JMIR Research Protocols

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

The Use of Virtual World-based Cardiac Rehabilitation to Encourage Healthy Lifestyle Choices Among Cardiac Patients: Intervention Development and Pilot Study Protocol

Background: Despite proven benefits through the secondary prevention of cardiovascular disease (CVD) and reduction of mortality, cardiac rehabilitation (CR) remains underutilized in cardiac patients. Underserved populations most affected by CVD including rural residents, low socioeconomic status patients and racial/ethnic minorities, have the lowest participation rates due to access barriers. Internet-and mobile-based lifestyle interventions have emerged as potential modalities to complement and increase accessibility to CR. An outpatient CR program using virtual world technology may provide an effective alternative to conventional CR by overcoming patient access limitations such as geographics, work schedule constraints and transportation. Objective: The objective of this paper is to describe the research protocol of a two-phased, pilot study that will assess the feasibility (Phase 1) and comparative effectiveness (Phase 2) of a virtual world-based (Second Life®) CR program as an extension of a conventional CR program in achieving healthy behavioral change among post-acute coronary syndrome (ACS) and post-percutaneous coronary intervention (PCI) patients in comparison to a conventional CR program. We hypothesize that virtual world CR users will improve behaviors (physical activity, diet, smoking) to a greater degree than conventional CR participants. Methods: In Phase 1, we will recruit at least 10 patients enrolled in outpatient CR who were recently hospitalized for an ACS (unstable angina, ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction) or who recently underwent elective PCI at Mayo Clinic Hospital, Rochester Campus in Rochester, MN with at least one modifiable, lifestyle risk factor target (sedentary lifestyle, unhealthy diet and current smoking). Recruited patients will participate in a 12-week, virtual world health education program which will provide feedback on the feasibility, usability and design of the intervention. During Phase 2, we will conduct a 2-arm, parallel group, single-center, randomized controlled trial (RCT). Patients will be randomized at a 1:1 ratio to adjunct virtual world-based CR with conventional CR or conventional CR only. The primary outcome is a composite including at least one of the following: at least 150 minutes per week of physical activity, consumption of five or more fruits and vegetables daily and smoking cessation. Patients will be assessed at 3, 6 and 12 months. Results: The Phase 1 feasibility study is currently open for recruitment which will be followed by the Phase 2 RCT. The anticipated completion date for the study is May 2016. Conclusions: Research on the use of virtual world technology in health programs is in its infancy. It offers unique advantages over current web-based health interventions including social interactivity and active learning. It also increases accessibility to vulnerable populations who have higher burdens of CVD. This study will yield results on the effectiveness of a virtual world-based CR program as an innovative platform to influence healthy lifestyle behavior and self-efficacy. Clinical Trial: In process

2014-11-06

The year 2014 comes to an end - have you published enough in 2014 to keep your career moving ahead?

Add another paper to your 2014 publication list by publishing a grant proposal or protocol of your ongoing or planned research in our PubMed-indexed journal JMIR Res Protoc:

  • submit your protocol/proposal of your ongoing study to JMIR Res Protoc before Nov 15th, 2014, and if it is already reviewed/approved by your granting agency (attach review reports), WE GUARANTEE ACCEPTANCE/PUBLICATION BEFORE DEC 31, 2014, with FAST-TRACK FEES WAIVED (APF for already peer-reviewed proposals/protocols is $950)
  • NO SUBMISSION FEES for articles submitted to JMIR Res Protoc between Nov 6th-15th, 2014 (UPDATE: We now decided to permanently suspend submission fees for JMIR Res Protoc!)
  • for all studies published in JMIR Res Protoc, we offer a 20% discount on the APF if the subsequent full study results are published in a JMIR journal (this is a $490 value)
  • while many JMIR Res Protoc papers are from the field of ehealth, we publish protocols from all areas of medicine and health research, including wet lab science, systematic review protocols, clinical randomized trial protocols, qualitative study protocols, formative research such as usability studies etc.

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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: 4.7)
  • 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:

  • Screenshot of the beta version of COPDFlix social media resource center, modified following usability evaluation.

    Engaging Community Stakeholders to Evaluate the Design, Usability, and Acceptability of a Chronic Obstructive Pulmonary Disease Social Media Resource Center

    Abstract:

    Background: Patients with chronic obstructive pulmonary disease (COPD) often report inadequate access to comprehensive patient education resources. Objective: The purpose of this study was to incorporate community-engagement principles within a mixed-method research design to evaluate the usability and acceptability of a self-tailored social media resource center for medically underserved patients with COPD. Methods: A multiphase sequential design (qual → QUANT → quant + QUAL) was incorporated into the current study, whereby a small-scale qualitative (qual) study informed the design of a social media website prototype that was tested with patients during a computer-based usability study (QUANT). To identify usability violations and determine whether or not patients found the website prototype acceptable for use, each patient was asked to complete an 18-item website usability and acceptability questionnaire, as well as a retrospective, in-depth, semistructured interview (quant + QUAL). Results: The majority of medically underserved patients with COPD (n=8, mean 56 years, SD 7) found the social media website prototype to be easy to navigate and relevant to their self-management information needs. Mean responses on the 18-item website usability and acceptability questionnaire were very high on a scale of 1 (strongly disagree) to 5 (strongly agree) (mean 4.72, SD 0.33). However, the majority of patients identified several usability violations related to the prototype’s information design, interactive capabilities, and navigational structure. Specifically, 6 out of 8 (75%) patients struggled to create a log-in account to access the prototype, and 7 out of 8 patients (88%) experienced difficulty posting and replying to comments on an interactive discussion forum. Conclusions: Patient perceptions of most social media website prototype features (eg, clickable picture-based screenshots of videos, comment tools) were largely positive. Mixed-method stakeholder feedback was used to make design recommendations, categorize usability violations, and prioritize potential solutions for improving the usability of a social media resource center for COPD patient education.

  • FHI 360. Lifeline Intervention Message. 2013. SHARPER Project, Accra, Ghana.

    Scaled-Up Mobile Phone Intervention for HIV Care and Treatment: Protocol for a Facility Randomized Controlled Trial

    Abstract:

    Background: Adherence to prevention, care, and treatment recommendations among people living with HIV (PLHIV) is a critical challenge. Yet good clinical outcomes depend on consistent, high adherence to antiretroviral therapy (ART) regimens. Mobile phones offer a promising means to improve patient adherence and health outcomes. However, limited information exists on the impact that mobile phones for health (mHealth) programs have on ART adherence or the behavior change processes through which such interventions may improve patient health, particularly among ongoing clients enrolled in large public sector HIV service delivery programs and key populations such as men who have sex with men (MSM) and female sex workers (FSW). Objective: Our aim is to evaluate an mHealth intervention where text message reminders are used as supportive tools for health providers and as motivators and reminders for ART clients to adhere to treatment and remain linked to care in Ghana. Using an implementation science framework, we seek to: (1) evaluate mHealth intervention effects on patient adherence and health outcomes, (2) examine the delivery of the mHealth intervention for improving HIV care and treatment, and (3) assess the cost-effectiveness of the mHealth intervention. Methods: The 36-month study will use a facility cluster randomized controlled design (intervention vs standard of care) for evaluating the impact of mHealth on HIV care and treatment. Specifically, we will look at ART adherence, HIV viral load, retention in care, and condom use at 6 and 12-month follow-up. In addition, participant adoption and satisfaction with the program will be measured. This robust methodology will be complemented by qualitative interviews to obtain feedback on the motivational qualities of the program and benefits and challenges of delivery, especially for key populations. Cost-effectiveness will be assessed using incremental cost-effectiveness ratios, with health effects expressed in terms of viral load suppression and costs of resources used for the intervention. Results: This study and protocol was fully funded, but it was terminated prior to review from ethics boards and study implementation. Conclusions: This cluster-RCT would have provided insights into the health effects, motivational qualities, and cost-effectiveness of mHealth interventions for PLHIV in public sector settings. We are seeking funding from alternate sources to implement the trial.

  • MijnAVL: Homepage.

    Development of MijnAVL, an Interactive Portal to Empower Breast and Lung Cancer Survivors: An Iterative, Multi-Stakeholder Approach

    Abstract:

    Background: MijnAVL (MyAVL) is an interactive portal being developed to empower cancer survivors. Literature review and focus groups yielded the selection of features such as access to the electronic medical record (EMR), patient reported outcomes (PROs) and related feedback, and a physical activity support program. Objective: Our aim was to present a final design of MijnAVL based on (1) health professionals' evaluation of proposed features, (2) cancer survivors’ evaluation of a first draft, and (3) cancer survivors’ evaluation of a functional online prototype. Methods: Professionals from various disciplines gave input to the content of and procedures related to MijnAVL. Subsequently, 16 cancer survivors participated in an interview to evaluate content and graphic design of a first draft (shown with screenshots). Finally, 7 survivors participated in a usability test with a fully functional prototype. They performed predefined tasks (eg, logging in, finding a test result, completing a questionnaire) while thinking aloud. Descriptive statistics and simple content analysis were used to analyze the data of both the interviews and the usability tests. Results: Professionals supported access to the EMR (eg, histology reports, lab results, and their letters to general practitioners). They also informed the development of PROs and the physical activity support program. Based on the first draft, survivors selected the preferred graphic design, approved the features and provided suggestions for the content (eg, explanation of medical jargon, more concise texts, notification by emails). Usability tests revealed that it was relatively easy to navigate the website and use the different features. Recommendations included, among others, a frequently asked questions section and the use of hyperlinks between different parts of the website. Conclusions: The development of MijnAVL, an interactive portal to empower breast and lung cancer survivors, was performed iteratively and involved multiple groups of end-users. This approach resulted in a usable and understandable final version. Its effectiveness should be determined in further research.

