JMIR Publications

JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results

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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) publishes 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 new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor 2016: 5.175)

JMIR Res Protoc 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 

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 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)

 
 

Recent Articles:

  • Source: Pixabay; Copyright: jarmoluk; URL: https://pixabay.com/en/laboratory-analysis-diagnostics-2815641/; License: Public Domain (CC0).

    Immune-Enhancing Formulas for Patients With Cancer Undergoing Esophagectomy: Systematic Review Protocol

    Abstract:

    Background: Adult patients with an esophageal cancer can potentially be compromised with postoperative leaks or fistulae if patients’ nutritional status is in a vulnerable stage. Currently in Australia, there is a growing need for clinicians to know whether use of immune-enhancing formulas (IEFs) containing Arg, omega-3, and RNA are a cost-effective approach compared with isonitrogenous-isocaloric formulas to reduce postoperative infectious complications in esophagectomy patients. Since IEFs may carry higher costs, this has led to inconsistencies in practice among clinicians and hospitals. Objective: Our aim is to compile and present the most up-to-date nutrition evidence available regarding the provision of IEFs containing Arg, omega-3, and RNA to help clinicians develop an evidence-based nutrition care plan; identify available evidence of whether an esophagectomy patient should receive IEF; determine the cost-effectiveness and safety of such nutrition; and determine appropriate administration quantity and timing (pre-, peri-, or postesophagectomy). Methods: This review will include RCTs involving the use of IEFs enriched with Arg, omega-3 polyunsaturated fatty acids, and RNA in the pre-, peri-, or postoperative period (for at least 5-7 days) given orally or via enteral feeding tube, in adult cancer patients undergoing esophageal resection. Lower gastrointestinal, gastric, or head cancer surgery with parenteral nutrition or non-IEF or use of isolated immunonutrient (Arg vs omega-3 vs RNA) will be excluded. Primary outcome comprises postoperative infectious complications. Secondary outcomes (pre/postoperatively) consist of cost-effectiveness, length of stay, survival/mortality, quality of life, nutritional status, percentage of weight loss, and biochemical changes. The risk of bias will be independently assessed by the reviewers, using a domain-based evaluation tool. Blinding will be assessed for subjective and objective outcome measures. Publication bias will be visually assessed by funnel plots. A meta-analysis will be generated by the Review Manager 5.3 software and represented in forest plots. Results: The first results are expected in 2018. Outlining the protocol will ensure transparency for the completed review. Conclusions: This protocol for a systematic review and meta-analysis will enable a comprehensive appraisal of the literature to help determine whether overall institutional savings are associated with this approach. Findings will form a knowledge base relevant to stakeholders across the health system and researchers who are involved in decision making on evidence-based nutrition care plan pathways for patients undergoing esophagectomy, as well as the use of IEF, timing, and administration quantity. Trial Registration: PROSPERO Registration Number: CRD42017056908; http://www.crd.york.ac.uk/PROSPERO/ display_record.asp? ID=CRD42017056908 (Archived by WebCite at http://www.webcitation.org/6rLyeqaD6)

  • Source: Shutterstock; Copyright: takasu; URL: https://www.shutterstock.com/image-photo/doctor-explaining-patient-406647739; License: Licensed by the authors.

    Development and Usability Testing of a Computer-Tailored Decision Support Tool for Lung Cancer Screening: Study Protocol

    Abstract:

    Background: Awareness of lung cancer screening remains low in the screening-eligible population, and when patients visit their clinician never having heard of lung cancer screening, engaging in shared decision making to arrive at an informed decision can be a challenge. Therefore, methods to effectively support both patients and clinicians to engage in these important discussions are essential. To facilitate shared decision making about lung cancer screening, effective methods to prepare patients to have these important discussions with their clinician are needed. Objective: Our objective is to develop a computer-tailored decision support tool that meets the certification criteria of the International Patient Decision Aid Standards instrument version 4.0 that will support shared decision making in lung cancer screening decisions. Methods: Using a 3-phase process, we will develop and test a prototype of a computer-tailored decision support tool in a sample of lung cancer screening-eligible individuals. In phase I, we assembled a community advisory board comprising 10 screening-eligible individuals to develop the prototype. In phase II, we recruited a sample of 13 screening-eligible individuals to test the prototype for usability, acceptability, and satisfaction. In phase III, we are conducting a pilot randomized controlled trial (RCT) with 60 screening-eligible participants who have never been screened for lung cancer. Outcomes tested include lung cancer and screening knowledge, lung cancer screening health beliefs (perceived risk, perceived benefits, perceived barriers, and self-efficacy), perception of being prepared to engage in a patient-clinician discussion about lung cancer screening, occurrence of a patient-clinician discussion about lung cancer screening, and stage of adoption for lung cancer screening. Results: Phases I and II are complete. Phase III is underway. As of July 15, 2017, 60 participants have been enrolled into the study, and have completed the baseline survey, intervention, and first follow-up survey. We expect to have results by December 31, 2017 and to have data analysis completed by March 1, 2018. Conclusions: Results from usability testing indicate that the computer-tailored decision support tool is easy to use, is helpful, and provides a satisfactory experience for the user. At the conclusion of phase III (pilot RCT), we will have preliminary effect sizes to inform a future fully powered RCT on changes in (1) knowledge about lung cancer and screening, (2) perceived risk of lung cancer, (3) perceived benefits of lung cancer screening, (4) perceived barriers to lung cancer screening, (5) self-efficacy for lung cancer screening, and (6) perceptions of being adequately prepared to engage in a discussion with their clinician about lung cancer screening.

