JMIR Publications

JMIR Research Protocols

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

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Journal Description

 

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

JMIR Res Protoc is a new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor 2016: 5.175)

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

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

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

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

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

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

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

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

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

 
 

Recent Articles:

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/10/e201/; License: Creative Commons Attribution (CC-BY).

    Epidemiology of Hepatitis C Virus Among People Who Inject Drugs: Protocol for a Systematic Review and Meta-Analysis

    Abstract:

    Background: Hepatitis C virus (HCV) is a persistent epidemic among people who inject drugs (PWID), and PWID remain as the population experiencing the most significant impact of HCV-related morbidity and mortality worldwide. Objective: The purpose of this systematic review and meta-analysis is to synthesize data on the epidemiology of HCV infection among PWID. Our main objectives are to characterize the global and regional distribution and determinants of HCV infection among PWID. Methods: A search strategy is conducted that involves both the electronic and manual retrievals of literature. Reports are included in this review if they present data published between 2006 and 2015 on prevalent or incident HCV infection among current or former PWID. Standard meta-analytic techniques are performed to synthesize the pooled data and identify correlates of HCV infection. Results: The search strategy has been performed, and data collection is in progress. Data analysis will follow, and the final results of this systematic review/meta-analysis are expected by December 2017. Conclusions: This article describes the protocol for the systematic review and meta-analysis of epidemiology of HCV among PWID. We aim to provide synthesized data on HCV incidence and prevalence as well as to identify factors associated with HCV transmission. Our research contributes empirical evidence that informs scholarly, medical, and policy discussions concerning HCV. Trial Registration: PROSPERO CRD42016035687; https://www.crd.york.ac.uk/prospero/display_record.asp? ID=CRD42016035687 (Archived by WebCite at http://www.webcitation.org/6ttYLn65N)

  • Source: Pixabay; Copyright: Steve Buissinne; URL: https://pixabay.com/en/physiotherapy-weight-training-595529/; License: Public Domain (CC0).

    A Telerehabilitation Approach to Enhance Quality of Life Through Exercise Among Adults With Paraplegia: Study Protocol

    Abstract:

    Background: Despite compelling evidence linking physical activity and quality of life among adults with spinal cord injury (SCI), exercise participation rates are extremely low in this population. Unfortunately, a lack of behavioral exercise interventions, in particular theory-based randomized controlled trials (RCT), exists within the SCI literature. A pilot RCT is needed to first examine the feasibility to conduct such interventions and determine the appropriate effect size to inform future full-scale interventions. Objective: The overall goal of this pilot RCT is to test an 8-week innovative, video-based telerehabilitation intervention based on self-determination theory and aimed at enhancing the basic psychological needs, motivation, exercise participation, and quality of life‒related outcomes of adults with paraplegia. The objectives are to (1) determine if individuals in the intervention group have greater increases in their basic psychological needs and autonomous motivation and a decrease in controlled motivation compared to the control group, (2) determine whether the intervention group reports greater increases in exercise participation and quality of life‒related variables (eg, life satisfaction, participation in daily/social activities, depressive symptoms) compared to the control group, and (3) examine if adults with paraplegia who received the intervention report improved scores on psychosocial predictors of exercise (eg, action planning) and well-being (eg, positive affect) compared to the control group. We also aimed to examine the implementation characteristics of the intervention (eg, satisfaction with the technology, counselor’s ability to foster the psychological needs). Methods: Adults with paraplegia (N=24) living in the community will be recruited. All participants will be invited to complete assessments of their psychological needs, motivation, exercise, and quality of life‒related variables at three time points (baseline, 6, and 10 weeks). Following the baseline assessment, participants will be randomly assigned to the intervention or control group. Participants in the intervention group will participate in 8 weekly, 1-hour video-based telerehabilitation sessions with a trained physical activity counselor, while participants in the control group will be asked to continue with their regular routine. Results: We expect higher ratings of the basic psychological needs and autonomous motivation and lower scores for controlled motivation for the intervention group compared to the control group (Objective 1). We also expect that our video-based intervention will have moderate effects on exercise participation, as well as small-to-moderate positive effects on the quality of life‒related variables (Objective 2). Finally, we expect the intervention to have a small positive effect on psychosocial predictors of physical activity and well-being (Objective 3). Conclusions: We anticipate that the results will show that the intervention is appropriate for adults with paraplegia and feasible to test in a full-scale RCT. Trial Registration: ClinicalTrials.gov NCT02833935; https://clinicaltrials.gov/ct2/show/NCT02833935 (Archived by WebCite at http://www.webcitation.org/6u8U9x2yt)

  • Source: The Authors; Copyright: The Dup15q Alliance; URL: http://www.researchprotocols.org/2017/10/e194/; License: Licensed by the authors.