  • Screenshot of Alive-PD.

    A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol

    Abstract:

    Background: In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. Objective: Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. Methods: Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. Results: A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. Conclusions: The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or preventing progression of glycemic markers and indirectly in preventing progression to diabetes. Trial Registration: ClinicalTrials.gov NCT01479062; http://clinicaltrials.gov/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6U8ODy1vo).

  • Crush the Crave Logo.

    Effect of a Mobile Phone Intervention on Quitting Smoking in a Young Adult Population of Smokers: Randomized Controlled Trial Study Protocol

    Abstract:

    Background: Tobacco use remains the number one cause of preventable chronic disease and death in developed countries worldwide. In North America, smoking rates are highest among young adults. Despite that the majority of young adult smokers indicate wanting to quit, smoking rates among this age demographic have yet to decline. Helping young adults quit smoking continues to be a public health priority. Digital mobile technology presents a promising medium for reaching this population with smoking cessation interventions, especially because young adults are the heaviest users of this technology. Objective: The primary aim of this trial is to determine the effectiveness of an evidence-informed mobile phone app for smoking cessation, Crush the Crave, on reducing smoking prevalence among young adult smokers. Methods: A parallel randomized controlled trial (RCT) with two arms will be conducted in Canada to evaluate Crush the Crave. In total, 1354 young adult smokers (19 to 29 years old) will be randomized to receive the evidence-informed mobile phone app, Crush the Crave, or an evidence-based self-help guide known as “On the Road to Quitting” (control) for a period of 6 months. The primary outcome measure is a 30-day point prevalence of abstinence at the 6-month follow-up. Secondary outcomes include a 7-day point prevalence of abstinence, number of quit attempts, reduction in consumption of cigarettes, self-efficacy, satisfaction, app utilization metrics, and use of smoking cessation services. A cost-effectiveness analysis is included. Results: This trial is currently open for recruitment. The anticipated completion date for the study is April 2016. Conclusions: This randomized controlled trial will provide the evidence to move forward on decision making regarding the inclusion of technology-based mobile phone interventions as part of existing smoking cessation efforts made by health care providers. Evidence from the trial will also inform the development of future apps, provide a deeper understanding of the factors that drive change in smoking behavior using an app, and improve the design of cessation apps. This trial is among the first to assess the effect of a comprehensive and evidence-informed mHealth smoking cessation app on a large sample of young adult smokers. Strengths of the trial include the high-quality research design and in-depth assessment of the implementation of the intervention. If effective, the trial has the potential to demonstrate that including mHealth technology as a population-based intervention strategy can cost-effectively reach a greater proportion of the population and help young adult smokers to quit. Trial Registration: ClinicalTrials.gov NCT01983150; http://clinicaltrials.gov/ct2/show/NCT01983150 (Archived by WebCite at http://www.webcitation.org/6VGyc0W0i).

  • Screenshot of introductory page of web-based CBT modules.

    An Integrated Web-Based Mental Health Intervention of Assessment-Referral-Care to Reduce Stress, Anxiety, and Depression in Hospitalized Pregnant Women With...

    Abstract:

    Background: At prevalence rates of up to 40%, rates of depression and anxiety among women with medically complex pregnancies are 3 times greater than those in community-based samples of pregnant women. However, mental health care is not a component of routine hospital-based antenatal care for medically high-risk pregnant women. Objective: The purpose of this study is to evaluate the effectiveness and feasibility of the hospital-based implementation of a Web-based integrated mental health intervention comprising psychosocial assessment, referral, and cognitive behavioral therapy (CBT) for antenatal inpatients. Methods: This study is a quasi-experimental design. Pregnant women are eligible to participate if they are (1) <37 weeks gestation, (2) admitted to the antenatal inpatient unit for >72 hours, (3) able to speak and read English or be willing to use a translation service to assist with completion of the questionnaires and intervention, (4) able to complete follow-up email questionnaires, (5) >16 years of age, and (6) not actively suicidal. Women admitted to the unit for induction (eg, <72-hour length of stay) are excluded. A minimum sample of 54 women will be recruited from the antenatal high-risk unit of a large, urban tertiary care hospital. All women will complete a Web-based psychosocial assessment and 6 Web-based CBT modules. Results of the psychosocial assessment will be used by a Web-based clinical decision support system to generate a clinical risk score and clinician prompts to provide recommendations for the best treatment and referral options. The primary outcome is self-reported prenatal depression, anxiety, and stress symptoms at 6-8 weeks postrecruitment. Secondary outcomes are postpartum depression, anxiety, and stress symptoms; self-efficacy; mastery; self-esteem; sleep; relationship quality; coping; resilience; Apgar score; gestational age; birth weight; maternal-infant attachment; infant behavior and development; parenting stress/competence at 3-months postpartum; and intervention cost-effectiveness, efficiency, feasibility, and acceptability. All women will complete email questionnaires at 6-8 weeks postrecruitment and 3-months postpartum. Qualitative interviews with 10-15 health care providers and 15-30 women will provide data on feasibility and acceptability of the intervention. Results: The study was funded in September, 2014 and ethics was approved in November, 2014. Subject recruitment will begin January, 2015 and results are expected in December, 2015. Results of this study will determine (1) the effectiveness of an integrated Web-based prenatal mental health intervention on maternal and infant outcomes and (2) the feasibility of implementation of the intervention on a high-risk antenatal unit. Conclusions: This study will provide evidence and guidance regarding the implementation of a Web-based mental health program into routine hospital-based care for women with medically high-risk pregnancies.