  • Source: Flickr; Copyright: Simon Fraser University; URL: https://www.flickr.com/photos/sfupamr/8981968330/in/photostream/; License: Creative Commons Attribution (CC-BY).

    Improving Transition to Employment for Youth With Physical Disabilities: Protocol for a Peer Electronic Mentoring Intervention

    Abstract:

    Background: Although youth with disabilities have much to gain from employment readiness programs, they are often excluded from or have limited access to vocational programs. One encouraging approach to address gaps in vocational programming is through peer electronic mentoring (e-mentoring), which may facilitate a smoother transition to adulthood by offering support to enhance coping skills. Despite the increase in online communities, little is known about their impact on vocational mentoring for youth with physical disabilities and their parents. Objective: The aim of this paper is to develop, implement, and assess the feasibility of an online peer mentor employment readiness intervention for youth with physical disabilities and their parents to improve their self-determination, career maturity, and social support compared to controls. Methods: A mixed-methods feasibility randomized controlled trial (RCT) design will be conducted to develop and assess the feasibility, acceptability, and initial efficacy of the “Empowering Youth Towards Employment” intervention. Youth (aged 15 to 25) with physical disabilities and their parents will be randomly assigned to a control or experimental group (4-week, interactive intervention, moderated by peer mentors). Results: Data collection is in progress. Planned analyses include pre-post measures to determine the impact of the intervention on self-determination, career maturity, and social support. A qualitative thematic analysis of the discussion forums will complement the surveys to better understand why certain outcomes may have occurred. Conclusions: Our intervention includes evidence-informed content and was co-created by a multi-disciplinary group of researchers and knowledge users. It has the potential for widespread implications as a cost-effective resource to supplement educational and vocational programming for youth with disabilities. Trial Registration: Clinicaltrials.gov NCT02522507; https://clinicaltrials.gov/ct2/show/NCT02522507 (Archived by WebCite at http://www.webcitation.org/6uD58Pvjc)

  • Source: Flickr; Copyright: Lee Haywood; URL: https://www.flickr.com/photos/leehaywood/5266525534; License: Creative Commons Attribution + ShareAlike (CC-BY-SA).

    Should Medical Assistance in Dying Be Extended to Incompetent Patients With Dementia? Research Protocol of a Survey Among Four Groups of Stakeholders From...

    Abstract:

    Background: Alzheimer’s disease and related disorders affect a growing number of people worldwide. Quality of life is generally good in the early stages of these diseases. However, many individuals fear living through the advanced stages. Such fears are triggering requests for medical assistance in dying (MAiD) by patients with dementia. Legislation was recently passed in Canada and the province of Quebec allowing MAiD at the explicit request of a patient who meets a set of eligibility criteria, including competence. Some commentators have argued that MAiD should be accessible to incompetent patients as well, provided appropriate safeguards are in place. Governments of both Quebec and Canada are currently considering whether MAiD should be accessible through written requests made in advance of loss of capacity. Objective: Aimed at informing the societal debate on this sensitive issue, this study will compare stakeholders’ attitudes towards expanding MAiD to incompetent patients with dementia, the beliefs underlying stakeholders’ attitudes on this issue, and the value they attach to proposed safeguards. This paper describes the study protocol. Methods: Data will be collected via a questionnaire mailed to random samples of community-dwelling seniors, relatives of persons with dementia, physicians, and nurses, all residing in Quebec (targeted sample size of 385 per group). Participants will be recruited through the provincial health insurance database, Alzheimer Societies, and professional associations. Attitudes towards MAiD for incompetent patients with dementia will be elicited through clinical vignettes featuring a patient with Alzheimer’s disease for whom MAiD is considered towards the end of the disease trajectory. Vignettes specify the source of the request (from the patient through an advance request or from the patient’s substitute decision-maker), manifestations of suffering, and how close the patient is to death. Arguments for or against MAiD are used to elicit the beliefs underlying respondents’ attitudes. Results: The survey was launched in September 2016 and is still ongoing. At the time of submission, over 850 respondents have returned the questionnaire, mostly via mail. Conclusions: This study will be the first in Canada to directly compare views on MAiD for incompetent patients with dementia across key stakeholder groups. Our findings will contribute valuable data upon which to base further debate about whether MAiD should be accessible to incompetent patients with dementia, and if so, under what conditions.

