JMIR Publications

JMIR Research Protocols

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


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: Flickr; Copyright: Tunstall Telehealthcare; URL:; License: Creative Commons Attribution (CC-BY).

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


    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:; License: Creative Commons Attribution (CC-BY).

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

    Authors List:


    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: /; Copyright: JMIR Publications; URL:; 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...


    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 /; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

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


    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:; 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


    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:; License: Licensed by the authors.

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


    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: NCT02898584; (Archived by WebCite® at

  • Source: Image created by the Authors; Copyright: The Authors; URL:; License: Creative Commons Attribution (CC-BY).

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


    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:; 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...


    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: NCT02925143; (Archived by WebCite® at

  • Source: Pixabay; Copyright: Tracy Lundgren; URL:; License: Public Domain (CC0).

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


    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: NCT01684930; (Archived by WebCite at

  • Seren@ctif program. Source: The Authors; Copyright: Dominique Servant; URL:; License: Creative Commons Attribution (CC-BY).

    Efficacy of Seren@ctif, a Computer-Based Stress Management Program for Patients With Adjustment Disorder With Anxiety: Protocol for a Controlled Trial


    Background: Adjustment disorder with anxiety (ADA) is the most frequent and best characterized stress-related psychiatric disorder. The rationale for prescription of benzodiazepine monotherapy is a public health issue. Cognitive behavioral stress management programs have been studied in many countries. Several reports have shown beyond reasonable doubt their efficiency at reducing perceived stress and anxiety symptoms and improving patient quality of life. Considering the number of people who could benefit from such programs but are unable to access them, self-help programs have been offered. First presented as books, these programs became enriched with computer-based and digital supports. Regrettably, programs for stress management based on cognitive behavioral therapy (CBT), both face-to-face and digital support, have been only minimally evaluated in France. To our knowledge, the Seren@ctif program is the first French language self-help program for stress management using digital supports. Objective: The aim of this study is to assess the effectiveness of a 5-week standardized stress management program for reducing anxiety conducted via eLearning (iCBT) or through face-to-face interviews (CBT) with patients suffering from ADA compared with a wait list control group (WLC). These patients seek treatment in a psychiatric unit for anxiety disorders at a university hospital. The primary outcome is change in the State Trait Anxiety Inventory scale trait subscale (STAI-T) between baseline and 2-month visit. Methods: This is a multicenter, prospective, open label, randomized controlled study in 3 parallel groups with balanced randomization (1:1:1): computer-based stress management with minimal contact (not fully automated) (group 1), stress management with face-to-face interviews (group 2), and a WLC group that receives usual health care from a general practitioner (group 3). Programs are based on standard CBT principles and include 5 modules in 5 weekly sessions that include the following topics: stress and stress reaction and assessment; deep respiration and relaxation techniques; cognitive restructuring, mindfulness, and acceptance; behavioral skills as problem solving; and time management, healthy behaviors, and emotion regulation. In the Internet-based group, patients have minimal contact with a medical professional before and after every session. In the first session, a flash memory drive is supplied containing videos, audio files, a self-help book portfolio in the form of an eGuide, and log books providing the exercises to be completed between 2 sessions. The patient is encouraged to practice a 20-minute daily exercise 5 or 6 times per week. In the face-to-face group, patients receive the same program from a therapist with 5 weekly sessions without digital support. Interviews and self-assessments were collected face-to-face with the investigator. Results: The feasibility of this program is being tested, and results show good accessibility in terms of acceptance, understanding, and treatment credibility. Results are expected in 2018. Conclusions: To our knowledge, this is the first French study to examine the effectiveness of a computer-based stress management program for patients with ADA. The Seren@ctif program may be useful within the framework of a psychoeducative approach. It could also be advised for people suffering from other diseases related to stress and for people with a clinical level of perceived stress. Trial Registration: NCT02621775; (Archived by WebCite at

  • Source: Pixabay; Copyright: Anqa; URL:; License: Public Domain (CC0).

    Comparing the Effects of Oral Contraceptives Containing Levonorgestrel With Products Containing Antiandrogenic Progestins on Clinical, Hormonal, and...


