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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: Dragana_Gordic; URL: https://www.freepik.com/free-photo/closeup-side-view-portrait-young-sad-thoughtful-woman-leaning-against-street-lamp-night-bokeh-copy-space-background-upset-young-woman-with-mobile-phone-reads-message_1162701.htm; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (eHealth)

    May 25, 2020

    Daily Self-Monitoring of Symptoms and Skills Learning in Patients With Borderline Personality Disorder Through a Mobile Phone App: Protocol for a Pragmatic...

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    Background: Patient self-monitoring via mobile phones during psychotherapy can enhance and provide an overview of psychotherapeutic progress by graphically displaying current and previous symptom scores, providing feedback to the patient, delivering psychoeducative material, and providing timely data to the therapist or treatment team. Objective: This study will aim to assess the effects of using a mobile phone to self-monitor symptoms and acquire coping skills instead of using pen and paper during psychotherapy in patients with borderline personality disorder (BPD). Dialectical behavior therapy will be performed to treat BPD. The primary outcome is the mean time needed to learn coping skills directed at emotion regulation; the secondary outcome is changes in the BPD symptom score as measured by the Zanarini Rating Scale for Borderline Personality Disorder. Methods: This study is a pragmatic, multicenter randomized controlled trial. Participants were recruited through five public general psychiatric outpatient treatment facilities in Denmark. Patients are randomly assigned, on a 1:1 basis, to either the mobile phone condition (using the Monsenso mDiary mobile app) or pen-and-paper condition. Patients will complete several self-report questionnaires on symptom severity; assessments by trained raters on BPD severity will be performed as well. Survival analysis with a shared frailty model will be used to assess the primary outcome. Results: Recruitment began in June 2017 and was completed in February 2019 after 80 participants were recruited. The study ended in February 2020. It is expected that the benefits of mobile phone–based self-report compared to the pen-and-paper method will be demonstrated for skill learning speed and registration compliance. To our knowledge, this is the first trial exploring the impact of cloud-based mobile registration in BPD treatment. Conclusions: This trial will report on the effectiveness of mobile phone–based self-monitoring during psychiatric treatment. It has the potential to contribute to evidence-based clinical practice since apps are already in use clinically. Trial Registration: ClinicalTrials.gov NCT03191565; https://clinicaltrials.gov/ct2/show/NCT03191565

  • Source: freepik; Copyright: freepik; URL: https://www.freepik.com/free-photo/group-friends-working-out-together_6265334.htm#page=1&query=group%20exercise&position=24; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (non-eHealth)

    May 25, 2020

    Effectiveness of Group Cognitive Behavioral Therapy and Exercise in the Management of Major Depressive Disorder: Protocol for a Pilot Randomized Controlled...

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    Background: Despite evidence in scientific literature indicating the effectiveness of both cognitive behavioral therapy (CBT) and physical exercise in the management of major depressive disorder (MDD), few studies have directly compared them. Objective: This study aims to evaluate and compare the effectiveness of group CBT, physical exercise, and only wait-listing to receive treatment-as-usual (TAU) in the management of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or exercise arms of the study will achieve superior outcomes compared with participants wait-listed to receive TAU only. Methods: This prospective rater-blinded randomized controlled trial assesses the benefits of group CBT and exercise for participants with MDD. A total of 120 patients with MDD referred to addiction and mental health clinics in Edmonton, Canada, will be randomly assigned to one of the three equal-sized arms of the study to receive either weekly sessions of group CBT plus TAU, group exercise three times a week plus TAU, or only TAU for 14 weeks. Participants will be assessed at enrollment, 3 and 6 months post enrollment, midtreatment, and upon treatment completion for primary (functional and symptom variables) and secondary outcomes (service variables and health care utilization). In addition, participants in the intervention groups would be evaluated weekly with one functional measure. The data will be analyzed using repeated measures and effect size analyses, and correlational analyses will be completed between measures at each time point. Results: The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong amendment) and Good Clinical Practice (Canadian guidelines). Written informed consent will be obtained from each subject. The study received ethical clearance from the Health Ethics Research Board of the University of Alberta on September 7, 2018 (Pro 00080975) and operational approval from the provincial health authority (Alberta Health Services 43638). As of October 13, 2019, we have enrolled 32 participants. The results will be disseminated at several levels, including patients, practitioners, academics, researchers, and health care organizations. Conclusions: The results of the pilot trial may inform the implementation of a multicenter clinical trial and provide useful information for administrators and clinicians who are interested in incorporating group CBT and group exercise interventions into existing care. Trial Registration: ClinicalTrials.gov NCT03731728; https://clinicaltrials.gov/ct2/show/NCT03731728

  • Source: Freepik; Copyright: Freepik; URL: https://www.freepik.com/free-photo/woman-talking-phone-sitting-couch_1169627.htm; License: Licensed by JMIR.
    Formative Studies and eHealth/mHealth...