    Multisite Semiautomated Clinical Data Repository for Duplication 15q Syndrome: Study Protocol and Early Uses

    Abstract:

    Background: Chromosome 15q11.2-q13.1 duplication syndrome (Dup15q syndrome) is a rare disorder caused by duplications of chromosome 15q11.2-q13.1, resulting in a wide range of developmental disabilities in affected individuals. The Dup15q Alliance is an organization that provides family support and promotes research to improve the quality of life of patients living with Dup15q syndrome. Because of the low prevalence of this condition, the establishment of a single research repository would have been difficult and more time consuming without collaboration across multiple institutions. Objective: The goal of this project is to establish a national deidentified database with clinical and survey information on individuals diagnosed with Dup15q syndrome. Methods: The development of a multiclinic site repository for clinical and survey data on individuals with Dup15q syndrome was initiated and supported by the Dup15q Alliance. Using collaborative workflows, communication protocols, and stakeholder engagement tools, a comprehensive database of patient-centered information was built. Results: We successfully established a self-report populating, centralized repository for Dup15q syndrome research. This repository also resulted in the development of standardized instruments that can be used for other studies relating to developmental disorders. By standardizing the data collection instruments, it allows us integrate our data with other national databases, such as the National Database for Autism Research. A substantial portion of the data collected from the questionnaires was facilitated through direct engagement of participants and their families. This allowed for a more complete set of information to be collected with a minimal turnaround time. Conclusions: We developed a repository that can efficiently be mined for shared clinical phenotypes observed at multiple clinic sites and used as a springboard for future clinical and basic research studies.

  • Source: Flickr; Copyright: Tunstall Telehealthcare; URL: https://flic.kr/p/brnWyk; License: Creative Commons Attribution (CC-BY).

    Home Blood Pressure Management Intervention in Low- to Middle-Income Countries: Protocol for a Mixed Methods Study

    Abstract:

    Background: Control of hypertension in low- and middle-income countries (LMICs) is poor, often less than 10%. A strong body of evidence demonstrates that home blood pressure management lowers blood pressure, and recent guidelines from the National Institute for Clinical Health and Excellence recommends home blood pressure monitoring. However, the preponderance of data on the benefits of home blood pressure management comes from studies in high-income countries. Objective: The objective of the study is to examine whether an intervention of home blood pressure management is feasible in LMICs. Home blood pressure management is defined as self-monitoring of blood pressure and self-titration of antihypertensive medications. We will identify barriers and facilitators of home blood pressure management and explore unique contextual factors in LMICs that influence implementation of home blood pressure management. Methods: Participants will be recruited from 6 sites from 2015 to 2018. Patients and health care workers will be included. We will use mixed methods including focus groups, interviews, and standardized checklists. When possible, we will adapt materials from prior successful studies so that they are culturally and contextually appropriate. Results: This ongoing study is funded by the World Heart Federation. The information that is obtained will be used to develop a randomized clinical trial of home blood pressure management in LMICs. Conclusions: The data generated from this qualitative study will provide much needed information from patients and health care workers about barriers and facilitators of home blood pressure management and unique contextual factors that might influence implementation of home blood pressure management in LMICs.

  • Yale Heart Study logo. Source: Image created by the Author; Copyright: The Author; URL: http://www.researchprotocols.org/2017/10/e182/; License: Creative Commons Attribution (CC-BY).

