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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: Freepik; Copyright: rawpixel.com; URL: https://www.freepik.com/free-photo/nurse-measuring-patient-blood-pressure_2769131.htm#page=1&query=hypertension&position=1; License: Licensed by JMIR.

    The Association Between Selected Molecular Biomarkers and Ambulatory Blood Pressure Patterns in African Chronic Kidney Disease and Hypertensive Patients...

    Abstract:

    Background: Chronic kidney disease (CKD) is a burgeoning epidemic in sub-Saharan Africa. Abnormal blood pressure variations are prevalent in CKD and potentiate the risk of cardiovascular morbidity and mortality. Certain genetic variants (angiotensin II receptor type 1 1166 A>C and angiotensin-converting enzyme insertion and deletion polymorphisms) and biomarkers such as interleukin–6, tumor necrosis factor, soluble (s) E-selectin, homocysteine, and highly sensitive C-reactive protein have been shown to affect blood pressure variability among non-African CKD, hypertensive. and nonhypertensive CKD population. However, the contributions of the pattern, genetic, and environmental determinants of ambulatory blood pressure in African CKD have not been characterized. Understanding these interactions may help to develop interventions to prevent major cardiovascular events among people with CKD. Objective: The overarching objective of this study is to identify, document, and develop approaches to address related phenomic, genetic, and environmental determinants of ambulatory blood pressure patterns in African CKD and non-CKD hypertensive patients compared with normotensive controls. Methods: This is a longitudinal short-term follow-up study of 200 adult subjects with CKD and 200 each of age-matched hypertensives without CKD and apparently healthy controls. Demographic information, detailed clinical profile, electrocardiography, echocardiography, and 24-hr ambulatory blood pressure measurements will be obtained. Blood samples will be collected to determine albumin-creatinine ratio, fasting plasma glucose, lipid profile, electrolytes, urea and creatinine, C-reactive protein, serum homocysteine, fibroblast growth factor–23, and complete blood count, while 2 mL blood aliquot will be collected in EDTA (ethylenediaminetetraacetic acid) tubes and mixed using an electronic rolling system to prevent blood clots and subsequently used for DNA extraction and genetic analysis. Results: A total of 239 participants have been recruited so far, and it is expected that the recruitment phase will be complete in June 2020. The follow-up phase will continue with data analysis and publications of results. Conclusions: This study will help stratify Nigerian CKD patients phenotypically and genotypically in terms of their blood pressure variations with implications for targeted interventions and timing of medications to improve prognosis.

  • Simulation demonstrating user's interaction with the system via Microsoft Kinect (montage). Source: The Authors / WikiCommons; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2020/1/e10987/; License: Creative Commons Attribution (CC-BY).

    Using Augmented Reality to Motivate Oral Hygiene Practice in Children: Protocol for the Development of a Serious Game

    Abstract:

    Background: New technologies create possible new ways of action, interaction, and learning which is extremely relevant in the field of oral health education. There is a lack of protocol in using an immersive interactive ludic-educational interface to motivate oral hygiene practice in children by means of augmented reality. Objective: This study aims to present a protocol on the development of a serious game to motivate oral hygiene practice in children. Methods: A serious game will be designed by augmented reality techniques to improve toothbrushing effectiveness of children aged 6 to 10 years. The functional structure of this interface is activated by means of movements recognized by Kinect (Microsoft Corp). The toothbrushing technique will be available in the game, enabling the children to execute the movement in the virtual environment. By identifying errors, this game will be tailored to improve the oral health of children by correcting the technique and teaching the user the adequate toothbrushing method. A template analysis will be performed to identify barriers and facilitators in each scenario. Results: After the implementation of the virtual interactive and immersive panels, enrollment will begin and evaluations will be made by means of questionnaires distributed to participants who interact with the game. Thus, an analysis of the product efficacy will be conducted. The expected outcome will be to obtain a digital instrument to motivate oral hygiene practice and enhance health awareness in children. Conclusions: The serious game will support the prevention of oral diseases by sharing scientific research in the school environment and community.

  • Source: Menzies Image Gallery; Copyright: Menzies School of Health Research; URL: http://www.researchprotocols.org/2020/1/e15464/; License: Licensed by the authors.

