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:

  • PedAMINES app. Source: Image created by the authors; Copyright: The authors; URL: http://www.researchprotocols.org/2017/8/e167/; License: Creative Commons Attribution (CC-BY).

    A Mobile Device App to Reduce Medication Errors and Time to Drug Delivery During Pediatric Cardiopulmonary Resuscitation: Study Protocol of a Multicenter...

    Abstract:

    Background: During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusions is complex and time-consuming. The need for individual specific weight-based drug dose calculation and preparation places children at higher risk than adults for medication errors. Following an evidence-based and ergonomic driven approach, we developed a mobile device app called Pediatric Accurate Medication in Emergency Situations (PedAMINES), intended to guide caregivers step-by-step from preparation to delivery of drugs requiring continuous infusion. In a prior single center randomized controlled trial, medication errors were reduced from 70% to 0% by using PedAMINES when compared with conventional preparation methods. Objective: The purpose of this study is to determine whether the use of PedAMINES in both university and smaller hospitals reduces medication dosage errors (primary outcome), time to drug preparation (TDP), and time to drug delivery (TDD) (secondary outcomes) during pediatric CPR when compared with conventional preparation methods. Methods: This is a multicenter, prospective, randomized controlled crossover trial with 2 parallel groups comparing PedAMINES with a conventional and internationally used drug infusion rate table in the preparation of continuous drug infusion. The evaluation setting uses a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin. The study involving 120 certified nurses (sample size) will take place in the resuscitation rooms of 3 tertiary pediatric emergency departments and 3 smaller hospitals. After epinephrine-induced return of spontaneous circulation, nurses will be asked to prepare a continuous infusion of dopamine using either PedAMINES (intervention group) or the infusion table (control group) and then prepare a continuous infusion of norepinephrine by crossing the procedure. The primary outcome is the medication dosage error rate. The secondary outcome is the time in seconds elapsed since the oral prescription by the physician to drug delivery by the nurse in each allocation group. TDD includes TDP. Stress level during the resuscitation scenario will be assessed for each participant by questionnaire and recorded by the heart rate monitor of a fitness watch. The study is formatted according to the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of Electronic and Mobile Health Applications and Online TeleHealth (CONSORT-EHEALTH) and the Reporting Guidelines for Health Care Simulation Research. Results: Enrollment and data analysis started in March 2017. We anticipate the intervention will be completed in late 2017, and study results will be submitted in early 2018 for publication expected in mid-2018. Results will be reported in line with recommendations from CONSORT-EHEALTH and the Reporting Guidelines for Health Care Simulation Research . Conclusions: This paper describes the protocol used for a clinical trial assessing the impact of a mobile device app to reduce the rate of medication errors, time to drug preparation, and time to drug delivery during pediatric resuscitation. As research in this area is scarce, results generated from this study will be of great importance and might be sufficient to change and improve the pediatric emergency care practice. Clinical Trial: ClinicalTrials.gov NCT03021122; https://clinicaltrials.gov/ct2/show/NCT03021122 (Archived by WebCite at http://www.webcitation.org/6nfVJ5b4R)

  • Source: iStock by Getty Images; Copyright: DragonImages; URL: http://www.istockphoto.com/nl/foto/working-on-laptop-gm466163480-59636464; License: Licensed by the authors.

    Barriers and Facilitators for the Use of a Medical Mobile App to Prevent Work-Related Risks in Pregnancy: A Qualitative Analysis

    Abstract:

    Background: The number of women participating in the labor market in Europe has increased over the last several decades. At the same time, there is growing evidence that certain conditions of employment during pregnancy may have a negative influence on pregnancy outcomes. In order to better inform pregnant women, we aim to develop an app to help assess the health risk as a result of personal and work-related factors and provide personal advice for these women and their health care providers. Objective: The aim of this study was to compose a thematic overview of the perceived facilitators and barriers according to pregnant women, medical professionals, and employers for the use of a mobile app in obstetrical care to prevent occupational-related pregnancy complications. Methods: Two multidisciplinary focus group meetings with in total 14 participants were conducted with pregnant women, occupational physicians, general practitioners, midwives, obstetricians, and representatives of trade unions and employer organizations. Transcripts were analyzed by qualitatively coding procedures and constant comparative methods. Results: We identified 24 potential facilitators and 12 potential barriers for the use of the app in 4 categories: content of the app, the app as a mean to provide information, ease of use, and external factors. The 3 main facilitators identified were the need for a good interaction between the app and the user, apps were viewed as a more practical source of information, and the information should be understandable, according to the existing guidelines, and well-dosed. The 2 main barriers for use were extensive battery and memory use of the smartphone and sending frequent push notifications. Conclusions: The results of this study are important considerations in the developing process of a medical app implementing a guideline or evidence-based information in practice.