    May 22, 2020

    Assessing the Real-Time Mental Health Challenges of COVID-19 in Individuals With Serious Mental Illnesses: Protocol for a Quantitative Study

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    Background: The outbreak of coronavirus disease 2019 (COVID-19) has caused significant stress and mental health problems among the general public. However, persons at greatest risk for poor mental health outcomes, such as people with serious mental illness, have been largely overlooked. Objective: This paper presents the protocol for a study that aims to examine the mental health impact of COVID-19 and social distancing behaviors in people with serious mental illness and the behaviors undertaken to prevent COVID-19 infection in this group. Methods: Participants will include individuals with serious mental illness (eg, schizophrenia, bipolar disorder) and nonpsychiatric control participants who are currently participating in or have previously participated in several ongoing parent observational studies. Data will be collected from April 2020 through August 2020. Participants will complete phone interviews at 2 time points to assess their current emotional functioning and discuss the measures they have taken to prevent COVID-19 infection. Baseline (pre-COVID-19) mental health, sampled by ecological momentary assessment over an extended period, will be compared with current mental health, also sampled by ecological momentary assessment over an extended period. Demographic, cognitive, and psychosocial factors at baseline will be used to examine risk and resilience to current mental health and coping. Results: The inclusion of participants for the first round of telephone assessments started on April 3, 2020 and will be completed by May 31, 2020. As of April 30, 2020, 101 individuals had completed these first-round assessments. The second round of telephone assessments will likely occur between June 1, 2020, and August 31, 2020. Study results will be published in peer-reviewed scientific journals. Conclusions: Our findings will have broad implications for understanding the psychological consequences of COVID-19 among vulnerable persons with serious mental illness and will provide the opportunity to identify targets to reduce negative outcomes in the future. We also hope our efforts will provide a roadmap and resources for other researchers who would like to implement a similar approach.

  • Source: Freepik; Copyright: jcomp; URL: https://www.freepik.com/free-photo/close-up-physiotherapist-working-with-patient-clinic_5218092.htm; License: Licensed by JMIR.
    Systematic Review Protocols

    May 22, 2020

    Reported Outcomes in Published Systematic Reviews of Interdisciplinary Pain Treatment: Protocol for a Systematic Overview

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    Background: Interdisciplinary pain treatment (IPT) is a complex intervention; its outcomes are very diverse, as are the methodologies for handling those outcomes. This diversity may hamper evidence-based decision making. Presently, there is no gold standard recommendation of how to select reported outcomes in published systematic reviews and meta-analyses to explicitly demonstrate the effectiveness of IPT. Objective: In this systematic overview, we aim to evaluate the reported outcome domains and measurements across published systematic reviews and meta-analyses and to identify any methods, considerations, and discussion regarding the handling of the chosen outcome domains and measurements. Methods: This article describes the protocol for a systematic overview of the outcomes reported in published systematic reviews and meta-analyses of randomized control trials for the effectiveness of IPT versus any control. To this end, we searched the PubMed, Cochrane Library, and Epistemonikos databases from inception to December 2019. Two independent investigators screened the titles, the abstracts of the identified records, and the full texts of the potentially eligible systematic reviews and meta-analyses, performed data extraction according to predefined forms, and rated the quality of the included systematic reviews and meta-analyses. The quality of the included systematic reviews and meta-analyses will be rated with AMSTAR (A MeaSurement Tool to Assess systematic Reviews) 2. Data will be analyzed descriptively and stratified by AMSTAR 2. Results: We introduced the rationale and design of a systematic overview to summarize and map the chosen IPT outcome domains and the methods of handling these outcomes reported in published systematic reviews and meta-analyses. As of December 2019, we collected 5229 systematic reviews, of which 147 (2.81%) were examined in-depth for eligibility. Topline results are anticipated by September 2020. Conclusions: The results of this study will be published as soon as they are available. Our results will fill a gap in the related literature and will be used to inform the development of a set of recommendations that can be applied in systematic reviews and hopefully serve as a gold standard.

  • The Australian Eating Survey. Source: The Authors / Placeit; Copyright: The Authors / Placeit; URL: http://www.researchprotocols.org/2020/5/e15999/; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (eHealth)

    May 22, 2020

    Investigating the Efficacy and Cost-Effectiveness of Technology-Delivered Personalized Feedback on Dietary Patterns in Young Australian Adults in the Advice,...

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    Background: Web-based health interventions may be easier to access and time efficient relative to face-to-face interventions and therefore may be the most appropriate mode to engage young adults. Objective: This study aims to investigate the impact of 3 different levels of personalized web-based dietary feedback and support on changes in diet quality. Methods: The Advice, Ideas, and Motivation for My Eating (Aim4Me) study is a 12-month assessor-blinded, parallel-group randomized controlled trial evaluating the impact of 3 levels of web-based feedback on diet quality, measured using the Australian Recommended Food Score (ARFS). Participants (N=2570) will primarily be recruited via web-based methods and randomized to 1 of 3 groups. Group 1 (control) will receive the Healthy Eating Quiz, a web-based dietary assessment tool that generates a brief feedback report on diet quality. Individuals randomized to this group can use the brief feedback report to make positive dietary changes. Group 2 will receive the Australian Eating Survey, a web-based dietary assessment tool that generates a comprehensive feedback report on diet quality as well as macro- and micronutrient intake. Group 2 will use the comprehensive feedback report to assist in making positive dietary changes. They will also have access to the Aim4Me website with resources on healthy eating and tools to set goals and self-monitor progress. Group 3 will receive the same intervention as Group 2 (ie, the comprehensive feedback report) in addition to a tailored 30-min video consultation with an accredited practicing dietitian who will use the comprehensive feedback report to assist individuals in making positive dietary changes. The self-determination theory was used as the framework for selecting appropriate website features, including goal setting and self-monitoring. The primary outcome measure is change in diet quality. The completion of questionnaires at baseline and 3, 6, and 12 months will be incentivized with a monetary prize draw. Results: As of December 2019, 1277 participants have been randomized. Conclusions: The web-based delivery of nutrition interventions has the potential to improve dietary intake of young adults. However, the level of support required to improve intake is unknown. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618000325202; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374420

  • The figure shows a woman playing one of the Jintronix games. Source: Image created by the authors; Copyright: Dorra Rakia Allegue; URL: http://www.researchprotocols.org/2020/5/e14629/; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (funded,...