    The Impact of Hearing Impairment on the Life Trajectories of Aboriginal Children in Remote Australia: Protocol for the Hearing Loss in Kids Project

    Abstract:

    Background: Previous studies have reported a high prevalence of chronic otitis media (OM) and hearing impairment (HI) in Aboriginal children in the Northern Territory (NT) of Australia. Children affected by these disorders are believed to be at increased risk for adverse outcomes in early childhood development, school attendance, academic performance, and child maltreatment and youth offending. However, to date, there have been no studies quantifying the association between HI and these outcomes in this population. Objective: This study will investigate the association between HI and the 5 outcomes in Aboriginal children living in remote NT communities. Methods: Individual-level information linked across multiple administrative datasets will be used to conduct a series of retrospective observational studies on selected developmental and school outcomes. The predictor variables for all studies are the results from audiometric hearing assessments. The outcome measures are as follows: Australian Early Development Census results, representing developmental readiness for school, assessed around 5 years of age; Year 1 school attendance rates; Year 3 school-based academic performance, assessed in the National Assessment Program—Literacy and Numeracy; incidence of child maltreatment events (including both notifications and substantiated cases); and incidence of a first guilty verdict for youth offenders. Confounding and moderating factors available for the analysis include both community-level factors (including school fixed effects, socioeconomic status, level of remoteness, and housing crowdedness) and individual-level factors (including maternal and perinatal health and hospital admissions in early childhood). Results: The study commenced in 2018, with ethics and data custodian approvals for data access and linkage. This has enabled the completion of data linkage and the commencement of data analysis for individual component studies, with findings expected to be published in 2019 and 2020. Conclusions: This study will provide first evidence of the impact of OM-related HI on the developmental, educational, and social outcomes of Australian Aboriginal children. The findings are expected to have significant implications for policy development, service design, and resource allocation.

  • Tweet2Quit mobile website (montage). Source: The Authors / Pexels (Artem Beliaikin); Copyright: The Authors; URL: https://www.researchprotocols.org/2020/1/e16417; License: Licensed by JMIR.

    The Use of Web-Based Support Groups Versus Usual Quit-Smoking Care for Men and Women Aged 21-59 Years: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Existing smoking cessation treatments are challenged by low engagement and high relapse rates, suggesting the need for more innovative, accessible, and interactive treatment strategies. Twitter is a Web-based platform that allows people to communicate with each other throughout the day using their phone. Objective: This study aims to leverage the social media platform of Twitter for fostering peer-to-peer support to decrease relapse with quitting smoking. Furthermore, the study will compare the effects of coed versus women-only groups on women’s success with quitting smoking. Methods: The study design is a Web-based, three-arm randomized controlled trial with two treatment arms (a coed or women-only Twitter support group) and a control arm. Participants are recruited online and are randomized to one of the conditions. All participants will receive 8 weeks of combination nicotine replacement therapy (patches plus their choice of gum or lozenges), serial emails with links to Smokefree.gov quit guides, and instructions to record their quit date online (and to quit smoking on that date) on a date falling within a week of initiation of the study. Participants randomized to a treatment arm are placed in a fully automated Twitter support group (coed or women-only), paired with a buddy (matched on age, gender, location, and education), and encouraged to communicate with the group and buddy via daily tweeted discussion topics and daily automated feedback texts (a positive tweet if they tweet and an encouraging tweet if they miss tweeting). Recruited online from across the continental United States, the sample consists of 215 male and 745 female current cigarette smokers wanting to quit, aged between 21 and 59 years. Self-assessed follow-up surveys are completed online at 1, 3, and 6 months after the date they selected to quit smoking, with salivary cotinine validation at 3 and 6 months. The primary outcome is sustained biochemically confirmed abstinence at the 6-month follow-up. Results: From November 2016 to September 2018, 960 participants in 36 groups were recruited for the randomized controlled trial, in addition to 20 participants in an initial pilot group. Data analysis will commence soon for the randomized controlled trial based on data from 896 of the 960 participants (93.3%), with 56 participants lost to follow-up and 8 dropouts. Conclusions: This study combines the mobile platform of Twitter with a support group for quitting smoking. Findings will inform the efficacy of virtual peer-to-peer support groups for quitting smoking and potentially elucidate gender differences in quit rates found in prior research. Clinical Trial: ClinicalTrials.gov NCT02823028; https://clinicaltrials.gov/ct2/show/NCT02823028

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/1/e16275/; License: Creative Commons Attribution (CC-BY).

    Effects of Bluetooth-Enabled Desk Ellipticals on Office Work Performance: Rationale, Design, and Protocol for a Randomized Trial With Overweight and Obese...