  • Source: Flickr; Copyright: Patrick Q; URL: https://flic.kr/p/4JfeHe; License: Creative Commons Attribution + Noncommercial (CC-BY-NC).

    The Spanish Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and...

    Abstract:

    Background: Anxiety and depression are common, impairing conditions that evidence high comorbidity rates in adolescence. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) is one of the few existing resources aimed at applying transdiagnostic treatment principles to target core dysfunctions associated with both anxiety and depression within a single protocol. To our knowledge, this is the first study examining the efficacy of the UP-A adapted as a universal preventive intervention program. Objective: The primary aim of this study is to examine whether the Spanish version of the UP-A is more effective than a waitlist (WL) control group in reducing and preventing symptoms of anxiety and depression when employed as a universal, classroom-based preventive intervention. The secondary aim is to investigate changes in a broad range of secondary outcome measures, including negative and positive affect, anxiety sensitivity, emotional avoidance, top problems ratings, school grades, depression and anxiety-related interference, self-esteem, life satisfaction, quality of life, conduct problems, hyperactivity/inattention symptoms, peer problems, prosocial behavior, school adjustment, and discipline problems. Other aims are to assess a range of possible predictors of intervention effects and to examine the feasibility and the acceptability of implementing UP-A in a prevention group format and in a school setting. Methods: A cluster, randomized, WL, controlled trial design with classroom as the unit of randomization was used in this study. Five classes including a total of 152 adolescents were randomized to the experimental or WL control groups. Participants in the experimental group received 9 55-minute sessions delivered by advanced doctoral and masters students in clinical psychology. The WL control group will receive the intervention once the 3-month follow-up assessment is completed. Results: We have recruited participants to the cluster randomized controlled trial (RCT) and have conducted the intervention with the experimental group. We expect the WL control group to complete the intervention in July 2017. Data analysis will take place during the second semester of 2017. Conclusions: We expect the experimental group to outperform the WL control group at post-intervention and 3-month follow-up. We also expect the WL control group to show improvements in primary and secondary outcome measures after receiving the intervention. Results will have implications for researchers, families, and education providers. Trial Registration: Clinicaltrials.gov NCT03123991; https://clinicaltrials.gov/ct2/show/NCT03123991 (Archived by WebCite at http://www.webcitation.org/6qp7GIzcR)

  • Source: Pixabay; Copyright: Monika; URL: https://pixabay.com/en/contact-us-facebook-message-1207802/; License: Public Domain (CC0).

    Feasibility of a Facebook Intervention for Exercise Motivation and Cardiac Rehabilitation Adherence: Study Protocol

    Abstract:

    Background: While cardiac rehabilitation has been shown to be effective at improving coronary heart disease (CHD), participation is generally poor. Attempts to increase uptake and adherence often fail. Use of a Facebook intervention for this population may be a unique opportunity to support self-determined motivation and affect adherence. Objective: To evaluate the impact of a Facebook intervention on motivation for exercise and adherence to cardiac rehabilitation in patients with CHD during a 12-week, Phase II cardiac rehabilitation program. Methods: A prospective, randomized controlled pilot study, grounded in Self-Determination Theory, will be conducted. Participants will be recruited from inpatient, or the intake visit to outpatient, cardiac rehabilitation, and then randomly assigned to the intervention or comparison group. Participants in the intervention group will take part in a private Facebook group. Weekly posts will be designed to support self-determined motivation, measured at baseline and postcardiac rehabilitation by the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3). The Psychological Need Satisfaction for Exercise (PNSE) scale will measure fulfillment of needs that affect motivation. Participants in the comparison group will be given the same materials, but these will be supplied via handouts and email. The number of sessions attended will be tallied and analyzed using t tests. Overall motivation will be evaluated using analysis of covariance (ANCOVA) models. Multivariate analysis of variance models will be used to evaluate differences in the change across motivation subtypes. If significant, ANCOVA models for each subtype will be fit. ANCOVA models will be used to compare changes in needs satisfaction, overall and separately among the three subscales, between groups. Engagement in the Facebook group will be measured by number of “likes” and self-report of weekly visits to the group. Results: This project was funded in July 2017 and recruitment is currently underway. The recruitment goal is 60 cardiac rehabilitation patients. Data collection is anticipated to be complete by July 2018. Conclusions: This pilot study will be the first to examine the effect of a Facebook intervention on patient adherence and motivation for exercise in a cardiac rehabilitation setting. Engagement in the Facebook group and participation in the study will help to determine the feasibility of using Facebook to affect adherence and motivation in cardiac rehabilitation patients, potentially improving outcomes through the use of a unique intervention. Trial Registration: ClinicalTrials.gov NCT02971813; https://clinicaltrials.gov/ct2/show/NCT02971813 (Archived by WebCite at http://www.webcitation.org/6sRsz8Zpa)