    Studying Acute Coronary Syndrome Through the World Wide Web: Experiences and Lessons

    Authors List:

    Abstract:

    This study details my viewpoint on the experiences, lessons, and assessments of conducting a national study on care-seeking behavior for heart attack in the United States utilizing the World Wide Web. The Yale Heart Study (YHS) was funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH). Grounded on two prior studies, the YHS combined a Web-based interview survey instrument; ads placed on the Internet; flyers and posters in public libraries, senior centers, and rehabilitation centers; information on chat rooms; a viral marketing strategy; and print ads to attract potential participants to share their heart attack experiences. Along the way, the grant was transferred from Ohio State University (OSU) to Yale University, and significant administrative, information technology, and personnel challenges ensued that materially delayed the study’s execution. Overall, the use of the Internet to collect data on care-seeking behavior is very time consuming and emergent. The cost of using the Web was approximately 31% less expensive than that of face-to-face interviews. However, the quality of the data may have suffered because of the absence of some data compared with interviewing participants. Yet the representativeness of the 1154 usable surveys appears good, with the exception of a dearth of African American participants.

  • The website for Ned (montage). Source: getned.com / Placeit.net; Copyright: JMIR Publications; URL: http://getned.com; License: Creative Commons Attribution (CC-BY).

    Adoption, Acceptability, and Effectiveness of a Mobile Health App for Personalized Prostate Cancer Survivorship Care: Protocol for a Realist Case Study of...

    Abstract:

    Background: By 2030, prostate cancer will be the most commonly diagnosed cancer in North America. To mitigate this impending challenge, comprehensive support mechanisms for disease- and treatment-specific changes in health and well-being must be proactively designed and thoughtfully implemented for streamlined survivorship care. mHealth apps have been lauded as a promising complement to current outpatient treatment and monitoring strategies, but have not yet been widely used to support prostate cancer survivorship needs. A realist evaluation is needed to examine the impact of such apps on the prostate cancer survivorship experience. Objective: We seek to gain an understanding of how an mHealth app for prostate cancer survivorship care called Ned (No Evident Disease) is adopted and accepted by patients, caregivers, and clinicians. We also aim to determine the effect of Ned on health-related quality of life, satisfaction with cancer care, unmet needs, self-efficacy, and prostate cancer-related levels of anxiety. Methods: The Ned case study is a 12-month mixed-methods embedded single-case study with a nested within-group pre-post comparison of health outcomes. We will give 400 patients, 200 caregivers, and 10 clinicians access to Ned. Participants will be asked to complete study assessments at baseline, 2 months, 6 months, and 12 months. We will conduct 30 semistructured qualitative interviews with patients (n=20) and their caregivers (n=10) poststudy to gain insight into their experience with the app. Results: We recruited our first survivor in October 2017 and anticipate completing this study by May 2019. Conclusions: This will, to our knowledge, be the first realist case study to evaluate an app for prostate cancer survivorship care. Prostate cancer survivors are set to increase in number and longevity, heightening the need for integrated survivorship solutions to provide them with optimal and durable outcomes. The knowledge gained from this study will comprehensively inform how and why Ned works, for whom, and in what circumstances. Understanding the impact of digital health interventions such as Ned on how survivors care for themselves is critical to realizing patient-centered care.

  • Source: The Authors / Placeit.net; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/10/e196/; License: Creative Commons Attribution (CC-BY).

    Knowledge Management Framework for Emerging Infectious Diseases Preparedness and Response: Design and Development of Public Health Document Ontology

    Abstract:

    Background: There are increasing concerns about our preparedness and timely coordinated response across the globe to cope with emerging infectious diseases (EIDs). This poses practical challenges that require exploiting novel knowledge management approaches effectively. Objective: This work aims to develop an ontology-driven knowledge management framework that addresses the existing challenges in sharing and reusing public health knowledge. Methods: We propose a systems engineering-inspired ontology-driven knowledge management approach. It decomposes public health knowledge into concepts and relations and organizes the elements of knowledge based on the teleological functions. Both knowledge and semantic rules are stored in an ontology and retrieved to answer queries regarding EID preparedness and response. Results: A hybrid concept extraction was implemented in this work. The quality of the ontology was evaluated using the formal evaluation method Ontology Quality Evaluation Framework. Conclusions: Our approach is a potentially effective methodology for managing public health knowledge. Accuracy and comprehensiveness of the ontology can be improved as more knowledge is stored. In the future, a survey will be conducted to collect queries from public health practitioners. The reasoning capacity of the ontology will be evaluated using the queries and hypothetical outbreaks. We suggest the importance of developing a knowledge sharing standard like the Gene Ontology for the public health domain.