    May 21, 2020

    Optimization of Upper Extremity Rehabilitation by Combining Telerehabilitation With an Exergame in People With Chronic Stroke: Protocol for a Mixed Methods...

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    Background: Exergames have the potential to provide an accessible, remote approach for poststroke upper extremity (UE) rehabilitation. However, the use of exergames without any follow-up by a health professional could lead to compensatory movements during the exercises, inadequate choice of difficulty level, exercises not being completed, and lack of motivation to pursue exercise programs, thereby decreasing their benefits. Combining telerehabilitation with exergames could allow continuous adjustment of the exercises and monitoring of the participant’s completion and adherence. At present, there is limited evidence regarding the feasibility or efficacy of combining telerehabilitation and exergames for stroke rehabilitation. Objective: This study aims to (1) determine the preliminary efficacy of using telerehabilitation combined with exergames on UE motor recovery, function, quality of life, and motivation in participants with chronic stroke, compared with conventional therapy (the graded repetitive arm supplementary program; GRASP); (2) examine the feasibility of using the technology with participants diagnosed with stroke at home; and (3) identify the obstacles and facilitators for its use by participants diagnosed with stroke and stroke therapists and understand the shared decision-making process. Methods: A mixed methods study protocol is proposed, including a randomized, blinded feasibility trial with an embedded multiple case study. The intervention consists of the provision of a remote rehabilitation program, during which participants will use the Jintronix exergame for UE training and the Reacts Application to conduct videoconferenced sessions with the therapists (physical or occupational therapists). We plan to recruit 52 participants diagnosed with stroke, randomly assigned to a control group (n=26; 2-month on-paper home exercise program: the GRASP with no supervision) and an experimental group (n=26; 2-month home program using the technology). The primary outcome is the Fugl-Meyer UE Assessment, a performance-based measure of UE impairment. The secondary outcomes are self-reported questionnaires and include the Motor Activity Log-28 (quality and frequency of use of the UE), Stroke Impact Scale-16 (the quality of life), and Treatment Self-Regulation Questionnaire (motivation). Feasibility data include process, resources, management, and scientific outcomes. Qualitative data will be collected by interviews with both participants and therapists. Results: At present, data collection was ongoing with one participant who had completed the exergame- telerehabilitation based intervention. We expect to collect preliminary efficacy data of this technology on the functional and motor recovery of the UE, following a stroke; collect feasibility data with users at home (adherence, safety, and technical difficulties); and identify the obstacles and facilitators for the technology use and understand the shared decision-making process. Conclusions: This paper describes the protocol underlying the study of a telerehabilitation-exergame technology to contribute to understanding its feasibility and preliminary efficacy for UE stroke rehabilitation. Trial Registration: ClinicalTrials.gov NCT03759106; http://clinicaltrials.gov/show/NCT03759106.

  • Source: iStock; Copyright: kali9; URL: https://www.istockphoto.com/ca/photo/three-senior-black-women-exercising-together-gm538685625-58750216?irgwc=1&esource=AFF_IS_IR_TinEye_77643_&asid=TinEye&cid=IS&utm_medium=affiliate&utm_source=TinEye&utm_content=77643&clickid=Wx%3AQaJylwxyOW-3wUx0Mo3cgUk; License: Licensed by the authors.
    Non-randomized Protocols and Methods...

    May 19, 2020

    Impact of Built Environments on Body Weight (the Moving to Health Study): Protocol for a Retrospective Longitudinal Observational Study

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    Background: Studies assessing the impact of built environments on body weight are often limited by modest power to detect residential effects that are small for individuals but may nonetheless comprise large attributable risks. Objective: We used data extracted from electronic health records to construct a large retrospective cohort of patients. This cohort will be used to explore both the impact of moving between environments and the long-term impact of changing neighborhood environments. Methods: We identified members with at least 12 months of Kaiser Permanente Washington (KPWA) membership and at least one weight measurement in their records during a period between January 2005 and April 2017 in which they lived in King County, Washington. Information on member demographics, address history, diagnoses, and clinical visits data (including weight) was extracted. This paper describes the characteristics of the adult (aged 18-89 years) cohort constructed from these data. Results: We identified 229,755 adults representing nearly 1.2 million person-years of follow-up. The mean age at baseline was 45 years, and 58.0% (133,326/229,755) were female. Nearly one-fourth of people (55,150/229,755) moved within King County at least once during the follow-up, representing 84,698 total moves. Members tended to move to new neighborhoods matching their origin neighborhoods on residential density and property values. Conclusions: Data were available in the KPWA database to construct a very large cohort based in King County, Washington. Future analyses will directly examine associations between neighborhood conditions and longitudinal changes in body weight and diabetes as well as other health conditions.

