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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: Gustavo Fring; URL: https://www.pexels.com/photo/woman-in-blue-scrub-suit-helping-woman-sitting-on-bed-3985299/; License: Licensed by JMIR.
    Non-Randomized Study Protocols and...

    Nov 23, 2020

    Risk Perception of Health Professionals in Intrapartum Care Decisions: Protocol for a Mixed Methods Study

    Authors List:

    Abstract:

    Background: Risk perception plays an important role in decision-making processes. Differences in obstetric intervention rates suggest that, in addition to medical indications, the risk perception of obstetric health professionals might have a major influence on their decision-making process during childbirth. Although studies have investigated whether risk perception affects the role of midwifery or influences decision making during childbirth, little is known about what obstetric health professionals actually perceive as risk or risky situations and whether different risk perceptions lead to more interventions during intrapartum care. Objective: The objective of this study is to understand the association of risk perception and the decision-making processes of obstetric health professionals (midwives and obstetricians) in Germany during intrapartum care. The study has 3 specific aims: (1) gain insight into what obstetric health professionals perceive as risk in the German clinical setting, (2) assess the extent to which personal and systemic factors have an impact on obstetric health professionals’ risk perception, and (3) investigate whether different perceptions of risk are associated with different decisions being made by obstetric health professionals. Methods: This is an exploratory sequential mixed methods study with 2 phases, a qualitative followed by a quantitative phase. In the first phase, qualitative data are collected and analyzed by conducting focus group discussions and applying qualitative content analysis to address aim 1. In the second phase, for aims 2 and 3 and to help explain the qualitative results, quantitative data are collected and analyzed by conducting an observational study using case vignettes within a survey constructed on the basis of the qualitative results. Results: Enrollment in the first (qualitative) phase began in July 2019, and data collection and analysis have been completed. The second (quantitative) phase is currently planned, and data collection is expected to start in December 2020. First results of the qualitative phase are expected to be submitted for publication in 2020, with completion of the second phase scheduled for 2021. Conclusions: This mixed methods study will examine the perception of risk and its association with the decision-making processes of obstetric health professionals during their care of women in childbirth. The rationale for this approach is that the qualitative data and their analysis explore participants' views in more depth, while the quantitative data will help to provide and explore a general understanding of the research problem. The results are expected to be relevant to health care professionals, policymakers, and educational institutions in order to minimize underuse, overuse, and misuse of interventions during intrapartum care. Trial Registration: German Clinical Trials Register DRKS00017172; https://tinyurl.com/y2zoowkx

  • Source: flickr; Copyright: NEC Corporation of America; URL: https://www.flickr.com/photos/42956186@N04/14445634744; License: Creative Commons Attribution (CC-BY).
    Scoping Review Protocols

    Nov 20, 2020

    Use and Evaluation of Computerized Clinical Decision Support Systems for Early Detection of Sepsis in Hospitals: Protocol for a Scoping Review

    Authors List:

    Abstract:

    Background: Sepsis is a leading cause of death in hospitals, with high associated costs for both patients and health care systems worldwide. Early detection followed by timely intervention is critical for successful sepsis management and, hence, can save lives. Health care institutions are increasingly leveraging clinical data captured in electronic health records for the development of computerized clinical decision support (CCDS) systems aimed at enhancing the early detection of sepsis. However, a comprehensive evidence base regarding sepsis CCDS systems to inform clinical practice, research, and policy is currently lacking. Objective: This scoping review aims to systematically describe studies reporting on the use and evaluation of CCDS systems for early detection of sepsis in hospitals. Methods: The methodology for conducting scoping reviews presented by the Joanna Briggs Institute Reviewer’s Manual and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) will be used and adapted as guides. A comprehensive literature search of 10 electronic databases will be conducted to identify all empirical quantitative and qualitative studies that investigate the use of CCDS systems for early detection of sepsis in hospitals. Detailed inclusion and exclusion criteria have been developed. Two reviewers will independently screen all articles based on these criteria. Any discrepancies will be resolved through discussion and further review by a third researcher if required. Results: Electronic database searches have retrieved 12,139 references after removing 10,051 duplicates. As of the submission date of this protocol, we have completed the title and abstract screening. A total of 372 references will be included for full-text screening. Only 15.9% (59/372) of these studies were focused on children: 11.0% (41/372) for pediatric and 4.8% (18/372) for neonatal patients. The scoping review and the manuscript will be completed by December 2020. Conclusions: Results of this review will guide researchers in determining gaps and shortcomings in the current evidence base for CCDS system use and evaluation in the early detection of sepsis. The findings will be shared with key stakeholders in clinical care, research, policy, and patient advocacy.

