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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
BACKGROUND: Medically underserved people with type 2 diabetes mellitus 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: The purpose of this study was to...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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JMIR Publications
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10209787/ https://www.ncbi.nlm.nih.gov/pubmed/37163341 http://dx.doi.org/10.2196/43669 |
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author | Mitchell, Suzanne E Bragg, Alexa De La Cruz, Barbara A Winter, Michael R Reichert, Matthew J Laird, Lance D Moldovan, Ioana A Parker, Kimberly N Martin-Howard, Jessica Gardiner, Paula |
author_facet | Mitchell, Suzanne E Bragg, Alexa De La Cruz, Barbara A Winter, Michael R Reichert, Matthew J Laird, Lance D Moldovan, Ioana A Parker, Kimberly N Martin-Howard, Jessica Gardiner, Paula |
author_sort | Mitchell, Suzanne E |
collection | PubMed |
description | BACKGROUND: Medically underserved people with type 2 diabetes mellitus 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: The purpose of this study was to compare the effectiveness of diabetes medical group visits (DMGVs) delivered in an immersive telemedicine platform versus an in-person (IP) setting and establish the noninferiority of the technology-enabled approach for changes in hemoglobin A(1c) (HbA(1c)) and physical activity (measured in metabolic equivalent of task [MET]) at 6 months. METHODS: This study is a noninferiority 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 (aged ≥18 years) who self-reported African American or Black race or Hispanic or Latina ethnicity and had type 2 diabetes mellitus and HbA(1c) ≥8%. Participants attended 8 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 (VW) participants met remotely via an avatar-driven, 3D VW linked to video teleconferencing. Follow-up occurred 6 months post enrollment. Primary outcomes were mean changes in HbA(1c) and physical activity at 6 months, with noninferiority 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, SD 10.6 years; n=195, 63% African American or Black; n=105, 34% Hispanic or Latina; n=151 IP; and n=158 in VW), 207 (67%) met per-protocol criteria. In the intention-to-treat analysis, we confirmed noninferiority for primary outcomes. We found similar improvements in mean HbA(1c) by group at 6 months (IP: –0.8%, SD 1.9%; VW: –0.5%, SD 1.8%; mean difference 0.3, 97.5% CI –∞ to 0.3; P<.001). However, there were no detectable improvements in physical activity (IP: –6.5, SD 43.6; VW: –9.6, SD 44.8 MET-hours; mean difference –3.1, 97.5% CI –6.9 to ∞; P=.02). The proportion of participants with significant diabetes distress and depressive symptoms at 6 months decreased in both groups. CONCLUSIONS: In this noninferiority randomized controlled trial, immersive telemedicine was a noninferior platform for delivering diabetes care, eliciting comparable glycemic control improvement, and enhancing patient engagement, compared to IP DMGVs. TRIAL REGISTRATION: ClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/ct2/show/NCT02726425 |
format | Online Article Text |
id | pubmed-10209787 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | JMIR Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-102097872023-05-26 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 Mitchell, Suzanne E Bragg, Alexa De La Cruz, Barbara A Winter, Michael R Reichert, Matthew J Laird, Lance D Moldovan, Ioana A Parker, Kimberly N Martin-Howard, Jessica Gardiner, Paula J Med Internet Res Original Paper BACKGROUND: Medically underserved people with type 2 diabetes mellitus 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: The purpose of this study was to compare the effectiveness of diabetes medical group visits (DMGVs) delivered in an immersive telemedicine platform versus an in-person (IP) setting and establish the noninferiority of the technology-enabled approach for changes in hemoglobin A(1c) (HbA(1c)) and physical activity (measured in metabolic equivalent of task [MET]) at 6 months. METHODS: This study is a noninferiority 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 (aged ≥18 years) who self-reported African American or Black race or Hispanic or Latina ethnicity and had type 2 diabetes mellitus and HbA(1c) ≥8%. Participants attended 8 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 (VW) participants met remotely via an avatar-driven, 3D VW linked to video teleconferencing. Follow-up occurred 6 months post enrollment. Primary outcomes were mean changes in HbA(1c) and physical activity at 6 months, with noninferiority 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, SD 10.6 years; n=195, 63% African American or Black; n=105, 34% Hispanic or Latina; n=151 IP; and n=158 in VW), 207 (67%) met per-protocol criteria. In the intention-to-treat analysis, we confirmed noninferiority for primary outcomes. We found similar improvements in mean HbA(1c) by group at 6 months (IP: –0.8%, SD 1.9%; VW: –0.5%, SD 1.8%; mean difference 0.3, 97.5% CI –∞ to 0.3; P<.001). However, there were no detectable improvements in physical activity (IP: –6.5, SD 43.6; VW: –9.6, SD 44.8 MET-hours; mean difference –3.1, 97.5% CI –6.9 to ∞; P=.02). The proportion of participants with significant diabetes distress and depressive symptoms at 6 months decreased in both groups. CONCLUSIONS: In this noninferiority randomized controlled trial, immersive telemedicine was a noninferior platform for delivering diabetes care, eliciting comparable glycemic control improvement, and enhancing patient engagement, compared to IP DMGVs. TRIAL REGISTRATION: ClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/ct2/show/NCT02726425 JMIR Publications 2023-05-10 /pmc/articles/PMC10209787/ /pubmed/37163341 http://dx.doi.org/10.2196/43669 Text en ©Suzanne E Mitchell, Alexa Bragg, Barbara A De La Cruz, Michael R Winter, Matthew J Reichert, Lance D Laird, Ioana A Moldovan, Kimberly N Parker, Jessica Martin-Howard, Paula Gardiner. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 10.05.2023. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included. |
spellingShingle | Original Paper Mitchell, Suzanne E Bragg, Alexa De La Cruz, Barbara A Winter, Michael R Reichert, Matthew J Laird, Lance D Moldovan, Ioana A Parker, Kimberly N Martin-Howard, Jessica Gardiner, Paula 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Original Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10209787/ https://www.ncbi.nlm.nih.gov/pubmed/37163341 http://dx.doi.org/10.2196/43669 |
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