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: 4.7)
  • 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: http://www.coventry.ac.uk/research/research-directories/current-projects/2014/workplan/workplan-project-information; Created by and copyright: the authors.

    A Guided Workbook Intervention (WorkPlan) to Support Work-Related Goals Among Cancer Survivors: Protocol of a Feasibility Randomized Controlled Trial

    Abstract:

    Background: Returning to and staying at work following illness is associated with better physical and psychological functioning. Not working has been shown to be associated with reduced self-esteem, lowered self-efficacy, and decreased belief in one's ability to return to the workplace. Although there is a growing body of research looking at what predicts return to work following cancer treatment, there are fewer studies examining interventions targeting return to work. Objective: The primary objective is to assess the feasibility and acceptability of a theoretically led workbook intervention designed to support cancer patients in returning to work to inform a fully powered randomized controlled trial (RCT). Methods: This is a multicenter feasibility RCT where the main analysis uses a qualitative approach. Sixty participants (aged 18-65 years) who have received a diagnosis of cancer and who intend to return to work will be randomized to either the WorkPlan intervention group or a usual care group (ratio 1:1). Participants in the intervention group will receive a guided workbook intervention (which contains activities aimed at eliciting thoughts and beliefs, identifying targets and actions, and concrete steps to achieve goals) and will receive telephone support over a 4-week period. The primary outcome measure is time taken to return to work (in days), and secondary outcome measures include mood, quality of life, illness perceptions, and job satisfaction. Data will be collected through postal questionnaires administered immediately postintervention and at 6- and 12-month follow-ups. In addition, interviews will be undertaken immediately postintervention (to explore acceptability of the intervention and materials) and at 12-month follow-up (to explore perceptions of participation in the trial and experiences of returning to work). Results: Enrollment for the study will be completed in May 2016. Data analysis will commence in April 2017, and the first results are expected to be submitted for publication in late 2017. Conclusions: Currently no standardized return-to-work intervention based on targeting cancer patient beliefs is in existence. If the intervention is shown to be feasible and acceptable, the results of this study will inform a future full RCT with the potential to provide a valuable and cost-efficient tool in supporting cancer survivors in the return-to-work process. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN56342476; http://www.isrctn.com/ISRCTN56342476 (Archived by WebCite at http://www.webcitation.org/6gblhEPXd).

  • Image display of the UP24 monitor (Jawbone, San Francisco, CA) and Digi-walker digital pedometer (YAMAX, San Antonio, TX) taken by and copyright the authors.

    Testing Activity Monitors’ Effect on Health: Study Protocol for a Randomized Controlled Trial Among Older Primary Care Patients

    Abstract:

    Background: Cardiovascular disease is the leading cause of mortality in the United States. Maintaining healthy levels of physical activity is critical to cardiovascular health, but many older adults are inactive. There is a growing body of evidence linking low motivation and inactivity. Standard behavioral counseling techniques used within the primary care setting strive to increase motivation, but often do not emphasize the key component of self-control. The addition of electronic activity monitors (EAMs) to counseling protocols may provide more effective behavior change and increase overall motivation for exercise through interactive self-monitoring, feedback, and social support from other users. Objective: The objective of the study is to conduct a three month intervention trial that will test the feasibility of adding an EAM system to brief counseling within a primary care setting. Participants (n=40) will be randomized to receive evidence-based brief counseling plus either an EAM or a pedometer. Methods: Throughout the intervention, we will test its feasibility and acceptability, the change in primary outcomes (cardiovascular risk and physical activity), and the change in secondary outcomes (adherence, weight and body composition, health status, motivation, physical function, psychological feelings, and self-regulation). Upon completion of the intervention, we will also conduct focus groups with the participants and with primary care stakeholders. Results: The study started recruitment in October 2015 and is scheduled to be completed by October 2016. Conclusions: This project will lay the groundwork and establish the infrastructure for intervention refinement and ultimately translation within the primary care setting in order to prevent cardiovascular disease on a population level. Trial Registration: ClinicalTrails.gov NCT02554435; https://clinicaltrials.gov/ct2/show/NCT02554435 (Archived by WebCite at http://www.webcitation/6fUlW5tdT)

  • Screenshots of the three primary features of PRIME (from left to right): Goals (goal-setting), Community (text-based motivational coaching), and Moments (social networking and community feed).

    Feasibility of PRIME: A Cognitive Neuroscience-Informed Mobile App Intervention to Enhance Motivated Behavior and Improve Quality of Life in Recent Onset...