  • Postoperative radiographs. Source: Image created by the authors; Copyright: The authors; URL: http://www.researchprotocols.org/2017/8/e159/; License: Creative Commons Attribution (CC-BY).

    Are Routine Radiographs Needed the Day After Open Reduction and Internal Fixation Surgery for Distal Radius and Ankle Fractures: Study Protocol for a...

    Abstract:

    Background: Distal radius and ankle fractures are one of the most common operatively treated fractures. To date, there is no consensus concerning the need for a standard postoperative radiograph. This leads to undesirable practice variations. A standardized radiograph in the department of radiology would theoretically be more reproducible and operator independent than an intraoperatively obtained fluoroscopic image. However, if adequate intraoperative radiographs have been obtained, it is questionable if these postoperative radiographs are necessary and will lead to changes in the treatment strategy. If standard postoperative radiographs are no longer required, this would lead to a reduction in radiation exposure and health care costs. The hypothesis is that routine standardized postoperative radiographs do not influence the quality of care for patients operated on for either a distal radius or an ankle fracture if adequate intraoperative standardized radiographs have been obtained. Objective: The primary aim of this study is to evaluate if there is a need for routine postoperative radiographs after an osteosynthesis of a distal radius or ankle fracture. Methods: In a prospective, randomized controlled, open label trial based on a noninferiority design, we will enroll 332 patients. Patients will be randomized either in the control or the intervention group. The control group will be treated according to our current, standard protocol in which all patients receive a standard anterior-posterior and lateral radiograph on the first postoperative day. Patients randomized to the intervention group will be treated without a standard postoperative radiograph. All patients (N=332) will have a routine clinical and radiographic control after 6 weeks in the outpatient clinic. Primary outcome is a change in treatment plan, defined as either additional imaging or a reoperation based on the postoperative imaging. Secondary outcome measures include a 36-Item Short Form Survey, Patient-Rated Wrist Hand Evaluation, Foot and Ankle Outcome Score, Visual Analogue Scale, and the range of motion. Those questionnaires will be filled out at the 6-week outpatient control. Results: The trial was started in August 2016, and 104 patients have been enrolled up to this point. Conclusions: Our findings will be reported in peer-reviewed publications and may lead to a strong reduction in radiation exposure and health care costs. A preliminary, conservative estimation suggests a yearly cost saving of CHF 1.3 million in Switzerland.

  • Source: www.pixabay.com; Copyright: Dariusz Sankowski; URL: https://pixabay.com/en/iphone-6s-plus-apple-white-screen-1032779/; License: Public Domain (CC0).

    mHealth Technologies for Palliative Care Patients at the Interface of In-Patient to Outpatient Care: Protocol of Feasibility Study Aiming to Early Predict...

    Abstract:

    Background: Palliative care patients are a particularly vulnerable population and one of the critical phases in patients’ trajectories is discharge from specialized in-patient palliative care into outpatient care, where availability of a palliative care infrastructure is highly variable. A relevant number of potentially avoidable readmissions and emergency visits of palliative patients is observed due to rapid exacerbation of symptoms indicating the need for a closer patient monitoring. In the last years, different mHealth technology applications have been evaluated in many different patient groups. Objective: The aim of our study is to test feasibility of a remote physical and social tracking system in palliative care patients. Methods: A feasibility study with explorative, descriptive study design, comprised of 3 work packages. From the wards of the Clinic of Radiation-Oncology at the University Hospital Zurich, including the specialized palliative care ward, 30 patients will be recruited and will receive a mobile phone and a tracking bracelet before discharge. The aim of work package A is to evaluate if severely ill patients accept to be equipped with a tracking bracelet and a mobile phone (by semiquantitative questionnaires and guideline interviews). Work package B evaluates the technical feasibility and quality of the acquired electronic health data. Work package C will demonstrate whether physical activity parameters, such as step count, sleep duration, social activity patterns like making calls, and vital signs (eg, heart rate) do correlate with subjective health data and can serve as indicator to early detect and predict changes in patients’ health status. Activity parameters will be extracted from the mobile phone’s and wristband’s sensor data using signal processing methods. Subjective health data is captured via electronic version of visual analog scale and Distress Thermometer as well as the European Organization for Research and Treatment of Cancer – Quality of Life Questionnaire C30 in paper version. Results: Enrollment began in February 2017. First study results will be reported in the middle of 2018. Conclusions: Our project will deliver relevant data on patients’ acceptance of activity and social tracking and test the correlation between subjective symptom assessment and objective activity in the vulnerable population of palliative care patients. The proposed study is meant to be preparatory work for an intervention study to test the effect of wireless monitoring of palliative care patients on symptom control and quality of life.

