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Design and Methods for a Comparative Effectiveness Pilot Study: Virtual World vs. Face-to-Face Diabetes
Milagros C Rosal1, Robin Heyden, Roanne Mejilla
1University of Massachusetts Medical School, Division of Preventive and Behavioral Medicine, Worcester, MA, United States. milagros.rosal@umassmed.edu.
JMIR Research Protocols
|April 25, 2013
Summary
This pilot study tested a virtual world diabetes self-management intervention for African American women. Results will inform future trials on technology-based health disparities solutions.
Area of Science:
- Health disparities research
- Technology-based health interventions
- Diabetes self-management
Background:
- Type 2 diabetes disproportionately affects minority groups, including African Americans, exacerbating health disparities.
- Limited treatment access and high attrition rates worsen diabetes outcomes in minority populations.
- Technology-based interventions show promise for improving access but require feasibility and effectiveness evidence, especially for those with lower educational attainment and computer literacy.
Purpose of the Study:
- To compare the feasibility and potential efficacy of a virtual world (VW) diabetes self-management intervention against a traditional face-to-face format.
- To assess engagement levels in the VW intervention compared to the face-to-face control group.
- To evaluate the potential impact on physiological and behavioral outcomes related to diabetes self-management.
Main Methods:
- A pilot randomized clinical trial involving 100 African American women with uncontrolled type 2 diabetes.
- Randomization into either a virtual world (VW) intervention or a face-to-face control group, both delivering the same curriculum over eight sessions.
- Assessment of feasibility through participant engagement (session completion) and potential efficacy through changes in glycemic control and self-management behaviors.
Main Results:
- The study's primary outcomes are the feasibility of the VW intervention and its potential efficacy on glucose control and self-management behaviors.
- Comparisons will be made against the face-to-face control condition.
- Statistical analyses include Kolmogorov-Smirnov tests, binomial tests, and t tests to evaluate changes in variable distributions and proportions.
Conclusions:
- The findings will determine if the virtual world intervention is feasible and promising for this population.
- If successful, the intervention will be advanced to a larger randomized controlled trial (RCT).
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