  • Source: Pexels; Copyright: freestocks.org; URL: https://www.pexels.com/photo/women-holding-space-gray-iphone-x-and-black-pen-744461/; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (funded,...

    Nov 20, 2020

    Development of a Personalized Mobile Mental Health Intervention for Workplace Cyberbullying Among Health Practitioners: Protocol for a Mixed Methods Study

    Authors List:

    Abstract:

    Background: Workplace cyberbullying harms the psychological and social functioning of professionals working in an organization and may decrease the productivity and efficiency of daily life tasks. A recent study on trainee doctors across 8 different United Kingdom National Health Service trusts found health issues and job dissatisfaction in people who have experienced workplace cyberbullying. This disabling effect is even more noticeable in low-socioeconomic communities within low-income countries. In Malaysia, there is a need to create a personalized mobile mental health intervention program for health care professionals. These programs should be directed to prevent and decrease psychosocial issues and enhance coordination among health care professionals to solve health issues in the community. Objective: Our main objective is to study the pre-effects and posteffects of the Personalized Mobile Mental Health Intervention (PMMH-I) for workplace cyberbullying in public and private hospitals in Malaysia. Methods: A hospital-based multimethod multi-analytic evidential approach is proposed, involving social and psychological health informatics. The project has been subdivided into 3 stages, starting with Phase 1, a prevalence study, followed by exploratory studies. Phase 2 consists of a quasi-experimental design, whereas the development of a prototype and their testing will be proposed in Phase 3. Each stage includes the use of quantitative and qualitative methods (mixed-method program), using SPSS (version 26.0; IBM Corp) and Stata (version 16.1; StataCorp) as tools for quantitative research, and NVivo (version 1.0; QSR International) and Atlas.ti (version 9.0.16; ATLAS.ti Scientific Software Development GmbH) for qualitative research. Results: The results of this study will determine the pre- and posteffectiveness of an integrated PMMH-I for health care professionals. The prototype system platform will be developed and implemented in a public and private hospital. Results from Phase 1 will be published in 2021, followed by the implementation of Phase 2 in subsequent years. Conclusions: This study will provide evidence and guidance regarding the implementation of a personalized mobile mental health intervention for health care professionals into routine public and private hospitals to enhance communication and resolve conflicts.

  • The Active Brains logo. Source: Image created by the authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/9/e18929/; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (funded,...

    Nov 20, 2020

    The Active Brains Digital Intervention to Reduce Cognitive Decline in Older Adults: Protocol for a Feasibility Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults. Objective: In this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial. Methods: In the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463). Results: Results will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021. Conclusions: The findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial. Trial Registration: International Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980

  • Source: Creative Commons; Copyright: RTIfightsNTDs; URL: https://search.creativecommons.org/photos/c7d25c3d-6803-4dc9-a138-9f8ce589b005; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (non-eHealth)

    Nov 19, 2020

    Mass Drug Administration With High-Dose Ivermectin and Dihydroartemisinin-Piperaquine for Malaria Elimination in an Area of Low Transmission With High...

    Authors List:

    Abstract:

    Background: With a decline in malaria burden, innovative interventions and tools are required to reduce malaria transmission further. Mass drug administration (MDA) of artemisinin-based combination therapy (ACT) has been identified as a potential tool to further reduce malaria transmission, where coverage of vector control interventions is already high. However, the impact is limited in time. Combining an ACT with an endectocide treatment that is able to reduce vector survival, such as ivermectin (IVM), could increase the impact of MDA and offer a new tool to reduce malaria transmission. Objective: The study objective is to evaluate the impact of MDA with IVM plus dihydroartemisinin-piperaquine (DP) on malaria transmission in an area with high coverage of malaria control interventions. Methods: The study is a cluster randomized trial in the Upper River Region of The Gambia and included 32 villages (16 control and 16 intervention). A buffer zone of ~2 km was created around all intervention clusters. MDA with IVM plus DP was implemented in all intervention villages and the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program plans. Results: The MDA campaigns were carried out from August to October 2018 for the first year and from July to September 2019 for the second year. Statistical analysis will commence once the database is completed, cleaned, and locked. Conclusions: This is the first cluster randomized clinical trial of MDA with IVM plus DP. The results will provide evidence on the impact of MDA with IVM plus DP on malaria transmission. Trial Registration: ClinicalTrials.gov NCT03576313; https://clinicaltrials.gov/ct2/show/NCT03576313

  • Source: Rawpixel; Copyright: eyeeyeview; URL: https://www.rawpixel.com/image/2298857/free-photo-image-heart-attack-heart-disease-heart-attack; License: Licensed by JMIR.
    Non-randomized Protocols and Methods...