  • Laboratorial activity on caries detection (montage). Source: IuSTC Group / Placeit.net; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/8/e155/; License: Creative Commons Attribution (CC-BY).

    Impact of a Tutored Theoretical-Practical Training to Develop Undergraduate Students’ Skills for the Detection of Caries Lesions: Study Protocol for a...

    Abstract:

    Background: Tutored laboratorial activities could be a manner of improving the competency development of students. However, its impact over conventional theoretical classes has not yet been tested. Additionally, different university contexts could influence this issue and should be explored. Objective: To assess the impact of a tutored theoretical-practical training for teaching undergraduate students to detect caries lesions as compared with theoretical teaching activities. The impact of these teaching/learning activities will be assessed in terms of efficacy, cost/benefit, retention of knowledge/acquired competences, and student acceptability. Methods: Sixteen centers (7 centers from Brazil and 9 centers from other countries throughout the world) are involved in the inclusion of subjects for this protocol. A randomized controlled study with parallel groups will be conducted. One group (control) will be exposed to a 60- to 90-minute conventional theoretical class and the other group (test) will be exposed to the same theoretical class and also a 90-minute laboratory class, including exercises and discussions based on the evaluation of a pool of images and extracted teeth. The mentioned outcomes will be evaluated immediately after the teaching activities and also in medium- and long-term analyses. To compare the long-term outcomes, students who enrolled in the university before the participating students will be interviewed for data collection and these data will be used as a control and compared with the trained group. This stage will be a nonrandomized phase of this study, nested in the main study. Appropriate statistical analysis will be performed according to the aims of this study. Variables related to the centers will also be analyzed and used to model adjustment as possible sources of variability among results. Results: This ongoing study is funded by a Brazilian national funding agency (CNPq- 400736/2014-4). We expect that the tutored theoretical-practical training will improve the undergraduate students’ performance in the detection of caries lesions and subsequent treatment decisions, mainly in terms of long-term retention of knowledge. Our hypothesis is that tutored theoretical-practical training is a more cost-effective option for teaching undergraduate students to detect caries lesions. Conclusions: If our hypothesis is confirmed, the use of laboratory training in conjunction with theoretical classes could be used as an educational strategy in Cariology to improve the development of undergraduate students’ skills in the detection of caries lesions and clinical decision-making.

  • Source: Pixabay; Copyright: Anna Sulencka; URL: https://pixabay.com/en/computer-hands-work-keyboard-2265803/; License: Public Domain (CC0).

    An Electronic Health Record–Based Strategy to Systematically Assess Medication Use Among Primary Care Patients With Multidrug Regimens: Feasibility Study

    Abstract:

    Background: Medication nonadherence and misuse are public health and patient safety concerns. With the increased adoption of electronic health records (EHRs), greater opportunities exist to communicate directly with, and collect data from, patients through secure portals linked to EHRs. Objective: The study objectives were to develop and pilot test a method of monitoring patient medication use in outpatient settings and determine the feasibility and acceptability of this approach. Methods: Adult primary care patients on multidrug regimens were recruited from an academic internal medicine clinic by a trained research assistant. After completing a baseline, in-person interview, patients were sent a link to a questionnaire about medication use via the patient portal. One week later, the RA contacted patients to complete a follow-up telephone interview assessing patient satisfaction and experience with the questionnaire. Patient EHRs were also reviewed to determine the questionnaire completion rate. Results: Of 100 patients enrolled, 89 completed the follow-up interview and 82 completed the portal questionnaire. The mean age of the sample was 61.8 (range 31-88) years. Approximately half (54/100, 54%) of the sample was male, two-thirds were white (67/100, 67%) and 26% (26/100) African-American. A total of 44% reported an annual household income of <$50,000 per year, and 17% (17/100) reported a high school or less level of education. No significant differences were found in questionnaire completion rates by sociodemographic characteristics or prior portal use. Most (68/73, 93%) found the questionnaire easy to access, easy to complete (72/73, 99%), and valuable (73/89, 82%). Time constraints and log-in difficulties were the main reasons for noncompletion. Conclusions: The portal questionnaire was well received by a socioeconomically diverse group of patients with high completion rates achieved. Routine use of a portal-based questionnaire could provide a valuable signal to providers and care teams about patient medication use and identify patients needing additional support.

