Design and Methods for a Comparative Effectiveness Pilot Study: Virtual World vs. Face-to-Face Diabetes Self-Management

Abstract

BackgroundType 2 diabetes (diabetes) is a serious threat to public health in the United States and disproportionally affects many racial/ethnic minority groups, including African Americans. Limited access to treatment and high attrition rates further contribute to health disparities in diabetes-related morbidity and mortality among minorities. Greater opportunities for increasing access and decreasing barriers to treatment are needed. Technology-based interventions have potential for accomplishing this goal but evidence of feasibility and potential effectiveness is lacking, especially for populations that traditionally have limited educational attainment and low computer literacy.ObjectiveThis paper describes the design and methods of a pilot randomized clinical trial that will compare the feasibility and potential efficacy of delivering a diabetes self-management intervention via a virtual world vs. a face-to-face format.MethodsStudy participants (n=100) will be African American women with uncontrolled type 2 diabetes recruited from primary care practices and affiliated health centers at a large safety net hospital in Massachusetts. Participants will be randomized into a virtual world-based (VW) intervention condition or a face-to-face control condition. Both conditions provide the same theory-based curriculum and equivalent exposure to the self-management program (eight group sessions), and both will be delivered by a single intervention team (a dietitian and a diabetes educator). Assessments will be conducted at baseline and 4 months. Feasibility will be determined by evaluating the degree to which participants engage in the VW-based intervention compared to face to face (number of sessions completed). Potential efficacy will be determined by comparing change in physiological (glycemic control) and behavioral (self-reported dietary intake, physical activity, blood glucose self-monitoring, and medication adherence) outcomes between the experimental and control groups.ResultsThe primary outcomes of interest are feasibility of the VW intervention and its potential efficacy on glucose control and diabetes self-management behaviors, compared to the face-to-face condition. Analysis will use a two-sample Kolmogorov-Smirnov test for changes in variable distribution. P values will be calculated using binomial tests for proportions and t tests for continuous variables.ConclusionsIf the intervention is found to be feasible and promising, it will be tested in a larger RCT.

A Virtual World Versus Face-to-Face Intervention Format to Promote Diabetes Self-Management Among African American Women: A Pilot Randomized Clinical Trial

“…A randomized clinical trial design was used. A detailed description of the study methods has already been published [ 20 ]. The Institutional Review Boards at Boston Medical Center and the University of Massachusetts Medical School approved the trial, and all participants provided written consent prior to participating in the trial.…”

“…The first session used an individual format followed by eight weekly 90-minute group sessions (group size was 8-9 participants). A single intervention team (a registered dietitian who is a certified diabetes educator, and a nurse practitioner), trained in behavioral counseling and motivational interviewing principles, delivered all sessions in the virtual world environment or face-to-face using the same protocol consisting of a detailed intervention manual and materials (intervention delivery methods are described in greater detail elsewhere) [ 20 ]. Intervention fidelity was monitored, and providers were given feedback on behavioral counseling process and content.…”

eHealth technologies to support nutrition and physical activity behaviors in diabetes self-management

“…T2DM self-management education can be delivered in a virtual reality environment or in a traditional in-person format. These methods were compared in a study which used a multidisciplinary team (dietitian, diabetes educator, and nurse practitioner) to deliver care to the participant in an initial individual consult, followed by eight group sessions at weekly intervals 60. The eHealth intervention used food exhibits and exercise facilities in a virtual world.…”

InsuOnline, a Serious Game to Teach Insulin Therapy to Primary Care Physicians: Design of the Game and a Randomized Controlled Trial for Educational Validation

“…The inclusion of game elements adds entertainment to the learning experience, increasing the intrinsical motivation of the learner to practice and to learn, making the learning experience more enjoyable and potentially more effective [39]. For these reasons, games can be a more interesting and successful approach to CME than simulators and other forms of distance education, such as virtual world interventions [40] or telemedicine consultations [41]. …”