  • Source: Shutterstock; Copyright: Sebastian Kaulitzki; URL: https://www.shutterstock.com/image-illustration/lung-cancer-41587516?irgwc=1&utm_medium=Affiliate&utm_campaign=TinEye&utm_source=77643&utm_term=; License: Licensed by JMIR.

    Real-World Treatment Sequences and Outcomes Among Patients With Non-Small Cell Lung Cancer (RESOUNDS) in the United States: Study Protocol

    Abstract:

    Background: Survival outcomes are related to treatment choices in a line of therapy and to treatment sequences across all lines of therapy. Objective: The Real-World Treatment Sequences and Outcomes among Patients with NSCLC (RESOUNDS) study is designed to (1) evaluate treatment sequences used for patients who receive at least two lines of therapy for non-small cell lung cancer (NSCLC) in the United States and (2) evaluate patient outcomes in terms of progression-free and overall survival related to treatment sequencing. Additional objectives include the evaluation of symptoms, comorbidities, and health care resource utilization and costs. Methods: Patients will be censored at loss to follow-up due to leaving the health plan or reaching the end of the study period. Results: This study is ongoing. Conclusions: The RESOUNDS cohort study is a novel approach to building a comprehensive dataset that mimics a prospective observational study using linked patient-level data from four real-world data sources. This study will provide timely information on the sequencing of treatments for patients with NSCLC.

  • Source: Shutterstock; Copyright: iVectorStock; URL: https://www.shutterstock.com/image-vector/arterial-blood-pressure-checking-concept-466434533?src=WntUcedBnN3As3IlG7PDiQ-1-2; License: Licensed by the authors.

    Utilizing Consumer Health Informatics to Support Management of Hypertension by Clinical Pharmacists in Primary Care: Study Protocol

    Abstract:

    Background: Hypertension (HTN) is a major public health concern in the United States given its wide prevalence, high cost, and poor rates of control. Multiple strategies to counter this growing epidemic have been studied, and home blood pressure (BP) monitoring, mobile health (mHealth) interventions, and referrals to clinical pharmacists for BP management have all shown potential to be effective intervention strategies. Objective: The purpose of this study is to establish feasibility and acceptability of BPTrack, a clinical pharmacist-led mHealth intervention that aims to improve BP control by supporting home BP monitoring and medication adherence among patients with uncontrolled HTN. BPTrack is an intervention that makes home-monitored BP data available to clinical pharmacists for use in HTN management. Secondarily, this study seeks to understand barriers to adoption of this intervention, as well as points of improvement among key stakeholders, so that larger scale dissemination of the intervention may be achieved and more rigorous research can be conducted. Methods: This study is recruiting up to 25 individuals who have poorly controlled HTN from a Family Medicine clinic affiliated with a large Midwestern academic medical center. Patient participants complete a baseline visit, including installation and instructions on how to use BPTrack. Patient participants are then asked to follow the BP monitoring protocol for a period of 12 weeks, and subsequently complete a follow-up visit at the conclusion of the study period. Results: The recruitment period for the pilot study began in November 2016, and data collection is expected to conclude in late-2017. Conclusions: This pilot study seeks to document the feasibility and acceptability of a clinical pharmacist-led mHealth approach to managing HTN within a primary care setting. Through our 12-week pilot study, we expect to lend support for this approach, and lay the foundation for translating this approach into wider-scale implementation. This mHealth intervention seeks to leverage the multidisciplinary care team already in place within primary care, and to improve health outcomes for patients with uncontrolled HTN. Trial Registration: Clinicaltrials.gov NCT02898584; https://clinicaltrials.gov/ct2/show/NCT02898584 (Archived by WebCite® at http://www.webcitation.org/6u3wTGbe6)

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/10/e150/; License: Creative Commons Attribution (CC-BY).

