Clinical Trials Directory

Trials / Completed

CompletedNCT02726425

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)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
309 (actual)
Sponsor
Boston Medical Center · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALDiabetes Self Management Medical Group VisitsThe 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.

Timeline

Start date
2015-07-01
Primary completion
2020-05-01
Completion
2020-05-01
First posted
2016-04-01
Last updated
2020-09-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02726425. Inclusion in this directory is not an endorsement.