  • SONIC study participant completing data collection procedures.

    Cross-Sectional Study of 24-Hour Urinary Electrolyte Excretion and Associated Health Outcomes in a Convenience Sample of Australian Primary Schoolchildren:...

    Abstract:

    Background: Dietary sodium and potassium are involved in the pathogenesis of cardiovascular disease. Data exploring the cardiovascular outcomes associated with these electrolytes within Australian children is sparse. Furthermore, an objective measure of sodium and potassium intake within this group is lacking. Objective: The primary aim of the Salt and Other Nutrient Intakes in Children (“SONIC”) study was to measure sodium and potassium intakes in a sample of primary schoolchildren located in Victoria, Australia, using 24-hour urine collections. Secondary aims were to identify the dietary sources of sodium and potassium, examine the association between these electrolytes and cardiovascular risk factors, and assess children’s taste preferences and saltiness perception of manufactured foods. Methods: A cross-sectional study was conducted in a convenience sample of schoolchildren attending primary schools in Victoria, Australia. Participants completed one 24-hour urine collection, which was analyzed for sodium, potassium, and creatinine. Completeness of collections was assessed using collection time, total volume, and urinary creatinine. One 24-hour dietary recall was completed to assess dietary intake. Other data collected included blood pressure, body weight, height, waist and hip circumference. Children were also presented with high and low sodium variants of food products and asked to discriminate salt level and choose their preferred variant. Parents provided demographic information and information on use of discretionary salt. Descriptive statistics will be used to describe sodium and potassium intakes. Linear and logistic regression models with clustered robust standard errors will be used to assess the association between electrolyte intake and health outcomes (blood pressure and body mass index/BMI z-score and waist circumference) and to assess differences in taste preference and discrimination between high and low sodium foods, and correlations between preference, sodium intake, and covariates. Results: A total of 780 children across 43 schools participated. The results from this study are expected at the end of 2015. Conclusions: This study will provide the first objective measure of sodium and potassium intake in Australian schoolchildren and improve our understanding of the relationship of these electrolytes to cardiovascular risk factors. Furthermore, this study will provide insight into child taste preferences and explore related factors. Given the cardiovascular implications of consuming too much sodium and too little potassium, monitoring of these nutrients during childhood is an important public health initiative.

  • Example of a personal NHL care pathway (personal section of the e-tool). Original is in Dutch.

    Development and Evaluation of an Educational E-Tool to Help Patients With Non-Hodgkin's Lymphoma Manage Their Personal Care Pathway

    Abstract:

    Background: An overload of health-related information is available for patients on numerous websites, guidelines, and information leaflets. However, the increasing need for personalized health-related information is currently unmet. Objective: This study evaluates an educational e-tool for patients with non-Hodgkin’s lymphoma (NHL) designed to meet patient needs with respect to personalized and complete health-related information provision. The e-tool aims to help NHL patients manage and understand their personal care pathway, by providing them with insight into their own care pathway, the possibility to keep a diary, and structured health-related information. Methods: Together with a multidisciplinary NHL expert panel, we developed an e-tool consisting of two sections: (1) a personal section for patients’ own care pathway and their experiences, and (2) an informative section including information on NHL. We developed an ideal NHL care pathway based on the available (inter)national guidelines. The ideal care pathway, including date of first consultation, diagnosis, and therapy start, was used to set up the personal care pathway. The informative section was developed in collaboration with the patient association, Hematon. Regarding participants, 14 patients and 6 laymen were asked to evaluate the e-tool. The 24-item questionnaire used discussed issues concerning layout (6 questions), user convenience (3 questions), menu clarity (3 questions), information clarity (5 questions), and general impression (7 questions). In addition, the panel members were asked to give their feedback by email. Results: A comprehensive overview of diagnostics, treatments, and aftercare can be established by patients completing the questions from the personal section. The informative section consisted of NHL information regarding NHL in general, diagnostics, therapy, aftercare, and waiting times. Regarding participants, 6 patients and 6 laymen completed the questionnaire. Overall, the feedback was positive, with at least 75% satisfaction on each feedback item. Important strengths mentioned were the use of a low health-literacy level, the opportunity to document the personal care pathway and experiences, and the clear overview of the information provided. The added value of the e-tool in general was pointed out as very useful for preparing the consultation with one’s doctor and for providing all information on one website, including the opportunity for a personalized care pathway and diary. The majority of the revisions concerned wording and clarity. In addition, more explicit information on immunotherapy, experimental therapy, and psychosocial support was added. Conclusions: We have developed a personal care management e-tool for NHL patients. This tool contains a unique way to help patients manage their personal care pathway and give them insight into their NHL by providing health-related information and a personal diary. This evaluation showed that our e-tool meets patients’ needs concerning personalized health-related information, which might serve as a good example for other oncologic diseases. Future research should focus on the possible impact of the e-tool on doctor-patient communication during consultations.