    Nov 19, 2020

    Quality Assessment of an Integrated Care Pathway Using Telemonitoring in Patients with Chronic Heart Failure and Chronic Obstructive Pulmonary Disease:...

    Authors List:

    Abstract:

    Background: Chronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD) often coexist and are associated with a high morbidity and reduced quality of life (QoL). Although these diseases share similarities in symptoms and clinical course, and exacerbations of both diseases often overlap, care pathways for both conditions are usually not integrated. This results in frequent outpatient consultations and suboptimal treatment during exacerbations, leading to frequent hospital admissions. Therefore, we propose an integrated care pathway for both diseases, using telemonitoring to detect deterioration at an early stage and a single case manager for both diseases. Objective: This study aims to investigate whether an integrated care pathway using telemonitoring in patients with combined CHF and COPD results in a higher general health-related QoL (HRQoL) as compared with the traditional care pathways. Secondary end points include disease-specific HRQoL, level of self-management, patient satisfaction, compliance to the program, and cost-effectiveness. Methods: This is a monocenter, prospective study using a quasi-experimental interrupted time series design. Thirty patients with combined CHF and COPD are included. The study period of 2.5 years per patient is divided into a preintervention phase (6 months) and a postintervention phase (2 years) in which end points are assessed. The intervention consists of an on-demand treatment strategy based on monitoring symptoms related to CHF/COPD and vital parameters (weight, blood pressure, heart rate, oxygen saturation, temperature), which are uploaded on a digital platform. The monitoring frequency and the limit values of the measurements to detect abnormalities are determined individually. Monitoring is performed by a case manager, who has the opportunity for a daily multidisciplinary meeting with both the cardiologist and the pulmonologist. Routine appointments at the outpatient clinic are cancelled and replaced by telemonitoring-guided treatment. Results: Following ethical approval of the study protocol, the first patient was included in May 2018. Inclusion is expected to be complete in May 2021. Conclusions: This study is the first to evaluate the effects of a novel integrated care pathway using telemonitoring for patients with combined CHF and COPD. Unique to this study is the concept of remote on-demand disease management by a single case manager for both diseases, combined with multidisciplinary meetings. Moreover, modern telemonitoring technology is used instead of, rather than as an addition to, regular care. Trial Registration: Netherlands Trial Register NL6741; https://www.trialregister.nl/trial/6741

  • Source: Freepik; Copyright: wavebreakmedia_micro; URL: https://www.freepik.com/free-photo/sad-doctor-leaning-wall_9597529.htm#page=1&query=doctor%20stress&position=0; License: Licensed by JMIR.
    Systematic Review Protocols

    Nov 18, 2020

    The Effect of the COVID-19 Pandemic on Health Care Workers’ Anxiety Levels: Protocol for a Meta-Analysis

    Authors List:

    Abstract:

    Background: The COVID-19 pandemic has been declared a public health emergency of international concern; this has caused excessive anxiety among health care workers. In addition, publication bias and low-quality publications have become widespread, which can result in the dissemination of unreliable findings. Objective: This paper presents the protocol for a meta-analysis with the following two aims: (1) to examine the prevalence of anxiety among health care workers and determine whether it has increased due to the COVID-19 pandemic, and (2) to investigate whether there has been an increase in publication bias. Methods: All related studies that were published/released from 2015 to 2020 will be searched in electronic databases (Web of Science, PubMed, PsyArXiv, and medRxiv). The risk of bias in individual studies will be assessed using the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist. The heterogeneity of the studies will be assessed using the I2 statistic. The effect size (prevalence rates of anxiety) and a 95% CI for each paper will also be calculated. We will use a moderator analysis to test for the effect of COVID-19 on health care workers’ anxiety levels and detect publication bias in COVID-19 studies. We will also assess publication bias using the funnel plot and Egger regression. In case of publication bias, if studies have no homogeneity, the trim-and-fill procedure will be applied to adjust for missing studies. Results: Database searches will commence in November 2020. The meta-analysis will be completed within 2 months of the start date. Conclusions: This meta-analysis aims to provide comprehensive evidence about whether COVID-19 increases the prevalence of anxiety among health care workers and whether there has been an increase in publication bias and a deterioration in the quality of publications due to the pandemic. The results of this meta-analysis can provide evidence to help health managers to make informed decisions related to anxiety prevention in health care workers.

