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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726425
• Other study ID #: H-34220
• Secondary ID: 1R01DK106531
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: May 2020

Study information

• Verified date: September 2020
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Boston Medical Center	Boston University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Sargent College of Health and Rehabilitation Sciences, University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

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