  • Source: flickr; Copyright: UNICEF Ethiopia; URL: https://www.flickr.com/photos/unicefethiopia/17081446587; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).
    Grant Proposals (funded, non-ehealth)

    May 19, 2020

    Person and Family Centeredness in Ethiopian Cancer Care: Proposal for a Project for Improving Communication, Ethics, Decision Making, and Health

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    Background: Cancer is a major burden in Ethiopia. The Oncology Department of Tikur Anbessa (Black Lion) Specialized Hospital in Addis Ababa is the sole specialist unit for cancer care in the country. With only a handful of oncologists, a lack of resources, and a huge patient load, the work is challenging, especially in terms of achieving effective and ethical patient consultations. Patients, usually accompanied by family members, often wait for a long time to receive medical attention and frequently depart without treatment. Handling consultations effectively is essential to help patients as much as possible within such limitations. Objective: The project has the following three main aims: (1) to enhance and expand the understanding of communicative and associated ethical challenges in Ethiopian cancer care; (2) to enhance and expand the understanding of the implications and use of person- and family-centered solutions to address such communicative challenges in practice; and (3) to plan and evaluate interventions in this area. Methods: This project develops and consolidates a research collaboration to better understand and mitigate the communicative challenges in Ethiopian cancer care, with a focus on the handling and sharing of decision making and ethical tension among patients, staff, and family. Using theoretical models from linguistics, health communication, and health care ethics, multiple sources of data will be analyzed. Data sources currently include semistructured interviews with Ethiopian staff (n= 16), patients (n= 54), and family caregivers (n= 22); survey data on cancer awareness (n=150) and attitudes toward breaking bad news (n=450); and video recordings of medical consultations (n=45). In addition, we will develop clinical and methodological solutions to formulate educational interventions. Results: The project was awarded funding by the Swedish Research Council in December 2017 for the period 2018 to 2021. The research ethics boards in Sweden and Ethiopia approved the project in May 2018. The results of the studies will be published in 2020 and 2021. Conclusions: The project is the first step toward providing unique and seminal knowledge for the specific context of Ethiopia in the areas of physician-patient communication research and ethics. It contributes to the understanding of the complexity of the role of family and ethical challenges in relation to patient involvement and decision making in Ethiopia. Improved knowledge in this area can provide a fundamental model for ways to improve cancer care in many other low-resource settings in Africa and the Middle East, which share central cultural prerequisites, such as a strong patriarchal family structure, along with strong and devout religiosity. The project will also serve to develop greater understanding about the current challenges in Western health systems associated with greater family and patient participation in decision making. In addition, the project will contribute to improving the education of Ethiopian health professionals working in cancer care by developing a training program to help them better understand and respond to identified challenges associated with communication.

  • Source: Pexels; Copyright: Ekaterina Bolovtsova; URL: https://www.pexels.com/photo/photo-of-man-talking-on-the-phone-4049428/; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (eHealth)

    May 14, 2020

    Development of a Digital Content-Free Speech Analysis Tool for the Measurement of Mental Health and Follow-Up for Mental Disorders: Protocol for a...

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    Background: The prevalence of mental disorders worldwide is very high. The guideline-oriented care of patients depends on early diagnosis and regular and valid evaluation of their treatment to be able to quickly intervene should the patient’s mental health deteriorate. To ensure effective treatment, the level of experience of the physician or therapist is of importance, both in the initial diagnosis and in the treatment of mental illnesses. Nevertheless, experienced physicians and psychotherapists are not available in enough numbers everywhere, especially in rural areas or in less developed countries. Human speech can reveal a speaker’s mental state by altering its noncontent aspects (speech melody, intonations, speech rate, etc). This is noticeable in both the clinic and everyday life by having prior knowledge of the normal speech patterns of the affected person, and with enough time spent listening to the patient. However, this time and experience are often unavailable, leaving unused opportunities to capture linguistic, noncontent information. To improve the care of patients with mental disorders, we have developed a concept for assessing their most important mental parameters through a noncontent analysis of their active speech. Using speech analysis for the assessment and tracking of mental health patients opens up the possibility of remote, automatic, and ongoing evaluation when used with patients’ smartphones, as part of the current trends toward the increasing use of digital and mobile health tools. Objective: The primary objective of this study is to evaluate measurements of participants' mental state by comparing the analysis of noncontent speech parameters to the results of several psychological questionnaires (Symptom Checklist-90 [SCL-90], the Patient Health Questionnaire [PHQ], and the Big 5 Test). Methods: In this paper, we described a case-controlled study (with a case group and one control group). The participants will be recruited in an outpatient neuropsychiatric treatment center. Inclusion criteria are a neurological or psychiatric diagnosis made by a specialist, no terminal or life-threatening illnesses, and fluent use of the German language. Exclusion criteria include psychosis, dementia, speech or language disorders in neurological diseases, addiction history, a suicide attempt recently or in the last 12 months, or insufficient language skills. The measuring instrument will be the VoiceSense digital voice analysis tool, which enables the analysis of 200 specific speech parameters, and the assessment of findings using psychometric instruments and questionnaires (SCL-90, PHQ, Big 5 Test). Results: The study is ongoing as of September 2019, but we have enrolled 254 participants. There have been 161 measurements completed at timepoint 1, and a total of 62 participants have completed every psychological and speech analysis measurement. Conclusions: It appears that the tone and modulation of speech are as important, if not more so, than the content, and should not be underestimated. This is particularly evident in the interpretation of the psychological findings thus far acquired. Therefore, the application of a software analysis tool could increase the accuracy of finding assessments and improve patient care. Trial Registration: ClinicalTrials.gov NCT03700008; https://clinicaltrials.gov/ct2/show/NCT03700008

  • Source: Freepik; Copyright: Freepik; URL: https://www.freepik.com/free-photo/cheerful-multiethnic-medics-with-papers_1891461.htm; License: Licensed by JMIR.
    Non-Randomized Studies (funded, eHealth)

    May 13, 2020

    The NASSS-CAT Tools for Understanding, Guiding, Monitoring, and Researching Technology Implementation Projects in Health and Social Care: Protocol for an...