  • PTSD following sexual assault is a global concern. Source: Prove Unifesp; Copyright: @prove.unifesp; URL: https://www.facebook.com/prove.unifesp/; License: Public Domain (CC0).
    RCTs - Protocols/Proposals (non-eHealth)

    Nov 18, 2020

    Posttraumatic Stress Disorder and Neuroprogression in Women Following Sexual Assault: Protocol for a Randomized Clinical Trial Evaluating Allostatic Load and...

    Authors List:

    Abstract:

    Background: Posttraumatic stress disorder (PTSD) is a prevalent, chronic, and severe disorder related to traumatic events. Women are disproportionately affected by PTSD than men and are more at risk in the occurrence of sexual assault victimization. Estimates suggest that 50% of women develop PTSD following sexual assault and successful clinical management can be challenging. Growing evidence has implicated neural, immune, and endocrine alterations underpinning PTSD, but only few studies have assessed the evolution of acute PTSD in women. Objective: This study aims to measure whether the onset of PTSD is associated with accelerated aging in women following sexual assault. We hypothesize that the increase of allostatic load caused by PTSD leads to neuroprogression. We will implement a randomized clinical trial to compare responses to treatment with either interpersonal psychotherapy adapted for PTSD (IPT-PTSD) or the selective serotonin reuptake inhibitor sertraline. Methods: We will include women between 18 and 45 years of age, who experienced sexual assault from 1 to 6 months before the initial evaluation, and present with a Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnosis of PTSD. Baseline evaluation will comprise clinical and psychometric assessments, structural and functional magnetic resonance imaging, neuropsychological testing, polysomnography, evaluation of immune and endocrine parameters, and genetic analyses. Age-matched female healthy controls will be included and subjected to the same evaluation. Patients will be randomized for treatment in 1 of the 2 arms of the study for 14 weeks; follow-up will continue until 1 year after inclusion via treatment as usual. The researchers will collect clinical and laboratory data during periodic clinical assessments up to 1-year follow-up. Results: Data collection started in early 2016 and will be completed by the end of the first semester of 2020. Analyses will be performed soon afterward, followed by the elaboration of several articles. Articles will be submitted in early 2021. This research project has obtained a grant from the Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP 2014/12559-5). Conclusions: We expect to provide insight into the consequences of recent sexual assault exposure in women by investigating the degree of neuroprogression developing from an early stage of PTSD. We also expect to provide important evidence on the efficacy of a non-exposure psychotherapy (IPT-PTSD) to mitigate PTSD symptoms in recently sexually assaulted women. Further, we aim to obtain evidence on how treatment outcomes are associated with neuroprogression measures. Trial Registration: Brazilian Clinical Trials Registry RBR-3z474z; http://www.ensaiosclinicos.gov.br/rg/RBR-3z474z/

  • TOC image. Source: Shutterstock; Copyright: Syda Productions; URL: https://www.shutterstock.com/image-photo/alcoholism-alcohol-addiction-people-concept-male-1103218733; License: Licensed by the authors.
    Non-randomized Protocols and Methods...

    Nov 17, 2020

    Implementation and Evaluation of a Text Message–Based Addiction Counseling Program (Text4Hope-Addiction Support): Protocol for a Questionnaire Study

    Authors List:

    Abstract:

