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

NCT ID: NCT02726425

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 309 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2020-05-31

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Diabetes Self Management Medical Group Visits

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Diabetes Self Management Medical Group Visits

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzanne E Mitchell, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25212580 (View on PubMed)

Mitchell SE, Bragg A, De La Cruz BA, Winter MR, Reichert MJ, Laird LD, Moldovan IA, Parker KN, Martin-Howard J, Gardiner P. Effectiveness of an Immersive Telemedicine Platform for Delivering Diabetes Medical Group Visits for African American, Black and Hispanic, or Latina Women With Uncontrolled Diabetes: The Women in Control 2.0 Noninferiority Randomized Clinical Trial. J Med Internet Res. 2023 May 10;25:e43669. doi: 10.2196/43669.

Reference Type: DERIVED

PMID: 37163341 (View on PubMed)

Other Identifiers

1R01DK106531

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-34220

Identifier Type: -

Identifier Source: org_study_id