    Abstract:

    Background: Workplaces that provide opportunities for physical activity without requiring extra time for activity could help counteract the obesity epidemic. Desk ellipticals can contribute to activity-supportive workplace environments; however, the feasibility of engaging employees in pedaling ellipticals during simultaneous office work has not been well evaluated. Objective: We aim to present the rationale and methods from an ongoing randomized trial with overweight and obese employees that will evaluate (1) the effects of pedaling a compact desk elliptical on work performance and (2) the influence of different incentive types and schedules on desk pedaling quantity. Methods: Overweight and obese medical center employees are being recruited in dyads for a 2 (gift card type: healthier food vs Amazon) by 3 (gift card schedule: immediate incentive contingent on individual pedaling quantity; immediate incentive partially contingent on dyads’ joint pedaling quantity; and delayed noncontingent pedaling incentive) cluster randomized within-subjects factorial trial. All participants receive a Bluetooth-enabled desk elliptical for 4 weeks and access to a mobile app that provides real-time pedaling feedback. The primary aims are to assess (1) change in employee work performance from pre- to postelliptical installation via employee and supervisor ratings and (2) effects of gift card type and schedule on quantity of objectively measured desk pedaling completed. Results: Data collection is ongoing. We expect to complete main outcome analyses in 2020. Conclusions: This trial represents one of the earliest attempts to assess the effects of desk pedaling and pedaling-incentive types in real-world offices. It could help bridge the research-to-practice gap by providing evidence on whether desk pedaling can be sustained without compromising work performance.

  • Source: Unsplash; Copyright: Drew Hays; URL: https://unsplash.com/photos/tGYrlchfObE; License: Licensed by JMIR.

    Behavioral, Nutritional, and Genetic Risk Factors of Colorectal Cancers in Morocco: Protocol for a Multicenter Case-Control Study

    Abstract:

    Background: Colorectal cancer (CRC) has been reported as the third most commonly diagnosed cancer worldwide and is currently considered as a major public health concern. A peak increase in incidence has been noted in economically transitioning countries like Morocco where industrialization started shifting from a traditional lifestyle and diet toward a more westernized diet and lifestyle. Objective: This paper aims to present the protocol of a large-scale Moroccan case-control study that aims at investigating associations of diet, other lifestyle factors, and genetic traits with CRC risk in Morocco. Methods: A case-control study was conducted between 2009 and 2017, including 3032 case-control pairs (1516 cases and 1516 controls) matched on sex, age, and center in 5 major public health hospitals in Morocco. Questionnaires on sociodemographic data, lifestyle, family history of CRC, and nonsteroidal anti-inflammatory drugs (NSAIDs) were completed by trained investigators during face-to-face interviews. In addition, participants completed a semiquantitative food-frequency questionnaire, developed to assess food intake in the Moroccan population. Information regarding genetic factors was recorded for cases, and paraffin blocks (with embedded tumor tissues) are available in 3 collaborating hospitals. Conditional logistic regression analysis is planned to assess associations between diet and CRC risk. Binary logistic regression is considered to predict associations between mutations and nutritional risk factors including only CRC case series. Results: Altogether, 2966 cases-control pairs (1483 cases and 1483 controls) were considered eligible and included in this study. Both cases and controls did not differ significantly with respect to age (P=.36), sex (P=.51), center (P>.99), marital status (P=.30), and NSAID use (P=.08). However, participants in the control group were significantly more likely to have a high income level and live in urban areas and to have a high level of education than cases. Conclusions: This is the first study investigating potential risk factors of CRC such as lifestyle, diet, and genetic factors, originating from a southern Mediterranean country with low but increasing CRC prevalence. Identified risk factors allow the establishment of evidence-based preventive actions regarding nutrition and other lifestyle habits adapted to the Moroccan context. In brief, this study will promote cancer research and prevention in Morocco.

  • Source: freepik; Copyright: freepik; URL: https://www.freepik.com/free-photo/person-s-hand-typing-keyboard-near-ultrasound-scan-report-blister-pills-coffee-cup-desk_5234422.htm#page=2&query=doctor+with+laptop&position=44; License: Licensed by JMIR.

    Evaluation of a Health Information Technology–Enabled Panel Management Platform to Improve Anticoagulation Control in a Low-Income Patient Population:...