    Background: Oral contraceptives (OCs) have been used as a first-line option for medical treatment in women with polycystic ovary syndrome (PCOS). Despite theoretical superiority of products containing antiandrogenic progestins compared to OCs containing levonorgestrel (LNG), the clinical advantage of these compounds remains unclear. Objective: The aim of this study was to compare the effects of OCs containing LNG with products containing antiandrogenic progestins including cyproterone acetate, drospirenone, and desogestrel on clinical, hormonal, and metabolic parameters and quality of life in women with PCOS. Methods: We conducted a 6-arm crossover randomized controlled trial with each arm including OCs containing LNG and one of those 3 OCs containing antiandrogenic progestins. The anthropometric and clinical manifestations and hormonal and biochemical parameters of participants were assessed at 6 time points including baseline, after washout period, and 3 and 6 months after intervention. Results: The study is ongoing and follow-up of recruited women will continue until 2018. Conclusions: This study will provide scientific evidence on comparability of OCs with the various progesterones that will assist in decision making taking into account cost effectiveness. Trial Registration: Iranian Registry of Clinical Trials IRCT201702071281N2; keyword=&id=1281&number=2&prt=12869&total=10&m=1 (Archived by WebCite at

  • Source: Unsplash; Copyright: Jiří Wagner; URL:; License: Licensed by the authors.

    Influence of Information and Communication Technologies on the Resilience and Coping of Sexual and Gender Minority Youth in the United States and Canada...


    Background: Sexual and gender minority youth are a population in peril, exemplified by their disproportionate risk of negative experiences and outcomes. Sexual and gender minority youth may be particularly active users of information and communication technologies (ICTs), and it is important to identify the potential contributions of ICTs to their resilience and well-being. Objective: Our aim was to (1) investigate the use of ICTs by sexual and gender minority youth, (2) identify the ways that ICTs influence the resilience and coping of sexual and gender minority youth, focusing on promotion of well-being through self-guided support-seeking (particularly using mobile devices), (3) develop a contextually relevant theoretical conceptualization of resilience incorporating minority stress and ecological approaches, (4) generate best practices and materials that are accessible to multiple interested groups, and (5) identify whether video narratives are a viable alternative to collect qualitative responses in Web-based surveys for youth. Methods: Mixed methods, cross-sectional data (N=6309) were collected via a Web-based survey from across the United States and Canada from March-July 2016. The sample was generated using a multipronged, targeted recruitment approach using Web-based strategies and consists of self-identified English-speaking sexual and gender minority youth aged 14-29 with technological literacy sufficient to complete the Web-based survey. The survey was divided into eight sections: (1) essential demographics, (2) ICT usage, (3) health and mental health, (4) coping and resilience, (5) sexual and gender minority youth identities and engagement, (6) fandom communities, (7) nonessential demographics, and (8) a video submission (optional, n=108). The option of a 3-5 minute video submission represents a new research innovation in Web-based survey research. Results: Data collection is complete (N=6309), and analyses are ongoing. Proposed analyses include (1) structural equation modeling of quantitative data, (2) grounded theory analysis of qualitative data, and (3) an integrative, mixed methods analysis using a data transformation design. Theoretical and methodological triangulation of analyses integrates an interwoven pattern of results into a comprehensive picture of a phenomenon. Results will be reported in 2017 and 2018. Conclusions: This research study will provide critical insights into the emerging use of ICTs by sexual and gender minority youth and identify intervention strategies to improve their well-being and reduce risks encountered by this vulnerable population. Implications for practice, research, and knowledge translation are provided.

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  • 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.

  • Evaluating the CARE4Carer blended care intervention for partners of patients with acquired brain injury: protocol for a randomized controlled trial

    Date Submitted: Oct 8, 2017

    Open Peer Review Period: Oct 9, 2017 - Oct 23, 2017

    Background: Support programs for partners of patients with acquired brain injury are necessary, since these partners experience several unfavorable consequences of caregiving, such as a high burden, e...

    Background: Support programs for partners of patients with acquired brain injury are necessary, since these partners experience several unfavorable consequences of caregiving, such as a high burden, emotional distress, and poor quality of life. Evidence-based support strategies that can be included in these support programs are psycho-education, skill building, problem solving and improving feelings of mastery. A promising approach would seem to be to combine web-based support with face-to-face consultations, creating a blended care intervention. Objective: This paper outlines the protocol of a randomized controlled trial to evaluate the CARE4Carer blended care intervention for partners of patients with acquired brain injury. Methods: A multicenter two-arm randomized controlled trial will be conducted. A total of 120 partners of patients with acquired brain injury will be recruited from five rehabilitation centers in the Netherlands. The blended care intervention consists of a nine-session web-based support program and two face-to-face consultations with a social worker. Themes that will be addressed are: giving partners insight into their own situation, including possible pitfalls and strengths, learning how to cope with the situation, getting a grip on thoughts and feelings, finding a better balance in the care for the patient with acquired brain injury, thinking about other possible care options, taking care of oneself, and communication. The intervention lasts 20 weeks and the control group will receive usual care. The outcome measures will be assessed at baseline and at 24- and 40-week follow-up. The primary outcome is caregiver mastery. Secondary outcome measures are strain, burden, family functioning, emotional functioning, coping, quality of life, participation, and social network. Results: The effect of the intervention on the primary and secondary outcome measures will be determined. Additional economic and process evaluations will be conducted. Conclusions: The findings of this study will be used to improve the care for partners of patients with acquired brain injury. Barriers and facilitators that emerge from the process evaluation will be used in the nationwide implementation of the intervention. Clinical Trial: Dutch Trial Register NTR6197,