  • Opening the Black Box of eHealth. Source: Pixabay; Copyright: Pixabay; URL: https://pixabay.com/nl/trechter-vector-drop-data-geel-2487506/; License: Public Domain (CC0).

    Opening the Black Box of Electronic Health: Collecting, Analyzing, and Interpreting Log Data

    Abstract:

    In electronic health (eHealth) research, limited insight has been obtained on process outcomes or how the use of technology has contributed to the users’ ability to have a healthier life, improved well-being, or activate new attitudes in their daily tasks. As a result, eHealth is often perceived as a black box. To open this black box of eHealth, methodologies must extend beyond the classic effect evaluations. The analyses of log data (anonymous records of real-time actions performed by each user) can provide continuous and objective insights into the actual usage of the technology. However, the possibilities of log data in eHealth research have not been exploited to their fullest extent. The aim of this paper is to describe how log data can be used to improve the evaluation and understand the use of eHealth technology with a broader approach than only descriptive statistics. This paper serves as a starting point for using log data analysis in eHealth research. Here, we describe what log data is and provide an overview of research questions to evaluate the system, the context, the users of a technology, as well as the underpinning theoretical constructs. We also explain the requirements for log data, the starting points for the data preparation, and methods for data collection. Finally, we describe methods for data analysis and draw a conclusion regarding the importance of the results for both scientific and practical applications. The analysis of log data can be of great value for opening the black box of eHealth. A deliberate log data analysis can give new insights into how the usage of the technology contributes to found effects and can thereby help to improve the persuasiveness and effectiveness of eHealth technology and the underpinning behavioral models.

  • An expert endoscopist and standardized nurse demonstrate a virtual reality colonoscopy procedure in the presence of a standardized patient. Source: Image created by the authors; Copyright: The authors; URL: http://www.researchprotocols.org/2017/8/e153/; License: Creative Commons Attribution (CC-BY).

    Simulation-Based Training of Non-Technical Skills in Colonoscopy: Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Non-technical skills (NTS), such as communication and professionalism, contribute to the safe and effective completion of procedures. NTS training has previously been shown to improve surgical performance. Moreover, increases in NTS have been associated with improved clinical endoscopic performance. Despite this evidence, NTS training has not been tested as an intervention in endoscopy. Objective: The aim of this study is to evaluate the effectiveness of a simulation-based training (SBT) curriculum of NTS on novice endoscopists’ performance of clinical colonoscopy. Methods: Novice endoscopists were randomized to 2 groups. The control group received 4 hours of interactive didactic sessions on colonoscopy theory and 6 hours of SBT. Hours 5 and 6 of the SBT were integrated scenarios, wherein participants interacted with a standardized patient and nurse, while performing a colonoscopy on the virtual reality (VR) simulator. The NTS (intervention) group received the same teaching sessions but the last hour was focused on NTS teaching. The NTS group also reviewed a checklist of tasks relevant to NTS concepts prior to each integrated scenario case and was provided with dedicated feedback on their NTS performance during the integrated scenario practice. All participants were assessed at baseline, immediately after training, and 4 to 6 weeks post-training. The primary outcome measure is colonoscopy-specific performance in the clinical setting. Results: In total, 42 novice endoscopists completed the study. Data collection and analysis is ongoing. We anticipate completion of all assessments by August 2017. Data analysis, manuscript writing, and subsequent submission for publication is expected to be completed by December 2017. Conclusions: Results from this study may inform the implementation of NTS training into postgraduate gastrointestinal curricula. NTS curricula may improve attitudes towards patient safety and self-reflection among trainees. Moreover, enhanced NTS may lead to superior clinical performance and outcomes in colonoscopy. Trial Registration: Clinicaltrial.gov NCT02877420; https://www.clinicaltrials.gov/ct2/show/NCT02877420 (Archived by WebCite at http://www.webcitation.org/6rw94ubXX NCT02877420)

  • Source: Image created by the authors; Copyright: The authors; URL: http://www.researchprotocols.org/2017/8/e154/; License: Creative Commons Attribution (CC-BY).