  • Source: Pixabay; Copyright: Gerd Altmann; URL: https://pixabay.com/en/school-questions-who-what-how-why-2253459/; License: Public Domain (CC0).

    The Association of Health Literacy and Electronic Health Literacy With Self-Efficacy, Coping, and Caregiving Perceptions Among Carers of People With...

    Abstract:

    Background: In the last decade, electronic health (eHealth) literacy has attracted the attention of the scientific community, as it is associated with the self-management of patients with chronic diseases and the quality and cost of care. It is estimated that 80% of people with chronic diseases are cared for at home by a family member, friend, or relative. Informal carers are susceptible to physical and mental health problems, as well as social and financial hardships. Nevertheless, there seems to be a research gap in terms of carers’ needs, skills, and available resources in the age of new technologies, with the vital role of eHealth literacy of the carers remaining unexplored. Objective: The aim of this study was to investigate the level of eHealth literacy and health literacy of primary and secondary carers of people with dementia, to explore the association between health and eHealth literacy, as well as their association with the caregiving variables: self-efficacy, coping, and caring perceptions. Methods: A sample of 200 primary carers (the carer who supports the people with dementia in everyday living) and 200 secondary carers (family member, friend, or other person in the social network assisting the primary carer in their role) will be recruited from dementia day care centers and Alzheimer’s associations in Greece and Cyprus. The study will be a cross-sectional correlational descriptive study. Tools to be used include the eHealth Literacy Scale adapted for carers to measure eHealth literacy, European Health Literacy Survey Questionnaire 16 (HLS-EU-Q16), Single Item Literacy Screener, Revised Scale for Caregiving Self-Efficacy, Carers of Older People in Europe (COPE) index for caregiving perceptions, and COPE brief to measure selected coping strategies. Descriptive statistics will be reported, and correlations between different variables will be explored with parametric and nonparametric measures. Results: As a preliminary study, the HLS-EU-Q16 has been validated in 107 older people. The internal consistency of the scale as estimated using Cronbach alpha coefficient was .77, somewhat lower than other validation studies. Recruitment of pilot study participants started in May 2017. Conclusions: Carers’ eHealth literacy is a new field. Whereas previous studies have focused on the role and impact of low eHealth literacy and health literacy among older adults, the eHealth literacy of carers, and in fact carers of people with dementia, has not been explored. We hypothesize an association between eHealth literacy and health literacy level with carers’ perceptions about caregiving role, self-efficacy, and coping strategies. A possible moderator in these associations is the secondary carers’ eHealth and health literacy level, which will also be explored. By confirming the above hypotheses, tailored eHealth literacy interventions for carers of people with dementia and their families will be developed as a direct outcome of this research.

  • The Move More Pack. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/11/e220/; License: Creative Commons Attribution (CC-BY).

    The Effect of the Move More Pack on the Physical Activity of Cancer Survivors: Protocol for a Randomized Waiting List Control Trial with Process Evaluation

    Abstract:

    Background: Physical activity can improve many common side effects of cancer treatment as well as improve physical function and quality of life (QOL). In addition, physical activity can improve survival rate and reduce cancer recurrence. Despite these benefits, only 23% of cancer survivors in England are active to recommended levels. Cancer survivors are interested in lifestyle behavior change. Home-based interventions offer a promising means for changing physical activity behavior. Prediagnosis levels of physical activity and self-efficacy have been reported to be predictors of physical activity behavior change. The Move More Pack, which has undergone revision, is a printed resource with supporting Internet-based tools that aims to increase the physical activity of cancer survivors in the United Kingdom. The revised Move More Pack is underpinned by the theory of planned behavior and the social cognitive theory. Objective: The aim of this proposed study was to investigate the effect of the revised Move More Pack, supported by Internet-based tools, on physical activity, self-efficacy, and health-related QOL (HRQOL) of cancer survivors in the United Kingdom. Methods: This study is a two-arm waiting list randomized control trial with embedded process evaluation. A sample of 99 participants per arm will be recruited by invitation through an email database of cancer survivors held by UK charity Macmillan Cancer Support and an advert placed on the Macmillan Cancer Support Facebook page. Each participant is randomized to receive brief physical activity information and the UK guidelines for physical activity, or brief physical activity information and the revised Move More Pack with supporting Internet-based tools. The intervention and control arm will be followed up at 12 weeks to identify changes in self-reported physical activity, self-efficacy, and HRQOL based on Web-based questionnaires. The control arm will receive the revised Move More Pack at 12 weeks with follow-up at 24 weeks. The intervention arm is followed up at 24 weeks to determine maintenance of reported changes. Subgroup analyses will be completed based on participants’ prediagnosis level of physical activity and baseline self-efficacy as possible predictors of positive changes. Use of each component of the revised Move More Pack will be assessed using a 4-point Likert scale. Semistructured phone interviews will evaluate the use and perceived usefulness of the revised Move More Pack. Results: Participant recruitment started in March 2017. Projected completion of this study is October 2018. Conclusions: This study’s findings will identify if the proposed low-cost broad reach intervention improves physical activity, self-efficacy, and the HRQOL of cancer survivors. The process evaluation is designed to contextualize the use and perceived usefulness of the revised Move More Pack, help augment its efficient distribution, and identify potential improvements to its design.