    Background: With the emergence of the COVID-19 pandemic, providing counseling to people with drug or alcohol addiction while maintaining physical distance has been challenging. This protocol describes the use of text messaging (as used in the Text4Hope-Addiction Support program) as a convenient, evidence-based, cost-effective, and accessible population-level mental health intervention with high user satisfaction proven in prior research. Objective: The project goal is to implement a program of daily supportive text messaging (Text4Hope-Addiction Support) to reduce drug or alcohol cravings as well as anxiety and depression, typically associated with alcohol and substance use disorders. The aim of this study is to evaluate the prevalence of cravings, anxiety, and depressive symptoms; demographic correlates of the same; and the outcomes of the Text4Hope-Addiction Support intervention in mitigating cravings, anxiety, and depressive symptoms. Methods: Self-administered, anonymous, online questionnaires will be used to assess cravings for the primary substance of addiction (Brief Substance Craving Scale), anxiety (Generalized Anxiety Disorder-7), and depressive symptoms (Patient Health Questionnaire-9). Data will be collected at baseline (onset of receiving text messages), program midpoint (6 weeks), and program end (12 weeks). Results: As of October 2020, data collection is in progress; and it is expected to be completed by fall 2021. Data analysis will include parametric and nonparametric techniques, focusing on primary outcomes (ie, cravings, anxiety, and depressive symptoms) and metrics of use, including the number of subscribers and user satisfaction. Conclusions: This Text4Hope-Addiction Support project will provide key information regarding the prevalence rates of cravings, anxiety, and depressive symptoms among persons with alcohol and substance use disorders; demographic correlates of cravings, anxiety, and depression; and outcome data related to this scalable population-level intervention. Information from this study will be valuable for addiction care practitioners; it will inform the policy and decision making regarding population-level addiction treatment and support during emergencies.

  • Source: Pexels; Copyright: Ketut Subiyanto; URL: https://www.pexels.com/photo/black-woman-messaging-on-modern-cellphone-4350099/; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (eHealth)

    Nov 16, 2020

    Digital Support for Healthier Eating Habits Among Patients With Type 2 Diabetes: Protocol for a Randomized Clinical Trial Within Primary Care (HAPPY Trial)

    Authors List:

    Abstract:

    Background: Despite the large impact that dietary habits have in the management of diabetes, few tools for supporting healthy eating habits are available for persons with diabetes. Objective: The aim of this randomized clinical trial is to evaluate the effect of a 12-week, mobile health (mHealth), app-based intervention promoting healthy eating habits among patients with type 2 diabetes. Methods: The HAPPY (Healthy eating using APP technologY) trial is a randomized clinical trial with two arms aiming to include 200 patients, 18 years of age or older, with type 2 diabetes. Both women and men are eligible for inclusion. Study participants are randomized 1:1 to an intervention group, where they are instructed to use a smartphone app promoting healthy eating, or to a control group, where they receive standard primary care only, for a period of 12 weeks. Each week a new topic (eg, vegetable intake) is introduced via the app. After an introduction text, the user is given a topic-related activity to perform (eg, eat one additional serving of vegetables per day during that week). The app records daily progress and sends automatic reminders or feedback to the user. Dietary intake, body composition, clinical variables, and biomarkers are measured at baseline and at 3- and 6-month follow-ups. An extensive web-based questionnaire comprising several validated questionnaires assessing a number of lifestyle factors is distributed via email at baseline and at 3-, 6-, and 12-month follow-ups; lifestyle factors include, for example, sleep, physical activity, eating behavior, and health-related quality of life. The effect of the intervention on dietary intake (primary outcome) and on glycated hemoglobin and blood lipid levels, body composition, blood pressure, other lifestyle factors, and overall health (secondary outcomes) will be assessed. Results: Data collection is ongoing. Recruitment of participants started in January 2019. Findings from the study are expected to be published by the end of 2021. Conclusions: Technology development provides new ways to promote and support long-term adherence to healthier eating habits. mHealth-based approaches allow for real-time interaction and the delivery of an intervention at any time. Further, focusing on overall diet allows the user to apply new knowledge to current eating patterns, creating an individualized approach. In this study, we evaluate the effect of using a new smartphone app promoting healthy eating habits on dietary intake, clinical markers, and lifestyle factors among patients with type 2 diabetes. Trial Registration: ClinicalTrials.gov NCT03784612; https://clinicaltrials.gov/ct2/show/NCT03784612

  • Source: Pixabay; Copyright: Engin_Akyurt; URL: https://pixabay.com/es/photos/coronavirus-virus-paciente-5064371/; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (eHealth)

    Nov 16, 2020

    A Self-Administered Multicomponent Web-Based Mental Health Intervention for the Mexican Population During the COVID-19 Pandemic: Protocol for a Randomized...

