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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed-indexed journal, publishing peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.

JMIR Res Protoc is a journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (JMIR Impact Factor 2017: 4.671).

While the original focus was on eHealth studies, JMIR Res Protoc now publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions.

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

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

JRP is compatible with the concept of "Registered Reports" and since May 2018, published protocols receive a Registered Report Identifier (What is a Registered Report Identifier?) and acceptance of the subsequent results paper is "in principle" guaranteed in any JMIR journal and partner journals - see What is a Registered Report?. 

JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal.

JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols.

JMIR Res Protoc provides a "dry-run" for peer-review of the final results paper, and allows feedback/critique of the methods, often while they still can be fixed.

JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced.

JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods.

Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine.

Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others).

JMIR Res Protoc is also a unique crowdfunding platform, allowing backers to crowdfund carefully peer-reviewed projects that are not junk-science, and giving researchers additional small funding to conduct and publish their research results. Each article is published with a crowdfunding widget, allowing readers to make nominal donations to the project, which benefit the authors (currently in beta).

Need more reasons? Read the Knowledge Base article on "Why should I publish my protocol/grant proposal"!

 
 

Recent Articles:

  • eMums Plus logo. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/1/e11549/; License: Licensed by JMIR.
    RCTs - Protocols/Proposals (funded,...

    Jan 16, 2019

    Evaluating the Effectiveness of an App-Based Nurse-Moderated Program for New Mothers With Depression and Parenting Problems (eMums Plus): Protocol for a...

    Authors List:

    Abstract:

    Background: Postnatal depression adversely affects many mothers and infants with good evidence that caregiving difficulties associated with depressive symptoms play a key role in later adverse childhood outcomes. In many countries, there is only limited support available for women who experience symptoms of depression during the postnatal period, particularly those experiencing subthreshold symptom levels. Furthermore, mental health services and community family health services in many countries tend to focus primarily on providing help for depressive symptoms or maternal caregiving, respectively, despite these problems commonly being comorbid. Group-based nurse-led interventions delivered over the Web through mobile phone “apps” have the potential to be a cost-effective method of providing a large number of mothers with easy access to integrated support for both maternal depressive symptoms and caregiving difficulties. Objective: This paper describes the protocol for a pragmatic randomized controlled trial of a 4-month group-based nurse-led intervention delivered over the Web when infants were 2-6 months. The primary aims of the trial are to determine whether the intervention (1) reduces levels of maternal depressive symptoms and (2) improves the quality of maternal caregiving when infants are 8-12 months of age. Methods: The trial aimed to recruit and randomize 160 mothers of infants aged 2-8 weeks to either the intervention (eMums plus) or standard care. Assessments were completed when infants were aged 1-2 (preintervention), 8, and 12 months. The primary outcomes were the level of maternal depressive symptoms and the quality of maternal caregiving assessed when infants were aged 12 months. The intervention provided specific support for problems with mood and problems with caregiving. The intervention was delivered by community health nurses as a part of routine service delivery to mothers via a mobile phone app. Results: Participant recruitment was carried out from March to July 2017. Follow-up data collection was completed in mid-2018. Data analysis has commenced. Conclusions: In the past, many mothers participated in nurse-led face-to-face groups postnatally. However, mothers’ groups held in clinics can be difficult for busy mothers to attend. The eMums intervention was delivered over the Web by nurses, allowing easy access by mothers early in an infant’s life. The intervention was evaluated while delivered as part of the routine service practice by community child health nurses. The advantage of evaluating the effectiveness of the intervention in the routine service practice is that if it is found to be effective, it can be more easily adopted by the service provider than if it had been assessed in an efficacy trial. International Registered Report Identifier (IRRID): RR1-10.2196/11549

  • Source: Flickr / The Authors; Copyright: The Authors; URL: https://www.flickr.com/photos/mattradickal/6214764720/in/photostream/; License: Creative Commons Attribution + ShareAlike (CC-BY-SA).
    Non-Randomized Studies (funded,...

    Jan 16, 2019

    Human Papillomavirus Infection and Transmission Among Couples Through Heterosexual Activity (HITCH) Cohort Study: Protocol Describing Design, Methods, and...

    Authors List:

    Abstract:

    Background: Human papillomavirus (HPV) epidemiological research has generally been individual based, typically focusing on women, with couple-based research mostly consisting of cross-sectional assessment of prevalent HPV infection in both partners. Objective: The HPV Infection and Transmission among Couples through Heterosexual activity (HITCH) study was set up to investigate the transmissibility of HPV among young, recently formed couples in Montreal, Canada. This paper provides an overview of the HITCH cohort study design and procedures as well as a narrative summary of the most important findings. Methods: HITCH is a longitudinal investigation of HPV transmission in recently formed heterosexual partnerships initiated within 6-month pre-enrollment, a time at which considerable transmission is believed to occur. A total of 549 newly formed dyads were recruited (2005-2011) from postsecondary institutions, including 502 young women and their male partners. An additional 46 males were enrolled at follow-up, as some women enrolled a subsequent partner at follow-up. Women aged 18-24 years were followed for 24 months for acquisition of HPV types not present at enrollment, whereas men returned for a single follow-up visit at month 4, for a sum total of 3361 clinic visits. The last follow-up visit occurred in January 2014. Extensive sociodemographic, sexual behavioral, and medical history data were collected every 2-4 months using computer-assisted, self-administered questionnaires. Furthermore, participants provided genital, blood, oral, and hand specimens for HPV assessment. Results: Although in its early analysis stage, HITCH has produced important publications. Findings from HITCH have increased the available knowledge about the natural history of HPV transmission and its determinants, provided further evidence regarding oral-oral and oral-genital routes of HPV transmission, and supplied empirically valid epidemiological parameters of HPV transmission to assist mathematical modelers in health economic assessments. In addition, HITCH data were made available to several multistudy collaborations evaluating new HPV detection assays and evidence for-or-against HPV type replacement following the introduction of HPV vaccination. Conclusions: HITCH will continue to offer a unique resource for research on HPV transmission. International Registered Report Identifier (IRRID): RR1-10.2196/11284