    Abstract:

    Background: Warfarin is one of the most commonly prescribed medications in the United States, and it causes a significant proportion of adverse drug events. Patients taking warfarin fall outside of the recommended therapeutic range 30% of the time, largely because of inadequate laboratory monitoring and dose adjustment. This leads to an increased risk of blood clots or bleeding events. We propose a comparative effectiveness study to examine whether a technology-enabled anticoagulation management program can improve long-term clinical outcomes compared with usual care. Objective: Our proposed intervention is the implementation of an electronic dashboard (integrated into a preexisting electronic health record) and standardized workflow to track patients’ laboratory results, identify patients requiring follow-up, and facilitate the use of a validated nomogram for dose adjustment. The primary outcome of this study is the time in therapeutic range (TTR) at 6 months post intervention (a validated metric of anticoagulation quality among patients receiving warfarin). Methods: We will employ a pre-post quasi-experimental design with a nonequivalent usual-care comparison site and a difference-in-differences approach to compare the effectiveness of a technology-enabled anticoagulation management program compared with usual care at a large university-affiliated safety-net clinic. Results: We used a commercially available health information technology (HIT) platform to host a registry of patients on warfarin therapy and create the electronic dashboard for panel management. We developed the intervention with, and for, frontline clinician users, using principles of human-centered design. This study is funded until September 2020 and is approved by the University of California, San Francisco Institutional Review Board until June 22, 2020. We completed data collection in September 2019 and expect to complete our proposed analyses by February 2020. Conclusions: We anticipate that the intervention will increase TTR among patients taking warfarin and that the use of this HIT platform will facilitate tracking and monitoring of patients on warfarin, which could enable outreach to those overdue for visits or laboratory monitoring. We will use these findings to iteratively improve the platform in preparation for a larger, multiple-site, pragmatic clinical trial. If successful, our study will demonstrate the integration of HIT platforms into existing electronic health records to improve patient care in real-world clinical settings.

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/1/e16320/; License: Licensed by JMIR.

    Testing the Effectiveness of Enhanced Alcohol Warning Labels and Modifications Resulting From Alcohol Industry Interference in Yukon, Canada: Protocol for a...

    Abstract:

    Background: Alcohol warning labels are a promising, well-targeted strategy to increase public awareness of alcohol-related health risks and support more informed and safer use. However, evidence of their effectiveness in real-world settings remains limited and inconclusive. Objective: This paper presents a protocol for a real-world study examining the population-level impact of enhanced alcohol warning labels with a cancer message; national drinking guidelines; and standard drink information on attention, processing, and alcohol-related behaviors among consumers in Canada. Postimplementation modifications to the original protocol due to interference by national alcohol industry representatives are also described. Methods: This quasi-experimental study involved partnering with local governments in two northern Canadian territories already applying alcohol warning labels on alcohol containers for sale in liquor stores. The study tested an 8-month intervention consisting of three new enhanced, rotating alcohol warning labels in an intervention site (Whitehorse, Yukon) relative to a comparison site (Yellowknife, Northwest Territories) where labelling practices would remain unchanged. Pre-post surveys were conducted at both sites to measure changes in awareness and processing of label messages, alcohol-related knowledge, and behaviors. Liquor store transaction data were collected from both sites to assess changes in population-level alcohol consumption. The intervention was successfully implemented for 1 month before it was halted due to complaints from the alcohol industry. The government of the intervention site allowed the study to proceed after a 2-month pause, on the condition that the cancer warning label was removed from rotation. Modifications to the protocol included applying the two remaining enhanced labels for the balance of the intervention and adding a third wave of surveys during the 2-month pause to capture any impact of the cancer label. Results: This study protocol describes a real-world quasi-experimental study that aimed to test the effectiveness of new enhanced alcohol warning labels as a tool to support consumers in making more informed and safer alcohol choices. Alcohol industry interference shortly after implementation compromised both the intervention and the original study design; however, the study design was modified to enable completion of three waves of surveys with cohort participants (n=2049) and meet the study aims. Conclusions: Findings from this study will directly inform alcohol labelling policies in Canada and internationally and provide further insight into the alcohol industry’s attempts to disrupt research in this area. Additional unimpeded real-world evaluations of enhanced alcohol warning labels are recommended.

  • Source: Care Link Advantage; Copyright: Care Link Advantage; URL: http://www.researchprotocols.org/2020/1/e15027/; License: Creative Commons Attribution (CC-BY).

    Caring Near and Far by Connecting Community-Based Clients and Family Member/Friend Caregivers Using Passive Remote Monitoring: Protocol for a Pragmatic...

