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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Diabetes Self Management Medical Group Visits

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
• Enrollment (Actual): 309
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	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.
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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Boston University; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Massachusetts, Worcester; Sargent College of Health and Rehabilitation Sciences
• Investigators: Principal Investigator: Suzanne E Mitchell, MD, MS, Boston Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: March 28, 2016
• First Submitted That Met QC Criteria: March 28, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Diabetes self management; Second Life platform; Medical group visits
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: H-34220; 1R01DK106531 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No