  • Listeo+ app. Source: Image created by the authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/1/e10938/; License: Creative Commons Attribution + Noncommercial + ShareAlike (CC-BY-NC-SA).
    RCTs - Protocols/Proposals (funded,...

    Jan 16, 2019

    Effect of a Mobile App on Preoperative Patient Preparation for Major Ambulatory Surgery: Protocol for a Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: Inadequate preoperative patient preparation causes organizational, economic, and emotional problems to patients and professionals. In Spain, no current evidence is available on either the rate of compliance or the impact of good compliance with preoperative recommendations by patients in the ambulatory setting. However, it is known that around 25% of surgical cancellations in the major ambulatory surgery (MAS) are due to poor compliance with these recommendations and, therefore, avoidable. Introducing innovative tools based on mobile health (mHealth) apps may help patients meet the preoperative recommendations and, consequently, reduce the rate of cancellations in the ambulatory setting. Objective: The objective of this study was to evaluate the effectiveness of the Listeo+ mHealth app as a tool for improving compliance with preoperative recommendations in MAS versus standard of care (SOC). Methods: A multicenter, randomized, open-label clinical trial that compares SOC with the additional use of Listeo+, a specific mHealth app for MAS preoperative patient monitoring, is being conducted. The study will include patients aged ≥18 years with surgical indication for MAS who meet the necessary technological and connectivity requirements. Patients in the control group will receive written preoperative recommendations, while those in the intervention group will additionally use the Listeo+ mHealth app. There will be a competitive recruitment of 790 patients during 6 months in 4 hospitals in Andalusia (Spain) that belong to the National Health System. The primary efficacy outcome is the level of compliance with preoperative recommendations. Secondary outcomes include the rate of cancellations, associated resource consumption, and perceived usability and utility with Listeo+ by participants of the intervention group. Simple randomization 1:1 procedure will be used to allocate patients to each study group. Results: The technological development of Listeo+ and the integration and interoperability of information systems was completed in September 2017. Subsequently, simulation tests were performed with Listeo+, and a pilot study was initiated with real patients that concluded successfully in October 2017. Patient recruitment began in December 2017 in the 4 participating centers. After an intermediate analysis performed 10 months after the start of the recruitment phase, the data collection and cleaning phases are estimated to be completed in April 2019, and the analysis with the final results will be conducted in July 2019. Conclusions: Progress in the integration and interoperability of information systems represents a major step forward in the field of mHealth. The app will allow health professionals to monitor in real-time patients’ preparation and critical preoperative recommendations fulfillment. We expect a reduction in avoidable preoperative cancellations due to a lack of or a poor patient preparation. Self-assessed Web-based questionnaires and focus group will provide important information about the perceived usability and utility of Listeo+ app among patients and health care professionals. International Registered Report Identifier (IRRID): DERR1-10.2196/10938

  • ATN CARES study logo. Source: The Authors; Copyright: ATN CARES; URL: http://www.researchprotocols.org/2019/1/e10807/; License: Public Domain (CC0).
    Theme Issue (2018): Adolescent...

    Jan 16, 2019

    Acute HIV Infection in Youth: Protocol for the Adolescent Trials Network 147 (ATN147) Comprehensive Adolescent Research and Engagement Studies (CARES) Study

    Authors List:

    Abstract:

    Background: Early treatment studies have shown that prompt treatment of HIV with combination antiretroviral therapy (cART) can limit the size of latent viral reservoirs, thereby providing clinical and public health benefits. Studies have demonstrated that adolescents have a greater capacity for immune reconstitution than adults. Nevertheless, adolescents who acquired HIV through sexual transmission have not been included in early treatment studies because of challenges in identification and adherence to cART. Objective: This study aimed to identify and promptly treat with cART youth aged 12 to 24 years in Los Angeles and New Orleans who have acute, recent, or established HIV infection, as determined by Fiebig stages 1 to 6 determined by viral RNA polymerase chain reaction, p24 antigen presence, and HIV-1 antigen Western blot. The protocol recommends treatment on the day of diagnosis when feasible. Surveillance and dedicated behavioral strategies are used to retain them in care and optimize adherence. Through serial follow-up, HIV biomarkers and response to antiretroviral therapy (ART) are assessed. The study aims to assess viral dynamics, decay and persistence of viral reservoirs over time, and correlate these data with the duration of viral suppression. Methods: A total of 72 youth (36 acutely infected and 36 treatment naïve controls) are enrolled across clinical sites using a current community-based strategy and direct referrals. Youth are prescribed ART according to the standard of care HIV-1 management guidelines and followed for a period of 2 years. Assessments are conducted at specific time points throughout these 2 years of follow-up for monitoring of adherence to ART, viral load, magnitude of HIV reservoirs, and presence of coinfections. Results: The study began enrolling youth in July 2017 across study sites in Los Angeles and New Orleans. As of September 30, 2018, a total of 37 youth were enrolled, 12 with recently acquired, 16 with established HIV infection as determined by Fiebig staging, and 9 pending determination of Fiebig status. Recruitment and enrollment are ongoing. Conclusions: We hypothesize that the size of the HIV reservoir and immune activation markers will be different across groups treated with cART, that is, those with acute or recent HIV infection and those with established infection. Adolescents treated early who are virally suppressed will have diminished HIV reservoirs than those with established infection. These youth may be potential candidates for a possible HIV vaccine and additional HIV remission intervention trials. Our study will inform future studies of viral remission strategies. International Registered Report Identifier (IRRID): DERR1-10.2196/10807