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    Background: Projects to implement health care and social care innovations involving technologies are typically ambitious and complex. Many projects fail. Greenhalgh et al’s nonadoption, abandonment, scale-up, spread, and sustainability (NASSS) framework was developed to analyze the varied outcomes of such projects. Objective: We sought to extend the NASSS framework to produce practical tools for understanding, guiding, monitoring, and researching technology projects in health care or social care settings. Methods: Building on NASSS and a complexity assessment tool (CAT), the NASSS-CAT tools were developed (in various formats) in seven co-design workshops involving 50 stakeholders (industry executives, technical designers, policymakers, managers, clinicians, and patients). Using action research, they were and are being tested prospectively on a sample of case studies selected for variety in conditions, technologies, settings, scope and scale, policy context, and project goals. Results: The co-design process resulted in four tools, available as free downloads. NASSS-CAT SHORT is a taster to introduce the instrument and gauge interest. NASSS-CAT LONG is intended to support reflection, due diligence, and preliminary planning. It maps complexity through stakeholder discussion across six domains, using free-text open questions (designed to generate a rich narrative and surface uncertainties and interdependencies) and a closed-question checklist; this version includes an action planning section. NASSS-CAT PROJECT is a 35-item instrument for monitoring how subjective complexity in a technology implementation project changes over time. NASSS-CAT INTERVIEW is a set of prompts for conducting semistructured research or evaluation interviews. Preliminary data from empirical case studies suggest that the NASSS-CAT tools can potentially identify, but cannot always help reconcile, contradictions and conflicts that block projects’ progress. Conclusions: The NASSS-CAT tools are a useful addition to existing implementation tools and frameworks. Further support of the implementation projects is ongoing. We are currently producing digital versions of the tools, and plan (subject to further funding) to establish an online community of practice for people interested in using and improving the tools, and hold workshops for building cross-project collaborations.

  • Source: Pexels.com; Copyright: Daria Shevtsova; URL: https://www.pexels.com/photo/person-holding-space-gray-iphone-x-1440722/; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (eHealth)

    May 13, 2020

    Social Media Interventions for Risky Drinking Among Adolescents and Emerging Adults: Protocol for a Randomized Controlled Trial

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    Background: Despite intervention efforts to date, the prevalence of risky drinking among adolescents and emerging adults remains high, increasing the risk for health consequences and the development of alcohol use disorders. Peer influences are particularly salient among this age group, including via social media. Thus, the development of efficacious early interventions for youth, delivered with a broad reach via trained peers on social media, could have an important role in addressing risky drinking and concomitant drug use. Objective: This paper describes the protocol of a randomized controlled trial (RCT) testing the efficacy of a social media intervention among adolescents and emerging adults who meet the criteria for risky drinking (using the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]), delivered with and without financial incentives for participation, compared with an attention placebo control condition (ie, entertaining social media content), on alcohol consumption and consequences. Methods: This RCT involved recruiting 955 youths (aged 16-24 years) via advertisements on Facebook and Instagram to self-administer a brief web-based screening survey. Those screening positive for past 3-month risky drinking (AUDIT-C positive: ages 16-17 years: ≥3 females and ≥4 males; and ages 18-24 years: ≥4 females and ≥5 males) were eligible for the RCT. After providing consent (a waiver of parental consent was obtained for minors), participants completed a web-based baseline survey and several verification procedures, including a selfie photo matched to Facebook profile photos. Participants were then randomized to join invitation-only secret Facebook groups, which were not searchable or viewable by parents, friends, or anyone not recruited by the study. The 3 conditions were social media intervention with incentives, social media intervention without incentives (SMI), and attention placebo control. Each condition lasted 8 weeks and consisted of bachelor’s-level and master’s-level therapist electronic coaches posting relevant content and responding to participants’ posts in a manner consistent with Motivational Interviewing. Participants in the control condition and SMI condition did not receive payments but were blind to condition assignment between these 2 conditions. Follow-ups are ongoing and occur at 3, 6, and 12 months poststart of the groups. Results: We enrolled 955 participants over 10 waves of recruitment who screened positive for risky drinking into the RCT. Conclusions: The findings of this study will provide the critical next step in delivering early alcohol interventions to the youth, capitalizing on social media platforms, which could have significant public health impact by altering alcohol use trajectories of adolescents and emerging adults engaged in risky drinking. Trial Registration: ClinicalTrials.gov NCT02809586; https://clinicaltrials.gov/ct2/show/NCT02809586.

  • Source: Image created by the Authors; Copyright: The Authors; URL: https://medvirknu.dk/sites/medvirknu.dk/files/media/dokumenter/2017-08/medvirk-postkort.pdf; License: Creative Commons Attribution (CC-BY).
    Grant Proposals (funded, non-ehealth)

    May 13, 2020

    Evaluation and Dissemination of a Checklist to Improve Implementation of Work Environment Initiatives in the Eldercare Sector: Protocol for a Prospective...

