JMIR Publications

JMIR Research Protocols

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

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Journal Description

 

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

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

  • Source: CGI Denmark / Placeit.net; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/5/e96/; License: Creative Commons Attribution (CC-BY).

    A Personalized and Interactive Web-Based Health Care Innovation to Advance the Quality of Life and Care of Patients With Heart Failure (ACQUIRE-HF): A Mixed...

    Abstract:

    Background: Heart failure (HF) is a progressive, debilitating, and complex disease, and due to an increasing incidence and prevalence, it represents a global health and economic problem. Hence, there is an urgent need to evaluate alternative care modalities to current practice to safeguard a high level of care for this growing population. Objective: Our goal was to examine the feasibility of engaging patients to use patient-centered and personalized tools coupled with a Web-based, shared care and interactive platform in order to empower and enable them to live a better life with their disease. Methods: We used a mixed methods, single-center, pre-post design. Patients with HF and reduced left ventricular ejection fraction (n=26) were recruited from the outpatient HF clinic at Odense University Hospital (Svendborg Hospital), Denmark, between October 2015 and March 2016. Patients were asked to monitor their health status via the platform using the standardized, disease-specific measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ), and to register their weight. A subset of patients and nursing staff were interviewed after 3-month follow-up about their experiences with the platform. Results: Overall, patients experienced improvement in patient-reported health status but deterioration in self-care behavior between baseline and 3-month follow-up. The mean score reflecting patient expectations toward use prior to start of the study was lower (16 [SD 5]) than their actual experiences with use of the platform (21 [SD 5]) after 3-month follow-up. Of all patients, 19 completed both a baseline and follow-up KCCQ. A total of 9 experienced deterioration in their health status (range from 3-34 points), while 10 experienced an improvement (range from 1-23 points). The qualitative data indicated that the majority of patients found the registration and monitoring on the platform useful. Both nursing staff and patients indicated that such monitoring could be a useful tool to engage and empower patients, in particular when patients are just diagnosed with HF. Conclusions: The use of patient tracking and monitoring of health status in HF using a standardized and validated measure seems feasible and may lead to insights that will help educate, empower, and engage patients more in their own disease management, although it is not suitable for all patients. Nursing staff found the patient-centered tool beneficial as a communication tool with patients but were more reticent with respect to using it as a replacement for the personal contact in the outpatient clinic.

  • Source: Pixabay; Copyright: Karolina Grabowska; URL: https://pixabay.com/de/mann-lesung-touchscreen-blog-791049/; License: Public Domain (CC0).

    Development of a Modular Research Platform to Create Medical Observational Studies for Mobile Devices

    Abstract:

    Background: Observational studies have proven to be a valuable resource in medical research, especially when performed on a large scale. Recently, mobile device-based observational studies have been discovered by an increasing number of researchers as a promising new source of information. However, the development and deployment of app-based studies is not trivial and requires profound programming skills. Objective: The aim of this project was to develop a modular online research platform that allows researchers to create medical studies for mobile devices without extensive programming skills. Methods: The platform approach for a modular research platform consists of three major components. A Web-based platform forms the researchers’ main workplace. This platform communicates via a shared database with a platform independent mobile app. Furthermore, a separate Web-based login platform for physicians and other health care professionals is outlined and completes the concept. Results: A prototype of the research platform has been developed and is currently in beta testing. Simple questionnaire studies can be created within minutes and published for testing purposes. Screenshots of an example study are provided, and the general working principle is displayed. Conclusions: In this project, we have created a basis for a novel research platform. The necessity and implications of a modular approach were displayed and an outline for future development given. International researchers are invited and encouraged to participate in this ongoing project

  • Source: The Authors / Placeit.net; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/5/e94/; License: Creative Commons Attribution (CC-BY).

    Using Beta-Version mHealth Technology for Team-Based Care Management to Support Stroke Prevention: An Assessment of Utility and Challenges

    Abstract:

    Background: Beta versions of health information technology tools are needed in service delivery models with health care and community partnerships to confirm the key components and to assess the performance of the tools and their impact on users. We developed a care management technology (CMT) for use by community health workers (CHWs) and care managers (CMs) working collaboratively to improve risk factor control among recent stroke survivors. The CMT was expected to enhance the efficiency and effectiveness of the CHW-CM team. Objective: The primary objective was to describe the Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities (SUCCEED) CMT and investigate CM and CHW perceptions of the CMT’s usefulness and challenges for team-based care management. Methods: We conducted qualitative interviews with all users of the beta-version SUCCEED CMT, namely two CMs and three CHWs. They were asked to demonstrate and describe their perceptions of the CMT’s ease of use and usefulness for completing predefined key care management activities. They were also probed about their general perceptions of the CMT’s information quality, ease of use, usefulness, and impact on CM and CHW roles. Interview transcripts were coded using a priori codes. Coded excerpts were grouped into broader themes and then related in a conceptual model of how the CMT facilitated care management. We also conducted a survey with 14 patients to obtain their perspective on CHW tablet use during CHW-patient interactions. Results: Care managers and community health workers expressed that the CMT helped them keep track of patient interactions and plan their work. It guided CMs in developing and sharing care plans with CHWs. For CHWs, the CMT enabled electronic collection of clinical assessment data, provided decision support, and provided remote access to patients’ risk factor values. Long loading times and downtimes due to outages were the most significant challenges encountered. Additional issues included extensive use of free-text responses and manual data transfer from the electronic medical record. Despite these challenges, patients overall did not perceive the tablet as interfering with CHW-patient interactions. Conclusions: Our findings suggest useful functionalities of CMTs supporting health care and community partners in collaborative chronic care management. However, usability issues need to be addressed during the development process. The SUCCEED CMT is an initial step toward the development of effective health information technology tools to support collaborative, team-based models of care and will need to be modified as the evidence base grows. Future research should assess the CMT’s effects on team performance.

  • Hand holding cell phone. Source: The authors; Copyright: The authors; URL: https://s18.postimg.org/9yqxgojt5/TOC_Picture.jpg; License: Creative Commons Attribution (CC-BY).

    The Use of Text Messaging to Improve the Hospital-to-Community Transition in Acute Coronary Syndrome Patients (Txt2Prevent): Intervention Development and...

    Abstract:

    Background: Acute coronary syndrome, including acute myocardial infarction (AMI), is one of the leading causes for hospitalization, with AMI 30-day readmission rates around 20%. Supporting patient information needs and increasing adherence to recommended self-management behaviors during transition from hospital to home has the potential to improve patient outcomes. Text messages have been effective in other interventions and may be suitable to provide support to patients during this transition period. Objective: The goal of this study is to pilot test a text messaging intervention program (Txt2Prevent) that supports acute coronary syndrome patients for 60 days postdischarge. The primary objective is to compare self-management, as measured by the Health Education Impact Questionnaire, between patients receiving only usual care versus those who receive usual care plus the Txt2Prevent intervention. The secondary objectives are to compare medication adherence, health-related quality of life, self-efficacy, health care resource use (and associated costs), all-cause and cardiovascular disease (CVD) readmission, and all-cause and CVD mortality rates between the 2 groups. The third objective is to assess acceptability of the text messaging intervention and feasibility of the study protocol. Methods: This is a randomized controlled trial with blinding of outcome assessors. The Txt2Prevent program includes automated text messages to patients about standard follow-up care, general self-management, and healthy living. The content of the text messages was informed by and developed based on interviews with patients, discharge materials, theoretical domains of behavior, and a clinical advisory group composed of patients, clinicians, and researchers. We will recruit 76 consecutive cardiac in-patients with acute coronary syndrome who are treated with either medical management or percutaneous coronary intervention from a hospital in Vancouver, Canada. Results: Assessments at baseline will include measures for demographic information, self-management, health-related quality of life, and self-efficacy. Assessments at follow-up will include medication adherence, readmissions, health care resource use, and mortality in addition to the reassessment of baseline measures. Baseline assessments are done in-person while follow-up assessments are completed through a combination of mailed packages and phone calls. Semistructured interviews with participants will also be performed to better understand participant experiences managing their condition and with the text messages. Conclusions: This study will determine preliminary efficacy, feasibility, and acceptability of the Txt2Prevent program to support acute coronary syndrome patients in the transition to home following hospital discharge. The results of this study will be used to inform a larger trial. Trial Registration: ClinicalTrials.gov NCT02336919; https://clinicaltrials.gov/ct2/show/NCT02336919 (Archived by WebCite at http://www.webcitation.org/6qMjEqo6O)

  • Source: Unsplash; Copyright: Brooke Lark; URL: https://unsplash.com/photos/AdMHAf_cdns; License: Public Domain (CC0).