  • NMIBC-SI logo. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/11/e216/; License: Creative Commons Attribution (CC-BY).

    Psychometric Evaluation of a Patient-Reported Symptom Index for Nonmuscle Invasive Bladder Cancer: Field Testing Protocol

    Abstract:

    Background: Nonmuscle invasive bladder cancer (NMIBC) is a chronic condition requiring intensive follow-up, repeated endoscopic examinations, tumor resections, and intravesical treatments that can occur every 3 months for life. In this clinical context, patient-reported outcomes (PROs) are a critical concern for patients and their managing clinicians. PROs have enormous potential to be integral to treatment assessment and recommendations for NMIBC; however, current PRO measures are inadequate for NMIBC because they lack key NMIBC-specific symptoms and side effects associated with contemporary treatments. Objective: The overarching aim of this study was to develop and evaluate a patient-reported symptom index (SI) for individuals with NMIBC (the NMIBC-SI) that is acceptable to patients; reliable, valid, and responsive to differences between contemporary treatments for NMIBC; and fit for purpose as an endpoint in clinical trials. Methods: The NMIBC-SI will be evaluated in 2 field tests across a total of 3 years. Field test 1 is a cross-sectional study design involving 225 adult NMIBC patients recruited while undergoing active treatment or those who completed final treatment within the past week. Data collected include patient demographics, clinical features of the tumor, risk category, treatment type, comorbidity, and PROs. Field test 2 is a prospective longitudinal study involving 225 newly diagnosed NMIBC-SI patients. Clinical data and patient-completed questionnaires will be collected at 4 time points during treatment: before tumor resection, 1 week after resection, end-of-induction intravesical therapy, and 1-year follow-up. Standard psychometric tests will be performed to assess the reliability, validity, responsiveness, and clinical utility of the NMIBC-SI. Results: Participant recruitment to field test 1 commenced in February 2017. Recruitment for field test 2 is planned to commence in January 2018. Final results are expected to be published in 2019. The NMIBC-SI will be freely available for use via registration. Conclusions: This study protocol contains detailed methods that will be used across multiple international sites. Phase 2 in the development of the NMIBC-SI will enable a comprehensive evaluation of its reliability, validity, and responsiveness to ensure that the NMIBC-SI is fit for purpose in clinical research and provides an evidence base for the ongoing improvement of future therapies for NMIBC. Trial Registration: ClinicalTrials.gov NCT03091764; http://clinicaltrials.gov/ct2/showNCT03091764 (Archived by WebCite at http://www.webcitation.org/6umBhQeNX)

  • Source: Flickr; Copyright: agilemktg1; URL: https://www.flickr.com/photos/68716695@N06/29609189672; License: Public Domain (CC0).

    Patient Transfers and Risk of Back Injury: Protocol for a Prospective Cohort Study With Technical Measurements of Exposure

    Abstract:

    Background: More than one third of nurses experience musculoskeletal pain several times during a normal work week. Consistent use of assistive devices during patient transfers is associated with a lower risk of occupational back injuries and low back pain (LBP). While uncertainties exist regarding which type of assistive devices most efficiently prevent LBP, exposure assessments using technological advancements allow for quantification of muscle load and body positions during common work tasks. Objective: The main objectives of this study are (1) to quantify low back and neck/shoulder muscle load in Danish nurses during patient transfers performed with different types of assistive devices, and (2) to combine the exposure profile for each type of assistive device with fortnightly questionnaires to identify the importance of muscle load (intensity and frequency of transfers) and body position (degree of back inclination and frequency) on LBP intensity and risk of back injury during a patient transfer. Methods: A combination of technical measurements (n=50) and a prospective study design (n=2000) will be applied on a cohort of female nurses in Danish hospitals. The technical measurements will be comprised of surface electromyography and accelerometers, with the aim of quantifying muscle load and body positions during various patient transfers, including different types of assistive devices throughout a workday. The study will thereby gather measurements during real-life working conditions. The prospective cohort study will consist of questionnaires at baseline and 1-year follow-up, as well as follow-up via email every other week for one year on questions regarding the frequency of patient transfers, use of assistive devices, intensity of LBP, and back injuries related to patient transfers. The objective measurements on muscle load and body positions during patient handlings will be applied to the fortnightly replies regarding frequency of patient transfer and use of different assistive devices, in order to identify risk factors for back injuries related to patient transfers and intensity of LBP. Results: Data collection is scheduled to commence during the winter of 2017. Conclusions: The design of this study is novel in its combination of technical measurements applied on a prospective cohort, and the results will provide important information about which assistive devices are associated with intensity of LBP and risk of back injury related to patient transfers. Furthermore, this study will shed light on the dose-response relationship between intensity, duration, and frequency of patient transfers and the intensity of LPB in Danish nurses, and will thereby help to guide and improve electronic health practices among this population.