  • mKidney Mobile Health System logo. Source: Image created by the Authors; Copyright: The Authors; URL: https://www.mkidney.org/; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (funded,...

    Jan 15, 2019

    The Impact of the mKidney mHealth System on Live Donor Follow-Up Compliance: Protocol for a Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: Every year, more than 5500 healthy people in the United States donate a kidney for the medical benefit of another person. The Organ Procurement and Transplantation Network (OPTN) requires transplant hospitals to monitor living kidney donors (LKDs) for 2 years postdonation. However, the majority (115/202, 57%) of transplant hospitals in the United States continue to fail to meet nationally mandated requirements for LKD follow-up. A novel method for collecting LKD follow-up is needed to ease both the transplant hospital-level and patient-level burden. We built mKidney—a mobile health (mHealth) system designed specifically to facilitate the collection and reporting of OPTN-required LKD follow-up data. The mKidney mobile app was developed on the basis of input elicited from LKDs, transplant providers, and thought leaders. Objective: The primary objective of this study is to evaluate the impact of the mKidney smartphone app on LKD follow-up rates. Methods: We will conduct a two-arm randomized controlled trial (RCT) with LKDs who undergo LKD transplantation at Methodist Specialty and Transplant Hospital in San Antonio, Texas. Eligible participants will be recruited in-person by a study team member at their 1-week postdonation clinical visit and randomly assigned to the intervention or control arm (1:1). Participants in the intervention arm will receive the mHealth intervention (mKidney), and participants in the control arm will receive the current standard of follow-up care. Our primary outcome will be policy-defined complete (all components addressed) and timely (60 days before or after the expected visit date) submission of LKD follow-up data at required 6-month, 1-year, and 2-year visits. Our secondary outcome will be hospital-level compliance with OPTN reporting requirements at each visit. Data analysis will follow the intention-to-treat principle. Additionally, we will collect quantitative and qualitative process data regarding the implementation of the mKidney system. Results: We began recruitment for this RCT in May 2018. We plan to enroll 400 LKDs over 2 years and follow participants for the 2-year mandated follow-up period. Conclusions: This pilot RCT will evaluate the impact of the mKidney system on rates of LKD and hospital compliance with OPTN-mandated LKD follow-up at a large LKD transplant hospital. It will provide valuable information on strategies for implementing such a system in a clinical setting and inform effect sizes for future RCT sample size calculations. International Registered Report Identifier (IRRID): DERR1-10.2196/11000

  • Designing digital health interventions. Source: Image created by the Authors; Copyright: Yunlong Wang; URL: http://www.researchprotocols.org/2019/1/e1/; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).
    Proposals (eHealth)

    Jan 15, 2019

    Integrating Taxonomies Into Theory-Based Digital Health Interventions for Behavior Change: A Holistic Framework

    Authors List:

    Abstract:

    Digital health interventions (DHIs) have been emerging in the last decade. Due to their interdisciplinary nature, DHIs are guided and influenced by theories (eg, behavioral theories, behavior change technologies, and persuasive technology) from different research communities. However, DHIs are always coded using various taxonomies and reported in insufficient perspectives. This inconsistency and incomprehensiveness will cause difficulty in conducting systematic reviews and sharing contributions among communities. Therefore, based on existing related work, we propose a holistic framework that embeds behavioral theories, behavior change technique taxonomy, and persuasive system design principles. Including four development steps, two toolboxes, and one workflow, our framework aims to guide DHI developers to design, evaluate, and report their work in a formative and comprehensive way.

  • Home assessment using an electronic tablet. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/1/e11674/; License: Creative Commons Attribution (CC-BY).
    Non-Randomized Studies (funded, eHealth)

    Jan 14, 2019

    Using an Electronic Tablet to Assess Patients’ Home Environment by Videoconferencing Prior to Hospital Discharge: Protocol for a Mixed-Methods Feasibility...