    Abstract:

    Background: Despite improvements in treating psychosis, schizophrenia remains a chronic and debilitating disorder that affects approximately 1% of the US population and costs society more than depression, dementia, and other medical illnesses across most of the lifespan. Improving functioning early in the course of illness could have significant implications for long-term outcome of individuals with schizophrenia. Yet, current gold-standard treatments do not lead to clinically meaningful improvements in outcome, partly due to the inherent challenges of treating a population with significant cognitive and motivational impairments. The rise of technology presents an opportunity to develop novel treatments that may circumvent the motivational and cognitive challenges observed in schizophrenia. Objective: The purpose of this study was two-fold: (1) to evaluate the feasibility and acceptability of implementing a Personalized Real-Time Intervention for Motivation Enhancement (PRIME), a mobile app intervention designed to target reward-processing impairments, enhance motivation, and thereby improve quality of life in recent onset schizophrenia, and (2) evaluate the empirical benefits of using an iterative, user-centered design (UCD) process. Methods: We conducted two design workshops with 15 key stakeholders, followed by a series of in-depth interviews in collaboration with IDEO, a design and innovation firm. The UCD approach ultimately resulted in the first iteration of PRIME, which was evaluated by 10 RO participants. Results from the Stage 1 participants were then used to guide the next iteration that is currently being evaluated in an ongoing RCT. Participants in both phases were encouraged to use the app daily with a minimum frequency of 1/week over a 12-week period. Results: The UCD process resulted in the following feature set: (1) delivery of text message (short message service, SMS)-based motivational coaching from trained therapists, (2) individualized goal setting in prognostically important psychosocial domains, (3) social networking via direct peer-to-peer messaging, and (4) community “moments feed” to capture and reinforce rewarding experiences and goal achievements. Users preferred an experience that highlighted several of the principles of self-determination theory, including the desire for more control of their future (autonomy and competence) and an approach that helps them improve existing relationships (relatedness). IDEO, also recommended an approach that was casual, friendly, and nonstigmatizing, which is in line with the recovery model of psychosis. After 12-weeks of using PRIME, participants used the app, on average, every other day, were actively engaged with its various features each time they logged in and retention and satisfaction was high (20/20, 100% retention, high satisfaction ratings). The iterative design process lead to a 2- to 3-fold increase in engagement from Stage 1 to Stage 2 in almost each aspect of the platform. Conclusions: These results indicate that the neuroscience-informed mobile app, PRIME, is a feasible and acceptable intervention for young people with schizophrenia.

  • Image: Medtronic Reveal XT device by St. Anthony's Medical Center. “St. Anthony's implants first Miniature Cardiac Monitor.”  Published on Feb 27, 2014. Retrieved from https://youtu.be/nyufPI1Mb4s covered under the Fair Dealings.

    Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure: Results from the CARRYING ON for HF Pilot Study

    Abstract:

    Background: There’s scarce evidence about cardiovascular events (CV) in patients with hospitalization for acute heart failure (HF) and no indication for immediate device implant. Objective: The CARdiac RhYthm monitorING after acute decompensatiON for Heart Failure study was designed to assess the incidence of prespecified clinical and arrhythmic events in this patient population. Methods: In this pilot study, 18 patients (12 (67%) male; age 72±10; 16 (89%) NYHA II-III), who were hospitalized for HF with low left ventricular ejection fraction (LVEF) (<40%) and no immediate indication for device implant received an implantable loop recorder (ILR) before hospital discharge. Follow-up visits were scheduled at 3 and 6 months, and at every 6 months until study closure; device data were remotely reviewed monthly. CV mortality, unplanned CV hospitalization, and major arrhythmic events during follow-up were analyzed. Results: During a median follow-up of 593 days, major CV occurred in 13 patients (72%); of those, 7 patients had at least 1 cardiac arrhythmic event, 2 had at least a clinical event (CV hospitalization or CV death), and 4 had both an arrhythmic and a CV event. Six (33%) patients experienced 10 major clinical events, 5 of them (50%) were HF related. During follow-up, 2 (11%) patients died due to a CV cause and 3 (16%) patients received a permanent cardiac device. Conclusions: After an acute HF hospitalization, patients with LVEF<40% and who are not readily eligible for permanent cardiac device implant have a known high incidence of major CV event. In these patients, ILR allows early detection of major cardiac arrhythmias and the ability to react appropriately in a timely manner. Trial Registration: ClinicalTrials.gov NCT01216670; https://clinicaltrials.gov/ct2/show/NCT01216670

  • Image of health information search by using a internet browser on a personal computer. Photo taken by the corresponding author.

