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Diabetes Learning in Virtual Environments: Testing the Efficacy of Self-Management Training and Support in Virtual Environments (Randomized Controlled Trial Protocol)

Vorderstrasse, Allison A.; Melkus, Gail D.; Pan, Wei; Lewinski, Allison A.; Johnson, Constance M.

doi: 10.1097/NNR.0000000000000128
Brief Report

Background: Ongoing self-management improves outcomes for those with Type 2 diabetes (T2D); however, there are many barriers to patients receiving assistance in this from the healthcare system and peers. Findings from our pilot study showed that a virtual diabetes community on the Internet with real-time interaction among peers with T2D—and with healthcare professionals—is feasible and has the potential to influence clinical and psychosocial outcomes.

Objective: The purpose of this article is to present the protocol for the Diabetes Learning in Virtual Environments (LIVE) trial.

Protocol: Diabetes LIVE is a two-group, randomized controlled trial to compare effects of a virtual environment and traditional Web site on diet and physical activity. Our secondary aims will determine the effects on metabolic outcomes; effects of level of engagement and social network formation in LIVE on behavioral outcomes; potential mediating effects of changes in self-efficacy; and diabetes knowledge, diabetes-related distress, and social support on behavior change and metabolic outcomes. We will enroll 300 subjects at two sites (Duke University/Raleigh-Durham, NC and New York University/New York, NY) who have T2D and do not have serious complications or comorbidities. Those randomly assigned to the intervention group have access to the LIVE site where they can find information, synchronous classes with diabetes educators, and peer support to enhance self-management. Those in the control group have access to the same informational and educational content in a traditional asynchronous Web format. Measures of self-management, clinical outcomes, and psychosocial outcomes are assessed at baseline and 3, 6, 12, and 18 months.

Discussion: Should LIVE prove effective in improved self-management of diabetes, similar interventions could be applied to other prevalent chronic diseases. Innovative programs such as LIVE have potential for improving healthcare access in an easily disseminated alternative model of care that potentially improves the reach of self-management training and support.

Allison A. Vorderstrasse, DNSc, APRN-BC, is Associate Professor, Duke University School of Nursing and School of Medicine, Durham, North Carolina.

Gail D. Melkus, EdD, C-NP, FAAN, is Associate Dean for Research and Florence and William Downs Professor in Nursing Research, New York University College of Nursing.

Wei Pan, PhD, is Associate Professor and Biostatistician; Allison A. Lewinski, MPH, RN, is PhD Student; and Constance M. Johnson, PhD, RN, FAAN, is Associate Professor, Duke University School of Nursing and School of Medicine, Durham, North Carolina.

Accepted for publication August 17, 2015.

The authors acknowledge that this study is funded by a grant from the National Institutes of Health, National Heart, Lung, Blood Institute (1R01-HL118189-01). The Diabetes LIVE protocol is registered at clinicaltrials.gov. The registration number is: NCT02040038.

The authors declare no conflicts of interest.

Corresponding author: Allison A. Vorderstrasse, DNSc, APRN-BC, Duke University School of Nursing, 307 Trent Drive, DUMC 3322, Durham, NC 27710 (e-mail: allison.vorderstrasse@duke.edu).

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