    Abstract:

    Background: Significant chronic disease challenges exist among older adults. However, most older adults want to remain at home even if their health conditions challenge their ability to live independently. Yet publicly funded home care resources are scarce, private home care is expensive, and family/friend caregivers have limited capacity. Many older adults with chronic illness would require institutional care without the support from family member/friend caregivers. This role raises the risk of physical health problems, stress, burnout, and depression. Passive remote monitoring (RM), the use of sensors that do not require any action by the individual for the system to work, may increase the older adult’s ability to live independently while also providing support and peace of mind to both the client and the family member/friend caregiver. Objective: This paper presents the protocol of a study conducted in two provinces in Canada to investigate the impact of RM along with usual home care (the intervention) versus usual home care alone (control) on older adults with complex care. The primary outcome for this study is the occurrence of and time to events such as trips to emergency, short-term admission to the hospital, terminal admission to the hospital awaiting admission to long-term care, and direct admission to long-term care. The secondary outcomes for this study are (1) health care costs, (2) client functional status and quality of life in the home, (3) family/friend caregiver stress, and (4) family/friend caregiver functional health status. Methods: The design for this study is an unblinded pragmatic randomized controlled trial (PRCT) with two parallel arms in two geographic strata (Ontario and Nova Scotia). Quantitative and qualitative methodologies will be used to address the study objectives. This PRCT is conceptually informed by the principles of client-centered care and viewing the family as the client and aims at providing supported self-management. Results: This study is supported by the Canadian Institutes for Health Research. A primary completion date is anticipated in fall 2022. Conclusions: Findings from this real-world rigorous randomized trial will support Canadian decision-makers, providers, and clients and their caregivers in assessing the health, well-being, and economic benefits and the social and technological challenges of integrating RM technologies to support older adults to stay in their home, including evaluating the impact on the burden of care experienced by family/friend caregivers. With an aging population, this technology may reduce institutionalization and promote safe and independent living for the elderly as long as possible. Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN) 79884651; http://www.isrctn.com/ISRCTN79884651

  • Person using the EMPOWER app. Source: Image created by Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/1/e15058/; License: Creative Commons Attribution (CC-BY).

    Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-Being, Engagement, and Recovery: Protocol for a Feasibility Cluster Randomized...

    Abstract:

    Background: Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. Objective: This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. Methods: We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants’ own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. Results: Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. Conclusions: The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. Clinical Trial: International Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262

  • N1 App: Back your wellness with data. Source: Image created by the Authors; Copyright: Icahn School of Medicine at Mount Sinai; URL: https://www.researchprotocols.org/2020/1/e16362; License: Licensed by JMIR.

    Factors Associated With Trial Completion and Adherence in App-Based N-of-1 Trials: Protocol for a Randomized Trial Evaluating Study Duration, Notification...

    Abstract:

    Background: N-of-1 trials promise to help individuals make more informed decisions about treatment selection through structured experiments that compare treatment effectiveness by alternating treatments and measuring their impacts in a single individual. We created a digital platform that automates the design, administration, and analysis of N-of-1 trials. Our first N-of-1 trial, the app-based Brain Boost Study, invited individuals to compare the impacts of two commonly consumed substances (caffeine and L-theanine) on their cognitive performance. Objective: The purpose of this study is to evaluate critical factors that may impact the completion of N-of-1 trials to inform the design of future app-based N-of-1 trials. We will measure study completion rates for participants that begin the Brain Boost Study and assess their associations with study duration (5, 15, or 27 days) and notification level (light or moderate). Methods: Participants will be randomized into three study durations and two notification levels. To sufficiently power the study, a minimum of 640 individuals must begin the study, and 97 individuals must complete the study. We will use a multiple logistic regression model to discern whether the study length and notification level are associated with the rate of study completion. For each group, we will also compare participant adherence and the proportion of trials that yield statistically meaningful results. Results: We completed the beta testing of the N1 app on a convenience sample of users. The Brain Boost Study on the N1 app opened enrollment to the public in October 2019. More than 30 participants enrolled in the first month. Conclusions: To our knowledge, this will be the first study to rigorously evaluate critical factors associated with study completion in the context of app-based N-of-1 trials. Clinical Trial: ClinicalTrials.gov NCT04056650; https://clinicaltrials.gov/ct2/show/NCT04056650

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2020/1/e15910/; License: Creative Commons Attribution + Noncommercial + ShareAlike (CC-BY-NC-SA).

