Clinical trial NCT02726425: Women in Control: A Virtual World Study of Diabetes Self-Management
Official title: Women in Control: A Virtual World Study of Diabetes Self-Management. Translational Research to Improve Diabetes and Obesity Outcomes (R01)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes self management
Second Life platform
Medical group visits
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
name: Boston University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-04-01
Enrollment: 309
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in physical activity level
timeFrame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
measure: Change in disease control (HbA1c)
timeFrame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Secondary outcomes:
measure: Patient Activation
timeFrame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
measure: Medication Adherence
timeFrame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
measure: Depression
timeFrame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
measure: Improvement in cholesterol, hypertension and body weight
timeFrame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
measure: Health-Related Quality of Life
timeFrame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
measure: Dietary Habits
timeFrame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
measure: Functional Status
timeFrame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
measure: Stress
timeFrame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
measure: Social Support
timeFrame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
measure: Health Service Utilization
timeFrame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Suzanne E Mitchell, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitchell SE, Mako M, Sadikova E, Barnes L, Stone A, Rosal MC, Wiecha J. The comparative experiences of women in control: diabetes self-management education in a virtual world. J Diabetes Sci Technol. 2014 Nov;8(6):1185-92. doi: 10.1177/1932296814549829. Epub 2014 Sep 10.