    Development of an Evidence-Informed Blog to Promote Healthy Eating Among Mothers: Use of the Intervention Mapping Protocol

    Abstract:

    Background: Low adherence to dietary guidelines and a concurrent rise of obesity-related chronic diseases emphasize the need for effective interventions to promote healthy eating. There is growing recognition that behavior change interventions should draw on theories of behavior change. Online interventions grounded in theory lead to increased effectiveness for health behavior change; however, few theory-driven social media-based health promotion interventions have been described in the literature. Objective: The objective of this study was to describe the application of the Intervention Mapping (IM) protocol to develop an evidence-informed blog to promote healthy eating among French-Canadian mothers of preschool and school-aged children. Methods: The following six steps of the IM protocol were performed. In Step 1, a preliminary needs assessment included a literature search on theoretical domains predicting Vegetables and Fruits intakes and Milk and Alternatives intakes in adults (ie, knowledge, beliefs about capabilities, beliefs about consequences, intention/goals) and a qualitative study including focus groups to identify female Internet users’ perceptions of their use of healthy eating blogs. In Step 2, two behavioral outcomes were selected (ie, increase daily intakes of Vegetables and Fruits and Milk and Alternatives of mothers to reach Canadian dietary recommendations) and subsequently divided into six performance objectives inspired by national and international dietary recommendations such as planning for healthy meals. A matrix of change objectives was then created by crossing performance objectives with theoretical domains predicting Vegetables and Fruits intakes and Milk and Alternatives intakes in adults. Step 3 consisted of selecting theory-based intervention methods (eg, modeling and goal setting) and translating them into practical applications for the context of a dietary intervention delivered through a blog. A 6-month intervention was developed in Step 4 in which we aimed to address one performance objective per month in weekly blog publications written by a registered dietitian. For Step 5, we sought to include engagement-promoting methods (eg, peer and counselor support) to promote mothers’ use of the blog and adherence to the intervention. Finally in Step 6, a randomized controlled trial has been launched to evaluate the effects of the blog on dietary behaviors of French-Canadian mothers. Results: The intervention study is expected to be completed in March 2018. Conclusions: An intervention mapping protocol allowed for effective decision making in the development of a novel knowledge translation tool to increase adherence to dietary recommendations among mothers of preschool and school-aged children.

  • SENSOR Study logo. Source: Image created by the authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2017/5/e89/; License: Creative Commons Attribution (CC-BY).

    The SENSOR Study: Protocol for a Mixed-Methods Study of Self-Management Checks to Predict Exacerbations of Pseudomonas Aeruginosa in Patients with Long-Term...

    Abstract:

    Background: There are an estimated three million people in the United Kingdom with chronic obstructive pulmonary disease (COPD), and the incidence of bronchiectasis is estimated at around 0.1% but is more common in COPD and severe asthma. Both COPD and bronchiectasis are characterized by exacerbations in which bacteria play a central role. Pseudomonas aeruginosa is isolated from sputum samples from 4% to 15% of adults with COPD and is more likely to be isolated from patients with severe disease. Earlier detection of exacerbations may improve morbidity and mortality by expediting treatment. Aseptika Ltd has developed a system for patients to self-monitor important physiological measurements including levels of physical activity, peak flow, forced expiratory volume (FEV1), and biomarkers for P aeruginosa in sputum. Objective: We aim to test this system in 20 participants with P aeruginosa colonization and 10 controls with Haemophilus influenzae. Methods: We plan to recruit 30 adult participants with COPD or non-CF bronchiectasis who have cultured P aeruginosa or H influenzae during an exacerbation in the last 6 months. They must produce sputum on most days and should have been stable for 4 weeks prior to entry. Daily data collected will include symptoms, health care usage, medication, weight, FEV1, physical activity level, blood pressure, oxygen saturation, and temperature. Sputum and urine samples will be provided daily. These data will be analyzed to assess predictive value in detecting upcoming exacerbations. Qualitative data will be gathered through self-administered questionnaires and semistructured interviews to gather information on participant coping and their use of the technology involved. Results: Recruitment has been completed and results from the study should be available at the end of 2017. Conclusions: The SENSOR study aims to test a home-monitoring system in people with chronic airway infection and is currently underway.

  • Computer game-based rehabilitation. Source: The Authors; Copyright: Kanitkar Anuprita; URL: http://www.researchprotocols.org/2017/5/e93/; License: Creative Commons Attribution (CC-BY).