  • Influence of radiofrequency electromagnetic waves on fertility system: A protocol of systematic review and meta-analyses

    Date Submitted: Oct 3, 2017

    Open Peer Review Period: Oct 9, 2017 - Oct 23, 2017

    Background: Concerns about the potential impact of mobile health are growing, which has increased the user of the mobile phone, tablet, etc. over the past few years. Cell phones, wireless telephones,...

    Background: Concerns about the potential impact of mobile health are growing, which has increased the user of the mobile phone, tablet, etc. over the past few years. Cell phones, wireless telephones, mobile base stations and power lines are one of the main sources of our daily exposure to radiofrequency electromagnetic radiation (RF-EMR). There are more than 2 billion mobile phones in use worldwide (1-3). Exposure to RF energy depends on the frequency of the mobile phone used. The most common frequency of used phones is 1900-900 MHz in the United States, while in many parts of the world these phones work at frequencies from 1800 to 850 MHz. The higher frequency has the higher energy. Radial energy is absorbed by the three main mechanisms in the human body: (i) aueral effect: The body receives and absorbs the RF signal depending on the size of the body part and the signal wavelength; (ii) RF signal binding with tissue; and (iii) absorption intensification (4,5). The effects of electromagnetic radiation can be divided into two main categories - thermal properties and non-thermal properties. The thermal properties caused by the increase in temperature due to the energy absorption of oscillating electric fields. This can lead to heat in the exposed parts of the body. Thermal effects are calculated in terms of SAR (specific absorption rate) calculation. This SAR depends largely on the antenna, location, and frequency settings (6). Some studies showed that human exposure to radiofrequency waves can cause cognitive, behavioral impairments and decreased learning and memory. Also, induce significant thermal effects may be associated with adverse health effects such as sleep problems, impairment of the nervous system, health problems, and increased cancer risk, hearing and reproductive (7,8). Infertility is an inability to get pregnant after one year of intercourse without the use of contraceptive methods and affecting 15% of couples. 30-50% of the infertility causes related to male infertility, as well as 40 to 30% of the male infertility causes referred to sperm disorders (9). The influence of mobile exposure on man fertility have been studied in recent years. [10] In normal physiological conditions, spermatogenesis is a balanced process of maturation, cell division, and storage, which is particularly susceptible to environmental stimuli and chemical. However, its mechanism is unclear but they guess that particularly sensitive could be Cytoskeleton, consist of charged proteins: middle actions, and microtubules. The cytoskeleton is structural and functional part of the cell that plays a main role in motility of the sperm and is actively participates the morphological alterations that happen during mammalian sperm genesis (10-11). A study of EMFs effects on female rats using a transmission electron microscopy (TEM), representing an increase existence of numerous drops of lipid in patches and luteal cells also increase in the number of autophilia vaccines and macrophages in some granulosic cells (12). Other researchers showed that EMFs increase macrophages in the range of lutea corpora and growing follicles. They believe that EMFs increase apoptosis in mice ovaries. In addition, most researchers believe that EMF damage stromal cells in the uterine and uterine tubes through apoptosis to the glandular epithelium, ovarian cortex, luminal epithelium (13, 14). Now it is necessary to explore the safety criteria for these radiations in the direction toward future research. The physical phenomena of electronic devices that exposed RF are very close to the body. Therefore, it could be used RF shielding in electronic devices that can block RF-EMF waves, various time scales for a fixed minute with intermittent and increasing distance from them. Systematic review papers are a type of review that analyzes the findings of other studies and provide the best evidence for decision about health approach (15). yildirim et al(2015) in assessing the potential harmful effects of RF on sperm parameters, we found that there is no significant difference between sperm counts and sperm morphology excluding sperm motility, due to mobile phone usage period(16). Due to conflicting results and since no systematic review performed the effects of RF-EMF exposed from other electronic devices on fertility system in recent year, the evidence base study is necessary. Objective: The main objectives of this study are to clarify the best evidence associated with the influence of radiofrequency electromagnetic field on the male and female reproductive system and considered any common observations that could provide insights on a potential mechanism. The other objective of this study is determining the effect of a radiofrequency electromagnetic field on primary or secondary infertility. Methods: Inclusion criteria Types of participants -Couples who were infertile (inability to get pregnant after one year of intercourse without the use of contraceptive methods) -Infertile male and women 18–65-year-old who used the radio-frequency electromagnetic device for various exposure times -infertile couples did not have any underlying disease - Hormonal assessment, diagnostic imaging techniques, biopsy, spermatograms were used to assess the reproductive system. - No limitation in frequency‏ and duration use of device Type of intervention This systematic review will include only human studies that participants used any device that exposed radiofrequency electromagnetic waves for any frequency and duration. No restriction has in exposure condition, type of signal device, distance and exposure time. Comparator All studies with or without the control group will be included in this study. Outcomes This current systematic review will consider papers that include change rate in reproductive system parameters after the use of radio-frequency electromagnetic devices (Sperm and endocrine parameter, testis, and ovary function) as primary outcomes. The secondary outcomes will be primary or secondary infertility. The outcomes measurement will be assessed by hormonal assessment, diagnostic imaging techniques, biopsy, and spermatograms. Types of studies Any observational study designs will be included. Case reports and case series, review, and letter to the editor article will not be included. Articles with incomplete data were excluded from the study. We will try to contact the authors by email whose studies related but not accessible. Search strategy In this systematic review, the databases and gray literatures will be searched with no language and date limitation. The following databases were " Cochrane Library (Wiley), MEDLINE (Ovid), Pub Med, EMBASE, CINAHL (EBSCO), ProQuest, Scopus, Science Direct, Google Scholar "and Persian databases. Also, the reference lists of articles and reports will be checked. The gray literatures will be included the International Clinical Trials Registry Platform, Dissertations, Thesis Global, and Thesis. The combination of the mesh terms "radiofrequency electromagnetic", and "male reproductive system" or "female reproductive system" will be used for searching. To ensure the inclusion of all the related articles, search will be sensitive. The title and abstract of the articles would be evaluated ; any disagreement will be resolved through the discussion between authors. The full-text of articles will be assessed to the objectives of this systematic review. Quality assessment Papers selected for retrieval will be evaluated by two independent referees for methodological validation before entering the review using the standard evaluation tool "OTTAWA" for cohort studies and non-randomized controlled trials. (17). Any differences which rises between reviewers, will be resolved through conversation or with a third reviewer. Data extraction The data from the articles extracted in this study using the standard data extraction tool that is accessible in JBI-SUMARI by two independent reviewers. The data extracted will comprise specific details about the populations, interventions, study methods and results are important to the question of review and particular goals. Any differences that arise will be resolved through discussion or with a third reviewer. Authors of papers will be contacted to request missing or additional data where required. We will try to contact the corresponding authors of studies by email if it is necessary to obtain data missing from published articles. Data synthesis By using STATA V.12 software, analyses will be conducted. Heterogeneity will be evaluated by the I2 statistic, and χ2 test (recommended by the Cochrane Handbook for Systematic Reviews of Interventions). We will explain the I2 statistic using the guide. When substantial heterogeneity (I2>50%) is evident among the articles, the results of this study will be presented in the text qualitatively. The author's decision to use the random-effects model will be based on understanding of whether not all included trials share a common effect size, They are not only on results of tests but also on statistical heterogeneity. All results of this paper will be given to two inputs. For classified data the effect sizes are calculated as OR and for continuous data the weighted average difference and their 95% CI for analysis. By using the standard x2 Non-correlation will be evaluated. If statistical data of studies do not collect, the results of this article will be presented in the appropriate tables and figures. By using a funnel plot, Begg's, and Egger's tests publication bias will be explored. If it is possible, this systematic review will be performed subgroup meta-analysis based on the type of device and exposure time disagreement. Results: This is a protocol for a systematic review, and the result is not presented. The results of this study will be submitted to a peer-reviewed journal for publication and also presented at PROSPERO (International prospective register of systematic reviews), which the number of PROSPERO is CRD42017072462. Conclusions: The purpose of systematic review is to present the comprehensive summary of related article to a study question and it can be the best answer to the controversy between studies (18). This systematic review will provide the evidence base data about the effect of radiofrequency electromagnetic waves on fertility system changes. This article will also classify the harmful effect of RF waves on primary and secondary infertility. Due to the growth of infertility rate among people, negative outcomes of this problem for couple, and heath care system, the results of this study can be useful for decrease the infertility rate (19).