate in the intervention. Dyads will complete a baseline assessment which will include cognition and QoL measures, and will subsequently be randomized (1:1) to the iCST app intervention in addition to usual care, or to usual care only. All participants will be followed-up at 5 weeks and 11 weeks post-baseline. A range of feasibility outcomes will be assessed including recruitment and retention rates, intervention fidelity and usability, and acceptability of the outcome measures. A sample of the experimental group will be invited to a semi-structured post-trial interview to further examine the experience of using the iCST app. Results: Recruitment began in November 2018 with 43 dyads recruited from primary and secondary care settings. Participants were randomized to the iCST app (n = 21) or TAU control group (n = 22) with a relatively low attrition rate throughout the study (n = 2). Dementia support groups and (online) research databases led to the majority of the referrals for the study. Conclusions: This study will investigate whether it is feasible to conduct a full-scale RCT to evaluate the clinical effectiveness of the iCST app in comparison to usual care alone. In addition, it will further examine the usability of the iCST app. The data will provide information on potential modifications to be made to the intervention, study design, and study process. Clinical Trial: ClinicalTrials.gov, NCT03282877. Registered on 19 July 2017.

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