    The Effectiveness of a Computer Game-Based Rehabilitation Platform for Children With Cerebral Palsy: Protocol for a Randomized Clinical Trial

    Abstract:

    Background: It is difficult to engage young children with cerebral palsy (CP) in repetitive, tedious therapy. As such, there is a need for innovative approaches and tools to motivate these children. We developed the low-cost, computer game-based rehabilitation platform CGR that combines fine manipulation and gross movement exercises with attention and planning game activities appropriate for young children with CP. Objective: The objective of this study is to provide evidence of the therapeutic value of CGR to improve upper extremity (UE) motor function for children with CP. Methods: This randomized controlled, single-blind, clinical trial with an active control arm will be conducted at 4 sites. Children diagnosed with CP between the ages of 4 and 10 years old with moderate UE impairments and fine motor control abnormalities will be recruited. Results: We will test the difference between experimental and control groups using the Quality of Upper Extremity Skills Test (QUEST) and Peabody Developmental Motor Scales, Second Edition (PDMS-2) outcome measures. The parents of the children and the therapist experiences with the interventions and tools will be explored using semi-structured interviews using the qualitative description approach. Conclusions: This research protocol, if effective, will provide evidence for the therapeutic value and feasibility of CGR in the pediatric rehabilitation of UE function. Trial Registration: Clinicaltrials.gov NCT02728375; http:https://clinicaltrials.gov/ct2/show/NCT02728375 (Archived by WebCite at http://www.webcitation.org/6qDjvszvh)

  • Participatory design workshops. Image sourced and copyright owned by authors. Source: Image sourced by authors; Copyright: The Authors; URL: http://www.researchprotocols.org/author/downloadFile/7084/119943;

    Development of a Web-Based Health Care Intervention for Patients With Heart Disease: Lessons Learned From a Participatory Design Study

    Abstract:

    Background: The use of telemedicine technologies in health care has increased substantially, together with a growing interest in participatory design methods when developing telemedicine approaches. Objective: We present lessons learned from a case study involving patients with heart disease and health care professionals in the development of a personalized Web-based health care intervention. Methods: We used a participatory design approach inspired by the method for feasibility studies in software development. We collected qualitative data using multiple methods in 3 workshops and analyzed the data using thematic analysis. Participants were 7 patients with diagnosis of heart disease, 2 nurses, 1 physician, 2 systems architects, 3 moderators, and 3 observers. Results: We present findings in 2 parts. (1) Outcomes of the participatory design process: users gave valuable feedback on ease of use of the platforms’ tracking tools, platform design, terminology, and insights into patients’ monitoring needs, information and communication technologies skills, and preferences for self-management tools. (2) Experiences from the participatory design process: patients and health care professionals contributed different perspectives, with the patients using an experience-based approach and the health care professionals using a more attitude-based approach. Conclusions: The essential lessons learned concern planning and organization of workshops, including the finding that patients engaged actively and willingly in a participatory design process, whereas it was more challenging to include and engage health care professionals.

  • Young men in Myanmar, 2012. Source: flickr; Copyright: Lelebella; URL: https://goo.gl/6yYt3H; License: Creative Commons Attribution (CC-BY).

    The Parasol Protocol: An Implementation Science Study of HIV Continuum of Care Interventions for Gay Men and Transgender Women in Burma/Myanmar

    Abstract:

    Background: Efforts to improve HIV diagnosis and antiretroviral therapy (ART) initiation among people living with HIV and reduce onward transmission of HIV rely on innovative interventions along multiple steps of the HIV care continuum. These innovative methods are particularly important for key populations, including men who have sex with men (MSM) and transgender women (TW). The HIV epidemic in Myanmar is concentrated among key populations, and national efforts now focus on reducing stigma and improving engagement of MSM and TW in HIV prevention and care. Objective: This study aims to test the use of several innovations to address losses in the HIV care continuum: (1) use of respondent-driven sampling (RDS) to reach and engage MSM and TW in HIV testing, (2) HIV self-testing (HIVST) to increase HIV testing uptake and aid early diagnosis of infection, (3) community-based CD4 point-of-care (POC) technology to rapidly stage HIV disease for those who are HIV infected, and (4) peer navigation support to increase successful health system navigation for HIV-infected MSM and TW in need of ART or HIV engagement in care. Methods: To assess the effect of HIVST, we will implement a randomized trial in which MSM and TW adults in the greater Yangon metropolitan area who are HIV uninfected will be recruited via RDS (N=366). Participants will complete a baseline socio-behavioral survey and will be randomized to standard, voluntary counseling and testing (VCT) or to HIVST. Biologic specimens will be collected during this baseline visit for confirmatory testing using dried blood spots. Participants will be asked to return to the study office to complete a second study visit in which they will report their HIV test result and answer questions on the acceptability of the assigned testing method. Aim 1 participants with confirmed HIV infection and who are not engaged in care (N=49) will be offered direct enrollment into Aims 2 and 3, which include immediate CD4 POC and the option for peer navigation, respectively. Aims 2 and 3 participants will be prospectively followed for 12 months with data collection including interviewer-administered sociobehavioral survey, CD4 POC, and viral load testing occurring biannually. Participants who accept peer navigation will be compared to those who decline peer navigation. Analyses will estimate the impact of CD4 POC on engagement in care and the impact of peer navigation on ART adherence and viral load. Results: Formative qualitative research was conducted in June and September 2015 and led to further refinement of recruitment methods, HIVST instructions and counseling, and peer navigation methods. Aim 1 recruitment began in November 2015 with subsequent enrollment into Aims 2 and 3 and is currently ongoing. Conclusions: These innovative interventions may resolve gaps in the HIV care continuum among MSM and TW and future implementation may aid in curbing the HIV epidemic among MSM and TW in Myanmar.