    Uterine Fundectomy in Patients With Benign Etiology Undergoing Hysterectomy: New Surgical Technique

    Abstract:

    Background: Hysterectomy is the most common surgical procedure in gynecology, not only in cases of malignancies but also in many benign cases. Many uterine preservation techniques have been introduced as alternatives to hysterectomy. Objective: We aimed to propose a new uterine surgical procedure. In this paper, we compare the utility of this new technique to the limitations of current procedures. Methods: Uterine fundectomy may be considered as a subtotal hysterectomy. In this new technique, the uterine fundus including all pathologic tissue is cut as a reverse trapezoid by monopolar cautery. The upper side of the trapezoid, which includes the whole uterine fundus, is removed, but the fallopian tubes and cornual segment are preserved. A small uterine cavity remains, as well as the endometrial tissue lining it. Results: Patient recruitment for this study began in April 2017 and is expected to end approximately 12 months later. Assessment of the primary outcomes is expected to take place in April 2018. Conclusions: Uterine preservation is particularly critical in developing new surgical approaches that can lead to a positive impact on patient satisfaction. This protocol outlines the first attempt to prospectively test surgical fundectomy in candidates for hysterectomy for benign indications.

  • Graphic from the e-learning module and study logo. Source: Image created by the authors; Copyright: The Capital Region of Denmark, HR Development, and Jakob Louis Demant Thomsen; URL: http://jmir.org; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    Improving Neuromuscular Monitoring and Reducing Residual Neuromuscular Blockade With E-Learning: Protocol for the Multicenter Interrupted Time Series INVERT...

    Abstract:

    Background: Muscle relaxants facilitate endotracheal intubation under general anesthesia and improve surgical conditions. Residual neuromuscular blockade occurs when the patient is still partially paralyzed when awakened after surgery. The condition is associated with subjective discomfort and an increased risk of respiratory complications. Use of an objective neuromuscular monitoring device may prevent residual block. Despite this, many anesthetists refrain from using the device. Efforts to increase the use of objective monitoring are time consuming and require the presence of expert personnel. A neuromuscular monitoring e-learning module might support consistent use of neuromuscular monitoring devices. Objective: The aim of the study is to assess the effect of a neuromuscular monitoring e-learning module on anesthesia staff’s use of objective neuromuscular monitoring and the incidence of residual neuromuscular blockade in surgical patients at 6 Danish teaching hospitals. Methods: In this interrupted time series study, we are collecting data repeatedly, in consecutive 3-week periods, before and after the intervention, and we will analyze the effect using segmented regression analysis. Anesthesia departments in the Zealand Region of Denmark are included, and data from all patients receiving a muscle relaxant are collected from the anesthesia information management system MetaVision. We will assess the effect of the module on all levels of potential effect: staff’s knowledge and skills, patient care practice, and patient outcomes. The primary outcome is use of neuromuscular monitoring in patients according to the type of muscle relaxant received. Secondary outcomes include last recorded train-of-four value, administration of reversal agents, and time to discharge from the postanesthesia care unit as well as a multiple-choice test to assess knowledge. The e-learning module was developed based on a needs assessment process, including focus group interviews, surveys, and expert opinions. Results: The e-learning module was implemented in 6 anesthesia departments on 21 November 2016. Currently, we are collecting postintervention data. The final dataset will include data from more than 10,000 anesthesia procedures. We expect to publish the results in late 2017 or early 2018. Conclusions: With a dataset consisting of thousands of general anesthesia procedures, the INVERT study will assess whether an e-learning module can increase anesthetists’ use of neuromuscular monitoring. Trial Registration: Clinicaltrials.gov NCT02925143; https://clinicaltrials.gov/ct2/show/NCT02925143 (Archived by WebCite® at http://www.webcitation.org/6s50iTV2x)

  • Source: Pixabay; Copyright: Tracy Lundgren; URL: https://pixabay.com/en/beetroot-food-diet-vegetable-687251/; License: Public Domain (CC0).