    Developing an Evidence-Based Nursing Handover Standard for a Multi-Site Public Hospital in Switzerland: Protocol for a Web-Based, Modified Delphi Study

    Abstract:

    Background: Poor communication processes create opportunities for errors when caregivers fail to transfer complete and consistent information. Inadequate or nonexistent clinical handovers or failures to transfer information, responsibility, and accountability can have dire consequences for hospitalized patients. Clinical handover is practiced every day, in a multitude of ways, in all health care settings. Objective: The goal of this study is to build a consensus, evidence-based nursing handover standard for inpatients during shift changes or internal transfers between hospital wards. The study will be based on papers published by Slade et al. Methods: This protocol describes a modified Delphi data-collection survey involving a targeted panel sample of 300 nurse experts. A multi-round survey will select an anonymous panel from a multi-site public hospital in Switzerland. Each survey stage will be described and will build on the previous one. The study will end with a focus group discussion involving a randomly selected panel to explain why items for the evidence-based clinical nursing handover standard were accepted or not accepted. An item must achieve a consensus of ≥70% for inclusion. Results: The present study’s expected outcome is a consensus-built, evidence-based nursing handover standard for inpatients during shift changes or internal transfers between the wards of a multi-site public hospital in Switzerland. Conclusions: This survey will enable us to develop an evidence-based nursing handover standard for use during shift changes and internal inpatient transfers in a multi-site public hospital in Switzerland.

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  • A Multi-Lingual, Culturally-Competent Mobile Health Intervention to Improve Treatment Adherence for Women Living with HIV/AIDS: A Feasibility Study Protocol

    Date Submitted: Jan 2, 2020

    Open Peer Review Period: Dec 31, 2019 - Feb 25, 2020

    Design and Objective: This paper describes a protocol to investigate the feasibility of a mobile health (mHealth) intervention to improve adherence among women living with HIV. This is two-phase, mix...

    Design and Objective: This paper describes a protocol to investigate the feasibility of a mobile health (mHealth) intervention to improve adherence among women living with HIV. This is two-phase, mixed-methods, pilot, randomized controlled trial that begins with patient qualitative interviews to inform the application design. Participants will be randomized to one of two study arms. Study Population: Women (>=18 years of age) followed at an academic medical center women’s HIV clinic, with a recent history of non-adherence to HIV care (missed appointments, unsuppressed viral load, not taking medications as prescribed) will be enrolled. Intervention and Control: The experimental arm will receive the intervention, which includes health reminders and psycho-educational messaging, plus clinic standard of care reminders. The psycho-educational messaging will target patient-level barriers of HIV stigma and medical mistrust, and resiliency as a patient-level strength. The control arm will receive the standard of care reminders only—namely, mailed appointments and automated telephone calls. All aspects of the study and intervention, i.e. data measures, regulatory forms, and messaging, will be offered in participants’ preferred language (English, Spanish, or Haitian Creole). Outcome Measures: Primary outcome is study feasibility/acceptability. Secondary outcomes are changes in self-reported medication adherence, depressive symptoms (PHQ-9), HIV stigma (HSS), medical mistrust (GBMMS), and resiliency (CDRISC-25), and clinic attendance and viral suppression, extracted from participants’ medical records. Data will be assessed at baseline (T0), and two subsequent clinic visits--approximately 3-4 months post-baseline (T1); 6-9 months post-baseline (T2). Analysis: Audio recordings of qualitative data will be transcribed and analyzed iteratively. Bivariate analyses will compare data by study group (chi-square, odds ratios, t-tests). Exploratory analyses using analysis of variance will be constructed for each outcome variable—T1 and T2 values will be compared to T0, by study group. Trial Registration: NCT03738410

  • Development of the Advancing People of Color in Clinical Trials (ACT Now!) Intervention: A Web-based Randomized Controlled Trial

    Date Submitted: Dec 22, 2019

    Open Peer Review Period: Dec 22, 2019 - Feb 16, 2020

    Background: Participation in clinical trials among people of color remains low, compared with whites. This protocol describes the development of Act NOW! (Advancing People of Color in Clinical Trials...

    Background: Participation in clinical trials among people of color remains low, compared with whites. This protocol describes the development of Act NOW! (Advancing People of Color in Clinical Trials NOW!), a culturally tailored website designed to influence clinical trial decision making among people of color. Objective: This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy and willingness to enroll in clinical trials among people of color, compared to the standard NYU clinical trial enrollment website. Methods: Act NOW! is a randomized trial including two groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy, self-efficacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month post-intervention and 3-month follow-up. Website architecture and wire-framing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed t-test, with 80% power, at 0.05 alpha level, to increase clinical trial literacy, self-efficacy and willingness to enroll in clinical trials 3-months post-intervention. Results: We will design a culturally tailored website and leverage community stakeholders to influence clinical trial literacy, self-efficacy and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research informed approach through the use of a Community Steering Committee (CSC). The CSC provides input during the research study conception, development, implementation and enrollment. CSC relationships help to foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color, through an accessible, online website. Conclusions: A culturally tailored website may have the potential to increase literacy, self-efficacy and willingness to enroll in a clinical trial among people of color. Clinical Trial: Trial registration number NCT03243071 August 8, 2017.