  • Screenshot of the Cardiff and Vale University Health Board and Orthopaedic Centre patient information page. Source: Cardiff and Vale University Health Board; Copyright: Cardiff and Vale University Health Board; URL: http://www.cardiffandvaleuhb.wales.nhs.uk/page/78540; License: Creative Commons Attribution (CC-BY).

    Using Text Messaging in Long-Term Arthroplasty Follow-Up: A Pilot Study

    Abstract:

    Background: Patient-reported outcome measures (PROMs) and mobile technology have the potential to change the way patients are monitored following joint replacement surgery. Objective: The aim of this study was to determine the feasibility of text messaging to record PROMs in long-term follow-up of hip and knee arthroplasty. Our participants were 17 patients 2-years-plus post hip or knee arthroplasty attending clinic with a mobile telephone number on record. Methods: A simple PROM (Oswestry Very Short Form) was texted to the patient. Responses were compared to clinical, radiographic, and existing PROM findings. Patients were interviewed to discover their opinions on this use of texting. Results: A total of 11 patients engaged with the text messaging. Reasons for not engaging included wrong numbers, physical barriers, and lack of understanding. A total of 8 patients attending clinic allowed comparison of text messaging with clinical findings. The average age was 70 years. A total of 4 patient text messaging responses matched clinical and radiographic findings; 3 also matched PROM scores collected in clinic. The 3 patients with mixed responses had abnormal clinical, radiographic, or PROM findings. One patient’s text responses conflicted with clinical outcome. Analysis of patients’ views showed a generally positive opinion: patients were happy to communicate with surgeons by text. Practical problems, PROM limitations, and trustworthiness of texting were highlighted. Conclusions: Engaging with changing technology creates challenges for patients and health care professionals. Despite this, our results suggest text messaging is a promising way to communicate with arthroplasty patients. Earlier integration of text communication in the patient pathway may be important and needs further research.

  • Allergy. Source: Wikipedia; Copyright: Docmo at de.wikipedia; URL: https://es.wikipedia.org/wiki/Alergia#/media/File:Urtikaria_Fuss.jpg; License: Creative Commons Attribution + ShareAlike (CC-BY-SA).

    Crowdsourced Identification of Possible Allergy-Associated Factors: Automated Hypothesis Generation and Validation Using Crowdsourcing Services

    Abstract:

    Background: Hypothesis generation is an essential task for clinical research, and it can require years of research experience to formulate a meaningful hypothesis. Recent studies have endeavored to apply crowdsourcing to generate novel hypotheses for research. In this study, we apply crowdsourcing to explore previously unknown allergy-associated factors. Objective: In this study, we aimed to collect and test hypotheses of unknown allergy-associated factors using a crowdsourcing service. Methods: Using a series of questionnaires, we asked crowdsourcing participants to provide hypotheses on associated factors for seven different allergies, and validated the candidate hypotheses with odds ratios calculated for each associated factor. We repeated this abductive validation process to identify a set of reliable hypotheses. Results: We obtained two primary findings: (1) crowdsourcing showed that 8 of the 13 known hypothesized allergy risks were statically significant; and (2) among the total of 157 hypotheses generated by the crowdsourcing service, 75 hypotheses were statistically significant allergy-associated factors, comprising the 8 known risks and 53 previously unknown allergy-associated factors. These findings suggest that there are still many topics to be examined in future allergy studies. Conclusions: Crowdsourcing generated new hypotheses on allergy-associated factors. In the near future, clinical trials should be conducted to validate the hypotheses generated in this study.

  • Young woman with phone. Source: Pexels; Copyright: Kaboompics//Karolina; URL: https://www.pexels.com/photo/girl-using-mobile-phone-6411/; License: Public Domain (CC0).

