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

• ClinicalTrials.gov Identifier: NCT02726425
• Recruitment Status: Completed
• First Posted: April 1, 2016
• Last Update Posted: September 4, 2020
• Sponsor: Boston Medical Center
• Collaborators: University of Massachusetts, Worcester; Sargent College of Health and Rehabilitation Sciences; Boston University; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Boston Medical Center

Tracking Information

• First Submitted Date: March 28, 2016
• First Posted Date: April 1, 2016
• Last Update Posted Date: September 4, 2020
• Study Start Date: July 2015
• Actual Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 28, 2016)

• Change in physical activity level [ Time Frame: 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) [ Time Frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up ]
  Change in HbA1c from BMC laboratory blood testing results

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 28, 2016)

• Patient Activation [ Time Frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up ]
  Measured by change in PAM 13 score
• Medication Adherence [ Time Frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up ]
  Prescription fulfillment ratio per i2b2 database claims data analysis
• Depression [ Time Frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up ]
  Change in Patient Health Questionnaire (PHQ8) score
• Improvement in cholesterol, hypertension and body weight [ Time Frame: 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.
• Health-Related Quality of Life [ Time Frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up ]
  Change in Q-LES-Q screening survey
• Dietary Habits [ Time Frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up ]
  Multiple measures of 24-hr dietary recall
• Functional Status [ Time Frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up ]
  Measured by Sheehan disability scale
• Stress [ Time Frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up ]
  Measured by perceived stress scale (PSS-10)
• Social Support [ Time Frame: Data collection at baseline, post-intervention (8 weeks) and at 6 months follow up ]
  Measured by MOS social support survey
• Health Service Utilization [ Time Frame: 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Diabetes Mellitus

Intervention

Behavioral: Diabetes Self Management Medical Group Visits

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.

Study Arms

• Experimental: Second Life Participants
  Half of participants will receive the Diabetes Self Management Medical Group Visits intervention while meeting in the virtual world (Second Life platform)
  Intervention: Behavioral: Diabetes Self Management Medical Group Visits
• Active Comparator: Face-to-Face Participants
  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.
  Intervention: Behavioral: Diabetes Self Management Medical Group Visits

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 6, 2020): 309
• Original Estimated Enrollment (submitted: March 28, 2016): 228
• Actual Study Completion Date: May 2020
• Actual Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02726425
• Other Study ID Numbers: H-34220; 1R01DK106531 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Boston Medical Center
• Original Responsible Party: Suzanne Mitchell, Boston Medical Center, Physician, Family Medicine
• Current Study Sponsor: Boston Medical Center
• Original Study Sponsor: Same as current

Collaborators

• University of Massachusetts, Worcester
• Sargent College of Health and Rehabilitation Sciences
• Boston University
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Suzanne E Mitchell, MD, MS; Boston Medical Center

• PRS Account: Boston Medical Center
• Verification Date: September 2020