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/11/e219/; License: Creative Commons Attribution (CC-BY).

    Recruiting Women to a Mobile Health Smoking Cessation Trial: Low- and No-Cost Strategies

    Abstract:

    Background: Successful recruitment of participants to mobile health (mHealth) studies presents unique challenges over in-person studies. It is important to identify recruitment strategies that maximize the limited recruitment resources available to researchers. Objective: The objective of this study was to describe a case study of a unique recruitment process used in a recent mHealth software app designed to increase smoking cessation among weight-concerned women smokers. The See Me Smoke-Free app was deployed to the Google Play Store (Alphabet, Inc., Google, LLC), where potential participants could download the app and enroll in the study. Users were invited in-app to participate in the study, with no in-person contact. The recruitment activities relied primarily on earned (free) and social media. Methods: To determine the relationship between recruitment activities and participant enrollment, the researchers explored trends in earned and social media activity in relation to app installations, examined social media messaging in relation to reach or impressions, and described app users’ self-reported referral source. The researchers collected and descriptively analyzed data regarding recruitment activities, social media audience, and app use during the 18-week recruitment period (March 30, 2015-July 31, 2015). Data were collected and aggregated from internal staff activity tracking documents and from Web-based data analytics software such as SumAll, Facebook Insights (Facebook, Inc.), and Google Analytics (Alphabet, Inc., Google, LLC). Results: Media coverage was documented across 75 publications and radio or television broadcasts, 35 of which were local, 39 national, and 1 international. The research team made 30 Facebook posts and 49 tweets, yielding 1821 reaches and 6336 impressions, respectively. From March 30, 2015 to July 31, 2015, 289 unique users downloaded the app, and 151 participants enrolled in the study. Conclusions: Research identifying effective online recruitment methods for mHealth studies remains minimal, and findings are inconsistent. We demonstrated how earned media can be leveraged to recruit women to an mHealth smoking cessation trial at low cost. Using earned media and leveraging social media allowed us to enroll 3 times the number of participants that we anticipated enrolling. The cost of earned media resides in the staff time required to manage it, particularly the regular interaction with social media. We recommend communication and cooperation with university public affairs and social media offices, as well as affiliate programs in journalism and communications, so that earned media can be used as a recruitment strategy for mHealth behavior change interventions. However, press releases are not always picked up by the media and should not be considered as a stand-alone method of recruitment. Careful consideration of an intervention’s broad appeal and how that translates into potential media interest is needed when including earned media as part of a comprehensive recruitment plan for mHealth research.

  • ReZone app (montage). Source: The Authors / Placeit.net; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2017/11/e213/; License: Creative Commons Attribution (CC-BY).

    An App to Help Young People Self-Manage When Feeling Overwhelmed (ReZone): Protocol of a Cluster Randomized Controlled Trial

    Abstract:

    Background: The association between behavioral difficulties and academic attainment is well established. Recent policy advising schools on managing behavior has promoted the early identification of behavioral difficulties. There is also increasing research into mHealth interventions to provide support for emotional and behavioral difficulties for young people. Objective: The primary aim of the proposed research is to examine the effectiveness of an mHealth intervention, ReZone, in reducing emotional and behavioral difficulties in young people. Methods: The protocol is a cluster trial of 12 classes with N=120 students with classes randomized to ReZone or management as usual. Multilevel modeling will be used to compare ReZone versus management as usual accounting for classroom-level variation. Results: Baseline data collection started in February 2017 and ended in April 2017. Follow-up data collection started in April 2017 and ended in June 2017. Conclusions: The proposed research will provide evidence as to whether ReZone is effective at helping young people to self-manage when feeling overwhelmed. Trial Registration: ISRCTN 13425994; http://www.isrctn.com/ISRCTN13425994 (Archived by WebCite at http://www.webcitation.org/6tePwwiHk)

  • Source: Wikimedia Commons; Copyright: Sigismund von Dobschütz; URL: https://commons.wikimedia.org/wiki/File:Tablet-PC_Parkwohnstift_05.JPG; License: Creative Commons Attribution + ShareAlike (CC-BY-SA).

    The Importance of Trust in the Adoption and Use of Intelligent Assistive Technology by Older Adults to Support Aging in Place: Scoping Review Protocol

    Abstract:

    Background: Intelligent assistive technologies that complement and extend human abilities have proliferated in recent years. Service robots, home automation equipment, and other digital assistant devices possessing artificial intelligence are forms of assistive technologies that have become popular in society. Older adults (>55 years of age) have been identified by industry, government, and researchers as a demographic who can benefit significantly from the use of intelligent assistive technology to support various activities of daily living. Objective: The purpose of this scoping review is to summarize the literature on the importance of the concept of “trust” in the adoption of intelligent assistive technologies to assist aging in place by older adults. Methods: Using a scoping review methodology, our search strategy will examine the following databases: ACM Digital Library, Allied and Complementary Medicine Database (AMED), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medline, PsycINFO, Scopus, and Web of Science. Two reviewers will independently screen the initial titles obtained from the search, and these results will be further inspected by other members of the research team for inclusion in the review. Results: This review will provide insights into how the concept of trust is actualized in the adoption of intelligent assistive technology by older adults. Preliminary sensitization to the literature suggests that the concept of trust is fluid, unstable, and intimately tied to the type of intelligent assistive technology being examined. Furthermore, a wide range of theoretical lenses that include elements of trust have been used to examine this concept. Conclusions: This review will describe the concept of trust in the adoption of intelligent assistive technology by older adults, and will provide insights for practitioners, policy makers, and technology vendors for future practice.