  • Protocol of the DARIO randomized trial: Effects of alternative offers of screening sigmoidoscopy and colonoscopy on utilization and yield of endoscopic screening for colorectal neoplasms

    Date Submitted: Dec 18, 2019

    Open Peer Review Period: Dec 17, 2019 - Feb 11, 2020

    Background: Flexible sigmoidoscopy and colonoscopy are recommended screening options for colorectal cancer (CRC). Of these options, only colonoscopy which requires complete bowel cleansing and is more...

    Background: Flexible sigmoidoscopy and colonoscopy are recommended screening options for colorectal cancer (CRC). Of these options, only colonoscopy which requires complete bowel cleansing and is more invasive but visualizes the entire colon and rectum is offered for CRC screening, but use of this offer has been very limited. Objective: To assess the potential for increasing use of endoscopic CRC screening and the detection of advanced colorectal neoplasms by offering the choice between use of flexible sigmoidoscopy and colonoscopy. Methods: The DARIO study includes a cross-sectional study (Part I), followed by a prospective two-arm randomized controlled intervention trial (Part II) with an associated biobank study (Part III). Participation is possible in part I only, parts I and II, or all three parts. After obtaining informed consent from the municipalities 12,000 people, aged 50-54 years, from the Rhine-Neckar region in Germany are randomly selected from residential lists of the responsible population registries and are invited to complete a standardized questionnaire to investigate the nature, frequency, timing, and results of previous colorectal cancer screening and eventual diagnostic colonoscopies. In study part II participants from study part I with no colonoscopy in the preceding 5 years are randomized into two arms: arm A offering screening colonoscopy only, and arm B offering both options, either screening colonoscopy or screening sigmoidoscopy, to investigate whether the screening offer for less invasive sigmoidoscopy leads to a higher use of endoscopic screening and a higher number of detected and removed neoplasms > 0.5cm (primary endpoint). Part III of the study will use samples from participants in study part II to construct a liquid and tissue biobank for the evaluation of less invasive methods of early detection of colon cancer and for the more detailed characterization of the detected neoplasms. Blood, urine, stool and saliva samples are taken before the endoscopy. Tissue samples are obtained from the neoplasms removed during endoscopy. Results: 10,568 randomly selected women and men aged 50-54 years living in the Rhine-Neckar-Region of Germany have been invited for participation, 1432 could not be invited because they reached the age of 55 at the time of contact, 2789 women and men participated in study part I. Study parts II and III are ongoing. Conclusions: This study will answer the question if alternative offers of either screening sigmoidoscopy or screening colonoscopy will increase utilization and effectiveness of endoscopic CRC screening compared to an exclusive offer of screening colonoscopy. In addition, alternative non-invasive screening tests will be developed and validated. Clinical Trial: The trial was registered during recruitment of the participants in www.drks.de on September 30, 2019: German Clinical Trials Register DRKS-ID: DRKS0000

  • Influence of PARAmedical Interventions on Patient ACTivation in the Cancer Care Pathway : Protocol for implementation of the PAM 13 (PARACT multicentric study)

    Date Submitted: Dec 16, 2019

    Open Peer Review Period: Dec 16, 2019 - Feb 10, 2020

    Background: The increase in the number of cancers and the chronicization of care for some of them is a major problem for the French care system. Thus, patient empowerment is a goal sought in chronic...

    Background: The increase in the number of cancers and the chronicization of care for some of them is a major problem for the French care system. Thus, patient empowerment is a goal sought in chronic pathologies for several years. The Patient Activation Measure (PAM) has been developed to objectify the evolution of patients in this activation process. Indeed, patients with a high level of activation have less inappropriate use of care and better treatment adherence. Therefore, the implementation of an activation measure via the PAM 13 could highlight the patient’s needs and adapt the care to their needs. Objective: The main objectif of this study is to implement the PAM 13 as a tool for measuring the patients activation in care settings for cancer patients. Methods: This is a quasi-interventional, multicentric study open to implementation. The patient will be followed for 12 months. During this follow-up, the different patient contacts with the nurses and other health caregiver will be collected, as well as nursing strategies. The completion of the PAM 13, EQ-5D, HAD scale, and REALM R questionnaires will be done at baseline, at 6 months, and at 12 months. The completion will be carried out by a nurse. Results: Data collection for this study is ongoing. To date, 170 patients have participated in 3 of the 5 establishments of treatment of cancer. Conclusions: This pioneering implementation study in French cancer centers, would improve the implement targeted nursing interventions, in order to offer the patient a personalized care pathway. On the other hand, the measurement of the level of activation and the implementation of measures intended to increase it, would be a major advantage in reducing social health inequalities. Clinical Trial: ClinicalTrials.gov Identifier: NCT03240341 ANSM : 2017-A00235-48 IDRCB: 2017-A00235-48