    Combined Dietary Nitrate and Exercise Intervention in Peripheral Artery Disease: Protocol Rationale and Design

    Abstract:

    Background: Peripheral artery disease (PAD) is caused by atherosclerotic occlusions in the legs. It affects approximately 8-12 million people in the United States alone, one-third of whom suffer from intermittent claudication (IC), defined as ischemic leg pain that occurs with walking and improves with rest. Patients with IC suffer a markedly impaired quality of life and a high perception of disability. Improving pain-free walking time is a primary goal of rehabilitation in this population. Objective: The nitric oxide (NO)-PAD trial is designed to compare the effects that 12 weeks of supervised exercise training, in combination with a high inorganic nitrate-content (beetroot [BR] juice) beverage or placebo (PL) beverage, has on clinical outcomes of exercise and functional capacity in two groups of PAD+IC patients: exercise training plus beetroot (EX+BR) and exercise training plus placebo (EX+PL). The primary aims of this randomized controlled, double-blind pilot study are to determine group differences following 12 weeks of EX+BR versus EX+PL in the changes for (1) exercise capacity: pain-free walking time (claudication onset time, COT), peak walk time (PWT), and maximal exercise capacity (peak oxygen uptake, VO2peak) during a maximal-graded cardiopulmonary exercise test (max CPX) and (2) functional capacity: 6-minute walk (6MW) distance. The secondary aims will provide mechanistic insights into the exercise outcome measures and will include (1) gastrocnemius muscle oxygenation during exercise via near-infrared spectroscopy (NIRS); (2) gastrocnemius muscle angiogenesis: capillaries per unit area and per muscle fiber, and relative fraction of type I, IIa, IIb, and IId/x fibers; and (3) vascular health/function via brachial artery flow-mediated dilation, lower-limb blood flow via plethysmography, and pulse wave velocity and reflection. Methods: A total of 30 subjects between 40 and 80 years of age with PAD who are limited by IC will undergo exercise training 3 days per week for 12 weeks (ie, 36 sessions). They will be randomized to either the EX+BR or EX+PL group where participants will consume a beverage high in inorganic nitrate (4.2 mmol) or a low-nitrate placebo, respectively, 3 hours prior to each training session. Results: Data collection from this study has been completed and is in the process of analysis and write-up. While the study is too underpowered—EX+BR, n=11; EX+PL, n=13—to determine between-group differences in the primary outcomes of COT, PWT, and 6MW, preliminary observations are promising with Cohen d effect sizes of medium to large. Conclusions: Exercise training is currently the most effective therapy to increase functional capacity in PAD+IC. If the addition of inorganic nitrate to an exercise regimen elicits greater benefits, it may redefine the current standard of care for PAD+IC. Trial Registration: ClinicalTrials.gov NCT01684930; https://clinicaltrials.gov/ct2/show/NCT01684930 (Archived by WebCite at http://www.webcitation.org/6raXFyEcP)

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  • Individually-Tailored, Adaptive Intervention to Manage Gestational Weight Gain: Protocol for a Randomized Controlled Trial in Women with Overweight and Obesity

    Date Submitted: Oct 19, 2017

    Open Peer Review Period: Oct 20, 2017 - Nov 3, 2017

    Background: High gestational weight gain (GWG) is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in e...

    Background: High gestational weight gain (GWG) is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in effectively managing GWG, especially among pregnant women with overweight and obesity. Well-designed interventions are needed that take an individualized approach and target unique barriers to promote healthy weight gain. Objective: The primary aim of this publication is to describe the study protocol for Healthy Mom Zone, an individually-tailored, adaptive intervention for managing weight in pregnant women with overweight and obesity (OW/OB). Methods: We will explain the conceptual framework, theoretical components, intervention dosages, decision rules for how and when to adapt the intervention, intensive longitudinal data collection procedures, and methods for establishing initial validation of the intervention. Results: Recruitment of 31 pregnant women with OW/OB has occurred from January 2016 through July 2017. Baseline data has been collected on all participants. To date, 21 participants have completed the intervention and post-intervention follow-up assessments, 6 are currently in progress, 1 dropped-out, and 3 women had early miscarriages and are no longer active in the study. The majority of participants have received at least one adaptation to the intervention (e.g., baseline + step-up 1). Data analysis is still ongoing through Spring, 2018. Conclusions: This is one of the first intervention studies to use an individually-tailored, adaptive design to manage weight gain in pregnancy. Results from this study will be useful in designing a larger randomized trial to examine efficacy of this intervention.

  • Patient and Provider Engagement and Empowerment through Technology (P2E2T2) to Improve Health in Diabetes: A Randomized Controlled Trial Protocol Using mHealth Technology and Nurse Health Coaching

    Date Submitted: Oct 16, 2017

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

    Background: Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological tr...