    eHealth Use Among First-Generation Immigrants From Pakistan in the Oslo Area, Norway, With Focus on Diabetes: Survey Protocol

    Abstract:

    Background: A variety of eHealth services are available and commonly used by the general public. eHealth has the potential to engage and empower people with managing their health. The prerequisite is, however, that eHealth services are adapted to the sociocultural heterogeneity of the user base and are available in a language and with contents that fit the users’ preference, skills, and abilities. Pakistani immigrants in the Oslo area, Norway, have a much higher risk of Type-2 diabetes (T2D) than their Norwegian counterparts do. In spite of having access to information and communication technology (ICT) and the Internet, ICT skills in this population are reported to be relatively low. Further, there is insufficient information about their use of and attitudes toward eHealth services, necessitating investigation of this group in particular. Objective: This study targets first-generation immigrants from Pakistan living in the Oslo area and examines their use of and attitudes toward eHealth services, specifically: information searches, communication using ICT, and use of ICT for self-management or decision making, all concerning T2D. Methods: Due to a high prevalence of low literacy among the target population, we employed questionnaire-based individual interviews. The questionnaire was developed by implementing potentially relevant theoretical constructs (technology acceptance model (TAM) and health belief model (HBM)) as measures. To explore issues around language, culture, and general ICT skills, we also implemented questions that we assume were particularly relevant in the context studied but do not appear in any theoretical frameworks. The questionnaire was revised to reflect results of a pilot study involving 10 participants. We employed culturally sensitive sampling methods to reach informants who could otherwise fail to be included in the survey. Results: This paper presents a survey protocol. The data collection is ongoing. The aim is to collect 200 responses in total by March 2016. Conclusions: For eHealth to become an influential social innovation, equal access to eHealth services regardless of users’ language, culture, and ICT skills is a prerequisite. Results from this study will be of importance for understanding how people who may not maximally benefit from eHealth services today could be targeted in the future.

  • Image: Jorge Acosta and Kiebpoli Calnek. Image sourced and Copyright owned by Lisa Altshuler et al. 
Licensed under Creative Commons Attribution cc-by 2.0 https://creativecommons.org/licenses/by/2.0/.

    Transforming the Patient Role to Achieve Better Outcomes Through a Patient Empowerment Program: A Randomized Wait-List Control Trial Protocol

    Abstract:

    Background: In the patient-centered medical home model of health care, both health care providers (HCPs) and patients must understand their respective roles and responsibilities, view the other as a partner, and use communication skills that promote shared decision making. This is particularly necessary in chronic conditions where outcomes depend on behavior change and in underserved populations where the burden of chronic disease is high. Objective: The objectives of this study are to determine if a Patient Empowerment Program (PEP) (1) is acceptable to patients and feasible across multiple clinical sites; (2) will increase patient preference for control in medical decision making, improve patient perceptions of patient-HCP communication, and increase patient activation; (3) is associated with an increase in diabetes self-management behaviors; and (4) has an effect on hemoglobin A1c (HbA1c) level. Methods: This study recruited English-speaking adult patients with type 2 diabetes mellitus from three urban clinical sites in New York City and randomized them to an immediate intervention group that completed the PEP intervention or a deferred intervention group that served as a wait-list control and completed the PEP intervention after 3-4 months. The PEP intervention consists of two facilitated small group sessions. Session 1 focuses on defining HCP and patient roles in the medical encounter by introducing ideal communication behaviors in each role and by providing both positive and negative examples of patient-HCP encounters. Session 2 focuses on practicing communication skills by role-playing with actors who serve as standardized health care providers. After the role play, participants set goals for their own health care and for future interactions with their HCPs. Outcome measures include the Patient Activation Measure; Ask, Understand, Remember Assessment; Krantz Health Opinion Survey; SF-12v2 Health Survey; Diabetes Self-Management Questionnaire; and HbA1c. These measures will be assessed at the time of enrollment, after the waiting period (deferred intervention only), and then postintervention at 1 week, 3 months, and 6 months. Results: Study recruitment occurred from November 2014 to June 2015, with a total of 80 patients enrolled. To date, 45 participants have attended at least one session of the PEP intervention. Further intervention sessions and post-intervention follow-up are ongoing, with data collection set to be completed in April 2016 and results of data analysis available by June 2016. Conclusions: From preliminary participant self-report data, our PEP intervention is acceptable to low-income, low–health literate patients and feasible to hold across multiple clinical sites. Participants have reported learning specific ways to change their behaviors at their next HCP visit (eg, stating their opinions, asking more questions). With the forthcoming quantitative data on participant attitudinal and behavior change, the PEP intervention may ultimately empower participants within the medical encounter and improve health outcomes.