    Authors List:

    Abstract:

    Background: Occupational therapists working in hospitals are usually involved in discharge planning to assess patients’ safety and autonomy upon returning home. However, their assessment is usually done at the hospital due to organizational and financial constraints. The lack of visual data about the patients’ home may thus reduce the appropriateness and applicability of the support recommended upon discharge. Although various technological tools such as mobile devices (mobile health) are promising methods for home-based distance assessment, their application in hospital settings may raise several feasibility issues. To our knowledge, their usefulness and added value compared to standard procedure have not been addressed yet in previous studies. Moreover, several feasibility issues need to be explored. Objective: This paper aims to (1) document the clinical feasibility of using an electronic tablet to assess the patient's home environment by mobile videoconferencing and (2) explore the added value of using mobile videoconferencing, compared to the standard procedure. Methods: A feasibility and comparative study using a mixed-methods (convergent) design is currently undergoing. Six occupational therapists will assess the home environment of their patients in the hospital setting: they will first perform a semistructured interview (a) and then use mobile videoconferencing (b) to compare “a versus a+b.” Interviews with occupational therapists and patients and their caregivers will further explore the advantages and disadvantages of mobile videoconferencing. Two valid tools are used (the Canadian Measure of Occupational Performance and the telehealth responsivity questionnaire). Direct and indirect time is also collected. Results: The project was funded in the spring of 2016 and authorized by the ethics committee in February 2017. Enrollment started in April 2017. Five triads (n=4 occupational therapists, n=5 clients, n=5 caregivers) have been recruited until now. The experiment is expected to be completed by April 2019 and analysis of the results by June 2019. Conclusions: Mobile videoconferencing may be a familiar and easy solution for visualizing environmental barriers in the home by caregivers and clinicians, thus providing a promising and inexpensive option to promote a safe return home upon hospital discharge, but clinical feasibility and obstacles to the use of mobile videoconferencing must be understood. International Registered Report Identifier (IRRID): DERR1-10.2196/11674

  • Pame-playing. Source: Heather C Coit; Copyright: The University of Illinois at Urbana-Chamapaign; URL: https://www.researchprotocols.org/2019/1/e11470/; License: Licensed by the authors.
    RCTs - Protocols/Proposals (non-eHealth)

    Jan 14, 2019

    Rehabilitation for Children With Dystonic Cerebral Palsy Using Haptic Feedback in Virtual Reality: Protocol for a Randomized Controlled Trial

    Authors List:

    Abstract:

    Background: Cerebral palsy (CP) is the most common developmental motor disorder in children. Individuals with CP demonstrate abnormal muscle tone and motor control. Within the population of children with CP, between 4% and 17% present dystonic symptoms that may manifest as large errors in movement tasks, high variability in movement trajectories, and undesired movements at rest. These symptoms of dystonia typically worsen with physical intervention exercises. Objective: The aim of this study is to establish the effect of haptic feedback in a virtual reality (VR) game intervention on movement outcomes of children with dystonic CP. Methods: The protocol describes a randomized controlled trial that uses a VR game-based intervention incorporating fully automated robotic haptic feedback. The study consists of face-to-face assessments of movement before, after, and 1 month following the completion of the 6-session game-based intervention. Children with dystonic CP, aged between 7 and 17 years, will be recruited for this study through posted fliers and laboratory websites along with a group of typically developing (TD) children in the same age range. We anticipate to recruit a total of 68 participants, 34 each with CP and TD. Both groups of children will be randomly allocated into an intervention or control group using a blocked randomization method. The primary outcome measure will be the smoothness index of the interaction force with the robot and of the accelerometry signals of sensors placed on the upper limb segments. Secondary outcomes include a battery of clinical tests and a quantitative measure of spasticity. Assessors administering clinical measures will be blinded. All sessions will be administered on-site by research personnel. Results: The trial has not started and is pending local institutional review board approval. Conclusions: Movement outcomes will be examined for changes in muscle activation and clinical measures in children with dystonic CP and TD children. Paired t tests will be conducted on movement outcomes for both groups of children independently. Positive and negative results will be reported and addressed. Trial Registration: ClinicalTrials.gov NCT03744884; https://clinicaltrials.gov/ct2/show/NCT03744884 (Archived by WebCite at http://www.webcitation.org/74RSvmbZP) International Registered Report Identifier (IRRID): PRR1-10.2196/11470

  • Thought Challenger app (montage). Source: The Authors / Placeit; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2019/1/e11452/; License: Creative Commons Attribution (CC-BY).
    Non-randomized Protocols and Methods...

    Jan 14, 2019

    Use of Mental Health Apps by Breast Cancer Patients and Their Caregivers in the United States: Protocol for a Pilot Pre-Post Study

    Authors List:

    Abstract:

    Background: Over one-third of cancer patients experience clinically significant mental distress, and distress in caregivers can exceed that of the cancer patients for whom they care. There is an urgent need to identify scalable and cost-efficient ways of delivering mental health interventions to cancer patients and their loved ones. Objective: The aim of this study is to describe the protocol to pilot a mobile app–based mental health intervention in breast cancer patients and caregivers. Methods: The IntelliCare mental health apps are grounded in evidence-based research in psychology. They have not been examined in cancer populations. This pilot study will adopt a within-subject, pre-post study design to inform a potential phase III randomized controlled trial. A target sample of 50 individuals (with roughly equal numbers of patients and caregivers) at least 18 years of age and fluent in English will be recruited at a US National Cancer Institute designated clinical cancer center. Consent will be obtained in writing and a mobile phone will be provided if needed. Self-report surveys assessing mental health outcomes will be administered at a baseline session and after a 7-week intervention. Before using the apps, participants will receive a 30-min coaching call to explain their purpose and function. A 10-min coaching call 3 weeks later will check on user progress and address questions or barriers to use. Self-report and semistructured interviews with participants at the end of the study period will focus on user experience and suggestions for improving the apps and coaching in future studies. Results: This study is ongoing, and recruitment will be completed by the end of 2018. Conclusions: Results from this study will inform how scalable mobile phone-delivered programs can be used to support breast cancer patients and their loved ones. Trial Registration: ClinicalTrials.gov NCT03488745; https://clinicaltrials.gov/ct2/show/NCT03488745 International Registered Report Identifier (IRRID): DERR1-10.2196/11452

  • Source: Curatio / Smartmockups; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2019/1/e12322/; License: Creative Commons Attribution (CC-BY).
    RCTs - Protocols/Proposals (funded,...