    Authors List:

    Abstract:

    Background: The COVID-19 pandemic has become a public health emergency of international concern; it has not only threatened people's physical health but has also affected their mental health and psychological well-being. It is necessary to develop and offer strategies to reduce the psychological impact of the outbreak and promote adaptive coping. Objective: This study protocol aims to describe a self-administered web-based intervention (Mental Health COVID-19) based on the principles of positive psychology supported by elements of cognitive behavioral therapy and behavioral activation therapy to reduce the symptoms of anxiety and depression and increase positive emotions and sleep quality during and after the COVID-19 outbreak through a telepsychology system. Methods: A randomized controlled clinical superiority trial with two independent groups will be performed, with intrasubject measures at four evaluation periods: pretest, posttest, 3-month follow-up, and 6-month follow-up. Participants will be randomly assigned to one of two groups: self-administered intervention with assistance via chat or self-administered intervention without assistance via chat. The total required sample size will be 166 participants (83 per group). Results: The clinical trial is ongoing. This protocol was approved by the Research Ethics Board of the Free School of Psychology-University of Behavioral Sciences (Escuela libre de Psicología-Universidad de Ciencias del Comportamiento). The aim is to publish the preliminary results in December 2020. A conservative approach will be adopted, and the size effect will be estimated using the Cohen d index with a significance level (α) of .05 (95% reliability) and a conventional 80% power statistic. Conclusions: The central mechanism of action will be to investigate the effectiveness of an intervention based on positive psychology through a web platform that can be delivered through computers and tablets, with content that has been rigorously contextualized to the Mexican culture to provide functional strategies to help the target users cope with the COVID-19 pandemic. Trial Registration: ClinicalTrials.gov NCT04468893; https://clinicaltrials.gov/ct2/show/NCT04468893

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/11/e19000/; License: Creative Commons Attribution (CC-BY).
    Non-Randomized Study Protocols and...

    Nov 13, 2020

    Improving Physical Activity in Adults Admitted to a Hospital With Interventions Developed and Implemented Through Cocreation: Protocol for a Pre-Post...

    Authors List:

    Abstract:

    Background: Admission to a hospital is often related with hospital-associated disabilities. Improving physical activity during hospitalization is considered effective to counteract hospital-associated disabilities, whereas many studies report on very low physical activity levels. Gradually developing and implementing interventions in cocreation with patients and health care professionals rather than implementing predefined interventions may be more effective in creating sustainable changes in everyday clinical practice. However, no studies have reported on the use of cocreation in the development and implementation of interventions aimed at improving physical activity. Objective: This protocol presents a study that aims to investigate if interventions, which will be developed and implemented in cocreation, improve physical activity among patients in surgery, internal medicine, and cardiology hospital wards. The secondary aims are to investigate effectiveness in terms of the reduction in the time patients spend in bed, the length of hospital stay, and the proportion of patients going home after discharge. Methods: The Better By Moving study takes place for 12 months at the following five different wards of a university hospital: two gastrointestinal and oncology surgery wards, one internal medicine hematology ward, one internal medicine infectious diseases ward, and one cardiology ward. The step-by-step implementation model of Grol and Wensing is used, and all interventions are developed and implemented in cocreation with health care professionals and patients. Outcome evaluation is performed across the different hospital wards and for each hospital ward individually. The primary outcome is the amount of physical activity in minutes assessed with the Physical Activity Monitor AM400 accelerometer in two individual groups of patients (preimplementation [n=110], and 13 months after the start of the implementation [n=110]). The secondary outcomes are time spent in bed measured using behavioral mapping protocols, and length of stay and discharge destination assessed using organizational data. A process evaluation using semistructured interviews and surveys is adopted to evaluate the implementation, mechanisms of impact, context, and perceived barriers and enablers. Results: This study is ongoing. The first participant was enrolled in January 2018. The last outcome evaluation and process evaluation are planned for May and June 2020, respectively. Results are expected in April 2021. Conclusions: This study will provide information about the effectiveness of developing and implementing interventions in cocreation with regard to improving physical activity in different subgroups of hospitalized patients in a university hospital. By following step-by-step implementation and by performing process evaluation, we will identify the barriers and enablers for implementation and describe the effect of new interventions on improving physical activity among hospitalized patients. Trial Registration: Netherlands Trial Register NL8480; https://www.trialregister.nl/trial/8480

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    Date Submitted: Nov 17, 2020

    Open Peer Review Period: Nov 16, 2020 - Nov 25, 2020

    Background: After gastrectomy, patients may experience the postgastrectomy syndrome and face difficulties adapting to everyday diet. Recently, human health coaching via a mobile application (app) has...