  • Image Source: Smoke-Free Bench, copyright Michael Coghlan,
https://www.flickr.com/photos/mikecogh/5645977385/,
Licensed under Creative Commons Attribution cc-by 2.0 https://creativecommons.org/licenses/by/2.0/.

    Development and Testing of a Computerized Decision Support System to Facilitate Brief Tobacco Cessation Treatment in the Pediatric Emergency Department:...

    Abstract:

    Background: Tobacco smoke exposure (TSE) is unequivocally harmful to children's health, yet up to 48% of children who visit the pediatric emergency department (PED) and urgent care setting are exposed to tobacco smoke. The incorporation of clinical decision support systems (CDSS) into the electronic health records (EHR) of PED patients may improve the rates of screening and brief TSE intervention of caregivers and result in decreased TSE in children. Objective: We propose a study that will be the first to develop and evaluate the integration of a CDSS for Registered Nurses (RNs) into the EHR of pediatric patients to facilitate the identification of caregivers who smoke and the delivery of TSE interventions to caregivers in the urgent care setting. Methods: We will conduct a two-phase project to develop, refine, and integrate an evidence-based CDSS into the pediatric urgent care setting. RNs will provide input on program content, function, and design. In Phase I, we will develop a CDSS with prompts to: (1) ASK about child TSE and caregiver smoking, (2) use a software program, Research Electronic Data Capture (REDCap), to ADVISE caregivers to reduce their child's TSE via total smoking home and car bans and quitting smoking, and (3) ASSESS their interest in quitting and ASSIST caregivers to quit by directly connecting them to their choice of free cessation resources (eg, Quitline, SmokefreeTXT, or SmokefreeGOV) during the urgent care visit. We will create reports to provide feedback to RNs on their TSE counseling behaviors. In Phase II, we will conduct a 3-month feasibility trial to test the results of implementing our CDSS on changes in RNs’ TSE-related behaviors, and child and caregiver outcomes. Results: This trial is currently underway with funding support from the National Institutes of Health/National Cancer Institute. We have completed Phase I. The CDSS has been developed with input from our advisory panel and RNs, and pilot tested. We are nearing completion of Phase II, in which we are conducting the feasibility trial, analyzing data, and disseminating results. Conclusions: This project will develop, iteratively refine, integrate, and pilot test the use of an innovative CDSS to prompt RNs to provide TSE reduction and smoking cessation counseling to caregivers who smoke. If successful, this approach will create a sustainable and disseminable model for prompting pediatric practitioners to apply tobacco-related guideline recommendations. This systems-based approach has the potential to reach at least 12 million smokers a year and significantly reduce TSE-related pediatric illnesses and related costs.

  • Image Source:Luebke, copyright ZB6R3866, https://www.flickr.com/photos/thomas-luebke/13385750213/,
Licensed under Creative Commons Attribution cc-by 2.0 https://creativecommons.org/licenses/by/2.0/.

    Design and Methods of a Synchronous Online Motivational Interviewing Intervention for Weight Management

    Abstract:

    Background: While Internet-based weight management programs can facilitate access to and engagement in evidence-based lifestyle weight loss programs, the results have generally not been as effective as in-person programs. Furthermore, motivational interviewing (MI) has shown promise as a technique for enhancing weight loss outcomes within face-to-face programs. Objective: This paper describes the design, intervention development, and analysis of a therapist-delivered online MI intervention for weight loss in the context of an online weight loss program. Methods: The MI intervention is delivered within the context of a randomized controlled trial examining the efficacy of an 18-month, group-based, online behavioral weight control program plus individually administered, synchronous online MI sessions relative to the group-based program alone. Six individual 30-minute MI sessions are conducted in private chat rooms over 18 months by doctoral-level psychologists. Sessions use a semistructured interview format for content and session flow and incorporate core MI components (eg, collaborative agenda setting, open-ended questions, reflective listening and summary statements, objective data, and a focus on evoking and amplifying change talk). Results: The project was funded in 2010 and enrollment was completed in 2012. Data analysis is currently under way and the first results are expected in 2016. Conclusions: This is the first trial to test the efficacy of a synchronous online, one-on-one MI intervention designed to augment an online group behavioral weight loss program. If the addition of MI sessions proves to be successful, this intervention could be disseminated to enhance other distance-based weight loss interventions. Trial Registration: Clinicaltrials.gov NCT01232699; https://clinicaltrials.gov/ct2/show/NCT01232699

  • Source: https://www.flickr.com/photos/xshamx/3538898056, CC0 Licensed, Attribution: Sham Hardy.