    Background: Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological treatment, yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes. Objective: The objective of this clinical trial is to evaluate the impact of a mobile health enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus. Methods: A randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the Electronic Health Record to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at three and nine months. Primary and secondary outcomes include diabetes self-efficacy, HgbA1C, and quality of life measures. Results: Data collection for this trial, funded by the Patient-Centered Outcomes Research Institute, will be completed by December 2017. Results from the trial will be available mid-2018. Conclusions: This protocol details a patient-centered intervention using nurse health coaching, mobile health technologies, and integration of patient-generated data into the electronic health record. The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity, by offering coaching support to set reasonable and attainable health goals, and by creating a complete feedback loop by bringing patient generated data into the electronic health record. Clinical Trial: ClinicalTrials.gov NCT 02672176

  • An integrated approach to fight parasitic worm infections and diarrhoea: a cluster randomised trial study protocol

    Date Submitted: Oct 12, 2017

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

    Background: The global strategy to control helminthiases emphasises preventive chemotherapy. However, in the absence of access to clean water, improved sanitation and adequate hygiene, re-infection af...

    Background: The global strategy to control helminthiases emphasises preventive chemotherapy. However, in the absence of access to clean water, improved sanitation and adequate hygiene, re-infection after treatment can occur rapidly. Hence, integrated approaches are necessary to sustain preventive chemotherapy and make progress towards interruption of helminthiases transmission. Objective: The aim of the current study is to assess and quantify the effect of an integrated control package that consists of preventive chemotherapy, community-led total sanitation (CLTS) and health education, on soil-transmitted helminthiasis, schistosomiasis, intestinal protozoa infection and diarrhoea in rural Côte d’Ivoire. Methods: In a first step, a community health education programme will be developed that includes an animated cartoon for hygiene and health targeting school-aged children, coupled with a community health education theatre for the entire community. In a second step, a cluster randomised trial will be implemented in 56 communities of south-central Côte d’Ivoire with four intervention arms: (i) preventive chemotherapy; (ii) preventive chemotherapy plus CLTS; (iii) preventive chemotherapy plus health education; and (iv) all three interventions combined. In a third step, a baseline parasitological, anthropometric and hygiene-related knowledge, attitudes, practices and beliefs (KAPB) survey will be conducted. These surveys will be repeated 18 and 39 months after the baseline cross-sectional survey to determine the effect of different interventions on helminth and intestinal protozoa infection, nutritional indicators and KAPB. Monitoring of diarrhoea will be done over a 24-month period at 2-week intervals, starting right after the baseline survey. Results: This study will allow determining the effect of an integrated, community-based approach on infection patterns of intestinal parasites and diarrhoeal incidence, anthropometric measures and hygiene-related KAPB. Conclusions: The acceptability of an integrated control package in the community will be evaluated, including strengths and limitations. Clinical Trial: ISRCTN53102033 (assigned: 26 March 2014).

  • Type 1 Doing Well: Randomized Pilot Study Protocol for a Strengths-Based Behavioral Intervention for Parents of Adolescents with Type 1 Diabetes Using an mHealth App

    Date Submitted: Oct 13, 2017

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

    Background: Supportive parent involvement for adolescents’ type 1 diabetes self-management promotes optimal diabetes outcomes. However, family conflict is common and can interfere with collaborative...

    Background: Supportive parent involvement for adolescents’ type 1 diabetes self-management promotes optimal diabetes outcomes. However, family conflict is common and can interfere with collaborative family teamwork. Few interventions have used explicitly strengths-based approaches to help reinforce desired management behaviors and promote positive family interactions around diabetes care. Objective: This protocol describes the development of a new, strengths-based behavioral intervention for parents of adolescents with type 1 diabetes delivered via mobile-friendly web app called Type 1 Doing Well. Methods: Ten adolescent-parent dyads and five diabetes care providers participated in a series of qualitative interviews to inform the design of the app. The 3-month pilot intervention will involve n=82 parents receiving daily prompts to use the app, in which they will mark the diabetes-related strength behaviors (i.e., positive attitudes or behaviors related to living with or managing type 1 diabetes) their teen engaged in that day. Parents will also receive training on how to observe diabetes strengths and how to offer teen-friendly praise via the app. Each week, the app will generate a summary of the teen’s most frequent strengths from the previous week based on parent reports, and parents will be encouraged to praise their teen either in person or from a library of reinforcing text messages. Results: The major outcomes of this pilot study will include intervention feasibility and satisfaction data. Clinical and behavioral outcomes will include glycemic control, regimen adherence, family relationships and conflict, diabetes burden, and health-related quality of life. Conclusions: This strengths-based, mHealth intervention aims to help parents increase their awareness of and efforts to support their adolescents’ engagement in positive diabetes-related behaviors. If efficacious, this intervention has the potential to reduce the risk of family conflict, enhance collaborative family teamwork, and ultimately improve diabetes outcomes. Clinical Trial: NCT02877680