    Combination Analgesic Development for Enhanced Clinical Efficacy (CADENCE Trial): Study Protocol for a Double-Blind, Randomized, Placebo-Controlled Crossover...

    Abstract:

    Background: Fibromyalgia is a clinical disorder commonly presenting with chronic widespread pain as well as sleep disturbance, fatigue, depression, and cognitive dysfunction. There is an urgent need for treatment strategies that provide better pain relief and fewer adverse effects (AEs). Efforts to develop rational combinations of specific fibromyalgia treatments have demonstrated potential for measurable improvements in pain relief, quality of life, and health care utilization. More than half of fibromyalgia patients receive 2 or more analgesics but current combination use is based on limited evidence. As an early proof-of-concept project from the Canadian Institutes of Health Research–Strategy on Patient-Oriented Research Chronic Pain Network, this trial protocol is expected to advance the field by rigorously evaluating a new treatment combination for fibromyalgia. Objective: We will test the hypothesis that analgesic combinations containing at least one nonsedating agent would be as safe but more effective than either monotherapy because of additive pain relief without increasing overall AEs. Pregabalin (PGB), a sedating anticonvulsant, is proven effective for fibromyalgia, and the antioxidant, alpha-lipoic acid (ALA), one of the only nonsedating systemic agents proven effective for neuropathic pain, is currently being evaluated in fibromyalgia. Thus, we will conduct a clinical trial to compare a PGB+ALA combination to each monotherapy for fibromyalgia. Methods: Using a double-blind, double-dummy, crossover design, 54 adults with fibromyalgia will be randomly allocated to 1 of 6 sequences of treatment with PGB, ALA, and PGB+ALA combination. During each of 3 different treatment periods, participants will take 2 sets of capsules containing (1) ALA (or placebo) and (2) PGB (or placebo) for 31 days, followed by an 11-day taper/washout period. The primary outcome will be mean daily pain intensity (0 to 10 scale) at maximal tolerated doses (MTDs) during each period. Secondary outcomes, assessed at MTD, will include global improvement, adverse events, mood, and quality of life. Results: This trial attained ethics approval March 6, 2017 (Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board protocol number ANAE-313-17), and recruitment is set to start in August 2017. Conclusions: This trial will provide rigorous evidence comparing the efficacy of a PGB-ALA combination to PGB alone and ALA alone in the treatment of fibromyalgia. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN14939460; https://www.isrctn.com/ ISRCTN1493946 (Archived by WebCite at http://www.webcitation.org/6sFqAjxkt)

  • SpringboarD trial logo. Source: Image created by the authors; Copyright: The authors; URL: http://www.researchprotocols.org/2017/8/e145/; License: Creative Commons Attribution (CC-BY).

    A Web-Based Public Health Intervention to Reduce Functional Impairment and Depressive Symptoms in Adults With Type 2 Diabetes (The SpringboarD Trial):...

    Abstract:

    Background: Depressive symptoms are common in people with type 2 diabetes and contribute to adverse health consequences that substantially impact social and vocational function. Despite the existence of effective depression treatments, the majority of people with type 2 diabetes do not access these when needed. Web-based alternatives to more traditional psychotherapies offer a potential solution to reducing the personal and economic burdens of type 2 diabetes. Objective: This paper outlines the protocol for a randomized controlled trial (RCT) of myCompass, a Web-based public health psychotherapy intervention, in people with type 2 diabetes. Fully automated, interactive, and delivered via the Internet without clinician support, myCompass teaches cognitive behavioral therapy-based skills and supports symptom monitoring to improve daily functioning and reduce mild-to-moderate mental health symptoms. Methods: A two-arm RCT will be conducted. People with type 2 diabetes and mild-to-moderately severe depressive symptoms will be recruited from the community and general practice settings. Screening and enrollment is via an open-access website. Participants will be randomized to use either myCompass or an active placebo program for 8 weeks, followed by a 4-week tailing-off period. The placebo program is matched to myCompass on mode of delivery, interactivity, and duration. Outcomes will be assessed at baseline and at 3-month, 6-month, and 12-month follow-up. The primary study outcome is work and social functioning. Secondary study outcomes include depressive and anxious symptoms, diabetes-related distress, self-care behaviors, and glycemic control. Results: Nationwide recruitment is currently underway with the aim of recruiting 600 people with type 2 diabetes. Recruitment will continue until October 2017. Conclusions: This is the first known trial of a Web-based psychotherapy program that is not diabetes specific for improving social and vocational function in people with type 2 diabetes and mild-to-moderately severe depressive symptoms. With the increasing prevalence of type 2 diabetes and depression, a potentially scalable public health intervention could play a very large role in reducing unmet mental health need and ameliorating the personal and societal impact of illness comorbidity. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) Number: ACTRN12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109 (Archived by WebCite at http://www.webcitation.org/ 6rh3imVMh)

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    Open Peer Review Period: Aug 21, 2017 - Sep 4, 2017

    Background: There is a growing demand for peer workers (people who use their own lived experience to support others in their recovery) to work alongside consumers to improve outcomes and recovery. In...