    A Cross-Sectional Study on Attitudes to and Understanding of Risk of Acquisition of HIV: Design, Methods and Participant Characteristics

    Abstract:

    Background: The annual number of new human immunodeficiency virus (HIV) infections in the United Kingdom among men who have sex with men (MSM) has risen, and remains high among heterosexuals. Increasing HIV transmission among MSM is consistent with evidence of ongoing sexual risk behavior in this group, and targeted prevention strategies are needed for those at risk of acquiring HIV. Objective: The Attitudes to and Understanding of Risk of Acquisition of HIV (AURAH) study was designed to collect information on HIV negative adults at risk of HIV infection in the United Kingdom, based on the following parameters: physical and mental health, lifestyle, patterns of sexual behaviour, and attitudes to sexual risk. Methods: Cross-sectional questionnaire study of HIV negative or undiagnosed sexual health clinic attendees in the United Kingdom from 2013-2014. Results: Of 2630 participants in the AURAH study, 2064 (78%) were in the key subgroups of interest; 580 were black Africans (325 females and 255 males) and 1484 were MSM, with 27 participants belonging to both categories. Conclusions: The results from AURAH will be a significant resource to understand the attitudes and sexual behaviour of those at risk of acquiring HIV within the United Kingdom. AURAH will inform future prevention efforts and targeted health promotion initiatives in the HIV negative population.

  • Source: https://www.pexels.com/photo/pregnant-woman-standing-near-white-brown-bassinet-64263, CC0 Licensed.

    Comparing Brief Internet-Based Compassionate Mind Training and Cognitive Behavioral Therapy for Perinatal Women: Study Protocol for a Randomized Controlled...

    Abstract:

    Background: Depression that occurs during the perinatal period has substantial costs for both the mother and her baby. Since in-person care often falls short of meeting the global need of perinatal women, Internet interventions may function as an alternate to help women who currently lack adequate access to face-to-face psychological resources. However, at present there are insufficient empirically supported Internet-based resources for perinatal women. Objective: The aim of this study is to compare the relative efficacy of Internet-based cognitive behavioral therapy (CBT) to a novel Internet-based compassionate mind training approach (CMT) across measures of affect, self-reassurance, self-criticizing, self-attacking, self-compassion, depression, and anxiety. While CBT has been tested and has some support as an Internet tool for perinatal women, this is the first trial to look at CMT for perinatal women over the Internet. Methods: Participants were recruited through Amazon Mechanical Turk (MTurk) and professional networks. Following completion of demographic items, participants were randomly assigned to either the CBT or CMT condition. Each condition consisted of 45-minute interactive didactic and follow-up exercises to be completed over the course of two weeks. Results: Post course data was gathered at two weeks. A 2x2 repeated measures analysis of variance will be conducted to analyze differences between conditions at post course. Conclusions: The implications of the trial will be discussed as well as the strengths and limitations of MTurk as a tool for recruitment. We will also briefly introduce the future directions along this same line of research. Trial Registration: ClinicalTrials.gov NCT02469324; https://clinicaltrials.gov/ct2/show/NCT02469324 (Archived by WebCite at http://www.webcitation.org/6fkSG3yuW)

  • Picture of outside of GFJ. Copyright the authors.

    The Good Food Junction: a Community-Based Food Store Intervention to Address Nutritional Health Inequities

    Abstract:

    Background: This is a 2-year study to assess the early impacts of a new grocery store intervention in a former food desert. Objective: The purpose of the study is to understand the early health effects of the introduction of a large-scale food and nutrition-focused community-based population health intervention, the Good Food Junction (GFJ) Cooperative Store, in a geographically bounded group of socially disadvantaged neighborhoods (the “core neighborhoods”) in a midsized Canadian city. The GFJ grocery store was tasked with improving the access of residents to healthy, affordable food. The 5 research questions are: (1) What is the awareness and perception of the GFJ store among residents of the core neighborhoods? (2) Are there differences in awareness and perception among those who do and do not shop at the GFJ? (3) Will healthy food purchasing at the GFJ by residents of the core neighborhoods change over time, and what purchases are these individuals making at this store? (4) What early impact(s) will the GFJ have on key health-related outcomes (such as household food security status, vegetable and fruit intake, key aspects of self-reported mental health, self-reported health)? and (5) Are the effects of the intervention seen for specific vulnerable population groups, such as Aboriginal people, seniors (65 years old or older) and new immigrants (settled in Saskatoon for less than 5 years)? Methods: The research project examined initial impacts of the GFJ on the health of the residents in surrounding neighborhoods through a door-to-door cross-sectional survey of food access and household demographics; an examination of GFJ sales data by location of shoppers' residences; and a 1-year, 3-time-point longitudinal study of self-reported health of GFJ shoppers. Results: Analyses are on-going, but preliminary results show that shoppers are using the store for its intended purpose, which is to improve access to healthy food in a former food desert. Conclusions: To our knowledge this is the first large-scale study of a full-service grocery store intervention in a former food desert in Canada that has used multiple data sources, as well as longitudinal analyses, to examine its effects. Its findings will contribute significantly to the knowledge base on food environment interventions.