    EpxMedTracking: Feasibility Evaluation of an SMS-Based Medication Adherence Tracking System in Community Practice

    Abstract:

    Background: Medication adherence remains a difficult problem to both assess and improve in patients. It is a multifactorial problem that goes beyond the commonly cited reason of forgetfulness. To date, eHealth (also known as mHealth and telehealth) interventions to improve medication adherence have largely been successful in improving adherence. However, interventions to date have used time- and cost-intensive strategies or focused solely on medication reminding, leaving much room for improvement in using a modality as flexible as eHealth. Objective: Our objective was to develop and implement a fully automated short message service (SMS)-based medication adherence system, EpxMedTracking, that reminds patients to take their medications, explores reasons for missed doses, and alerts providers to help address problems of medication adherence in real time. Methods: EpxMedTracking is a fully automated bidirectional SMS-based messaging system with provider involvement that was developed and implemented through Epharmix, Inc. Researchers analyzed 11 weeks of de-identified data from patients cared for by multiple provider groups in routine community practice for feasibility and functionality. Patients included were those in the care of a provider purchasing the EpxMedTracking tool from Epharmix and were enrolled from a clinic by their providers. The primary outcomes assessed were the rate of engagement with the system, reasons for missing doses, and self-reported medication adherence. Results: Of the 25 patients studied over the 11 weeks, 3 never responded and subsequently opted out or were deleted by their provider. No other patients opted out or were deleted during the study period. Across the 11 weeks of the study period, the overall weekly engagement rate was 85.9%. There were 109 total reported missed doses including “I forgot” at 33 events (30.3%), “I felt better” at 29 events (26.6%), “out of meds” at 20 events (18.4%), “I felt sick” at 19 events (17.4%), and “other” at 3 events (2.8%). We also noted an increase in self-reported medication adherence in patients using the EpxMedTracking system. Conclusions: EpxMedTracking is an effective tool for tracking self-reported medication adherence over time. It uniquely identifies actionable reasons for missing doses for subsequent provider intervention in real time based on patient feedback. Patients enrolled on EpxMedTracking also self-report higher rates of medication adherence over time while on the system.

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  • The association of health and ehealth literacy with self-efficacy, coping and caregiving perceptions among carers of people with dementia: a research protocol for a descriptive correlational study

    Date Submitted: May 20, 2017

    Open Peer Review Period: May 23, 2017 - Jun 6, 2017

    Background: eHealth literacy has drawn the attention of the scientific community in the last decade as it influences the self-management of patients with chronic diseases, the quality and the cost of...

    Background: eHealth literacy has drawn the attention of the scientific community in the last decade as it influences the self-management of patients with chronic diseases, the quality and the cost of care. It is estimated that eighty percent of people with chronic diseases are cared for at home by a family member, friend or relative. Informal Carers are susceptible to physical and mental health problems and social and financial hardships. Nevertheless, there seems to be a research gap between carers’ needs and the new technologies with the vital role of eHealth literacy to remain unexplored. Objective: The study aims to explore the associations between self-efficacy, coping, caring perceptions, health and eHealth literacy amongst primary carers and secondary carers of people with dementia Methods: A sample of 165 primary carers (the carers who supports the people with dementia in activities of everyday living) and secondary carers (named family member, friend or other person in the social network assisting the primary carer in their role) will be recruited from dementia Day care centres and Alzheimer’s Associations in Greece and Cyprus. The study will be a cross sectional correlational descriptive study. Tools to be used include eHeals adapted for carers to measure ehealth literacy, Health Literacy Scale –EU Questionnaire 16, Single Item Literacy Screening, Revised Scale of Caregiving Self Efficacy, COPE index for caregiving perceptions and COPE brief to measure coping. Descriptive statistics will be reported and correlations between different variables will be explored with parametric and non-parametric measures. Results: During this period, Health Literacy Scale –EU-Questionnaire 16 has been validated in 107 older people. The recruitment of participants will start in May 2017. Conclusions: . Carers’ ehealth literacy is a new field. Researchers have well studied the impact of low ehealth literacy and health literacy among older adults without taking into consideration this specific population. We assume a moderating role of the ehealth literacy and health literacy level to carers’ perceptions about caregiving role, carers’ self-efficacy and coping strategies. Another possible moderator, secondary carers’ ehealth and health literacy level will be also discussed. By confirming the above assumptions, tailored ehealth literacy interventions for carers of people with dementia will be developed as a direct outcome of this research. Clinical Trial: N/A

  • Randomised controlled trial of an established direct to public peer support programme (Big White Wall) versus web-based information to aid self-management of depression and anxiety (The REBOOT* study). *Randomised Controlled Trial of the Effectiveness of Big White Wall Compared to Other Online SupporT

    Date Submitted: May 19, 2017

    Open Peer Review Period: May 21, 2017 - Jun 4, 2017

    Background: Regardless of geography or income, effective help for depression and anxiety only reaches a small proportion of those who might benefit from it. The scale of the problem suggests a role fo...