    Jan 11, 2019

    Delivery of Peer Support Through a Self-Management mHealth Intervention (Healing Circles) in Patients With Cardiovascular Disease: Protocol for a Randomized...

    Authors List:

    Abstract:

    Background: Cardiovascular disease (CVD) is a leading cause of hospitalization and death around the world. The prevalence of CVD is increasing and, therefore, development and investigation of effective programs to help people better self-manage their CVD and prevent secondary complications are needed. Objective: In this paper, we report on a protocol to evaluate Healing Circles—an evidence-based and patient-informed peer support mobile health program designed to facilitate self-management and support patients in their recovery from and management of CVD. We hypothesize that individuals with CVD who use Healing Circles will experience greater improvements to their self-management ability than individuals receiving usual care. Methods: In this single-blinded (assessor) randomized controlled trial, 250 community-living individuals with CVD will be randomized on a 1:1 basis to either Healing Circles or Usual Care. The primary outcome of self-management will be measured using the Health Education Impact Questionnaire version 3.0. Secondary outcomes include self-efficacy with chronic disease management, health-related quality of life, health resource use and costs, and electronic health literacy. Measurements will be taken at the baseline and every 6 months for 24 months. Results: The study started recruitment in September 2017. Individuals are currently being recruited for participation, and existing participants are currently on follow-up. Measurements will be taken every 6 months until the study end, which is anticipated in December 2019. Conclusions: Healing Circles is a novel program aimed toward improving self-management through peer support. Given our real-world study design, our findings will be readily translatable into practice. If the results support our hypothesis, it will indicate that Healing Circles is an effective intervention for improving self-management and reducing health care use. Trial Registration: ClinicalTrials.gov NCT03159325; https://clinicaltrials.gov/ct2/show/NCT03159325 (Archived by WebCite at http://www.webcitation.org/74DvxVKUd) International Registered Report Identifier (IRRID): DERR1-10.2196/12322

  • Source: Freepik; Copyright: Freepik; URL: https://www.freepik.com/free-photo/young-woman-suffering-from-stomach-pain_3480426.htm#term=pain&page=2&position=20; License: Licensed by JMIR.
    Systematic Review Protocols (funded)

    Jan 11, 2019

    Magnesium for the Management of Chronic Noncancer Pain in Adults: Protocol for a Systematic Review

    Authors List:

    Abstract:

    Background: Chronic pain is a highly prevalent and complex health problem that is associated with a severe symptom burden, as well as substantial economic and social impact. Many patients with chronic pain still suffer from unrelieved or undertreated pain due to the incomplete efficacy and dose-limiting adverse effects of current therapies. Long-term and high-dose opioid use has considerably increased in the past 20 years despite limited evidence supporting its effectiveness in several chronic pain conditions, and serious concerns have emerged regarding adverse effects and potential misuse. Until recently, the steady increase in opioid prescribing rates has been associated with rising opioid-related mortality and other serious problems, emphasizing the need for better nonopioid therapies. Emerging evidence supports the safe use of magnesium in controlling chronic pain, but its overall efficacy and safety is still unclear. Objective: This paper aims to assess the efficacy and safety of magnesium compared with a placebo for the treatment of chronic noncancer pain. Methods: We will conduct a detailed search on Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE from their inception until the date the searches are run to identify relevant randomized controlled trials. The reference lists of retrieved studies as well as Web-based trial registries will also be searched. We will include randomized double-blind trials comparing magnesium (at any dose, frequency, or route of administration) with placebo using participant-reported pain assessment. Two reviewers will independently evaluate studies for eligibility, extract data, and assess trial quality and potential bias. Risk of bias will be assessed using criteria outlined in the Cochrane Handbook for Systematic Review of Interventions. Primary outcomes for this review will include any validated measure of pain intensity or pain relief. Dichotomous data will be used to calculate the risk ratio and number needed to treat or harm. The quality of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. Results: This protocol is grant-funded and has undergone a peer-review process through the Queen’s University Department of Anesthesiology and Perioperative Medicine Vandewater Endowed Studentship. This project is also supported, in part, by the Chronic Pain Network of the Canadian Institutes of Health Research Strategy for Patient-Oriented Research. The electronic database search strategies are currently being developed and modified. The entire review is expected to be completed by January 1, 2019. Conclusions: The completion of this review is expected to identify available high-quality evidence describing the efficacy and safety of magnesium for the treatment of chronic noncancer pain. International Registered Report Identifier (IRRID): PRR1-10.2196/11654

  • LML app icon and study logo. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2019/1/e12112/; License: Creative Commons Attribution (CC-BY).
    Non-randomized Protocols and Methods...