    Authors List:

    Abstract:

    Background: To measure sustainable improvements in the work environment, a flexible and highly responsive tool is needed that will give important focus to the implementation process. A digital checklist was developed in collaboration with key stakeholders to document the implementation of changes in eldercare sector workplaces. Objective: This paper describes the study protocol of a dissemination study that aims to examine when, why, and how the digital checklist is spread to the Danish eldercare sector following a national campaign particularly targeting nursing homes and home care. Methods: This prospective observational study will use quantitative data from Google Analytics describing use of the checklist as documented website engagement, a survey among members in the largest union in the sector, information from a central business register, and monitoring of campaign activities. The evaluation will be guided by the five elements of the RE-AIM framework: reach, effectiveness, adoption, implementation, and maintenance. Results: The study was approved in June 2016 and began in October 2018. The campaign that is the foundation for the evaluation began in 2017 and ended in 2018. However, the webpage where we collect data is still running. Results are expected in 2020. Conclusions: This protocol provides a working example of how to evaluate dissemination of a checklist to improve implementation of work environment initiatives in the eldercare sector in Denmark. To our knowledge, implementation in a nationwide Danish work environment has not been previously undertaken. Given that the checklist is sector-specific for work environment initiatives and developed through systematic collaboration between research and practice, it is likely to have high utility and impact; however, the proposed evaluation will determine this. This study will advance dissemination research and, in particular, the evaluation of the impact of these types of studies. Finally, this study advances the field through digital tools that can be used for evaluation of dissemination efforts (eg, Google Analytics associated with website) in the context of a rigorous research design activity.

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  • Evaluating the efficacy of Drinks:Ration app and personalised text and push messaging to reduce alcohol consumption in a veteran population: Protocol for a Randomised Controlled Trial

    Date Submitted: May 13, 2020

    Open Peer Review Period: May 19, 2020 - Jul 19, 2020

    Background: Alcohol misuse is higher in the United Kingdom (UK) Armed Forces (AF) than the general population. Previous research has shown that interventions delivered via smartphone are efficacious i...

    Background: Alcohol misuse is higher in the United Kingdom (UK) Armed Forces (AF) than the general population. Previous research has shown that interventions delivered via smartphone are efficacious in promoting self-monitoring of alcohol use, have utility in reducing alcohol consumption and have a broad reach. Objective: The ultimate objective of this Randomised Controlled Trial (RCT) is to assess the efficacy of a 28-day brief alcohol intervention delivered via a smartphone app (Drinks:Ration) in reducing alcohol consumption at 3 months among veterans who drink at a hazardous or harmful level and are receiving, or have received, support for mental health symptoms in a clinical setting. Methods: In a two-arm Randomised Controlled Trial (RCT), a smartphone app which includes interactive digital features designed to enhance participant motivation and personalised messaging is compared to a smartphone app which only provides information on alcohol consumption. The trial will be conducted in a treatment-seeking veteran population recruited from Combat Stress; a UK veteran’s mental health charity. Recruitment, consent and data collection is performed automatically through the Drinks:Ration platform. The primary outcome is change in alcohol consumption between baseline (day 0) and 3-month follow-up (day 84) as measured using the Time-Line Follow back for Alcohol Consumption; secondary outcome measures include 1) change in baseline to follow-up Alcohol Use Disorder Identification Test score, and 2) change in baseline to follow-up World Health Organisation Quality of Life-BREF score to assess Quality of Adjusted Life Years. Process evaluation measures include 1) app usage, and 2) usability ratings as measured by the mHealth App Usability Questionnaire. Results: The study will begin recruitment in September 2020 and is expected to require 12 months to complete. Study results should be published in 2022. Conclusions: This study will test if a smartphone app has the efficacy to reduce alcohol consumption in a treatment-seeking veteran population using personalised messaging and interactive digital features. This innovative approach, if successful, may provide a means to deliver a low cost health promotion programme that has the potential to reach large groups, in particular those geographically dispersed such as military personnel.

  • Lung function variability in children and adolescents (LUV study): protocol for a prospective, non-randomized, clinical trial

    Date Submitted: May 17, 2020

    Open Peer Review Period: May 17, 2020 - Jul 12, 2020

    Background: Variability analysis of peak expiratory flow (PEF) and forced expiratory volume at 1 s (FEV1) has been used in research to predict exacerbations in adult individuals with asthma. However,...

