Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Oct 19, 2022
Date Accepted: Mar 10, 2023
Effectiveness of an immersive telemedicine platform for delivering diabetes medical group visits for African American/ Black and Hispanic/ Latina women with uncontrolled diabetes: The Women in Control 2.0 non-inferiority randomized clinical trial
ABSTRACT
Background:
Medically underserved persons with type 2 diabetes face limited access to group-based diabetes care, placing them at risk for poor disease control and complications. Immersive technology and telemedicine solutions could bridge this gap.
Objective:
To compare the effectiveness of diabetes medical group visits (DMGVs) delivered in an immersive telemedicine platform versus an in-person setting and establish non-inferiority of the technology-enabled approach for changes in Hemoglobin A1c (HbA1c) and physical activity (measured in metabolic equivalents of task, or MET) at 6 months.
Methods:
Non-inferiority randomized controlled trial conducted from February 2017 to December 2019 at an urban safety-net health system and community health center. We enrolled adult women (≥18 years) who self-identified as African American/ Black and/or Hispanic/Latina with type 2 diabetes and HbA1c≥ 8.0%. Participants attended eight weekly DMGVs, which included diabetes self-management education, peer support, and clinician counseling using a culturally adapted curriculum in English or Spanish. In-person participants convened in clinical settings, while virtual world participants met remotely via an avatar-driven, 3-dimensional virtual world linked to video teleconferencing. Follow-up occurred 6 months post-enrollment. Primary outcomes were mean changes in HbA1c and physical activity at six months, with non-inferiority margins of 0.7% and 12 MET-hours, respectively. Secondary outcomes included changes in diabetes distress and depressive symptoms.
Results:
Of 309 female participants, (mean age, 55 years [SD, 10.6]; 63% African American/ Black; 34% Hispanic/ Latina; 151 in person, 158 virtual world), 207 (67%) met per-protocol criteria. In the intention-to-treat, we confirmed non-inferiority for primary outcomes. We found similar improvements in mean HbA1c by group at six months [in-person: -0.8 [SD, 1.9]%; virtual world: -0.5 [SD, 1.8]%; mean difference: 0.3, 97.5% CI: (-∞, 0·3); p<0.001]. There were no detectable improvements in physical activity, however [in person: -6.5 [SD, 43.6]; virtual world: -9.6 [SD, 44.8] MET-hours; mean difference -3.1, 97.5% CI: (-6.9, ∞); p=0.02]. The proportion of participants with significant diabetes distress and depressive symptoms at six months decreased in both groups.
Conclusions:
In this non-inferiority randomized controlled trial, immersive telemedicine was a non-inferior platform for delivering diabetes care, eliciting comparable glycemic control improvement and enhancing patient engagement, compared to in-person DMGVs. Clinical Trial: ClinicalTrials.gov, NCT02726425.
Citation
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