  • Source: Pixabay; Copyright: thelester; URL: https://pixabay.com/en/architecture-university-students-1122359/; License: Public Domain (CC0).

    Development of a Behavior Change Intervention to Improve Sexual Health Service Use Among University Undergraduate Students: Mixed Methods Study Protocol

    Abstract:

    Background: University students are at risk for acquiring sexually transmitted infections and suffering other negative health outcomes. Sexual health services offer preventive and treatment interventions that aim to reduce these infections and associated health consequences. However, university students often delay or avoid seeking sexual health services. An in-depth understanding of the factors that influence student use of sexual health services is needed to underpin effective sexual health interventions. Objective: In this study, we aim to design a behavior change intervention to address university undergraduate students’ use of sexual health services at two universities in Nova Scotia, Canada. Methods: This mixed methods study consists of three phases that follow a systematic approach to intervention design outlined in the Behaviour Change Wheel. In Phase 1, we examine patterns of sexual health service use among university students in Nova Scotia, Canada, using an existing dataset. In Phase 2, we identify the perceived barriers and enablers to students’ use of sexual health services. This will include focus groups with university undergraduate students, health care providers, and university administrators using a semistructured guide, informed by the Capability, Opportunity, Motivation-Behaviour Model and Theoretical Domains Framework. In Phase 3, we identify behavior change techniques and intervention components to develop a theory-based intervention to improve students’ use of sexual health services. Results: This study will be completed in March 2018. Results from each phase and the finalized intervention design will be reported in 2018. Conclusions: Previous intervention research to improve university students’ use of sexual health services lacks a theoretical assessment of barriers. This study will employ a mixed methods research design to examine university students’ use of sexual health service and apply behavior change theory to design a theory- and evidence-based sexual health service intervention. Our approach will provide a comprehensive foundation to co-design a theory-based intervention with service users, health care providers, and administrators to improve sexual health service use among university students and ultimately improve their overall health and well-being.

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    Date Submitted: Nov 14, 2017

    Open Peer Review Period: Nov 17, 2017 - Dec 1, 2017

    Background: Young men who have sex with men (YMSM) and transgender people (TG) in the Detroit Metro Area (DMA) are the only risk group for whom HIV and STI incidence has increased since 2000, with HIV...

    Background: Young men who have sex with men (YMSM) and transgender people (TG) in the Detroit Metro Area (DMA) are the only risk group for whom HIV and STI incidence has increased since 2000, with HIV incidence nearly doubling among youth [1,2]. Substance use (including alcohol) is relatively frequent among YMSM and TG, and creates barriers to the optimal delivery of HIV prevention and care services [3-6]. Standard HIV Counseling, Testing, and Referral (CTR) is limited in providing strategies to identify and address substance use. Hence, in its current form, CTR may not be serving the prevention needs of substance-using YMSM and TG. Brief counseling interventions, grounded in principles of motivational interviewing, may offer a mechanism to meet the HIV prevention and care needs of substance-using YMSM and TG [7-15]. Objective: The prospective, four-arm factorial randomized control trial (RCT) aims to examine the efficacy of a Motivational Interviewing-based substance use brief intervention (SUBI) on participants’ substance use and engagement in HIV prevention. Methods: The research implements a prospective RCT (Project SWERVE) of 600 YMSM and TG recruited both online and in person. Eligible participants 1) are between the ages of 15-25, 2) live in the Detroit Metro Area (DMA), 3) self-identify as a man or transgender man or woman, 4) have had sexual contact with a man in the six months prior to enrollment, 5) self-report binge drinking or any substance use in the three months prior to enrollment, and 6) self-report an unknown or negative HIV status upon enrollment. Participants are randomized to receive, 3-months apart starting at baseline, two individual sessions. Sessions are CTR-only, SUBI-only, CTR followed by SUBI, or SUBI followed by CTR. Results: Project SWERVE was launched in April 2017 and enrollment is on-going. Conclusions: Incorporating a substance use brief intervention that utilizes the principles of motivational interviewing into HIV counseling, testing, and referral provides an opportunity to tailor counseling services for YMSM and TG to address additional client barriers to HIV and STI testing. Clinical Trial: ClinicalTrials.gov (NCT02945436); University of Michigan Institutional Review Board (HUM00105125)

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    Date Submitted: Nov 17, 2017

    Open Peer Review Period: Nov 17, 2017 - Dec 1, 2017

    Background: Effective antiretroviral therapy has greatly reduced human immunodeficiency virus (HIV) related morbidity and mortality, dramatically changing the demographics of the population of people...