    Background: Variability analysis of peak expiratory flow (PEF) and forced expiratory volume at 1 s (FEV1) has been used in research to predict exacerbations in adult individuals with asthma. However, there is a paucity of data regarding PEF and FEV1 variability in healthy or asthmatic children and adolescents. Objective: The objective of the present study is the assessment of PEF and FEV1 variability in: a) healthy children and adolescents, to define the normal daily fluctuation of PEF and FEV1 and the parameters that may influence it, and b) children and adolescents with asthma, to explore the differences from healthy subjects and reveal any specific variability changes prior to exacerbation. Methods: The study will include 100 healthy children and adolescents aged 6 to 18 years (assessment of normal PEF and FEV1 variability) and 100 children and adolescents of the same age with diagnosed asthma (assessment of PEF and FEV1 variability in asthmatics). PEF and FEV1 measurements will be performed using an ultra-portable spirometer (MIR Spirobank Smart) capable to smartphone connection. Measurements will be performed twice a day between 07:00-09:00 and 19:00-21:00 hours and will be dispatched via email to a central database for a period of 3 months. PEF and FEV1 variability will be assessed by detrended fluctuation and sample entropy analysis, aiming to define the normal pattern (healthy controls) and to detect and quantify any deviations (asthmatics). Results: The study is funded by the programme “C. Caratheodory” of the University of Patras, Greece (PN 47014/24.9.2018). It was approved by the Ethics Committee (decision 218/19-03-2019) and the Scientific Board (decision 329/02-04-2019) of the University Hospital of Patras, Greece. Patient recruitment started in January 2020 and, to date, 72 healthy children have been included (62 of them have completed the measurements). The anticipated duration of the study is 24 months.The first part of the study (assessment of lung function variability in healthy children and adolescents) will be completed in August 2020 and the results will be available for publication not later than October 2020. Conclusions: Healthy children and adolescents may present normal short- and long-term fluctuations in lung function; the pattern of this variability may be influenced by age, sex and environmental conditions. Significant lung function variability may also be present in children and adolescents with asthma, but the patterns may differ from those observed in healthy children and adolescents. Such data would improve our understanding regarding the chronobiology of asthma and permit the development of integrated tools for assessing the level of control and risk of future exacerbations. Clinical Trial: ClinicalTrials.gov, NCT04163146. Registered on 14 November 2019 (https://clinicaltrials.gov/ct2/show/ NCT04163146?term=NCT04163146&draw=2&rank=1).

  • Digitalization and the Social Lives of Older Adults

    Date Submitted: May 15, 2020

    Open Peer Review Period: May 15, 2020 - Jul 10, 2020

    Digital technologies are increasingly pervading our daily lives. Although older adults started using digital technologies later than other age groups, they are increasingly adopting these technologies...

    Digital technologies are increasingly pervading our daily lives. Although older adults started using digital technologies later than other age groups, they are increasingly adopting these technologies, especially with the goal of communicating with others. Less is known about how online social activities are embedded in older adults’ daily lives, how they complement other (offline) social activities, and how they contribute to social connectedness and well-being. In this study, micro-longitudinal data were collected from 120 older adults from German-speaking regions of Switzerland to examine these questions. Data collection took place from April 2019 to October 2019. Data collection took place over different time scales, including event-based (reporting all social interactions for 21 days), daily (well-being, loneliness, and technology use every evening for 21 days), hourly (cortisol assessments six time per day for 3 days), and baseline (relevant interindividual characteristics including socio-demographics, health, technology use, personality, and cognitive performance) assessments. Data generated by this project will allow us to understand how older adults use digital communication in their daily lives to communicate with others, how this relates to well-being and social connectedness, and how communication using digital technologies differs from other types of communication depending on situational and individual characteristics.

  • Virtual reality cognitive therapy on inpatient psychiatric wards: protocol for a qualitative investigation of staff and patient views across multiple NHS sites.

    Date Submitted: May 15, 2020

    Open Peer Review Period: May 15, 2020 - Jul 10, 2020

    Background: Patients on psychiatric wards typically have very limited access to individual psychological therapy. Inpatients often have significant time available – and an important transition back...

    Background: Patients on psychiatric wards typically have very limited access to individual psychological therapy. Inpatients often have significant time available – and an important transition back to everyday life to prepare for – but historically there have been few trained therapists available on wards for the delivery of evidence-based therapy. Automated virtual reality (VR) therapy may be one route to increase the provision of powerful psychological treatments in psychiatric hospitals. The gameChange automated VR cognitive therapy is targeted at helping patients overcome anxious avoidance and re-engage in everyday situations (e.g. walking down the street, taking a bus, going to a shop). This treatment target may fit well for many patients preparing for discharge. However, little is known about how VR therapy may be viewed in this setting. Objective: The objectives of the study are to: explore psychiatric hospital staff and patients’ initial expectations of VR therapy; gather patient and staff views of an automated VR cognitive therapy (gameChange) after briefly experiencing it; and identify potential differences across NHS mental health trusts for implementation. Guided by an implementation framework, the knowledge gained will be used to assess the feasibility of adoption of VR treatment into psychiatric hospitals. Methods: Focus groups will be conducted with NHS staff and patients on acute psychiatric wards at five NHS mental health trusts across England. Staff and patients will be interviewed in separate groups. Individual interviews will also be conducted when preferred by a participant. One to two wards will be visited within each of the five trusts. A total of 8-15 staff and patients per ward will be recruited, with a minimum total of 50 staff and patients recruited across all sites. Focus group questions have been derived from the Nonadoption, Abandonment, and Challenges to the Scale-Up, Spread, and Sustainability (NASSS) framework. Focus groups will firstly discuss expectations of VR therapy, before giving participants the opportunity to briefly try the gameChange VR therapy. Questions will then focus on opinions about the therapy and investigate feasibility of adoption, with particular consideration given to site specific issues. A thematic analysis will be conducted. Results: As of May 15th 2020 one patient focus group has been conducted. Conclusions: The study will provide a unique insight from patients and staff into the potential for implementing automated VR therapy on psychiatric wards. Perspectives will be captured both on the use of immersive technology hardware and therapy-specific issues in such settings.

  • Building a Digital Bridge to support patient-centred care transitions from hospital to home: Study Protocol

    Date Submitted: May 13, 2020

    Open Peer Review Period: May 13, 2020 - Jul 8, 2020

    Background: Older adults with multi-morbidity and complex care needs (CCN) are among those most likely to experience frequent care transitions between settings, particularly from hospital to home. Tra...

