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



Status:Recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:8/24/2018
Start Date:July 2015
End Date:June 2020
Contact:Suzanne E Mitchell, MD, MS
Email:suzanne.mitchell@bmc.org

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

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.

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.
We found this trial at
1
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Boston, Massachusetts 02118
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Boston, MA
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