    Jan 10, 2019

    Investigating Health Risk Environments in Housing Programs for Young Adults: Protocol for a Geographically Explicit Ecological Momentary Assessment Study

    Authors List:

    Abstract:

    Background: Young adults who experience homelessness are exposed to environments that contribute to risk behavior. However, few studies have examined how access to housing may affect the health risk behaviors of young adults experiencing homelessness. Objective: This paper describes the Log My Life study that uses an innovative, mixed-methods approach based on geographically explicit ecological momentary assessment (EMA) through cell phone technology to understand the risk environment of young adults who have either enrolled in housing programs or are currently homeless. Methods: For the quantitative arm, study participants age 18-27 respond to momentary surveys via a smartphone app that collects geospatial information repeatedly during a 1-week period. Both EMAs (up to 8 per day) and daily diaries are prompted to explore within-day and daily variations in emotional affect, context, and health risk behavior, while also capturing infrequent risk behaviors such as sex in exchange for goods or services. For the qualitative arm, a purposive subsample of participants who indicated engaging in risky behaviors are asked to complete an in-depth qualitative interview using an interactive, personalized geospatial map rendering of EMA responses. Results: Recruitment began in June of 2017. To date, 170 participants enrolled in the study. Compliance with EMA and daily diary surveys was generally high. In-depth qualitative follow-ups have been conducted with 15 participants. We expect to recruit 50 additional participants and complete analyses by September of 2019. Conclusions: Mixing the quantitative and qualitative arms in this study will provide a more complete understanding of differences in risk environments between homeless and housed young adults. Furthermore, this approach can improve recall bias and enhance ecological validity. International Registered Report Identifier (IRRID): DERR1-10.2196/12112

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    Open Peer Review Period: Jan 16, 2019 - Jan 30, 2019

    Background: The average life expectancy for people with a severe mental illness (SMI) such as schizophrenia or bipolar disorder is 15-20 years less than for the population as a whole. Diabetes contrib...

    Background: The average life expectancy for people with a severe mental illness (SMI) such as schizophrenia or bipolar disorder is 15-20 years less than for the population as a whole. Diabetes contributes significantly to this inequality, being 2-3 times more prevalent in people with SMI. Various risk factors have been implicated, including side effects of antipsychotic medication and unhealthy lifestyles, which often occur in the context of socio-economic disadvantage and healthcare inequality. However, little is known about how these factors interact to influence the risk of developing diabetes and poor diabetic outcomes, or how the organisation and provision of healthcare may contribute. Objective: The study aims to identify the determinants of diabetes and to explore variation in diabetes outcomes for people with SMI. Methods: This study will employ a concurrent mixed methods design combining the interrogation of electronic primary care health records from the Clinical Practice Research Datalink (CPRD GOLD) with qualitative interviews with adults with SMI and diabetes, their relatives/friends, and healthcare staff. The study has been funded for two years, from September 2017 to September 2019 and data collection has recently ended. Results: CPRD and linked health data will be used to explore the association of socio-demographic, illness and healthcare-related factors with both the development and outcomes of Type 2 diabetes in people with SMI. Experiences of managing the comorbidity and accessing healthcare will be explored through qualitative interviews using topic guides informed by evidence synthesis and expert consultation. Findings from both datasets will be merged to develop a more comprehensive understanding of diabetes risks, interventions and outcomes for people with SMI. Findings will be translated into recommendations for interventions and services using co-design workshops. Conclusions: Improving diabetes outcomes for people with SMI is a high priority area nationally and globally. Understanding how risk factors combine to generate high prevalence of diabetes and poor diabetic outcomes for this population is a necessary first step in developing healthcare interventions to improve outcomes for people with diabetes and SMI. Clinical Trial: The study is registered on the NIHR Central Portfolio Management System (CPMS; ref. no. 37024) and ClinicalTrials.gov (record identifier no. NCT03534921).

  • A mixed methods study exploring the views and experiences of internationally qualified midwives in Australia: Research Protocol

    Date Submitted: Jan 15, 2019

    Open Peer Review Period: Jan 16, 2019 - Jan 30, 2019

    Background: Approximately, 13% of the total Australian midwifery workforce is internationally qualified. Although they play a significant role in the Australian midwifery system, there is limited unde...

    Background: Approximately, 13% of the total Australian midwifery workforce is internationally qualified. Although they play a significant role in the Australian midwifery system, there is limited understanding of their transitional experiences. Objective: This mixed methods study aims to explore the transitional experiences and perspectives of internationally qualified midwives practising in Australia. Methods: This study uses an explanatory sequential mixed methods design incorporating two phases. The first phase of the study includes an e-survey that will be distributed to internationally qualified midwives in Australia, via the website e-bulletins of the Australian Nursing and Midwifery Federation and Australian College of Midwives. Additionally, potential respondents will be recruited via social media (Twitter, Facebook) and associated snowball sampling. At the end of the e-survey, respondents will be asked whether they are willing to take part in an interview. Data from the e-survey will be statistically analysed. The results of the e-survey and literature review will help to develop a guide for interview questions, with these interviews taking place during the second phase. A nested sample of participants will be created using the same selection criteria as for the e-survey. Semi-structured interviews will provide a deeper insight into the transitional experiences of internationally qualified midwives. Data will then be thematically analysed. Results: An integration of the e-survey results and interview findings will be synthesised to explore and better understand the transitional experiences of this group of midwives. The resulting data may potentially be used to formulate recommendations for future recruitment and retention practices, and to aid the Australian midwifery workforce in valuing diversity and fostering a supportive work environment. Conclusions: At the time of writing this protocol, data collection had not yet commenced, however collection was subsequently completed in late 2018 and analysis is currently underway. Clinical Trial: This study was approved by the University of South Australia Human Research Ethics Committee (Protocol Number: 0000036397).