    Background: Regardless of geography or income, effective help for depression and anxiety only reaches a small proportion of those who might benefit from it. The scale of the problem suggests a role for effective, safe, anonymised public health driven online services such as Big White Wall which offers immediate peer support at low cost. The primary aim of the study is to determine the effectiveness of randomisation to Big White Wall (BWW) compared to online information compiled by the UK’s National Health Service (NHS Choices Moodzone) in people with mild to moderate depression and anxiety. The secondary aims are to determine cost effectiveness, the population reach of this service and adoption by services. Method/Design: A pragmatic, parallel group, single blind RCT is being conducted using a fully automated trial website in which eligible participants are randomised to receive either 6 months access to BWW or signposted to the NHS Moodzone site. The recruitment of 2200 people to the study will be facilitated by a public health engagement campaign involving general marketing and social media, primary care clinical champions, healthcare staff, large employers and third sector groups. People will refer themselves to the study and will eligible if they are over 16 years, have mild to moderate depression or anxiety and have access to the internet. The primary outcome will be mental well-being at six weeks. We will also explore secondary end points in terms of cost effectiveness from a health and social perspective. In addition, the reach and adoption of BWW will be recorded and possible mechanisms of action will be explored. Discussion: This will be the first fully digital trial of a direct to public peer support programme for common mental disorders. The potential advantages of adding this to current NHS mental health services and the challenges of designing a public health campaign and randomised controlled trial of two digital interventions using a fully automated digital enrolment and data collection process are considered for people with depression and anxiety.

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    Date Submitted: May 19, 2017

    Open Peer Review Period: May 21, 2017 - Jun 4, 2017

    Various tests are used to detect diabetic peripheral neuropathy (DPN) by assessing sense perception in the feet. The aim of this study is to estimate the diagnostic accuracy of VibraTip against the go...

    Various tests are used to detect diabetic peripheral neuropathy (DPN) by assessing sense perception in the feet. The aim of this study is to estimate the diagnostic accuracy of VibraTip against the gold standard of sural nerve conduction velocity (SNCV) measurement, to assess whether the VibraTip device offers superior diagnostic accuracy to other routine tests for DPN, and to examine whether diagnostic tests based on vibration, including VibraTip, offer superior diagnostic accuracy for peripheral neuropathy compared with touch based tests. The study will include adults with diabetes type 2 who are due for check-up at a follow up clinic. Patients will be prospectively recruited. A cross-sectional study design will be employed to assess the diagnostic accuracy of 5 standard index tests for peripheral neuropathy, including VibraTip. The reference test will be SNCV measurement. The outcomes assessed will be the diagnostic accuracy of the 5 index tests against SNCV measurement, including positive predictive value, negative predictive value, negative likelihood ratio and positive likelihood ratio. Receiver operating characteristic (ROC) curves will be constructed and compared for each test.

  • The Use Of Social Media For The Promotion Of Education And Consultation In Adolescents Who Have Undergone Kidney Transplants: A Randomized Clinical Trial Comparing Knowledge, Satisfaction And Self-Esteem With The Group Undergoing Conventional Treatment.

    Date Submitted: May 17, 2017

    Open Peer Review Period: May 20, 2017 - Jun 3, 2017

    Background: Falling ill represents a traumatic experience especially in adolescence, since in addition to the moments of ambiguity and contradictions that this period bring, there is coping with the d...

