Women in Control: A Virtual World Study of Diabetes Self-Management
- Conditions
- Diabetes Mellitus
- Interventions
- Behavioral: Diabetes Self Management Medical Group Visits
- Registration Number
- NCT02726425
- Lead Sponsor
- Boston Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 309
- Diagnosed with type 2 diabetes mellitus (documented in the medical chart)
- Last recorded HbA1c >8.0
- Currently treated with diet, oral hypoglycemic agents or insulin
- Black/African American or Hispanic/Latina origin
- Has telephone access
- Able to understand and participate in study protocol
- Functionally capable of meeting the activity goals
- Understand and give informed consent
- Physician approval to participate in study
- Can communicate in English or Spanish
- History of diabetic ketoacidosis
- Currently or planning pregnancy
- Unable or unwilling to provide informed consent
- Plans to leave area within 6 month study period that would interfere with ability to attend 8 weekly sessions and/or 6 month follow up
- Required intermittent glucocorticoid therapy within past 3 months.
- Experienced acute coronary event (myocardial infarction or unsable angina) within previous 6 months
- Medical condition that precludes adherence to study dietary recommendations (i.e. Crohn's, ulcerative colitis, etc)
- Medical or serious psychiatric illness (dementia, suicidal within last 5 months, psychiatric hospitalization). Those with diagnosis of depression or who take antidepressents are eligible.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Second Life Participants Diabetes Self Management Medical Group Visits Half of participants will receive the Diabetes Self Management Medical Group Visits intervention while meeting in the virtual world (Second Life platform) Face-to-Face Participants Diabetes Self Management Medical Group Visits The other half of the participants will receive the Diabetes Self Management Medical Group Visitsintervention while meeting face-to-face in person at Boston Medical Center.
- Primary Outcome Measures
Name Time Method Change in physical activity level Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up Participants will wear an activity monitor for a week at each collection point. Results measured in METs/hr.
Change in disease control (HbA1c) Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up Change in HbA1c from BMC laboratory blood testing results
- Secondary Outcome Measures
Name Time Method Stress Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up Measured by perceived stress scale (PSS-10)
Health-Related Quality of Life Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up Change in Q-LES-Q screening survey
Functional Status Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up Measured by Sheehan disability scale
Improvement in cholesterol, hypertension and body weight Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up Serum LDL/HDL from BMC laboratory results. BP from home blood pressure monitor readings. BMI from weight/height measurements.
Patient Activation Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up Measured by change in PAM 13 score
Social Support Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up Measured by MOS social support survey
Health Service Utilization Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up Self-report and chart review of hospitalizations, PCP and specialist visits
Medication Adherence Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up Prescription fulfillment ratio per i2b2 database claims data analysis
Depression Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up Change in Patient Health Questionnaire (PHQ8) score
Dietary Habits Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up Multiple measures of 24-hr dietary recall
Trial Locations
- Locations (1)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States