  • Health Online for Teens (HOT) program for Australian adolescents above a healthy weight: study protocol

    Date Submitted: Jan 10, 2019

    Open Peer Review Period: Jan 14, 2019 - Jan 28, 2019

    Background: Over one quarter of Australian adolescents are overweight or obese, with obesity in adolescents strongly persisting into adulthood. Recent evidence suggests that the mid-teen years presen...

    Background: Over one quarter of Australian adolescents are overweight or obese, with obesity in adolescents strongly persisting into adulthood. Recent evidence suggests that the mid-teen years present a final window of opportunity to prevent irreversible damage to the cardiovascular system. As lifestyle behaviours may change with increased autonomy during adolescence, this life-stage is an ideal time to intervene and promote healthy diet and activity behaviours, wellbeing and self-esteem. As teenagers are prolific users and innate adopters of online technologies, app-based programs may be suitable for the promotion of healthy lifestyle behaviours and goal setting training. Objective: This study aims to explore the reach, engagement, user experience and satisfaction of the new app- and web-based Health Online for Teens (HOT) program in a sample of Australian adolescents above a healthy weight (i.e. overweight or obese) and their parents. Methods: Health Online for Teens (HOT) is a 14-week program for adolescents and their parents. The program is delivered online via the Moodle app- and website-based online learning environment and aims to promote adolescent lifestyle behaviour change in line with Australian Dietary Guidelines and Australia's Physical Activity and Sedentary Behaviour Guidelines for Young People (13 – 17 years). HOT aims to build parental and peer support during the program to support adolescents with healthy lifestyle behaviour change. This project is currently delivering the intervention to participants and data collection is ongoing. Results: Data collection for this study is ongoing. To-date, 35 adolescents and their parents have participated in one of three groups. Conclusions: Health Online for Teens (HOT) is a new online-only program for Australian adolescents and their parents which aims to reduce cardiovascular disease risk factors. This study protocol paper describes the HOT program in detail, along with the methods to measure reach, outcomes, engagement, user experiences, and program satisfaction. Clinical Trial: This study was prospectively registered in the Australian New Zealand Clinical Trials Registry (ANZCTR, http://www.anzctr.org.au) on 29 March 2018 with registration number: ACTRN12618000465257. The first participant was enrolled in to the study on 19 April 2018.

  • Protocol for a three-arm randomized trial of virtual reality and web-based growth mindset interventions for adolescent depression

    Date Submitted: Jan 11, 2019

    Open Peer Review Period: Jan 12, 2019 - Jan 26, 2019

    Depression is one of the leading causes of disability in youth, with a global economic burden of >$210 billion annually. However, up to 70% of youth with depression do not receive services. Even among...

    Depression is one of the leading causes of disability in youth, with a global economic burden of >$210 billion annually. However, up to 70% of youth with depression do not receive services. Even among those who do access treatment, 30-65% fail to respond and many drop-out prematurely, creating a need for more potent, accessible interventions. Accordingly, the goal of this project is to test the acceptability and efficacy of a novel, single-session, virtual reality (VR) depression intervention—the VR Personality Project—teaching growth mindset: the belief that personal attributes are malleable rather than fixed. In a previous trial, a single-session web-based growth mindset intervention significantly reduced depressive symptoms in high symptom-adolescents; however, this intervention did not benefit adolescents uniformly. For instance, the intervention significantly reduced depressive symptoms in adolescents who reported improvements in perceived control, but not in adolescents who reported no significant post-intervention increases in perceived control. The VR Personality Project was designed to systematically target and increase adolescents’ perceived control by offering a more immersive, engaging, user-directed intervention experience than the web-based intervention can provide. By targeting an identified predictor of intervention response, the VR Personality Project may be lead to larger reductions in depressive symptoms than existing web-based mindset interventions. To test this possibility, adolescents with elevated depressive symptoms (N=159; ages 12-16) will be randomized to one of three intervention conditions: the VR Personality Project; a web-based growth mindset intervention; or an active, web-based control. All programs are approximately 30 minutes in length and self-administered by youth. Adolescents and parents will report on youths’ depressive symptoms at pre-intervention and 3- and 9-month follow-up, and adolescents will report their levels of perceived control and related domains of functioning at pre- and post-intervention and 3- and 9-month follow-up. We predict that the VR and web-based mindset interventions will both lead to larger reductions in adolescent depressive symptoms than the control intervention across the follow-up period. We also predict that the VR-based intervention will lead to larger reductions in depressive symptoms than the web-based mindset intervention, and that these symptom reductions will be mediated by increases in adolescents’ perceived control from pre- to post-intervention. Results may suggest a novel, VR-based approach to reducing for adolescent depressive symptoms: One that is relatively affordable (< $200 for a commercially-available VR headset, a fraction of the cost of long-term psychotherapy) and potentially engaging to adolescents experiencing mood-related distress.

  • Smartphone Medication Adherence Saves Kidneys: study protocol for a randomized controlled trial

    Date Submitted: Jan 9, 2019

    Open Peer Review Period: Jan 11, 2019 - Jan 25, 2019

    Background: Despite significant advances in the care of kidney transplant recipients (KTRs), long-term graft survival remains poor. Poor medication adherence (MA) and poor control of comorbid medical...