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    Open Peer Review Period: Aug 17, 2017 - Aug 31, 2017

    Background: Background: Intelligent assistive technologies that complement and extend human abilities have proliferated in recent years. Service robots, home automation equipment, and other digital as...

    Background: 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 in 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: Objective: The purpose of this scoping review is to synthesize 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: Methods: Using a scoping review methodology, our search strategy will examine the following databases: ACM Digital Library, CINAHL, Medline, Scopus, and Web of Science. Two reviewers (AM, JL) will independently screen the initial titles obtained from the search, and these results will be further inspected by other members (RB, JM) of the research team for inclusion into the review. Results: 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, non-stable, and intimately tied to the sort of intelligent assistive technology being examined. Further, a wide range of theoretical lens that include elements of trust have been used to examine this concept. Conclusions: 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.

  • A Novel Mobile App & Population Management System to Manage Rheumatoid Arthritis Flares

    Date Submitted: Aug 17, 2017

    Open Peer Review Period: Aug 17, 2017 - Aug 31, 2017

    Background: Rheumatoid arthritis (RA) flares have a profound effect on patients, causing pain and disability. However, flares often occur between regularly scheduled healthcare provider (HCP) visits a...

    Background: Rheumatoid arthritis (RA) flares have a profound effect on patients, causing pain and disability. However, flares often occur between regularly scheduled healthcare provider (HCP) visits and are, therefore, difficult to monitor and manage. We sought to develop a smartphone application (app) combined with a population management system to help track RA flares between visits. Objective: The objective of this study is to implement a smartphone app + population management system to monitor RA disease activity between scheduled HCP visits over a period of 6-months. Methods: This is a randomized controlled trial that lasts for 6 months for each participant. We aim to recruit 190 patients, randomized 50:50 to the intervention group vs. the control group. The intervention group will be assigned the smartphone app and be prompted to answer daily questionnaires sent to their smartphones. Both groups will be assigned a population manager, who will check in with participants via telephone at 6-weeks and 18-weeks. The population manager will also communicate with participants in the intervention group if/when their responses indicate a sustained increase in RA disease activity. To assess patient satisfaction, the primary outcomes will be scores on the Treatment Satisfaction Questionnaire for Medication (TSQM) and Perceived Efficacy in Patient-Physician Interactions (PEPPI) questionnaire at 6 months. To determine the effect of the smartphone app on RA disease activity, the primary outcome will be the Clinical Disease Activity Index (CDAI) at 6 months. Results: The trial started in November 2016, and an estimated 2.5 years will be necessary to complete the study. Study results are expected to be published by the end of 2019. Conclusions: The completion of this study will provide important data regarding: 1) the assessment of validated outcome measures to assess RA disease activity with a smartphone app between routinely scheduled HCP visits, 2) patient engagement in monitoring their condition, and 3) communication between patients and HCPs through a population management system. Clinical Trial: NCT02822521

  • Testing the MD-Link, a low cost mobile electrocardiography (ECG) monitoring device, in patients with cardiovascular diseases: study protocol

    Date Submitted: Aug 17, 2017

    Open Peer Review Period: Aug 17, 2017 - Aug 31, 2017

    Background: Having mobile devices that provide patients with the ability to record and monitor the electrical activity of their hearts enhances patient self-care and the early detection of cardiac arr...