    Background: After gastrectomy, patients may experience the postgastrectomy syndrome and face difficulties adapting to everyday diet. Recently, human health coaching via a mobile application (app) has been used for obese patients or patients with chronic diseases, with significant improvements in clinical outcomes. Objective: The aim of this study is to evaluate and compare the effects of human health coaching via a mobile app and conventional face-to-face counseling in patients who underwent gastrectomy for gastric cancers. Methods: This study is a single-institution, prospective randomized controlled trial comparing the mobile health and face-to-face counselling groups. After randomization, participants assigned to the mobile health coaching group will receive health coaching via a mobile app for 3 months after discharge, and the assigned coaches will provide personalized advice based on the self-recorded health data. Participants in the face-to-face group will have 1- and 3-months postoperative dietary consultations with a clinical dietitian. The primary endpoint is the food restriction score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-STO22, and secondary endpoints included all other quality of life scale scores and nutritional parameters. The calculated sample size is 180, and the outcomes will be measured until 1-year post-surgery. Results: Recruitment started in May, 2020 and currently 51 patients have enrolled in the study. Anticipated date for the completion of enrolment is December 31, 2021 and entire data collection is expected to be completed by December 2022. Conclusions: This study will show the efficacy of human health coaching via a mobile app on dietary adaptation in patients who underwent gastrectomy. A relational approach based on personal data and timely intervention using a mobile platform could reduce patients’ trial and error and improve QoL. Clinical Trial: ClinicalTrials.gov, NCT04394585; http://clinicaltrials.gov/ct2/show/NCT040394585

  • The impact of enhanced recovery after surgery on total joint arthroplasty: A protocol for systematic review and meta-analysis

    Date Submitted: Nov 15, 2020

    Open Peer Review Period: Nov 15, 2020 - Jan 10, 2021

    Background: The number of total joint arthroplasty being performed is increasing worldwide. To match this increasing demand, there has been focus on hastening patients’ recovery of function. This ef...

    Background: The number of total joint arthroplasty being performed is increasing worldwide. To match this increasing demand, there has been focus on hastening patients’ recovery of function. This effort has culminated in formulation of enhanced recovery for surgery (ERAS) strategies. However, with evolving ERAS programs and new recommendations, a review of current evidence is required to provide clinicians with up-to-date information about its effect on outcomes for total joint arthroplasty. Objective: This study outlines the protocol for a systematic review and meta-analysis that aims to assess the utility of enhanced recovery after surgery programs on patient, health services and economic outcomes for primary, elective total hip and knee arthroplasty. Methods: A systematic search will be conducted in Medline (OVID), EMCARE (OVID), Web of Science, CINAHL, National Health Service Economic Evaluations Database and the Cochrane Library. Analytical, observational and experimental designs will be included in this systematic review. Only studies including patients undergoing primary, total knee and hip arthroplasty comparing ERAS programs with conventional surgery and postoperative care will be included. Data related to patient outcomes, health service outcomes, safety and economic evaluation will be extracted. Results: The search terms have been finalized, and the final primary database search will be completed in November 2020. The results of this systematic review will be disseminated in a peer-reviewed journal. Conclusions: This protocol will guide a systematic review assessing outcomes associated with ERAS surgery in primary, total hip and knee arthroplasty Clinical Trial: Open Science Framework. Doi: 10.17605/OSF.IO/Y4BHS

  • Assessing Mental Health in Emerging Adulthood through a Mental Health Navigator: A Study Protocol

    Date Submitted: Nov 15, 2020

    Open Peer Review Period: Nov 15, 2020 - Jan 10, 2021

    Background: Even the same psychological disorders present themselves differently among individuals, underscoring the need for a personalized model approach to the study of psychopathology. Emerging ad...

