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 2015: 4.532)

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:

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    The SmokefreeTXT (SFTXT) Study: Web and Mobile Data Collection to Evaluate Smoking Cessation for Young Adults


    Background: Text messaging (short message service, SMS) has been shown to be effective in delivering interventions for various diseases and health conditions, including smoking cessation. While there are many published studies regarding smoking cessation text messaging interventions, most do not provide details about the study’s operational methods. As a result, there is a gap in our understanding of how best to design studies of smoking cessation text messaging programs. Objective: The purpose of this paper is to detail the operational methods used to conduct a randomized trial comparing three different versions of the National Cancer Institute’s SmokefreeText (SFTXT) program, designed for smokers 18 to 29 years of age. We detail our methods for recruiting participants from the Internet, reducing fraud, conducting online data collection, and retaining panel study participants. Methods: Participants were recruited through website advertisements and market research online panels. Screening questions established eligibility for the study (eg, 18 to 29 years of age, current smoker). Antifraud measures screened out participants who could not meet the study requirements. After completing a baseline survey, participants were randomized to one of three study arms, which varied by type and timing of text message delivery. The study offered US $20 gift cards as incentives to complete each of four follow-up surveys. Automated email reminders were sent at designated intervals to increase response rates. Researchers also provided telephone reminders to those who had not completed the survey after multiple email reminders. We calculated participation rates across study arms and compared the final sample characteristics to the Current Population Survey to examine generalizability. Results: Recruitment methods drove 153,936 unique visitors to the SFTXT Study landing page and 27,360 began the screener. Based on the screening questions, 15,462 out of 27,360 responders (56.51%) were eligible to participate. Of the 15,462 who were eligible, 9486 passed the antifraud measures that were implemented; however, 3882 failed to verify their email addresses or cell phone numbers, leaving 5604 who were invited to complete the baseline survey. Of the 5604 who were invited, 4432 completed the baseline survey, but only 4027 were retained for analysis because 405 did not receive the intervention. Conclusions: Although antifraud measures helped to catch participants who failed study requirements and could have biased the data collected, it is possible that the email and cell phone verification check excluded some potentially eligible participants from the study. Future research should explore ways to implement verification methods without risking the loss of so many potential participants. ClinicalTrial: Clinical NCT01885052;; (Archived by WebCite at

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    Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol


    Background: Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Objective: Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. Methods: The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care–related infections were reviewed to develop the infection control protocol to support tablet maintenance. Results: This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. Conclusions: These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings.

  • picture of monitor and phone. Image sourced, modified and copyright owned by authors.

    Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial


    Background: Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving “optimal BP control” (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring—the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management. Objective: To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with “enhanced usual care” in community-dwelling seniors with diabetes and hypertension. Methods: A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors’ residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management. Results: Outcomes will be ascertained at 6 and 12 months. Within-study-arm change scores will be calculated and compared between study arms. These include: (1) clinical outcomes: proportion of subjects with a mean 24-hour ambulatory systolic BP in the optimal range (110-129 mmHg in patients 65-79 years and 110-139 mmHg in those ≥80 years: primary outcome); additional ambulatory and home BP outcomes; A1c and lipid profile; medications, cognition, health care use, cardiovascular events, and mortality. (2) Safety outcomes: number of serious episodes of hypotension, syncope, falls, and electrolyte disturbances (requiring third party assistance or medical attention). (3) Humanistic outcomes: quality of life, satisfaction, and medication adherence. (4) Economic outcomes: incremental costs, incremental cost-utility, and cost per mmHg change in BP of telemonitoring ± case management compared with usual care (health payor and societal perspectives). (5) Intervention usability and acceptability to patients and providers. Conclusion: The potential benefits of telemonitoring remain largely unstudied and unproven in seniors. This trial will comprehensively assess the impact of home BP telemonitoring across a range of outcomes. Results will inform the value of implementing home-based telemonitoring within supportive living residences in Canada. Trial Registration: NCT02721667; (Archived by Webcite at

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    Supporting Goal-Oriented Primary Health Care for Seniors with Complex Care Needs Using Mobile Technology: Evaluation and Implementation of the Health System...


    Background: Older adults experiencing multiple chronic illnesses are at high risk of hospitalization and health decline if they are unable to manage the significant challenges posed by their health conditions. Goal-oriented care approaches can provide better care for these complex patients, but clinicians find the process of ascertaining goals “too complex and too-time consuming,” and goals are often not agreed upon between complex patients and their providers. The electronic patient reported outcomes (ePRO) mobile app and portal offers an innovative approach to creating and monitoring goal-oriented patient-care plans to improve patient self-management and shared decision-making between patients and health care providers. The ePRO tool also supports proactive patient monitoring by the patient, caregiver(s), and health care provider. It was developed with and for older adults with complex care needs as a means to improve their quality of life. Objective: Our proposed project will evaluate the use, effectiveness, and value for money of the ePRO tool in a 12-month multicenter, randomized controlled trial in Ontario; targeting individuals 65 or over with two or more chronic conditions that require frequent health care visits to manage their health conditions. Methods: Intervention groups using the ePRO tool will be compared with control groups on measures of quality of life, patient experience, and cost-effectiveness. We will also evaluate the implementation of the tool. Results: The proposed project presented in this paper will be funded through the Canadian Institute for Health Research (CIHR) eHealth Innovation Partnerships Program (eHIPP) program (CIHR–348362). The expected completion date of the study is November, 2019. Conclusions: We anticipate our program of work will support improved quality of life and patient self-management, improved patient-centered primary care delivery, and will encourage the adoption of goal-oriented care approaches across primary health care systems. We have partnered with family health teams and quality improvement organizations in Ontario to ensure that our research is practical and that findings are shared widely. We will work with our established international network to develop an implementation framework to support continued adaptation and adoption across Canada and internationally.

  • Image Source: Cynthia Text Messaging Something Funny, copyright Kevin Stephenson,,
Licensed under Creative Commons Attribution cc-by 2.0

    A Cognitive Behavioral Therapy–Based Text Messaging Intervention Versus Medical Management for HIV-Infected Substance Users: Study Protocol for a Pilot...


    Background: Evidence-based psychosocial interventions for addictions and related conditions such as cognitive behavioral therapy (CBT) are underutilized. Obstacles to implementation of CBT in clinical settings include limited availability of quality training, supervision, and certification in CBT for clinicians; high rates of clinician turnover and high caseloads; and limited qualifications of the workforce to facilitate CBT expertise. Objective: Mobile phone–based delivery of CBT, if demonstrated to be feasible and effective, could be transformative in broadening its application and improving the quality of addiction treatment. No experimental interventions that deliver CBT targeting both drug use and medication adherence using text messaging have been previously reported; as such, the objective of this study is to develop and test an SMS-based treatment program for HIV-positive adults with comorbid substance use disorders. Methods: With user input, we developed a 12-week CBT-based text messaging intervention (TXT-CBT) targeting antiretroviral (ART) adherence, risk behaviors, and drug use in a population of HIV-infected substance users. Results: The intervention has been developed and is presently being tested in a pilot randomized clinical trial. Results will be reported later this year. Conclusions: This investigation will yield valuable knowledge about the utility of a cost-effective, readily deployable text messaging behavioral intervention for HIV-infected drug users.

  • Screen of the homepage, showing the nine modules of the online Reuma Uitgedaagd! (in Dutch). Source and copyright: the authors.

    Building a Tailored, Patient-Guided, Web-Based Self-Management Intervention ‘ReumaUitgedaagd!’ for Adults With a Rheumatic Disease: Results of a...


    Background: The chronic nature of rheumatic diseases imposes daily challenges upon those affected and causes patients to make daily decisions about the way they self-manage their illness. Although there is attention to self-management and evidence for the desirability of tailored interventions to support people with a rheumatic disease, interventions based on individual needs and preferences are scarce. Objective: To provide a systematic and comprehensive description of the theoretical considerations for building a Web-based, expert, patient-guided, and tailored intervention for adult patients with a rheumatic disease. Also, to present the results of a usability study on the feasibility of this intervention, and its study design in order to measure the effectiveness. Methods: To fit the intervention closely to the autonomy, needs, and preferences of the individual patient, a research team comprising patient representatives, health professionals, Web technicians, and communication experts was formed. The research team followed the new guidance by the Medical Research Council (MRC) for developing and evaluating complex interventions as a guide for the design of the intervention. Results: Considerations from self-determination theory and a comprehensive assessment of preferences and needs in patients with a rheumatic disease guided the development of the Web-based intervention. The usability study showed that the intervention was useful, easy to use, and accepted and appreciated by the target group of patients. The planned randomized controlled trial is designed to be conducted among 120 adults with a rheumatic disease, who are assigned to the self-management intervention or a self-help control group. Both groups will be asked to formulate personal goals they want to achieve concerning their self-management. Progress toward the personal goal is the primary outcome measure of this study. Self-reported Web-based measures will be assessed before randomization at baseline, and 3 and 6 months after randomization. Also, feasibility and adherence to the Web-based self-management intervention as process outcomes will be evaluated. Conclusion: By identifying the individual goals at the beginning of the intervention and customizing the intervention to the individual patient, we aim to improve the usefulness and effectiveness of the Web-based self-management intervention. If proven effective, ReumaUitgedaagd! Online will be implemented in the Netherlands.

  • Image Source: Mi Preciosa, copyright Tobias Lindman,,
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    A Mixed-Method Study to Determine the Benefits of Periconceptional Folic Acid Supplementation and Effects of Folic Acid Deficiency in Mothers on Birth Outcomes


    Background: Evidence from high income countries shows mothers who are supplemented with folic acid in their periconceptional period and early pregnancy have significantly reduced adverse outcomes like birth defects. However, in India there is a paucity of data on association of birth defects and folic acid supplementation. We identified a few important questions to be answered using separate scientific methods and then planned to triangulate the information. Objective: In this paper, we describe the protocol of our study that aims to determine the association of folic acid and pregnancy outcomes like neural tube defects (NTDs) and orofacial clefts (OFCs). We decided to fill the gaps in knowledge from India to determine public health consequences of folic acid deficiency and factors influencing dietary and periconceptional consumption of folic acid. Methods: The proposed study will be carried out in five stages and will examine the questions related to folic acid deficiency across selected locations in South and North India. The study will be carried out over a period of 4 years through the hierarchical evidence-based approach. At first a systematic review was conducted to pool the current birth prevalence of NTDs and orofacial clefts OFCs in India. To investigate the population prevalence, we plan to use the key informant method to determine prevalence of NTDs and OFCs. To determine the normal serum estimates of folic acid, iron, and vitamin B12 among Indian women (15-35 years), we will conduct a population-based, cross-sectional study. We will further strengthen the evidence of association between OFCs and folic acid by conducting a hospital-based, case-control study across three locations of India. Lastly, using qualitative methods we will understand community and health workers perspective on factors that decide the intake of folic acid supplements. Results: This study will provide evidence on the community prevalence of birth defects and prevalence folic acid and vitamin B12 deficiency in the community. The case-control study will help understand the association of folic acid deficiency with OFCs. Conclusions: The results from this study are intended to strengthen the evidence base in childhood disability for planning and policy initiatives.

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    Novel Use of Hydroxyurea in an African Region With Malaria: Protocol for a Randomized Controlled Clinical Trial


    Background: Sickle cell anemia (SCA), one of most prevalent monogenic diseases worldwide, is caused by a glutamic acid to valine substitution on the beta globin protein of hemoglobin, which leads to hemolytic anemia. Hydroxyurea, the only disease-modifying therapy approved by the Food and Drug Administration for SCA, has proven to be a viable therapeutic option for SCA patients in resource-rich settings, given clinical improvements experienced while taking the medication and its once-daily oral dosing. Significant studies have demonstrated its safety and clinical efficacy among children and adults in developed countries. In Sub-Saharan Africa, however, the risk of malaria, hematologic toxicities, and safety of hydroxyurea in children with SCA living in malaria-endemic areas are unknown. Objectives: Study objectives include determining the incidence of malaria in SCA patients taking hydroxyurea versus placebo; establishing the frequency of hematologic toxicities and adverse events (AEs) in children with SCA treated with hydroxyurea versus placebo; and defining the relationships between hydroxyurea treatment and fetal hemoglobin, soluble intracellular adhesion molecule-1, and nitric oxide levels, and between levels of these factors and risk of subsequent malaria. Methods: Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM, NCT01976416) is a prospective, randomized, placebo-controlled, double-blinded phase III trial to compare risk of malaria with oral hydroxyurea versus placebo. Children will be recruited from the Mulago Hospital Sickle Cell Clinic in Kampala, Uganda. Results: Two hundred Ugandan children aged between 1.00 and 3.99 years with confirmed SCA will be randomized into treatment groups by order of entry in the study, based on a predetermined blinded randomization list. The primary outcome of the trial is malaria incidence in the 2 study groups, defined as episodes of clinical malaria occurring over the 1-year randomized study treatment period. Conclusion: NOHARM will be the first prospective randomized, placebo-controlled clinical trial investigating the use of hydroxyurea for children with SCA in a malaria-endemic region within Africa. The results of this trial have the potential to significantly advance understanding of how to safely and effectively use hydroxyurea in children with SCA in malaria-endemic areas. Trial Registration: NCT01976416; (Archived by WebCite at

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Licensed under Creative Commons Attribution cc-by 2.0 Painting owned by author Marlou LA de Kroon.

    Prediction of Preadolescent Overweight and Poor Cardiometabolic Outcome in Children up to 6 Years of Age: Research Protocol


    Background: Dynamic risk estimations may enable targeting primary prevention of overweight and overweight-related adverse cardiometabolic outcome in later life, potentially serving as a valuable addition to universal primary prevention. This approach seems particularly promising in young children, as body mass index (BMI) changes at a young age are highly predictive of these outcomes, and parental lifestyle interventions at a young age are associated with improved long-term outcome. Objective: This paper describes the design of our study, which aims to develop digitized tools that can be implemented in the Dutch Child Health Care (CHC) system or by pediatricians for children up to 6 years of age. These tools will enable (1) dynamically predicting the development of overweight, hypertension or prehypertension, low high-density lipoprotein cholesterol (HDL-C) values, and high total cholesterol to HDL-C ratio by early adolescence and (2) identifying children who are likely to have poor cardiometabolic outcome by the age of 5-6 years and by the age of 10 years. Methods: Data will be obtained from the Generation R (n=7893) and Prevention and Incidence of Asthma and Mite Allergy (PIAMA; n=3963) cohorts, two Dutch prenatally recruited cohorts. We will select candidate predictors that can be assessed during the first visit and/or during subsequent visits to the CHC center or pediatrician, including sex; parental age, education level, and BMI; smoking exposure; ethnicity; birth weight; gestational age; breastfeeding versus formula feeding; and growth data through the age of 6 years. We will design dynamic prediction models that can be updated with new information obtained during subsequent CHC visits, allowing each measurement to be added to the model. Performance of the model will be assessed in terms of discrimination and calibration. Finally, the model will be validated both internally and externally using the combined cohort data and then converted into a computer-assisted tool called ProCOR (Prediction Of Child CardiOmetabolic Risk). Results: This is an ongoing research project financed by the Dutch government. The first results are expected in 2016. Conclusions: This study may contribute to the national implementation of digitized tools for assessing the risk of overweight and related cardiometabolic outcome in young children, enabling targeted primary prevention, ultimately yielding relevant health gains and improved resource allocation.

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    Working Time Arrangements as Potential Risk Factors for Ischemic Heart Disease Among Workers in Denmark: A Study Protocol


    Background: It has long been suspected that a worker’s risk of developing an ischemic heart disease (IHD) may be influenced by his or her working time arrangements. A multitude of studies have been performed, and special attention has been given to long working hours and nighttime work. The statistical powers of the individual studies have, however, generally been too low to either dismiss or confirm an actual relationship, and meta-analyses of underpowered studies are generally associated with publication bias. Hence, uncertainty remains and whether these factors indeed are related to IHD has yet to be settled. Objective: This project will test whether the incidences of IHD and usage of antihypertensive drugs among employees in Denmark are independent of weekly working hours and nighttime work. The objective of this paper is to present the intended analyses. Methods: We will link individual participant data from the Danish labor force survey, 1999–2013, to data on socioeconomic status, industry, emigrations, redeemed prescriptions, hospitalizations, and deaths from registers covering the entire population of Denmark. The study will include approximately 160,000 participants, who will be followed through the registers, from the time of the interview until the end of 2014, for first occurrence of IHD and for antihypertensive drug treatment. We will use Poisson regression to analyze incidence rates as a function of nighttime work and of weekly working hours. Results: We expect results to be ready in mid-2017. Conclusions: To our knowledge, this will be the largest study ever of its kind. It will, moreover, be free from hindsight bias, since the hypotheses, inclusion criteria, significance levels, and statistical models will be completely defined and published before we are allowed to link the exposure data to the outcome data.

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    Electronic Adherence Monitoring in a High-Utilizing Pediatric Asthma Cohort: A Feasibility Study


    Background: Inner-city, minority children with asthma have the highest rates of morbidity and death from asthma and the lowest rates of asthma controller medication adherence. Some recent electronic medication monitoring interventions demonstrated dramatic improvements in adherence in lower-risk populations. The feasibility and acceptability of such an intervention in the highest-risk children with asthma has not been studied. Objective: Our objective was to assess the feasibility and acceptability of a community health worker-delivered electronic adherence monitoring intervention among the highest utilizers of acute asthma care in an inner-city practice. Methods: This was a prospective cohort pilot study targeting children with the highest frequency of asthma-related emergency department and hospital care within a local managed care Medicaid plan. The 3-month intervention included motivational interviewing, electronic monitoring of controller and rescue inhaler use, and outreach by a community health worker for predefined medication alerts. We measured acceptability by using a modified technology acceptability model and changes in asthma control using the Asthma Control Test (ACT). Given prominent feasibility issues, we describe qualitative patterns of medication use at baseline only. Results: We enrolled 14 non-Hispanic black children with a median age of 3.5 years. Participants averaged 7.8 emergency or hospital visits in the year preceding enrollment. We observed three distinct patterns of baseline controller use: 4 patients demonstrated sustained use, 5 patients had periodic use, and 5 patients lapsed within 2 weeks. All participants initiated use of the electronic devices; however, no modem signal was transmitted for 5 or the 14 participants after a mean of 45 days. Of the 9 (64% of total) caregivers who completed the final study visit, all viewed the electronic monitoring device favorably and would recommend it to friends, and 5 (56%) believed that the device helped to improve asthma control. ACT scores improved by a mean of 2.7 points (P=.05) over the 3-month intervention. Conclusions: High-utilizer, minority families who completed a community health worker-delivered electronic adherence intervention found it generally acceptable. Prominent feasibility concerns, however, such as recruitment, data transmission failure, and lost devices, should be carefully considered when designing interventions in this setting.

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    A Web-Based Psychoeducational Intervention Program for Depression and Anxiety in an Adult Community in Selangor, Malaysia: Protocol of a Randomized...


    Background: Mental disorders are a major public health problem and are debilitating in many nations throughout the world. Many individuals either do not or are not able to access treatment. The Internet can be a medium to convey to the community accessible evidenced-based interventions to reduce these burdens. Objective: The objective of this study is to investigate the effectiveness of 4 weeks of a Web-based psychoeducational intervention program for depressive and anxiety symptoms in the community of Selangor, Malaysia. Methods: A two-arm randomized controlled trial of a single-blind study will be conducted to meet the objective of this study. We aim to recruit 84 participants each for the intervention and control groups. The recruitment will be from participants who participated in the first phase of this research. The primary outcomes of this study are depressive and anxiety scores, which will be assessed using the Patient Health Questionnaire 9 and Generalized Anxiety Disorder 7, respectively. The secondary outcome includes mental health literacy of the participants, which will be assessed using the self-developed and adapted Mental Health Literacy Questionnaire. The psychoeducational intervention program consists of four sessions, which will be accessed each week. The depressive and anxiety symptoms will be compared between participants who participated in the psychoeducational program compared with the control group. Depressive and anxiety scores and mental health literacy will be assessed at week 1 and at follow-ups at week 5 and week 12, respectively. Results: The psychoeducational intervention program consists of four sessions, which will be accessed at each week. The depressive and anxiety symptoms will be compared between the intervention and control groups using a series of mixed ANOVAs. Depressive and anxiety scores and mental health literacy will be assessed at week 1 and at two follow-ups at week 5 and week 12, respectively. Conclusions: To our knowledge, this study will be the first randomized controlled trial of a Web-based psychoeducational intervention program for depression and anxiety in an adult community in Malaysia. The results from this study will determine the effectiveness of a psychoeducational intervention program in the management of depression and anxiety among adults in the community. If proven to be effective, the intervention can serve as a new modality to manage and reduce the burden of these disorders in the community. ClinicalTrial: International Standard Randomized Controlled Trial Number (ISRCTN): 39656144; (Archived by WebCite at

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  • Partner Steps: a dyadic behavioral intervention to optimize same sex male couples’ engagement across the HIV care continuum

    Date Submitted: Jun 27, 2016

    Open Peer Review Period: Jun 27, 2016 - Jul 11, 2016

    Background: An estimated one- to two-thirds of new HIV infections among U.S. MSM occur within the context of primary partnerships. Thus, HIV interventions that recognize and harness the power of relat...

    Background: An estimated one- to two-thirds of new HIV infections among U.S. MSM occur within the context of primary partnerships. Thus, HIV interventions that recognize and harness the power of relationships are needed. Increasingly, HIV prevention efforts are being directed towards improving engagement across the HIV care continuum from testing to linkage to care, antiretroviral therapy (ART) adherence, engagement in care, and viral suppression. However, no behavioral interventions to our knowledge have attempted to address the HIV care continuum using a dyadic approach. Objective: The objective of this paper is to describe the development of and protocol for an innovative couples-based approach to improving treatment adherence and engagement in care among HIV serodiscordant and concordant HIV-positive same sex male couples in the United States. Methods: We developed the Partner Steps intervention by drawing from relationship-oriented theory, existing efficacious individual-level ART adherence interventions, couple-focused HIV prevention interventions, and expert consultation. We incorporated new content to address all aspects of the HIV care continuum (e.g., linkage to and retention in care) and to draw on relationship strengths through interactive activities. Results: The resulting theory-based Partner Steps intervention is delivered by a trained bachelors-level counselor (interventionist) over two in-person sessions with male-male dyads in which at least one partner has recent suboptimal engagement in HIV care. Each session is designed to utilize relationship strengths to increase motivation for HIV care and treatment, and cover sequential intervention “steps” relating to specific challenges in HIV care engagement and barriers to ART adherence. For each step, couples work with a trained interventionist to identify their unique challenges, actively problem-solve with the interventionist, and articulate and commit to working together to implement a plan in which each partner agrees to complete specific tasks. Conclusions: We drew on theory and evidence to develop novel intervention strategies that leverage strengths of relationships to address engagement across the entire HIV care continuum. We provide details on intervention development and content that may be of use to researchers as well as medical and mental health professionals for whom a dyadic approach to HIV prevention and care may best suit their patient population.

  • A Pilates exercise program for improving core strength, balance and functional autonomy in aged women: study protocol for a randomised controlled trial

    Date Submitted: Jun 22, 2016

    Open Peer Review Period: Jun 26, 2016 - Jul 10, 2016

    Background: Spain is one of the oldest countries of the European Union with a major proportion of women in the older age group. Consequently, there is a need to identify and implement effective strate...

    Background: Spain is one of the oldest countries of the European Union with a major proportion of women in the older age group. Consequently, there is a need to identify and implement effective strategies to ensure their independence to achieve typical activities of daily living. Core training is becoming a novel approach for enhancing strength, balance, functional autonomy, and preventing falls among elderly. However, real life conditions require concurrent attention-demanding tasks, increasing the risk of falling and contributing to disability. Objective: Pilates-based exercise is proposed as a combined core and mental training program grounded on learning functionally effective postural sets and motor patterns, that will provide better results than a muscular exercise program in older women trunk strength and other complementary physical and mental functions such as balance or functional autonomy. Methods: This is a 34-week randomised controlled trial in which 80 independent older women will be allocated to a Pilates-based exercise program, a muscular exercise program, or a no-exercise control group. The intervention will be divided into 22 weeks of supervised exercise and a 12 weeks follow-up. The primary outcome will be isokinetic and isometric trunk and hip flexion-extension strength. The secondary outcome will include static and dynamic balance, the number of falls, functional autonomy, body composition, habitual physical activity and a standardized gerontological evaluation. Every item will be measured at baseline and after 22 and 34 weeks. Results: Recruitment process is currently accomplished. Pilates and Muscular exercise programs logistics are ready to begin their implementation. Results are expected in 2017. Conclusions: We expect that our results will guide other exercise-based strategies to implement combined core and mental training programs as a better way to enhance trunk strength, balance and functional autonomy, to diminish the risk of falling and preserve functionality in aged women. In addition, the follow-up period will provide new relevant information about the efficacy of the learning process included in Pilates-based exercise. Clinical Trial: NCT02506491

  • Rationale and design of Genetic study in Cardio-Metabolic risk factors: Tehran Cardio-Metabolic Genetic Study (TCGS)

    Date Submitted: Jun 4, 2016

    Open Peer Review Period: Jun 26, 2016 - Jul 10, 2016

    Background: Nowadays cardio-metabolic risk factors comprise cardiovascular diseases and/or diabetes and need to be evaluated in different fields. The primary aim of the Tehran Cardiometabolic Genetic...

    Background: Nowadays cardio-metabolic risk factors comprise cardiovascular diseases and/or diabetes and need to be evaluated in different fields. The primary aim of the Tehran Cardiometabolic Genetic Study (TCGS) is to create a comprehensive genome-wide database of at least 16 000 Tehranians, participants of the ongoing Tehran lipid and glucose study (TLGS) cohort. Objective: We aimed to undertake a genome wide association study evaluating and comparing genetic patterns in a Tehranian population to other reference genetic databases. This is one of the very first studies of its kind in the Middle East, and addresses the knowledge gap on the allele frequency, genetic association and the role of consanguineous marriage among Iranian families. Methods: TCGS was designed in collaboration with the Research Institute for Endocrine Sciences (RIES) and DeCode genetic company. Participants selected had already been followed for over a 16-years period for major incident cardio-metabolic related health events including; myocardial infarction, stroke, diabetes mellitus, hypertension, obesity, hyperlipidemia and familial hypercholesterolemia. Results: The TCGS cohort described here comprises 16,247 (76.58%) of the 21,216 TLGS participants who provided a baseline blood sample adequate for plasma and DNA analysis. 3937 families were collected and the mean pedigree size in population of study was 6.76 range 3 to 52. Finally 5201 males and 6296 females with the total genotyping rate of 0.9836 were genotyped with HumanOmniExpress-24-v1-0 bead chips (containing 715,871 SNP loci with an average mean distance of 4 kb). Conclusions: Investigations conducting within the TCGS will seek to identify relevant patterns of genetic polymorphism that could be related to cardio-metabolic risk factors in Tehran’s participants. By linking genome-wide data to the existing databank of TLGS participant, which includes comprehensive behavioral, biochemical and clinical data on each participant since cohort inception in 1999, the TCGS will also allow exploration of gene-gene and gene-environment interactions as they relate to disease status.

  • Protocol for a randomised controlled trial of proactive online versus telephone-based information and support: Can electronic platforms deliver effective care for lung cancer patients?

    Date Submitted: Jun 21, 2016

    Open Peer Review Period: Jun 23, 2016 - Jul 7, 2016

    Introduction: Community-based services such as telephone support lines can provide valuable informational, emotional and practical support for cancer patients via telephone-based or electronic platfor...

    Introduction: Community-based services such as telephone support lines can provide valuable informational, emotional and practical support for cancer patients via telephone-based or electronic platforms. However, very little rigorous research has been directed toward examining the efficacy of such services in improving patient outcomes. This study will determine whether: proactive telephone or online-delivered support produces outcomes superior to printed information; and proactive online-delivered support produces outcomes comparable to proactive telephone support. Methods and analysis: A consecutive sample of 501 lung cancer outpatients will be recruited from 50 Australian health services to participate in a multicentre, blinded, patient-randomized controlled trial. To be eligible, individuals must: be 18 years or older; have received a lung cancer diagnosis (including mesothelioma) within the previous four months; have an approximate life expectancy of at least six months; and have internet access. Participants will be randomly allocated to: (1) an information booklet; (2) proactive support delivered by telephone; or, (3) proactive support delivered on-line by chat or by email. The primary patient outcomes are general psychological distress and the efficacy and impact of health education; secondary outcomes include unmet supportive care needs. The acceptability of proactive recruitment strategies will also be assessed. All outcomes are reported using pen-and-paper surveys at baseline, 3, and 6 months post recruitment. Discussion: Community-based electronic approaches, if found effective, have the potential to greatly increase the accessibility and continuity of supportive cancer care. This evidence may also inform the redesigning of helpline-style services to be both effective and responsive to patient needs.

  • Addressing the Gaps in Diabetes Care in First Nations communities with the Reorganizing the Approach to Diabetes through the Application of Registries (RADAR): The Project Protocol

    Date Submitted: Jun 22, 2016

    Open Peer Review Period: Jun 22, 2016 - Jul 6, 2016

    Background: Type-2 diabetes rates in First Nations communities are 3-5 times higher than the general Canadian population, resulting in a high burden of disease, complications and comorbidity. Limited...

    Background: Type-2 diabetes rates in First Nations communities are 3-5 times higher than the general Canadian population, resulting in a high burden of disease, complications and comorbidity. Limited community nursing capacity, isolated environments and a lack of electronic health records (EHR)/registries lead to a reactive, disorganized approach to diabetes care for First Nations people. The Reorganizing the Approach to Diabetes through the Application of Registries (RADAR) project was developed in alignments with federal calls for innovative, culturally relevant, community-specific programs for people with type-2 diabetes developed and delivered in partnership with target communities. Objective: To implement and assess the effectiveness of a system wide, scalable infrastructure – RADAR. RADAR applies both an integrated diabetes EHR/registry system (CARE platform) and centralized care coordinator (CC) service that will support local healthcare workers in transforming care for First Nations people with diabetes. Methods: The CC will work with local healthcare workers to support patient and community health needs (using the CARE platform) and build capacity in best practices for type-2 diabetes management. A modified stepped wedge controlled trial design will be used to evaluate the model. During the baseline phase, the CC will work with local healthcare workers to identify patients with type-2 diabetes and register them into the CARE platform, but not make any management recommendations. During the intervention phase, the CC will work with local healthcare workers to proactively manage patients with type-2 diabetes, including monitoring and recall of patients, relaying clinical information and coordinating care, facilitated through the shared use of the CARE platform. The RE-AIM framework will provide a comprehensive assessment of the model. Assessments of whether the intervention is Reaching the target population; has been Adopted by the community and staff; is being Implemented as intended in a cost-effective manner; the Effectiveness of the intervention (e.g. clinical changes over time – A1c, BP, cholesterol, foot and eye exams, etc.); and the Maintenance of the intervention will be extracted. Results: The primary outcome measure will be a 10% improvement in any one of A1c, BP, or cholesterol over the baseline values. Secondary endpoints will address other diabetes care indicators including: the proportion of clinical measures completed in accordance with guidelines (e.g., foot and eye examination, receipt of vaccinations, smoking cessation counseling); the number of patients registered in CARE; and the proportion of patients linked to a health services provider. The cost-effectiveness of RADAR specific to these communities will be assessed. Concurrent qualitative assessments will provide contextual information, such as the quality/usability of the CARE platform and the impact/satisfaction with the model. Conclusions: Through the application of health information systems and guidance from a CC, RADAR will systematically organize proactive diabetes care in First Nations communities to improve diabetes-related outcomes.

  • Effectiveness of Internet-based injury prevention program in enhancing mother’s knowledge on child safety

    Date Submitted: Jun 17, 2016

    Open Peer Review Period: Jun 17, 2016 - Jul 1, 2016

    Background: Provision of anticipatory guidance to parents is recommended as an effective strategy to prevent injuries among young children. Internet-based anticipatory guidance is suggested to reinfor...

    Background: Provision of anticipatory guidance to parents is recommended as an effective strategy to prevent injuries among young children. Internet-based anticipatory guidance is suggested to reinforce the effectiveness of injury prevention, and improve parents’ knowledge on child safety. Parents receiving the guidance can reduce their children’s exposure to injury risk by adopting better childcare practices and using appropriate child safety devices at home. Objective: This study will examine the effectiveness of Internet-based injury prevention program with parental anticipatory guidance in enhancing mothers’ knowledge on child safety. It aims at increasing mothers’ knowledge and motivation of learning about domestic injury prevention through a new Internet-based intervention model. It also targets to improve mothers’ attitude and their perceived behavioral control of domestic safety practice. Methods: The study would adopt a randomized controlled trial design and recruit 934 mothers from the antenatal clinics and postnatal wards of two major public hospitals in Hong Kong. Participating mothers will be randomized into the intervention or control group with equal likelihood. Mothers in intervention group will be provided with free access to an Internet-based injury prevention program with anticipatory guideline whereas those in the control group will receive relevant parenting booklet. Results: Mothers’ general and age-appropriate knowledge on child safety and motivation of learning about domestic injury prevention will be the primary outcome measures. Conclusions: The Internet is increasingly recognized as a practical and cost-effective platform for health education and safety information delivery. This study will examine the effectiveness of a new Internet-based intervention program for improving mothers’ knowledge and raising their awareness about the importance and consequences caused by domestic injuries.