  • Feature image for homepage illustration. Only to be used for this article 5319.

    The Effectiveness of Parent Training as a Treatment for Preschool Attention-Deficit/Hyperactivity Disorder: Study Protocol for a Randomized Controlled,...

    Abstract:

    Background: Parent training is recommended as the first-line treatment for attention-deficit/hyperactivity disorder (ADHD) in preschool children. The New Forest Parenting Programme (NFPP) is an evidence-based parenting program developed specifically to target preschool ADHD. Objective: The objective of this trial is to investigate whether the NFPP can be effectively delivered for children referred through official community pathways in everyday clinical practice. Methods: A multicenter randomized controlled parallel arm trial design is employed. There are two treatment arms, NFPP and treatment as usual. NFPP consists of eight individually delivered parenting sessions, where the child attends during three of the sessions. Outcomes are examined at three time points (T1, T2, T3): T1 (baseline), T2 (week 12, post intervention), and T3 (6 month follow/up). 140 children between the ages of 3-7, with a clinical diagnosis of ADHD, informed by the Development and Well Being Assessment, and recruited from three child and adolescent psychiatry departments in Denmark will take part. Randomization is on a 1:1 basis, stratified for age and gender. Results: The primary endpoint is change in ADHD symptoms as measured by the Preschool ADHD-Rating Scale (ADHD-RS) by T2. Secondary outcome measures include: effects on this measure at T3 and T2 and T3 measures of teacher reported Preschool ADHD-RS scores, parent and teacher rated scores on the Strength & Difficulties Questionnaire, direct observation of ADHD behaviors during Child’s Solo Play, observation of parent-child interaction, parent sense of competence, and family stress. Results will be reported using the standards set out in the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of nonpharmacological treatments. Conclusions: The trial will provide evidence as to whether NFPP is a more effective treatment for preschool ADHD than the treatment usually offered in everyday clinical practice. Trial Registration: ClinicalTrials.gov NCT01684644; https://clinicaltrials.gov/ct2/show/NCT01684644?term= NCT01684644&rank=1 (Archived by WebCite at http://www.webcitation/6eOOAe8Qe)

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  • Impact on outcome of mandatory insulin therapy in critically ill patients: the PERMIT study (mandatory insulin therapy versus usual care insulin therapy in the intensive care unit): protocol for a randomised controlled trial

    Date Submitted: Apr 28, 2016

    Open Peer Review Period: Apr 29, 2016 - May 13, 2016

    Background: Observational and interventional studies in patients with both acute medical conditions and long-standing diabetes have shown that improved blood glucose control confers a survival advanta...

    Background: Observational and interventional studies in patients with both acute medical conditions and long-standing diabetes have shown that improved blood glucose control confers a survival advantage or reduces complication rates. Policies of “tight” glycaemic control was rapidly adopted by many general ICUs worldwide in the mid 00’s, even though the results of the study were not generalisable to mixed medical/surgical ICUs with different intravenous feeding policies. Objective: The primary objective of the study is to assess the safety of mandatory insulin infusion in critically ill patients in a general ICU setting. Methods: This protocol summarizes the rationale and design of a randomised, controlled single centre trial investigating the effect of mandatory insulin therapy versus usual care insulin therapy for those patients admitted for a stay of longer than 48 hours. In total, 109 critically ill adults predicted to stay in intensive care for longer than 48 hours were consented. The primary outcome is to determine the safety of mandatory insulin therapy in critically ill patients using the number of episodes of hypoglycaemia per unit length of stay in intensive care. Secondary outcomes include duration of mechanical ventilation, duration of ICU and hospital stay, hospital mortality, and measures or renal, hepatic and haematological dysfunction. The primary analysis will be intention to treat. Recruitment started in July 2005 and completed in April 2007. Results: This protocol for a randomised controlled trial investigating the effect of mandatory insulin therapy should provide an answer to a key question for the management of patients in the intensive care unit and ultimately improving outcome. Conclusions: This is a trial protocol document. Clinical Trial: ISRCTN005504641

  • Predictors of vascular cognitive impairment post stroke in a Middle Eastern (Bahrain) cohort: A case-control proposed comparison.