  • By imagerymajestic, published on 29 November 2012, Stock Photo - image ID: 100121240; http://www.freedigitalphotos.net/images/On_The_Phone_g371-Female_Doctor_Talking_On_Cell_Phone_p121240.html.

    The Telehealth Skills, Training, and Implementation Project: An Evaluation Protocol

    Abstract:

    Background: Telehealth appears to be an ideal mechanism for assisting rural patients and doctors and medical students/registrars in accessing specialist services. Telehealth is the use of enhanced broadband technology to provide telemedicine and education over distance. It provides accessible support to rural primary care providers and medical educators. A telehealth consultation is where a patient at a general practice, with the assistance of the general practitioner or practice nurse, undertakes a consultation by videoconference with a specialist located elsewhere. Multiple benefits of telehealth consulting have been reported, particularly those relevant to rural patients and health care providers. However there is a paucity of research on the benefits of telehealth to medical education and learning. Objective: This protocol explains in depth the process that will be undertaken by a collaborative group of universities and training providers in this unique project. Methods: Training sessions in telehealth consulting will be provided for participating practices and students. The trial will then use telehealth consulting as a real-patient learning experience for students, general practitioner trainees, general practitioner preceptors, and trainees. Results: Results will be available when the trial has been completed in 2015. Conclusions: The protocol has been written to reflect the overarching premise that, by building virtual communities of practice with users of telehealth in medical education, a more sustainable and rigorous model can be developed. The Telehealth Skills Training and Implementation Project will implement and evaluate a theoretically driven model of Internet-facilitated medical education for vertically integrated, community-based learning environments

  • Schematic diagram of running man and AAEI estimation. ( The image is a composite of Microsoft office.com (free for public use) ).

    An Accumulated Activity Effective Index for Promoting Physical Activity: A Design and Development Study in a Mobile and Pervasive Health Context

    Abstract:

    Background: Increased physical activity has become a principal personal health goal worldwide because sufficient physical activity can reduce the risk of many adverse conditions. Motivating individuals to increase their levels of physical activity can increase life expectancy and contribute to a healthy life. Sharing and comparison of physical activity information by using the Internet, with fewer privacy concerns, might also help encourage people to promote and maintain sufficient physical activity. To promote and manage physical activity, an accumulated activity effective index (AAEI) is proposed in this paper. Objective: The purpose of the AAEI design is to maintain and promote physical activity. The public can easily accept a clear indicator that reveals the current status of physical activity. The AAEI is not only an assessment and tracking tool for personal physical activity, but is also useful for goal setting and for sharing content with the Internet community. Methods: The AAEI is derived from input in the form of accumulated physical activity, and evaluates the status of physical activities and days spent exercising. The term AAEI(t1,t2) is an index of the accumulated physical activity in the time interval (t1,t2), where the base unit of time is the day. The AAEI is determined according to accumulated physical activity and is adjusted using the previous status of physical activity. The previous status of physical activity is estimated according to the number of days spent exercising and the accumulated physical activity that has been performed. An analysis of the AAEI performance was conducted using a simulation model and a real-world trial with 2 participants. Results: The AAEI increased as the physical activity and days spent exercising accumulated. Conversely, the AAEI decreased with lack of physical activity and increased resting days. In simulation, the shape of the AAEI line indicated different types of exercise. The moving average AAEI represented long-term exercise. In the real-world trial, the AAEI confirmed that the simulation results were comparable to actual conditions. Conclusions: The AAEI proposed in this paper is a method that can be used to evaluate the status of a person’s physical activity. The AAEI is a simple numeric indication that is estimated by analyzing accumulated physical activity and the average number of days spent exercising. The AAEI is suitable for tracking personal physical activity, reminding the user of achievement goals, and allows data sharing by using the Internet. The results have demonstrated that the AAEI is a useful tool for physical activity management.

  • Photo of one of our participants wearing the accelerometer during daily life (in Amsterdam).

    Do Extreme Values of Daily-Life Gait Characteristics Provide More Information About Fall Risk Than Median Values?

