This study evaluates the comparative effectiveness of a diabetes self management (DSM) group medical visit in the virtual world (Second life) verses a face-to-face format, aimed to increase physical activity and improve glucose control among Black/African American and Hispanic women with uncontrolled diabetes mellitus.
The prevalence of diabetes mellitus (DM) in the US is disproportionately high among minority women. In order to participate as partners in healthcare, DM patients need self-management education and support. Diabetes self-management (DSM) support is effective in helping DM patients make good choices and achieve clinical goals but is difficult to deliver in medical practice settings. Virtual reality technology can assist DM patients and their clinical teams with DSM support by providing effective educational tools in an engaging, learner-centered context that fosters self-efficacy and skill proficiency. Our prior work demonstrated that virtual worlds, like Second Life (SL), are suitable for supporting DSM education for patients. SL, an Internet-based virtual world, is an example of an immersive, three-dimensional environment which supports social networking and interaction with information. The investigators now aim to enhance the existing diabetes curriculum using a medical group visit design to study whether the Women in Control virtual world group medical visit leads to similarly effective health and educational outcomes compared to face-to-face group medical visits. The investigators aims are to conduct a randomized, controlled trial of the comparative effectiveness of a virtual world DSM group medical visit format vs. a face-to-face DSM group visit format to increase physical activity and improve glucose control among Black/African American and Hispanic women with uncontrolled DM at six month follow up, and to conduct a qualitative, ethnographic study of participant engagement with the virtual world platform during the virtual world group sessions, between group sessions, and following completion of the eight-week curriculum to characterize learners' self-directed interactions with the technology platform and assess the correlation of these interactions with DSM behaviors and diabetes control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
309
The Women in Control DSM intervention involves: (1) 8-wk series of interactive, educational medical group visit sessions with groups of 10-12 participants, led by clinicians \& peer leaders lasting \~100'' in length conducted either in Spanish or English and (2) Individual consultation with a clinician lasting 10-15 minutes. Group visits will consist of experiential and discussion based learning of topics including the importance of diet, physical activity, medications, mindfulness and stress reduction to diabetes self management.
Boston Medical Center
Boston, Massachusetts, United States
Change in physical activity level
Participants will wear an activity monitor for a week at each collection point. Results measured in METs/hr.
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Change in disease control (HbA1c)
Change in HbA1c from BMC laboratory blood testing results
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Patient Activation
Measured by change in PAM 13 score
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Medication Adherence
Prescription fulfillment ratio per i2b2 database claims data analysis
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Depression
Change in Patient Health Questionnaire (PHQ8) score
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Improvement in cholesterol, hypertension and body weight
Serum LDL/HDL from BMC laboratory results. BP from home blood pressure monitor readings. BMI from weight/height measurements.
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Health-Related Quality of Life
Change in Q-LES-Q screening survey
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
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Dietary Habits
Multiple measures of 24-hr dietary recall
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Functional Status
Measured by Sheehan disability scale
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Stress
Measured by perceived stress scale (PSS-10)
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Social Support
Measured by MOS social support survey
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Health Service Utilization
Self-report and chart review of hospitalizations, PCP and specialist visits
Time frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up