    Background: Despite significant advances in the care of kidney transplant recipients (KTRs), long-term graft survival remains poor. Poor medication adherence (MA) and poor control of comorbid medical conditions, particularly hypertension (HTN), are major risk factors for premature graft rejection, graft loss, and death. Few randomized controlled trials (RCTs) have had success in improving sustained MA and blood pressure control among KTRs. We provide a rationale for a RCT evaluating a mobile health technology enabled, user centered, theory guided, medical regimen self-management system for KTRs called Smart phone medication adherence saves kidneys (SMASK). O Objective: ur objective is to determine whether the SMASK program compared to an enhanced standard care attention control arm is efficacious in improving MA and sustaining BP control among KTRs with uncontrolled HTN and poor MA. Methods: This two-arm six-month phase II single site efficacy RCT will involve 80 KTRs. They will be randomly assigned to the SMASK intervention arm or the control arm. The SMASK program includes multi-level components: 1) automated reminders from an electronic medication tray; 2) tailored text message motivational feedback and reinforcement guided by self-determination theory and based upon adherence to daily medication and BP monitoring and 3) automated summary reports and direct alerts to providers. Evaluations will occur at pre-intervention, months 3 and 6, and post-trial follow-ups at month 12. Results: Specific aims are to test the hypotheses that, compared to the SC cohort, the SMASK cohort will demonstrate significantly improved and sustained changes at months 3, 6 and 12 in: 1) Primary Outcome Variables: a) Medication adherence: % with electronic monitor-derived es >0.90; b) BP control: % reaching and sustaining KDIGO guidelines for BP control (clinic resting BP <130/80 mmHg). 2) Secondary Outcome Variables: a) Provider adherence to KDIGO guidelines as measured by timing of medication changes; b) Changes in Self-Determination Theory constructs (e.g., competence and autonomous regulation). 3) Exploratory Outcome Variables: a) Estimated glomerular filtration rate; b) Variability in calcineurin inhibitor trough levels; c) % reaching and sustaining 24-hr ambulatory BP<130/80 mmHg. After 6-month trial completion evaluation, interviews with random sample of SMASK subjects (n=20) and healthcare providers (3-5) will assess key user reactions including acceptability, usability, salience and aids/barriers to sustainability.intervention, months 3 and 6, and post-trial follow-ups at month 12. Conclusions: Data from RCT and interviews will be triangulated to further refine and optimize SMASK and prepare for a multi-site effectiveness RCT. Clinical Trial: ClinicalTrials.gov Identifier NCT02827695, Register 11 July 2016, https://clinicaltrials.gov/ct2/show/NCT02827695?term=mcgillicuddy&rank=2

  • Protocol of a Meta-Ethnography Review of Frameworks, Models and Theories in eHealth Research and Development to Support Self-Management of Cardiovascular Diseases

    Date Submitted: Jan 8, 2019

    Open Peer Review Period: Jan 11, 2019 - Jan 25, 2019

    Background: eHealth is a multidisciplinary and rapidly evolving field, thus is in need for research focused on knowledge accumulation, curation, and translation. Cardiovascular diseases represent a gl...

    Background: eHealth is a multidisciplinary and rapidly evolving field, thus is in need for research focused on knowledge accumulation, curation, and translation. Cardiovascular diseases represent a global healthcare crisis where eHealth can provide novel solutions to improve the efficiency and reach of self-management support for patients where they most need it: their homes and communities. A holistic understanding of the eHealth projects focused on such case is required to bridge the multidisciplinary gap and improve future research and development approaches. Objective: The primary objective of this review is to facilitate a holistic interpretation of eHealth projects aimed at providing self-management support of cardiovascular diseases in the natural setting of patients. The review aims to synthesize the operationalization of frameworks, models, and theories applied to the research and development process of eHealth. Methods: Noblit and Hare’s meta-ethnography approach will be used to review and synthesize the reports of researchers and practitioners on how they applied frameworks, models, and theories in their projects. A systematic literature search will be conducted on seven databases: Scopus, Web of Science, Embase, CINAHL, PsycINFO, ACM DL, and the Cochrane Library. Selected studies will be thoroughly read and coded to extract both the raw and the contextual data for the synthesis. The relation of the studies will be determined according to the elements of the frameworks, models, or theories they applied. A translation of these elements between each other will be conducted, and a synthesis of holistic principles for eHealth development for the case at hand is intended. Results: The search strategy has been completed, data extraction is almost finalized, and the first synthesis approaches are currently undergoing. The search yielded 1224 citations and after applying the selection criteria 17 papers remained . The final results are expected to be submitted for publication in 2019. Conclusions: The review is of importance because it aims to create a holistic understanding of a multidisciplinary topic at the crossroads of eHealth, cardiovascular diseases, and self-management. The value of meta-ethnography in contrast to other systematic reviews is that its synthesis approach seeks to generate a new understanding of a topic, while preserving the social and theoretical contexts in which findings emerge. Our results will show how useful this method can be in bridging the multidisciplinary gap of eHealth research and development, to inform and advance on the importance of holistic approaches, showcasing this for the case of self-management in cardiovascular diseases. Clinical Trial: PROSPERO CRD42018104397; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=104397 (Archived by WebCite at http://www.webcitation.org/75H1kP1Mm).

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