    Abstract:

    Background: Gait characteristics estimated from daily-life trunk accelerations reflect gait quality and are associated with fall incidence in older adults. While associations are based on median values of these gait characteristics, their extreme values may reflect either high-risk situations or steady-state gait and may thus be more informative in relation to fall risk. Objective: The objective of this study was to improve fall-risk prediction models by examining whether the use of extreme values strengthens the associations with falls. Methods: Trunk acceleration data (Dynaport MoveMonitor) were collected from 202 older adults over a full week. From all walking episodes, we estimated the median and, as reliable estimates of the extremes, the 10th and 90th percentiles of gait characteristics, all over 10-second epochs. In addition, the amount of daily activities was derived from the acceleration data, and participants completed fall-risk questionnaires. Participants were classified as fallers based on one or more falls during 6 months of follow-up. Univariate analyses were performed to investigate whether associations with falls were stronger for the extremes than for the medians. Subsequently, three fall-risk models were compared: (1) using questionnaire data only, (2) adding the amount of activities and medians of gait characteristics, and (3) using extreme values instead of medians in the case of stronger univariate associations of the extremes. Results: Stronger associations were found for the extreme characteristics reflecting high regularity, low frequency variability, and low local instability in anterior-posterior direction, for high symmetry in all directions and for low entropy in anterior-posterior and vertical directions. The questionnaire-only model improved significantly by adding activities and gait characteristics’ medians. Replacing medians by extremes with stronger associations did improve the fall prediction model, but not significantly. Conclusions: Associations were stronger for extreme values, indicating “high gait quality” situations (ie, 10th and 90th percentiles in case of positive and negative associations, respectively) and not for “low gait quality” situations. This suggests that gait characteristics during optimal performance gait provide more information about the risk of falling than high-risk situations. However, their added value over medians in prediction is limited.

  • Permission to use this image has been granted by thinkstockphotos.com.

    Text Messaging to Improve Hypertension Medication Adherence in African Americans: BPMED Intervention Development and Study Protocol

    Abstract:

    Background: Hypertension (HTN) is a major public health concern in the United States, with almost 78 million Americans age 20 years and over suffering from the condition. Moreover, HTN is a key risk factor for health disease and stroke. African Americans disproportionately shoulder the burdens of HTN, with greater prevalence, disease severity, earlier onset, and more HTN-related complications than age-matched whites. Medication adherence for the treatment of HTN is poor, with estimates indicating that only about half of hypertensive patients are adherent to prescribed medication regimens. Although no single intervention for improving medication adherence has emerged as superior to others, text message medication reminders have the potential to help improve medication adherence in African Americans with uncontrolled HTN as mobile phone adoption is very high in this population. Objective: The purpose of this two-phased study was to develop (Phase I) and test in a randomized controlled trial (RCT) (Phase II) a text message system, BPMED, to improve the quality of medication management through increasing medication adherence in African Americans with uncontrolled HTN. Methods: In Phase I, we recruited 16 target end-users from a primary care clinic, to assist in the development of BPMED through participating in one of three focus groups. Focus groups sought to gain patient perspectives on HTN, medication adherence, mobile phone use, and the use of text messaging to support medication adherence. Potential intervention designs were presented to participants, and feedback on the designs was solicited. In Phase II, we conducted two pilot RCTs to determine the feasibility, acceptability, and preliminary efficacy of BPMED in primary care and emergency department settings. Both pilot studies recruited approximately 60 participants, who were randomized equally between usual care and the BPMED intervention. Results: Although data collection is now complete, data analysis from the two pilot RCTs is still ongoing and results are expected in 2015. Conclusions: This study was designed to determine preliminary feasibility and acceptability of our approach among African Americans with uncontrolled HTN in primary care and emergency department settings. Results from these studies are of great interest as little work has been done to document the use of text message medication reminders to improve HTN-related outcomes, particularly within underserved urban minorities. Trial Registration: Clinicaltrials.gov NCT01465217; https://clinicaltrials.gov/ct2/show/NCT01465217 (Archived by WebCite at http://www.webcitation.org/6V0tto0lZ).

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  • The Use of Virtual World-based Cardiac Rehabilitation to Encourage Healthy Lifestyle Choices Among Cardiac Patients: Intervention Development and Pilot Study Protocol

    Date Submitted: Jan 25, 2015

    Open Peer Review Period: Jan 26, 2015 - Feb 11, 2015

    Background: Despite proven benefits through the secondary prevention of cardiovascular disease (CVD) and reduction of mortality, cardiac rehabilitation (CR) remains underutilized in cardiac patients....