    Date Submitted: Apr 25, 2016

    Open Peer Review Period: Apr 28, 2016 - May 12, 2016

    Background: Post stroke dementia and cognitive impairment are associated with poor long-term outcomes, including survival and disability after stroke. The contribution of genetic factors such as the p...

    Background: Post stroke dementia and cognitive impairment are associated with poor long-term outcomes, including survival and disability after stroke. The contribution of genetic factors such as the presence of ApoE ɛ4 allele and its association with cognitive impairment post stroke remains inconclusive, particularly in Middle Eastern regions. Objective: The aim of this study is to examine correlates and potential predictors of cognitive impairment, including biomarkers, in stroke patients and compare these functions to healthy older adults in a Middle Eastern cohort. Methods: A prospective stroke sample of n=200 patients (case group) and n=100 healthy ageing individuals (control group) will be recruited from the largest medical complex in Bahrain. A neuropsychological battery of cognitive assessments (global, executive and metacognition) will be conducted on all participants. Participants will be categorized into four sub-groups (non-vascular cognitive impairment, vascular cognitive impairment with no dementia, vascular dementia and mixed dementia) using standardised cognitive assessment scores and the DSM-IV dementia criteria. Biomarkers will include ApoE genotype, sRAGE, NEP, BACE1, biochemistry and haematology measurements. Results: The primary study outcome is to determine early risk factors for cognitive impairment after stroke in a Bahraini cohort. The study has received full ethical approval from the Bahrain Ministry of Health and from the affiliated university. Conclusions: With increasing stroke incidence rates in the Middle East, this research study will provide useful biological and epidemiological data for future development and planning of health policies and guidelines for stroke care within the Gulf region. Clinical Trial: Not a clinical trial - a research study proposal

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    Date Submitted: Apr 22, 2016

    Open Peer Review Period: Apr 28, 2016 - May 12, 2016

    Background: University hospitals make up the backbone of medical and economic services of hospitals in Germany: They qualify specialist physicians, ensure medical research and provide highly specializ...

    Background: University hospitals make up the backbone of medical and economic services of hospitals in Germany: They qualify specialist physicians, ensure medical research and provide highly specialized maximum medical care, which other hospitals can-not undertake (e.g. in transplantation, neurology and cardiology). This three-fold assignment must be managed despite a growing shortage of specialist physicians: Today, there are approximately 7,000 open positions for physicians; by the year 2020, the replacement for retired physicians and increased demand will total 30,000 positions. The job of a specialist physician in a university hospital demands a high workload, which makes it difficult to combine both family and career with personal flexibility. The situation will become more difficult because on the whole patients are becoming older and sicker and because specialist physicians are able to find more attractive working conditions in smaller hospitals, abroad or outside of curative medicine. Objective: A change of university hospitals towards retaining medical specialists with long-term career and work perspectives has begun, but is neither fast, nor sustainable enough to cope with the increasing challenges: Over 70% of the medical students are women, and according to forecasts, over 10,000 new part time positions need to be created for specialist physicians by 2019. In order to retain sufficient qualified employees, major improvements in quality are required in terms of working and training conditions. For this purpose, a sustainable innovation process is necessary which incorporates solutions from outside of the health care sector in order to be able to learn from experiences and mistakes from other industries. Methods: The project FacharztPlus aims to find suitable measures in order to retain specialist physicians for some more years after completion of five years of professional training. This should determine the suitability of additional qualifications alongside the professional career and an expertise-related work organization oriented to dif-ferent stages of life. A long-term perspective after professional training is not just attractive for retaining, but also for recruiting specialists. To achieve this, compari-sons with other industries are being made and effective, practical solution concepts will be developed. The measures, methods and instruments included in the solutions are assessed according to their transferability, then, after detailed imple-mentation planning, are developed into especially promising measures. These measures are implemented in the Department of Anesthesiology, Intensive Care and Pain Medicine at the University Hospital Muenster (Germany), University of Muenster (UKM) with approximately 150 physicians, of which 60 possess specialist physician qualifications as well as the University Hospitals in Aachen, Rostock, and Greifswald and in the further 44 departments of the UKM with the associated 9,000 employees and presented to the 22 teaching hospitals. Finally, the measures are then also utilized in professional associations, chambers and at congresses. Results: work in progress Conclusions: work in progress Clinical Trial: n/a

  • Advancing Interprofessional Primary Health Care Services in Rural Settings for People with Chronic Low Back Disorders: Protocol of a Community-Based Randomized Controlled Trial

    Date Submitted: Apr 27, 2016

    Open Peer Review Period: Apr 28, 2016 - May 12, 2016

    Background: Chronic low back disorders (CLBD) are a substantial burden on individuals and societies impacting up to 20% of Canadians. Rural and remote residents are approximately 30% more likely to ha...

