Women in Control: A Virtual World Study of Diabetes Self-Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Women in Control: A Virtual World Study of Diabetes Self-Management. Translational Research to Improve Diabetes and Obesity Outcomes (R01)

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Diabetes Self Management Medical Group Visits


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Second Life Participants<br>Half of participants will receive the Diabetes Self Management Medical Group Visits intervention while meeting in the virtual world (Second Life platform) | Behavioral: Diabetes Self Management Medical Group Visits<br>* 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.<br>|
| Active Comparator: Face-to-Face Participants<br>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. | Behavioral: Diabetes Self Management Medical Group Visits<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity level | Participants will wear an activity monitor for a week at each collection point. Results measured in METs/hr. | 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 | Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Activation | Measured by change in PAM 13 score | 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 | Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up | 
| Depression | Change in Patient Health Questionnaire (PHQ8) score | 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. | 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 | Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up | 
| Dietary Habits | Multiple measures of 24-hr dietary recall | Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up | 
| Functional Status | Measured by Sheehan disability scale | Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up | 
| Stress | Measured by perceived stress scale (PSS-10) | Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up | 
| Social Support | Measured by MOS social support survey | 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 | Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes self management, Second Life platform, Medical group visits