    Background: Despite proven benefits through the secondary prevention of cardiovascular disease (CVD) and reduction of mortality, cardiac rehabilitation (CR) remains underutilized in cardiac patients. Underserved populations most affected by CVD including rural residents, low socioeconomic status patients and racial/ethnic minorities, have the lowest participation rates due to access barriers. Internet-and mobile-based lifestyle interventions have emerged as potential modalities to complement and increase accessibility to CR. An outpatient CR program using virtual world technology may provide an effective alternative to conventional CR by overcoming patient access limitations such as geographics, work schedule constraints and transportation. Objective: The objective of this paper is to describe the research protocol of a two-phased, pilot study that will assess the feasibility (Phase 1) and comparative effectiveness (Phase 2) of a virtual world-based (Second Life®) CR program as an extension of a conventional CR program in achieving healthy behavioral change among post-acute coronary syndrome (ACS) and post-percutaneous coronary intervention (PCI) patients in comparison to a conventional CR program. We hypothesize that virtual world CR users will improve behaviors (physical activity, diet, smoking) to a greater degree than conventional CR participants. Methods: In Phase 1, we will recruit at least 10 patients enrolled in outpatient CR who were recently hospitalized for an ACS (unstable angina, ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction) or who recently underwent elective PCI at Mayo Clinic Hospital, Rochester Campus in Rochester, MN with at least one modifiable, lifestyle risk factor target (sedentary lifestyle, unhealthy diet and current smoking). Recruited patients will participate in a 12-week, virtual world health education program which will provide feedback on the feasibility, usability and design of the intervention. During Phase 2, we will conduct a 2-arm, parallel group, single-center, randomized controlled trial (RCT). Patients will be randomized at a 1:1 ratio to adjunct virtual world-based CR with conventional CR or conventional CR only. The primary outcome is a composite including at least one of the following: at least 150 minutes per week of physical activity, consumption of five or more fruits and vegetables daily and smoking cessation. Patients will be assessed at 3, 6 and 12 months. Results: The Phase 1 feasibility study is currently open for recruitment which will be followed by the Phase 2 RCT. The anticipated completion date for the study is May 2016. Conclusions: Research on the use of virtual world technology in health programs is in its infancy. It offers unique advantages over current web-based health interventions including social interactivity and active learning. It also increases accessibility to vulnerable populations who have higher burdens of CVD. This study will yield results on the effectiveness of a virtual world-based CR program as an innovative platform to influence healthy lifestyle behavior and self-efficacy. Clinical Trial: In process

  • Study protocol: A randomized controlled study of exposure therapy as aftercare for alcohol use disorder

    Date Submitted: Jan 16, 2015

    Open Peer Review Period: Jan 19, 2015 - Feb 2, 2015

    Background: Individuals with alcohol use disorder respond relatively well during outpatient treatment, but a significant proportion of individuals relapse after treatment when confronted with alcohol...

    Background: Individuals with alcohol use disorder respond relatively well during outpatient treatment, but a significant proportion of individuals relapse after treatment when confronted with alcohol in real life. Cue Exposure Treatment (CET) focuses on confronting alcohol cues in order to reduce cravings as well as the likelihood of relapse. Objectives: The objectives of the study are; 1.) To investigate whether CET aftercare delivered via a smartphone or in group sessions increases the efficiency of Cognitive Behavioural Treatment in groups of alcohol dependent individuals, 2.) To investigate whether CET as a smartphone application is as or more effective than CET group therapy, and 3.) To investigate whether CET as a smartphone application is more cost-effective than CET group aftercare and Aftercare as Usual. Methods: The study is implemented as an investigator-blinded randomized controlled trial. A total of 300 consecutively enrolled alcohol use disorder individuals recruited from an alcohol outpatient clinic will be randomized to one of the three following aftercare groups following conclusion of primary treatment: (1) CET as a smartphone application; (2) CET as group therapy, and (3) Standard aftercare treatment. It is hypothesized that the two experimental groups will achieve better treatment outcomes as compared to the control group (3). Perspectives: The individuals in the CET groups are given the opportunity to practice coping strategies during exposure to alcohol stimuli before they unavoidably are confronted with alcohol and associated stimuli in real life. Thus, CET may help prevent relapse after ended treatment and in the long term. Moreover, the CET application has the potential to improve AUD treatment and continuing care by offering psychological treatment anywhere and when the patient find it convenient. Protocol ID: Cue Exposure Study, RESCueH ClinicalTrials.gov ID: NCT02298751

  • Perceptions towards Video Technologies and Augmented Reality in Psychiatry Education: Initial Results and Further Study Protocol

    Date Submitted: Jan 16, 2015

    Open Peer Review Period: Jan 19, 2015 - Feb 2, 2015

    Abstract Background: Over the past decade, there have been major advances in terms of Web 2.0 technologies as well as in terms of smartphone-based technologies that will definitely have an impact on...