  • Cultural and contextual adaptation of an eHealth intervention: Adaptation framework and protocol for Horyzons-Canada

    Date Submitted: Oct 12, 2017

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

    Background: eHealth interventions have the potential to address challenges related to access, service engagement, and continuity of care in the delivery of mental health services. However, the initial...

    Background: eHealth interventions have the potential to address challenges related to access, service engagement, and continuity of care in the delivery of mental health services. However, the initial development and evaluation of such interventions can require substantive amounts of financial and human resource investments to bring them to scale. Therefore, it may be warranted to increase policy, services, and research attention on eHealth platforms that have the potential to be adapted for use across settings. Yet, limited attention has been placed on the methods and processes for adapting eHealth interventions to improve their applicability across cultural, geographical, and contextual boundaries. Objective: In this paper, we describe an adaptation framework and protocol to adapt an eHealth intervention designed to promote recovery and prevent relapses in youth receiving specialized services for first-episode psychosis. The online platform, called Horyzons, was originally developed and tested in Australia and is being prepared for a wider evaluation in Canada. Methods: Service users and service providers from two specialized early intervention programs for first-episode psychosis located in different provinces will explore a beta-version of the eHealth intervention through focus group discussions and extended personal explorations to identify the need for, and content of contextual and cultural adaptations. An iterative consultation process will then take place with service providers and users to develop and assess platform adaptations in preparation for a pilot study with a live version of the platform. Results: Data collection has been completed August 2017 and analysis is in process. Conclusions: This protocol contributes to an important gap in the literature pertaining to the specific principles, methods and steps involved in conducting a systematic reflection and change process in scaling up the evaluation of eHealth interventions across a diverse range of healthcare settings. Clinical Trial: N/A

  • DIABEO-telemedicine versus usual follow-up in the treatment of diabetic patients poorly controlled with a basal-bolus insulin regimen: the TELESAGE randomized, open label trial

    Date Submitted: Oct 10, 2017

    Open Peer Review Period: Oct 13, 2017 - Oct 27, 2017

    Background: Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal....

    Background: Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a software application uploaded onto smartphones (with an Internet connection) for calculation of bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO is associated with a significant improvement of glycemic control in poorly controlled diabetes type 1 (DT1) patients, particularly when combined with physicians’ teleconsultations. Here, we present the protocol of a new study (TELESAGE) conducted in a larger population of poorly controlled diabetic patients. Methods: TELESAGE is a multicentre, double-randomized, open-label, three parallel-arms study, conducted in approximately 100 centers in France. The study compares a control group (arm 1: usual follow-up) versus two DIABEO-telemedicine systems: one with physician-telemedicine (arm 2) and the other with nursing tele-monitoring and teleconsultations by diabetologist’s task delegation (arm 3). A first randomization step will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE is to demonstrate the superiority of a 12-month follow-up by the DIABEO-telemedicine system versus usual follow-up, with respect to improvement of HbA1c levels in approximately 696 DT1 or DT2 patients poorly controlled by a basal-bolus insulin regimen. Here, we present the baseline the protocol of the TELESAGE study. Discussion: The TELESAGE study is expected to confirm the previous results of TELEDIAB 1 study in a larger sample of diabetic patients. It is also expected to evaluate a nurse tele-monitoring system. If this is the case, the DIABEO-telemedicine service will clearly demonstrate its utility to become an integral part of the ambulatory care of an intensive insulin regimen treated patient. The study was registered by the French ANSM (Agence Nationale de Sécurité du Médicament; National Agency for Drug Safety) under Trial ID number: 2012-A00072-41.

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