    Background: Older adults with multi-morbidity and complex care needs (CCN) are among those most likely to experience frequent care transitions between settings, particularly from hospital to home. Transition periods mark vulnerable moments in care for individuals with CCN. Poor communication and incomplete information transfer between the various clinicians and organizations involved in the transition from hospital to home can impede access to needed support and resources. Establishing digitally supported communication that enables person-centred care and supported self-management may offer significant advantages as we support older adults with CCN transitioning from hospital to home. Objective: This protocol outlines the plan for the development, implementation and evaluation of a Digital Bridge co-designed to support person-centred health care transitions for older adults with CCN. The Digital Bridge builds on the foundation of two validated technologies; Care Connector, designed to improve inter-professional communication in hospital, and the electronic Patient Reported Outcomes (ePRO) tool, designed to support goal-oriented care planning and self-management in primary care settings. This project poses three overarching research questions that focus on adapting the technology to local contexts, evaluating the impact of the Digital Bridge in relation to the quadruple aim, and exploring the potential to scale and spread the technology. Methods: The study includes two phases: workflow co-design (PHASE 1), followed by implementation and evaluation (PHASE 2). PHASE 1 will include iterative co-design working groups with patients, caregivers, hospital providers and primary care providers to develop a transition workflow that will leverage the use of Care Connector and ePRO to support communication through the transition process. PHASE 2 will include implementation and evaluation of the Digital Bridge within one acute hospital system and one rehab hospital system in Ontario (n=600 patients; 300 baseline, 300 implementation). The primary outcome measure for this study is the Care Transitions Measure-3 to assess transition quality. An embedded ethnography will also be included to capture context and process data to inform the implementation assessment and the development of a scale and spread strategy. An Integrated Knowledge Translation approach is taken to inform the study. An Advisory Group will be established to provide insight and feedback regarding the project design and implementation, leading the development of the project KT strategy and associated outputs. Results: This study is funded by the Canadian Institute for Health Research Team Grant in Transitions in Care (FRN- 165733), is approved by the Trillium Health Partners REB, and undergoing review by the Sinai Health REB. Conclusions: Given the ‘real world’ implementation of Digital Bridge, there will be several practice changes in the research sites and variable adherence to the implementation protocols. Capturing and understanding these considerations is essential in order to identity the range of factors that may influence study Adopting a pragmatic trial design with an embedded case study will provide insights into outcomes as well as the mechanisms that are likely driving those outcomes. Clinical Trial: ClinicalTrials.gov ID: NCT04287192

  • Online Navigation for Pre-exposure Prophylaxis for HIV Prevention via Chat: the PleasePrEPMe Chat Experience

    Date Submitted: May 13, 2020

    Open Peer Review Period: May 13, 2020 - Jul 8, 2020

    Background: Pre-exposure prophylaxis (PrEP) is an HIV medication taken by an HIV-negative individual to prevent infection before exposure to the virus. Numerous clinical studies in various communities...

    Background: Pre-exposure prophylaxis (PrEP) is an HIV medication taken by an HIV-negative individual to prevent infection before exposure to the virus. Numerous clinical studies in various communities have shown high rates of effectiveness when PrEP is taken as prescribed. Since FDA approval of the first product for PrEP in 2012, uptake has been lower than the estimated 1.1 million US adults who could benefit from its use, with an estimated 70,394 individuals on PrEP in 2017. Of these, only 11% are Black and 13% Hispanic, highlighting racial/ethnic disparities in PrEP uptake. Patient navigators have been shown to be effective in improving the linkage and retention in care outcomes of people living with HIV across the HIV treatment cascade, and can be used throughout the PrEP care continuum to assist decision making and connect potential users to PrEP services. Objective: PleasePrEPMe Chat is a novel online strategy to improve engagement in PrEP care services with PrEP-eligible populations through an online navigation platform. Methods: Visitors connected with navigators via online bilingual (English, Spanish) chat. During the chat, navigators helped locate PrEP services through the PleasePrEPMe provider directory, provided links to HIV-prevention resources, and supported uninsured, insured, and undocumented visitors with benefits navigation. Results: From launch to December 31, 2019, PleasePrEPMe completed 2,191 online chats. Average interaction time was 16 minutes, with chats often covering more than one topic (68%). Conversation topics included healthcare navigation (50%), provider identification (44%), PrEP information (35%), PEP information (15%), and the California PrEP Assistance Program (11%). Referrals to PrEP- or non-PrEP-related resources included: directory updates, HIV testing and treatment, undetectable = untransmittable or U=U, reproductive health, sexually transmitted infections, and other prevention methods. A total of 368 chat visitors completed a voluntary satisfaction scale rating the quality and helpfulness of the service provided, producing an average rating of 4.7 out of 5. Conclusions: Online chat is a method for reaching people not already engaged in HIV-prevention services, supporting HIV-prevention decision making, and linking people seeking information online with in-person services. HIV-prevention conversations must necessarily include PrEP and PEP navigation to holistically serve the needs of visitors at all stages in the PrEP care continuum. Challenges around PrEP access include insurance and payment issues, confidentiality, and stigma. The nature of challenges seen in California may be different and not generalizable to states without Medicaid expansion or where the overall culture may be more politically conservative. Additional research evaluating online sexual health information services and understanding how social determinants of health influence online engagement are needed to better understand how to reach priority populations not well served by current HIV-prevention services.

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