    Abstract Background: Over the past decade, there have been major advances in terms of Web 2.0 technologies as well as in terms of smartphone-based technologies that will definitely have an impact on the way undergraduate and postgraduate students learn. In psychiatry, the most recent application of these advances has been in the usage of tele-technologies for training, educational smartphone applications and virtual reality technologies in role-play simulation. Several other disciplines have described the added efficacy of augmentation of students’ education needs using video technologies and augmented reality. There are currently no studies looking into the educational efficacy of videos and augmented reality specifically for psychiatry. Objective: The objectives of the current research are thus to (a) set up an online video vault and integrate augmented reality technologies into our hardcopy textbook, (b) to determine whether undergraduates students are amenable towards clinical psychiatry videos as an added aid for learning and (c) to determine whether students are amenable towards augmented reality technologies in enhancing their learning experiences in psychiatry. Methodology: We have described the methodology involved in setting up the online video vault, as well as in integrating augmented reality technologies into our hardcopy textbook. All of the students were provided with information about the portal and shown a demonstration on the first day of their clinical posting. A user perspective survey was administered to the students, right after the completion of their end of posting clinical assessment, looking specifically into initial student’s perception of the features made available to them. Results: Since the introduction of the online video portal to the undergraduate students till the end of their final examinations in January 2014, there has been a cumulative total of 58,635 independent views of the videos online. For the augmented reality features incorporated, a response rate of 78.3% was obtained for the interactive elements on the cover pages and a response rate of 83.3% was obtained for the interactive elements on the OSCE grids in the book. A total of 185 students participated in the perspective survey and 92.5% of the students perceive that clinical OSCE videos have been helpful for their psychiatry education. Further statistical analysis conducted revealed there is also no noted difference between gender and student’s perception of having clinical OSCE videos (χ²= 1.278, p=0.865). Conclusions: This is one of the initial studies that have demonstrated the likely effectiveness of including videos to augment psychiatry education, and one of the first studies to determine student’s perception of using augmented reality in psychiatry. We hope that further data could be acquired, to determine why student are receptive towards video and augmented technologies in the second phase of this study.

  • Scoping review of reviews protocol: Mapping a decade of physical activity interventions for primary prevention

    Date Submitted: Jan 15, 2015

    Open Peer Review Period: Jan 19, 2015 - Feb 2, 2015

    Background: Physical activity is a key behavioural component for the primary prevention of non-communicable disease. The uptake of physical activity is influenced by both individual and broader factor...

    Background: Physical activity is a key behavioural component for the primary prevention of non-communicable disease. The uptake of physical activity is influenced by both individual and broader factors including social, economic, and environmental conditions. Despite decades of interventions, physical activity levels continue to decrease globally across all age groups, which has given rise to disease and illness. Objective: This paper describes a scoping review of reviews protocol (SRR) that aims to map a decade of physical activity interventions promoting primary prevention. We used a population-based approach to design the study and highlighted factors relating to health equity that could influence physical activity participation. Methods: This paper describes five stages of a SRR design. Each stage was adapted from Arksey and O’Malley’s 2005 seminal scoping review methodology. We include a description of an iterative research team process used to design the SRR methods. The search strategy includes the following databases: Sport Discus, PubMed, Scopus, the Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycInfo and Educational Resources Information Centre (ERIC). We will summarize a decade of physical activity intervention reviews that include diverse review methodologies. Results: Two reviewers independently screened eligible studies and compared results to determine the final study selection. One reviewer will conduct the data extraction; a second reviewer will assess the results to ensure comprehensiveness and accuracy Conclusions: This paper describes a SRR protocol that aims to comprehensively map physical activity interventions for primary prevention. The goal of the SRR is to chart intervention trends and inform future directions in physical activity intervention research using a population-based approach.

  • Rationale and design of the Cognitive Impairment in Diabetes (Cog-ID) study

    Date Submitted: Jan 11, 2015

    Open Peer Review Period: Jan 16, 2015 - Jan 30, 2015

    Background: Cognitive impairment frequently co-occurs with type 2 diabetes (T2DM), but is often undiagnosed. Cognitive impairment affects self-management leading to treatment-related complications. Ob...

    Background: Cognitive impairment frequently co-occurs with type 2 diabetes (T2DM), but is often undiagnosed. Cognitive impairment affects self-management leading to treatment-related complications. Objective: This paper describes the Cognitive Impairment in Diabetes (Cog-ID) study which aims to develop a stepped diagnostic procedure, consisting of a screening test complemented by an evaluation by a general practitioner (GP) to detect undiagnosed cognitive impairment in older people with T2DM. Methods: The accuracy of two self-administered cognitive tests, the “Test Your Memory” (TYM) and “Self-Administered Gerocognitive Examination” (SAGE) alone, and in combination with an evaluation by a GP will be assessed. A diagnosis of mild cognitive impairment (MCI) or dementia at a memory clinic will serve as reference standard. The Cog-ID study will include 513 people from primary care aged ≥70 with T2DM. First, participants fill out the TYM and SAGE. Second, a standardized GP-evaluation for cognitive impairment, including a MMSE, will be performed. Subsequently, participants suspected of cognitive impairment (on either test or GP-assessment) and a random sample of 15% of participants without suspicion will be referred to the memory clinic. In the last step, the memory clinic, a medical examination, neuropsychological examination and MRI will be performed. Participants also fill out questionnaires assessing health status and depressive symptoms at baseline and after 6 and 24 months. Results: NA Conclusions: With the results physicians will be able to detect cognitive impairment that is already bothering patients through case-finding and can apply tailored care to reduce complications. In addition the results will form a base for the discussion whether early recognition of cognitive impairment is desirable.