  • Toward Evidence-Based Decision Aids for Patients with Parkinson's Disease: Protocol for an Interview Study, an Online Survey, and two Randomized Controlled Trials

    Date Submitted: Dec 16, 2019

    Open Peer Review Period: Dec 16, 2019 - Feb 10, 2020

    Background: Shared decision making is particularly important in situations with different treatment alternatives. For the treatment of idiopathic Parkinson's disease (IPD), both medicinal and surgical...

    Background: Shared decision making is particularly important in situations with different treatment alternatives. For the treatment of idiopathic Parkinson's disease (IPD), both medicinal and surgical approaches can be applied. Objective: In this research project, a series of studies will be conducted to investigate how decision aids for patients with IPD should be designed in order to support the decision-making process. Methods: In Study 1a, a qualitative interview study will be conducted to determine which needs frequently occur for patients with IPD. In Study 1b, the identified needs will then be rated as to their personal relevance by an independent group of patients in an online survey. In Study 2, a randomized controlled trial will be used to pre-test different decision aids with medical laypersons who have no Parkinson's disease. Study 3 will investigate in a randomized controlled trial the effect of the decision aids evaluated as positive in Study 2 on patients with IPD. Results: Data collection has not yet started. It is planned to present the study results and analyses at international conferences and to submit them to peer-reviewed journals. The findings will additionally be shared with clinicians and patients by presenting them at information events. Conclusions: This series of studies is intended to lead to a design of an evidence-based decision-aid for patients with IPD in order to support the informed and reflected shared decision-making process. A further intention is to contribute to a deeper understanding of IPD patients’ individual preferences and the impact of those preferences on treatment decisions.

  • Study protocol assessing the benefits of foot reflexology in digestive or lung cancer patients on platinum-based chemotherapy – Randomized controlled trial REFYO-R

    Date Submitted: Nov 28, 2019

    Open Peer Review Period: Nov 27, 2019 - Jan 22, 2020

    Background: Side effects of chemotherapy are feared by patients, specifically chemotherapy-induced nausea and vomiting. To relieve them, it is recommended to prescribe antiemetic drugs. However, some...

    Background: Side effects of chemotherapy are feared by patients, specifically chemotherapy-induced nausea and vomiting. To relieve them, it is recommended to prescribe antiemetic drugs. However, some patients report that they are not sufficiently effective. Moreover, patients with chronic disease, including cancer, are increasingly interested in alternative and complementary medicines and express the desire that non-pharmacological treatments be used in hospitals. Foot reflexology is a holistic approach that is reported to decrease significant reduction in the severity of chemotherapy-induced nausea and vomiting in breast cancer patients. Some chemotherapy for lung and digestive cancer patients is moderately or highly emitting. Objective: The primary objective of the present study is to assess the benefits of foot reflexology as a complement to conventional treatments on severity and frequency of chemotherapy-induced nausea and vomiting in digestive or lung cancer patients. The secondary objectives are quality of life, anxiety, and self-esteem. Methods: This study is an open label randomized controlled trial conducted over 22 months (18 months intervention and 4 months follow-up). Eligible participants are patients with a lung or digestive cancer with indication for platinum-based chemotherapy. Participants are randomized into two groups: conventional care with foot reflexology and conventional care without foot reflexology. Foot reflexology sessions (30 minutes) are performed on an outpatient or inpatient. It was estimated that 40 participants per group will be required. The benefits of foot reflexology will be assessed by comparing the relative change in the severity of nausea and vomiting, as assessed by a visual analogic scale, and the frequency of this between the two groups. Results: The results of this trial are expected in the first quarter of 2020. Patient enrolment is currently ongoing. Conclusions: The lack of knowledge regarding the efficacy and safety of foot reflexology limits oncologists to recommend this use. The present study will provide evidence on the benefits of foot reflexology. If efficacy is confirmed, foot reflexology may be a promising complement to conventional antiemetic drugs. Clinical Trial: The present study registered with clinicaltrials.gov: NCT03508180 (28/06/2018)

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