    Background: Chronic low back disorders (CLBD) are a substantial burden on individuals and societies impacting up to 20% of Canadians. Rural and remote residents are approximately 30% more likely to have CLBD. Reduced access to appropriate team-based health services, including physical therapy, is a key factor that may magnify the impact of CLBD on pain, physical function, overall quality of life, and health-related system and individual costs. Objective: The purpose of this project is to evaluate the validity, comparative effectiveness, and costs of an interprofessional management approach for people with CLBD delivered through telehealth. Methods: Three different health care delivery options in a rural Saskatchewan community with limited physical therapy services will be compared through a community-based randomized controlled trial: 1) usual care delivered by a local rural nurse practitioner (NP); 2) a new videoconferencing/ telehealth option connecting an urban-based physical therapist (PT) with a local NP; and 3) face-to-face services by a PT traveling to the community. Patient reported outcomes of pain, physical function, quality of life, satisfaction, and CLBD-care related costs will be evaluated up to 6 months after the intervention. Patient and provider experiences with the team telehealth approach will be explored through qualitative interviews. Validity of the new team care model will be explored through comparing the concordance of diagnosis and management recommendations arising from of a separate group of participants with CLBD. Results: The study was funded in July 2013 and ethics was approved in November 2013. Participant recruitment began in September 2014 and data collection was complete in December 2015. Results are anticipated in September 2016. Conclusions: CLBD is a widespread public health problem, more so in rural and remote areas, which require new innovative approaches to appropriate health care delivery. This study will provide evidence and guidance of interventions that have the potential to improve efficiency, coordination, and continuity to ensure that health needs are met in the right place, at the right time, by the appropriate care provider(s). Clinical Trial: ClinicalTrials.gov Identifier: NCT02225535; url: https://clinicaltrials.gov/ct2/show/NCT02225535

  • Developing a multidisciplinary model to guide employment outcomes amongst People Living with Spinal Cord Injuries in South Africa

    Date Submitted: Apr 19, 2016

    Open Peer Review Period: Apr 20, 2016 - May 4, 2016

    Background: Spinal cord injury often results in complete or partial loss of functioning of the upper and or lower limbs, leading to the affected individual experiencing difficulties in performing acti...

    Background: Spinal cord injury often results in complete or partial loss of functioning of the upper and or lower limbs, leading to the affected individual experiencing difficulties in performing activities of daily living. This in turn results in reduced participation in social, religious, recreational and economic activities (employment). The South Africa legal framework promotes the employment and assistance of people with disabilities However, rehabilitation interventions focus mainly on impairments and activity limitations, with few attempts to prepare those with SCI to return to gainful employment (Pefile, 2013). There is therefore a need for a well-coordinated, multi-sectorial, multi-disciplinary and multi-factorial rehabilitation intervention that will promote the employment of PLWSCI in South Africa. Objective: This study aims to develop a multi-disciplinary model to guide employment outcomes amongst people living with spinal cord injuries in South Africa. Methods: This study will utilise mixed methods during three phases. The first phase will explore the current rehabilitation practices and the second will establish the factors that influence employment outcomes amongst PLWSCI. The results will inform phase 3, the model development using a multi-stage Delphi technique to obtain feedback from a multidisciplinary team consisting of health care professionals, the Departments of Labour, Social Development, Education and Health, and non-government organisations representing PLWSCI. Results: The inclusion of PLWSI will be a crucial component of this study to ensure that it addresses their concerns and recommendations. A multi sectoral approach is key to the results reflecting the current status of rehabilitation interventions and desired outcomes of this study. Conclusions: Developing a multidisciplinary model to guide the employment outcomes of PLWSCI will ensure a coordinated response to integrate them into a productive life, and will assist them to achieve economic self-sufficiency, personal growth, social integration, life satisfaction and an improved quality of life. Clinical Trial: The study protocol received full ethical clearance from the University of KwaZulu-Natal (UKZN) Biomedical Research Ethics Committee (BE499/14) as well as from the KwaZulu-Natal Provincial Department of Health (KZ_2015RP38_59). This study is also registered with the Unites States National Institutes of Health (NCT02582619). Informed consent will be sought from all participants before they can participate in the study.

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