    Background: Effective antiretroviral therapy has greatly reduced human immunodeficiency virus (HIV) related morbidity and mortality, dramatically changing the demographics of the population of people living with HIV (PLHIV). The majority of PLHIV in France are well cared for insofar as their HIV infection is concerned but remain at risk for age-associated comorbidities. Their long-term, potentially complex, and growing care needs make the routine, longitudinal assessment of health-related quality of life and its determinants of relevance in the current treatment era. Objective: We describe the development of a web-based patient portal for PLHIV linked to patients’ electronic medical records and designed to promote better patient-physician communication and ultimately quality of care (both patient satisfaction and health outcomes). Methods: Participants who meet the eligibility criteria will be invited to engage with the web-based patient portal and provided with the information necessary to create a personal patient account. They will then be able to access the patient portal and complete a set of standardized validated questionnaires covering health-related quality of life and its potential social, behavioral and psychological determinants. The information provided via questionnaires will be presented in a summary format for clinicians together with their HIV care history. Results: The prototype of the patient portal will be finalized and the first two formative research phases of the study [pre-testing, usability testing, and pilot testing] will be conducted from December 2017 to March 2018. We describe the iterative processes planned to ensure that the proposed patient portal is ready for formal pilot testing, referred to herein as Phases 1a and 1b. We also describe the planned pilot testing designed to evaluate the use and acceptability of the portal from the patients’ perspective (Phase 2). Conclusions: The underlying information technology solution, ARPEGE®, has being developed in house. Should the feasibility study presented here yield promising results, the panel of services provided via the proposed portal could ultimately be expanded and used to experiment health promoting interventions in aging PLHIV in hospital-based care or adapted for use in other patient populations.

  • Study design for the Prediction of Cognitive Recovery After Stroke (PROCRAS) study: a role for new brain MRI modalities in daily clinical practice?

    Date Submitted: Nov 16, 2017

    Open Peer Review Period: Nov 16, 2017 - Nov 30, 2017

    Abstract Rationale Cognitive impairment is common after acute ischemic stroke, affecting up to 75% of patients. About half of them will show recovery, whereas the others will remain cognitively impa...

    Abstract Rationale Cognitive impairment is common after acute ischemic stroke, affecting up to 75% of patients. About half of them will show recovery, whereas the others will remain cognitively impaired or deteriorate. It is difficult to predict these different cognitive outcomes. Aim We aim to investigate whether diffusion tensor imaging (DTI) based measures of brain connectivity predict cognitive recovery after one year in addition to patient characteristics and stroke severity. A specific premise of the PROCRAS study is that it is conducted in a daily practice setting. Methods and design The PROCRAS study is a prospective, mono-center cohort study, conducted in a large teaching hospital in the Netherlands. 350 patients suffering from an ischemic stroke who screen positive for cognitive impairment on the Montreal Cognitive Assessment (MoCA < 26) in the acute stage, will undergo a 3T-MRI with a diffusion-weighted sequence and a neuropsychological assessment. Patients will be classified as being unimpaired, as having a mild vascular cognitive disorder or as having a major vascular cognitive disorder. One year after stroke patients will undergo follow-up neuropsychological assessment. Study Outcomes The primary endpoint is recovery of cognitive function one year after stroke in patients with a confirmed post-stroke cognitive disorder. The secondary endpoint is deterioration of cognitive function in the first year after stroke. Discussion The PROCRAS study will show the additional predictive value of DTI based measures of brain connectivity for cognitive outcome at one year in patients with a post-stroke cognitive disorder in a daily clinical practice setting.

  • What are the impacts of urban agriculture on the determinants of health? A scoping review protocol

    Date Submitted: Nov 15, 2017

    Open Peer Review Period: Nov 16, 2017 - Nov 30, 2017

    Background: Since the 1990s, urban agriculture (AU) has contributed to improving food security in low- and middle- income countries. Now, it is implemented as a multifunctional intervention that can i...