    Background: Falling ill represents a traumatic experience especially in adolescence, since in addition to the moments of ambiguity and contradictions that this period bring, there is coping with the disease. Renal transplantation provides a better quality of life but the dependence on dialysis is replaced by the greater responsibility of self-care. With advances in technology, contemporary communication methods are a strategic mechanism for the approximation of the adolescent and the multi-professional team. In this perspective, this research may provide possible changes and propose alternatives, using social networks for the integration of the multi-professional team, promoting education within a virtual environment for adolescents who have undergone kidney transplants. Objective: To compare the knowledge, satisfaction and self-esteem of adolescent renal transplant patients of two groups: patients undergoing conventional treatment versus patients undergoing conventional treatment, plus the full time use of social networks to aid in education and consultation. Methods: Non-blind randomized clinical trial with 128 adolescents (age 13 to 21) divided in two groups: the first group will receive the conventional care and the second group will be invited to participate in a secret group of the social network "Facebook". This group will be used as a new education platform to involve young renal transplant patients to participate in the guidelines provided to them by the multi-professional team. Outcome Knowledge : a ten question multiple choice questionnaire will be applied. Each question is worth 1 point. This questionnaire will be applied by the researcher, before and three months after the beginning of the study. Self-esteem: A validated version for Brazil of the Rosenberg Scale (1965) is used in order to evaluate self-esteem. Satisfaction: A structured questionnaire with closed questions will be used. It will be applied before and after the end of the study, where all participants will be subjected to the same questions and possible answers. Statistical analysis The Student's t Test will be utilized to analyze the statistics for the comparison of the groups. Results: Hypothesis: Low cost intervention. Strategies for self-care education. Improvement in self-esteem. Space for the exchange of experiences, exposing ideas and doubts. Improvements in team and patient interaction. Education using a language geared toward adolescents. Conclusions: Health professionals need to seek alternatives when educating patients, focusing on easily understandable ways for effective guidance. In the adolescent population, it is understood that the use of technology as support in education is a fundamental tool for this age group. The proposed project will directly benefit adolescent renal transplant patients as it uses language aimed directly at the target demographic. It attempts to overcome the traditional model by being more in contact with the current generation. This approach makes the content easier to assimilate and, consequently, increases understanding.

  • Effectiveness of a technology-based supportive educational parenting programme on parental outcomes in Singapore: A study protocol for a randomized controlled trial

    Date Submitted: May 17, 2017

    Open Peer Review Period: May 20, 2017 - Jun 3, 2017

    Background: Supportive educational programmes during the perinatal period are scarce in Singapore. There is no continuity of care available in terms of support from community care nurses in Singapore....

    Background: Supportive educational programmes during the perinatal period are scarce in Singapore. There is no continuity of care available in terms of support from community care nurses in Singapore. Parents are left on their own most of the time, which results in a stressful transition to parenthood. There is a need for easily accessible technology-based educational programmes that can support needy parents during the crucial perinatal period. Objective: The aim of this study is to examine the effectiveness of a technology-based supportive educational parenting programme on parental outcomes and to evaluate the cost effectiveness of this intervention compared to routine perinatal care. Methods: A randomized controlled two-group pretest and repeated posttest experimental design will be used. The study will recruit 118 parents (59 couples) from the antenatal clinics of a tertiary public hospital in Singapore. Eligible parents will be randomly allocated to receive either the supportive educational parenting programme or routine perinatal care from the hospital. Outcome measures include parenting self-efficacy, parental bonding, postnatal depression, social support, parenting satisfaction, and cost evaluation. Data will be collected at the antenatal period, immediate postnatal period, one month, and three months post-childbirth. Results: Recruitment of the study participants commenced in December 2016 and is still ongoing. The current recruitment stands at 49 couples for both study arms including the intervention (n=27) and control (n=22) groups. Data collection is projected to finish within 12 months, by December 2017. Conclusions: This study will identify a potentially clinically useful, effective, and cost-effective supportive educational parenting programme to improve parental self-efficacy and bonding in newborn care, which will then improve parents’ social support seeking behaviors, emotional wellbeing, and satisfaction with parenting. It is hoped that better supported and satisfied parents will consider having more children, which may in turn influence Singapore’s ailing birth rate. Clinical Trial: ISRCTN48536064

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

    Date Submitted: May 17, 2017

    Open Peer Review Period: May 20, 2017 - Jun 3, 2017

    Background: Hypertension 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 hav...

    Background: Hypertension 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 monitoring, mobile health interventions, and referral to a clinical pharmacist for blood pressure 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 mobile health intervention that aims to improve blood pressure control by supporting home blood pressure monitoring and medication adherence among patients with uncontrolled hypertension. BPTrack is an intervention that makes home monitored blood pressure data available to the clinical pharmacist for use in hypertension 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 hypertension from a Family Medicine clinic affiliated with a large Midwestern academic medical center. Participants complete a baseline visit, including installation and instruction in how to use BPTrack, the mobile health intervention. Participants are then asked to follow the blood pressure monitoring protocol for a period of twelve 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 mid-2017. Conclusions: This pilot study was designed to document the feasibility and acceptability of a clinical pharmacist-led mobile health approach to managing hypertension within a primary care setting. Through our 12-week pilot, we expect to lend support for this approach, as well as to lay the foundation for learning how to translate this approach into wider-scale implementation. This mobile health intervention seeks to leverage the multidisciplinary care team already in place within primary care, and to improve health-outcomes for patients with uncontrolled hypertension. Clinical Trial: NCT02898584

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