    Background: Even the same psychological disorders present themselves differently among individuals, underscoring the need for a personalized model approach to the study of psychopathology. Emerging adulthood is a developmental phase wherein individuals experience unique vulnerability to the development of psychopathology given their exposure to repeated stressors and their disruptions in routine, making them a population worthy of investigation. Objective: This prospective study aims to leverage multi-modal assessments to examine the feasibility of an individualized approach to understanding contextual factors relevant to changes in daily affect, sleep, physiology, and activities in the service of predicting changes in mental health. Methods: Recruited participants will be monitored for a period of time (between 3 and 12 months). Participants will download the Personicle application on their smartphone to track activities (e.g. home events, cycling) and be given wearable sensor devices to wear continuously (monitors sleep, physiology, and physical activity). They will be asked to report daily mood and complete weekly open-ended text responses as well as a battery of questionnaires every 3 months. Results: Our study has been approved by the Institutional Review Board and is currently undergoing data collection. Adjustments were made due to the COVID-19 pandemic to enable remote data collection and assess for COVID-19-related stress. Conclusions: This study will help advance the research of individualized approaches to understanding health and well-being through multi-modal systems and will demonstrate the benefit of using such approaches to study interrelations between stress, social relationships, technology and mental health.

  • Understanding Patterns of Healthy Aging Among Men Who Have Sex with Men: Study Methods Paper

    Date Submitted: Nov 13, 2020

    Open Peer Review Period: Nov 13, 2020 - Jan 8, 2021

    Background: With the greying of sexual and gender minority communities and the growing numbers of people over the age of 50 living with HIV, it is increasingly important to understand the psychosocial...

    Background: With the greying of sexual and gender minority communities and the growing numbers of people over the age of 50 living with HIV, it is increasingly important to understand the psychosocial aspects of aging and aging well. Objective: This paper describes the methods for the Understanding Patterns of Healthy Aging Among Men Who Have Sex With Men. Methods: This observational cohort study is conducted within the Multisite AIDS Cohort Study (MACS) and is designed to explore resiliencies to explain patterns of health and illness among midlife and older MSM. To be eligible a participant had to: (1) be an active participant in the MACS; (2) be at least 40 years old by April 1, 2016; and (3) report any sex with another man since enrollment in the MACS. Results: Eligible participants (N=1,318) completed 6 biannual surveys between April 2016-April 2019. The mean age of the sample was 59.6 years old (range=40-91). The sample was mostly white, educated, gay-identified and included both HIV-positive (49.8%) and HIV-negative (50.2%) men. Conclusions: Integrating resiliencies in surveillance applications of syndemics theory is a critical springboard for the development of effective interventions that support healthy aging among older MSM.

  • SARS-CoV-2 Infection in Healthcare Personnel and Their Household Contacts at a Tertiary Academic Medical Center: Protocol for a Longitudinal Cohort Study

    Date Submitted: Nov 17, 2020

    Open Peer Review Period: Nov 3, 2020 - Dec 29, 2020

    Background: Healthcare personnel are at high risk for exposure to the SARS-CoV-2 virus. While personal protective equipment may mitigate this risk, prospective data collection on its use and other ris...

    Background: Healthcare personnel are at high risk for exposure to the SARS-CoV-2 virus. While personal protective equipment may mitigate this risk, prospective data collection on its use and other risk factors for seroconversion in this population is needed. Objective: The primary objectives of this study are to (1) determine the incidence of and risk factors for SARS-CoV-2 infection among healthcare personnel at a tertiary medical center and (2) actively monitor personal protective equipment use, interactions between study participants via electronic sensors, secondary cases in households, and participant mental health and well-being. Methods: To achieve these objectives, we designed a prospective, observational study of SARS-CoV-2 infection among healthcare personnel and their household contacts at an academic tertiary care medical center. Enrolled healthcare personnel completed frequent surveys on symptoms and work activities and provided serum and nasal samples for SARS-CoV-2 testing every two weeks. Additionally, interactions between participants and their movement within the clinical environment were captured with a smartphone app and Bluetooth sensors. Finally, a subset of participants' households was randomly selected every two weeks for further investigation, and enrolled households provided serum and nasal samples via at-home collection kits. Results: As of September 30, 2020, 164 healthcare personnel and 33 household participants have been enrolled. Recruitment and follow-up are ongoing and expected to continue until March 2021. Conclusions: Much remains to be learned regarding risk of SARS-CoV-2 infection among healthcare personnel and their household contacts. Through use of a multi-faceted study design enrolling a well-characterized cohort, we will collect critical information regarding SARS-CoV-2 transmission in the healthcare setting and its linkage to the community.

  • 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.

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