    Background: Since the 1990s, urban agriculture (AU) has contributed to improving food security in low- and middle- income countries. Now, it is implemented as a multifunctional intervention that can influence a various determinants of health (e.g. food security, social relationships). However, studies of interest are from several research disciplines, use a wide range of methods, and show results that are sometimes inconsistent. There are no current studies that have been conducted to summarize conclusions of the overall effects of UA on health and its determinants. The objective of this protocol is to develop a research strategy for a scoping review that characterizes studies of beneficial and adverse impacts of UA on health and its determinants in a wide range of disciplines. Methods: Initially, with the help of a library specialist, a list of publications will be obtained through a systematic search of seven electronic bibliographic databases (PubMed, Embase®, MEDLINE® (Embase®), CINAHL Plus with full text, Academic Search Premier (EBSCO host), CAB Abstract (Ovid), and Web of Science). Secondly, a three-step screening by two independent reviewers will lead to a list of relevant publications that meet eligibility and inclusion criteria. Finally, data on the bibliography, type of participants, type of study, results of study, and countries will be extracted from included articles and analyzed to be presented in a peer-reviewed article. Discussion: This is an original study that seeks to integrate beneficial and adverse effects of UA on health at different level of influence (individuals, households, and community) in order to facilitate a better understanding of UA impacts. This protocol is a first of its kind and is expected to lead to a characterization of UA impacts based on sociodemographic profiles of participants and income levels of the studied countries. This will be relevant for policy makers and UA practitioners. The findings are expected to identify research gaps that will inform needs for UA research in specific fields (e.g. mental health), among certain population groups (e.g. adults) or within different economic contexts (e.g., low-, middle- or high-income countries?).

  • #Depressed: A Tumblr Pilot Intervention Study

    Date Submitted: Nov 14, 2017

    Open Peer Review Period: Nov 14, 2017 - Nov 28, 2017

    Background: Adolescents and young adults (AYAs) frequently post depression symptom references on social media; previous studies show positive associations between depression posts and self-reported de...

    Background: Adolescents and young adults (AYAs) frequently post depression symptom references on social media; previous studies show positive associations between depression posts and self-reported depression symptoms. Depression is common among AYAs and this population often experiences many barriers to mental health care. Thus, social media may be a new resource to identify, recruit and intervene with AYAs at risk for depression. Objective: The purpose of this pilot study was to test a social media intervention on Tumblr. We used social media to identify and recruit participants, and to deliver the intervention resource of online depression resources. Methods: This randomized pilot intervention identified Tumblr users age 15-23 who posted about depression using the search term “#depress”. Eligible participants were recruited via Tumblr messages; consented participants completed depression surveys and were then randomized to intervention of online mental health resources delivered via a Tumblr message, control participants did not receive resources. Post-intervention surveys assessed resource access and usefulness, and control groups were asked whether they would have liked to receive resources. Analyses included t-tests. Results: A total of 25 participants met eligibility, they were age 17.5 (SD=1.9) and 65.4% female with average PHQ-9 of 17.5 (SD=5.4). Among the 11 intervention participants, 36.3% reported accessing intervention resources and 63.6% felt the intervention was an acceptable approach. Only 28.6% of control group participants reported that receiving resources online would be acceptable. Participants of both groups suggested anonymity, supportiveness and ease of use as important characteristics in an online depression resource. Conclusions: The intervention was appropriately targeted to AYA at risk for depression, and recruitment via Tumblr was feasible. Most participants in the intervention group felt the social media approach was acceptable, and about a third utilized the online resources. Participants who had not experienced the intervention were less likely to find it acceptable. Future studies should explore this approach in larger samples. Social media may be an appropriate platform for online depression interventions for AYAs.

  • Evaluation of technology-based peer-support intervention program for preventing postnatal depression: A randomized controlled trial

    Date Submitted: Nov 14, 2017

    Open Peer Review Period: Nov 14, 2017 - Nov 28, 2017

    Background: Multiple international agencies, including the World Health Organization (WHO) and the International Monetary Fund (IMF), have emphasized the importance of maternal mental health for optim...

    Background: Multiple international agencies, including the World Health Organization (WHO) and the International Monetary Fund (IMF), have emphasized the importance of maternal mental health for optimal child health and development. Adequate social support is vital for the most vulnerable to postpartum mood disorders. Hence, an urgent need for sustainable social support programs to aid mothers ease into their new parenting role exists. Objective: This study aims to examine the effectiveness of technology-based Peer-Support Intervention Program (PIP) among mothers at risk for postnatal depression in the early postpartum period. Methods: A randomized controlled two-group pre-test and repeated post-test experimental design will be used. The study will recruit 118 mothers from the postnatal wards of a tertiary public hospital in Singapore. Eligible mothers will be randomly allocated to receive either PIP or routine perinatal care from the hospital. Peer volunteers will be mothers who have experienced self-reported depression and will be receiving face-to-face training to support new mothers at risk of depression. Outcome measures include postnatal depression, anxiety, loneliness, and social support. Data will be collected at immediate postnatal period (day of discharge from the hospital), at fourth week, and twelfth week post-childbirth. Results: The recruitment and training of peer support volunteers (N = 20) ended in June 2017, while recruitment of study participants commenced in July 2017 and is still ongoing. The current recruitment for new mothers stands at 73 with 36 in the control group and 37 in the intervention group. Data collection is projected to be completed by May 2018. Conclusions: This study will identify a potentially effective and clinically useful method to prevent postnatal depression in new mothers, which is the top cause of maternal morbidity. Receiving social support from others who share similar experiences may enhance the positive parenting experiences of mothers, which in turn can improve the psychosocial well-being of the mothers, tighten mother child bond, and enhance overall family dynamics for mothers and infants. Clinical Trial: ISRCTN14864807

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