    Background: Having mobile devices that provide patients with the ability to record and monitor the electrical activity of their hearts enhances patient self-care and the early detection of cardiac arrhythmia (irregular heartbeat), yet few such devices exist in Vietnam. Challenges exist for introducing mobile electrocardiography (ECG) monitoring devices in Vietnam, including patient accessibility and affordability. A low cost mobile electrocardiography monitoring device designed and developed in Vietnam, that allows patients to easily measure their heart’s electrical activity and navigate recordings may be a solution. Objective: The aim of this project is to assess the usability of a newly developed mobile ECG device, MD-Link, through the comparison of its outputs to the standard printed outputs from a 12-lead electrocardiogram, the Nihon Kohden Cardiofax S Electrocardiograph Model ECG-1250K. Methods: We will conduct this study in two stages: measurement of the ECG signals of patients using the MD-Link and the Nihon Kohden Cardiofax S, and analysis of the selected standard outputs collected from the ECG recordings of the MD-Link and the Nihon Kohden Cardiofax S. The MD-Link consists of (1) a mobile device (e.g. a smartphone), (2) two active dry electrodes as ECG touch sensors enabling convenient recording of ECG signals, and (3) an easy-to-use mobile application interface enabling the upload and accurate display of ECG recordings to patients and their clinicians. Our research team consisting of members from Dartmouth College, the Institute of Health, Population and Development (PHAD), Hanoi University of Science and Technology (HUST), and physicians and nurses from International Clinics Thanh Chan will assist in carrying out this project. Results: We will proceed with a publication plan that includes a project report and ultimately articles for peer-reviewed journals. We also hope to disseminate our work at relevant conferences to provide more coverage and exposure to the MD-Link mobile device. Conclusions: At the end of this project, we will have developed and tested the MD-Link, a low cost mobile ECG monitoring device with some supportive comparisons to standard ECG devices commonly used in heart clinics or hospitals in Vietnam. Our long-term goal is for the MD-Link to be easily accessible, affordable and to fit into a patient’s daily routine, thus increasing the levels of patient cardiovascular health.

  • Protocol Psychometric evaluation of a patient-reported Symptom Index for non-muscle invasive bladder cancer: field testing

    Date Submitted: Aug 16, 2017

    Open Peer Review Period: Aug 17, 2017 - Aug 31, 2017

    Background: Non-Muscle Invasive Bladder Cancer (NMIBC) is a chronic condition requiring intensive follow-up, repeated endoscopic examinations, tumour resections and intravesical treatments that can be...

    Background: Non-Muscle Invasive Bladder Cancer (NMIBC) is a chronic condition requiring intensive follow-up, repeated endoscopic examinations, tumour resections and intravesical treatments that can be 3-monthly and life-long. 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 the research is 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 two field tests. Field test 1 is a cross-sectional study design involving 225 adult NMIBC patients recruited while undergoing active treatment or completed final treatment within the last week. Data collected includes patient demographics, clinical features of the tumour, 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 four time-points during treatment: before tumour 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. Field Test 2 is planned to commence 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 provide an evidence-base for the on-going improvement of future therapies for NMIBC. Clinical Trial: ClinicalTrials.gov registration ID: NCT03091764

  • A tailored advice tool for skiers and snowboarders: design of a randomized controlled trial

    Date Submitted: Aug 17, 2017

    Open Peer Review Period: Aug 17, 2017 - Aug 31, 2017

    Background Being active in sports has many positive health effects. The direct effects of engaging in regular physical activity are particularly apparent in the prevention of several chronic diseases...

    Background Being active in sports has many positive health effects. The direct effects of engaging in regular physical activity are particularly apparent in the prevention of several chronic diseases, including: cardiovascular disease, diabetes, cancer, hypertension, obesity, depression and osteoporosis. Besides the beneficial health effects of being active, sports participation is unfortunately also associated with a risk for injuries. In many sports injury, e.g. winter sports, preventive measures are not compulsory. Therefore, a behavioral change in sports participants is necessary to increase the use of effective measures and subsequently prevent or reduce injuries in sports. The evidence-based intervention ‘Wintersportklaar’ is developed to stimulate injury preventive behavior among skiers and snowboarders. In this article the design of the effectiveness study will be described. Methods A randomized controlled trial with a follow-up period of 4 months during the winter sport season will be conducted. The participants consist of unexperienced skiers and snowboarders. At baseline, skiers and snowboarders in the intervention and control group are asked to report the injury preventive measures they usually take during their preparation to their winter sport holiday. One and three months after baseline, skiers and snowboarders are asked to report retrospectively in detail what they have done regarding injury prevention during their current winter sport preparation and winter sport holiday. Descriptive analyses (mean, standard deviation, frequency, range) are conducted for the different baseline variables in both study groups. To evaluate the success of the randomization, baseline values are analyzed for differences between the intervention and control group (Chi Square, independent T-tests and/or Mann-Whitney test). Chi square tests and/or logistic regression analyses are used to analyze behavioral change according to the intention to treat principle. Discussion To conquer the negative side effects of sports participation, the use of injury preventive measures is desirable. As the use of injury prevention is mostly not compulsory in skiing and snowboarding , a behavioral change is necessary to increase the use of effective injury preventive measures in winter sports. Trial Registration NTR6233

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