Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Mitchell SE

PROVIDER: S-EPMC10209787 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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 SE Bragg Alexa A De La Cruz Barbara A BA Winter Michael R MR Reichert Matthew J MJ Laird Lance D LD Moldovan Ioana A IA Parker Kimberly N KN Martin-Howard Jessica J Gardiner Paula P

Journal of medical Internet research 20230510

<h4>Background</h4>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.<h4>Objective</h4>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 th ...[more]

PMID: 37163341

Similar Datasets

Project description:BackgroundPhysiological adaptations occurring across successive pregnancies may increase the risk of adverse cardiovascular health outcomes in later life.Methods and resultsThe association between parity and metabolic syndrome was examined among 7467 Hispanic/Latina women of diverse backgrounds, aged 18 to 74 years, who participated in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) from 2008 to 2011. Metabolic syndrome components were defined according to American Heart Association/National Heart, Lung, and Blood Institute criteria and included abdominal obesity, elevated triglycerides, low high-density lipoprotein cholesterol, high blood pressure, and elevated fasting glucose. Logistic regression models estimated odds ratios (ORs) adjusting for sociodemographic, behavioral, and reproductive characteristics. At HCHS/SOL baseline, women reported none (21.1%), 1 (19.9%), 2 (25.7%), 3 (18.6%), 4 (8.8%), and ≥ 5 (5.9%) live births. When compared with women with 1 birth, those with 4 births had the highest odds of abdominal obesity (OR, 2.0; 95% confidence interval, 1.5-2.8) and overall metabolic syndrome (OR, 1.4; 95% confidence interval, 1.0-2.0) and those with ≥ 5 births had the highest odds of low high-density lipoprotein cholesterol (OR, 1.5; 95% confidence interval, 1.2-2.0) and elevated fasting glucose (OR, 1.6; 95% confidence interval, 1.1-2.4), after adjusting for age, background, education, marital status, income, nativity, smoking, physical activity, menopause, oral contraceptive use, hormone therapy, and field center. Further adjustment for percent body fat attenuated these associations. No associations were observed between parity and elevated triglycerides or high blood pressure.ConclusionsHigher parity is associated with an increased prevalence of selected components of the metabolic syndrome among Hispanic/Latina women in the US. High parity among Hispanics/Latinas with a high prevalence of abdominal obesity suggests high risk for metabolic dysregulation.

Project description:focused Rapid Assessment Process (fRAP) 2.0 is a community engagement approach combining geospatial mapping with rapid qualitative assessment in cyclical fashion within communities to capture multifactorial and multilevel features impacting primary care problems. fRAP 2.0 offers primary care researchers a methodology framework for exploring complex community features that impact primary healthcare delivery and outcomes. The fRAP 2.0 study design expands the fRAP from a sequential design to a cyclical process of geospatial mapping and rapid qualitative assessment in search of modifiable contextual factors. Research participants are stakeholders from various socioecological levels whose perspectives inform study outcomes that they may use to then become the agents of change for the very problems they helped explore. Here, we present a proof-of-concept study for fRAP 2.0 examining disparities in cervical cancer mortality rates among Hispanic women in Texas. The primary outcomes of interest are features at the community level, medical health system level and regional government policy levels that offer opportunities for collaborative interventions to improve cervical cancer outcomes. In this study, geospatial mapping of county and ZIP code-level variables impacting postdiagnosis cervical cancer care at community, medical and policy levels were created using publicly available data and then overlaid with maps created with Texas Cancer Registry data for cervical cancer cases in three of the largest population counties. Geographically disparate areas were then qualitatively explored using participant observation and ethnographic field work, alongside 39 key informant interviews. Roundtable discussion groups and stakeholder engagement existed at every phase of the study. Applying the fRAP 2.0 method, we created an action-oriented roadmap of next steps to improve cervical cancer care disparities in the three Texas counties with emphasis on the high disparity county. We identified local change targets for advocacy and the results helped convene a stakeholder group that continues to actively create on-the-ground change in the high-disparity county to improve cervical cancer outcomes for Hispanic women.

Project description:BackgroundVitamin D may protect against breast cancer. Although Black/African American women and Hispanic/Latina women have lower circulating vitamin D levels than non-Hispanic White women, few studies have examined the association between vitamin D and breast cancer within these racial/ethnic groups.MethodsThe vitamin D-breast cancer association was evaluated using a case-cohort sample of self-identified Black/African American and non-Black Hispanic/Latina women participating in the US-wide Sister Study cohort. Circulating 25-hydroxyvitamin D (25(OH)D) and 24,25-dihydroxyvitamin D (24,25(OH)2D) were measured using liquid chromatography-tandem mass spectrometry in blood samples collected at the baseline from 415 women (290 Black/African American women and 125 non-Black Hispanic/Latina women) who developed breast cancer. These were compared to concentrations in 1545 women (1084 Black/African American women and 461 Hispanic/Latina women) randomly selected from the cohort. Multivariable-adjusted Cox regression was used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs).ResultsOver a mean follow-up of 9.2 years, women with circulating 25(OH)D concentrations above the clinical cut point for deficiency (20.0 ng/mL) had lower breast cancer rates than women with concentrations ≤ 20 ng/mL (HR, 0.79; 95% CI, 0.61-1.02). The inverse association was strongest among Hispanic/Latina women (HR, 0.52; 95% CI, 0.29-0.93), with a weaker association observed among Black/African American women (HR, 0.89; 95% CI, 0.68-1.18; P for heterogeneity = 0.13). There were no clear differences by menopausal status, follow-up time, estrogen receptor status, or invasiveness. Neither 24,25(OH)2 D nor the 24,25(OH)2 D to 25(OH)D ratio were independently associated with breast cancer risk.ConclusionsThis prospective study supports the hypothesis that vitamin D may be protective against breast cancer incidence in women, including non-Black Hispanic/Latina and Black/African American women.Lay summaryVitamin D may protect against breast cancer. Although women of color have lower average vitamin D levels than non-Hispanic White women, few studies have considered the role of race/ethnicity. In a sample of self-identified Black/African American and Hispanic/Latina women, we observed that vitamin D concentrations measured in blood were inversely associated with breast cancer, particularly among Latinas. These findings indicate that vitamin D may protect women against breast cancer, including those in racial/ethnic groups with low average circulating levels.

Dataset Information

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

Objective

Methods

Results

Conclusions

Trial registration

Publications

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets