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Study was not funded
Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
January 10, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
African Americans (AA)/People of Color (POC) are disproportionately impacted by COVID-19 to an extent not observed in other racial/ethnic subgroups. People of color are uniquely affected because keeping diabetes under control - the best defense against COVID-19 - has become more difficult as the pandemic has disrupted medical care, exercise and healthy eating routines which are already well-known challenges for the African American community. Diabetes Self-Management Education and Support (DSMS/S) facilitates the knowledge, skills, and ability necessary for diabetes self-care as well as activities that assist a person in implementing and sustaining the behaviors needed to manage their condition on an ongoing basis. Now, given the implications of COVID-19 on the AA/POC diabetes community, it is imperative to enhance DSME/S with education about protection and prevention of COVID-19. To begin to solve this problem we will adapt and implement the "emPOWERed to Change" DSME/S program to provide enhanced type 2 diabetes mellitus (T2DM) education with an additional emphasis on COVID-19 protection and prevention. This study will employ Community Based Participatory Research methods and will be conducted virtually in the community setting. The proposed hypothesis, based on the Health Belief Model (HBM) and the Theory of Planned Behavior (TPB), is: African Americans (AA)/People of Color (POC) in Los Angeles County with type 2 diabetes mellitus (T2DM) randomized to participate in the "emPOWERed to Change" program (N=48) are more likely to demonstrate sustained glycemic control, increase in knowledge and skills related behaviors, and risk factors associated with T2DM and SARS-CoV-2 (COVID-19) and increased compliance with prevention, and vaccination as compared to those who are randomized to usual care (N=48) in this 12 week program. We propose a randomized control study design among 96 participants with 48 assigned to an intervention group and 48 assigned to a control group. This study will also explore the experience of the participants' appraisal of knowledge and skills acquisition for DSME/S to maintain T2DM control, reduce complications, and SARS-CoV-2 (COVID-19) prevention and protection. The ultimate goal is to design prospective larger behavioral studies (SuRe first or R21) with a multi-centered intervention with other RTRN institutions to demonstrate the applicability of this approach specifically focusing on the AA/POC community.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 4, 2021
Actual (reported)August 6, 2021
Actual (reported)January 10, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 28, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Type 2 Glycemic Control - HbA1c of 7% or less
Achieve Glycemic control defined as an HbA1c of 7% or less
12 weeks
Understanding of Diabetes Self-Management
12 weeks
Understand of COVID-19 Risks, Protection and Prevention
12 weeks
emPOWERed to Change Online Courses: 4 Critical Step to Manage Diabetes modules * Step 1 Learn about diabetes * Step 2 Know your diabetes ABCs * Step 3 Learn how to live with diabetes * Step 4 Get routine care to stay healthy Diabetes + COVID-19 Protection and Prevention modules * Introduction to understanding COVID-19 and the risks specific to T2DM * Learn preventive and protective measures to avoid COVID-19 * COVID-19 Vaccine education and Discussion guide * Community resource guide to access COVID-19 testing and vaccination Stress Management modules * Understanding of the relationship between diabetes and stress * Learn stress management techniques for diabetes Ongoing Program Support: Motivation for participation, medication adherence, accountability and peer-to-peer interaction and support (bi-weekly text messages \& private and closed Facebook community support group with peers and professionals)
Usual Standard of Care as deemed by participants provider(s)
Online Diabetes Self-Management Education and Support along with COVID-19 prevention and protection (vaccination) education and resource information
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Abazari P, Vanaki Z, Mohammadi E, Amini M. Inadequate investment on management of diabetes education. J Res Med Sci. 2012 Aug;17(8):792-8.
Azar KMJ, Shen Z, Romanelli RJ, Lockhart SH, Smits K, Robinson S, Brown S, Pressman AR. Disparities In Outcomes Among COVID-19 Patients In A Large Health Care System In California. Health Aff (Millwood). 2020 Jul;39(7):1253-1262. doi: 10.1377/hlthaff.2020.00598. Epub 2020 May 21.
Jay Vadgama, M.D.
Charles Drew University of Medicine and Science
0 participants (actual enrollment reported by the registry).
First Submitted
August 4, 2021
First Posted
August 6, 2021
Study Start
January 10, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Cooper, A., & Kar, P. (2014). A new dawn: The role of social media in diabetes education. Journal of Diabetes Nursing, 18(2), 68-71
Cyrus E, Clarke R, Hadley D, Bursac Z, Trepka MJ, Devieux JG, Bagci U, Furr-Holden D, Coudray M, Mariano Y, Kiplagat S, Noel I, Ravelo G, Paley M, Wagner EF. The Impact of COVID-19 on African American Communities in the United States. Health Equity. 2020 Oct 30;4(1):476-483. doi: 10.1089/heq.2020.0030. eCollection 2020.
Gabarron E, Arsand E, Wynn R. Social Media Use in Interventions for Diabetes: Rapid Evidence-Based Review. J Med Internet Res. 2018 Aug 10;20(8):e10303. doi: 10.2196/10303.
Hernández SR , C. K . COVID-19: a perfect storm of health care inequality. Oakland (CA): California Health Care Foundation; 2020 Apr 10 [cited 2021 May 31]. From: https://www.chcf.org/blog/covid-19-perfect-storm-health-care-inequality/
Kenny, C. (2014). Information technology, education and diabetes. Diabetes & Primary Care, 16(3), p. 111-112.
Kitsiou S, Pare G, Jaana M, Gerber B. Effectiveness of mHealth interventions for patients with diabetes: An overview of systematic reviews. PLoS One. 2017 Mar 1;12(3):e0173160. doi: 10.1371/journal.pone.0173160. eCollection 2017.
Los Angeles County Department of Public Health. COVID-19 racial, ethnic, and socioeconomic data and strategies report [Internet]. Los Angeles (CA): LA County Department of Public Health; 2020 Apr 28 [cited 2021 May 31]. http://www.lapublichealth.org/docs/RacialEthnicSocioeconomicDataCOVID19.pdf
McMahon, K. L. (2013). Power and Pitfalls of Social Media in Diabetes Care. Diabetes Spectrum, 26(4), 232-235. doi:10.2337/diaspect.26.4.232
Park S, Burford S, Nolan C, Hanlen L. The Role of Digital Engagement in the Self-Management of Type 2 Diabetes. Health Commun. 2016 Dec;31(12):1557-65. doi: 10.1080/10410236.2015.1089468. Epub 2016 Apr 28.
Public Policy Institute of California (2021). California's Digital Divide. https://www.ppic.org/publication/californias-digital-divide/
Snowden LR, Graaf G. COVID-19, Social Determinants Past, Present, and Future, and African Americans' Health. J Racial Ethn Health Disparities. 2021 Feb;8(1):12-20. doi: 10.1007/s40615-020-00923-3. Epub 2020 Nov 23.
Torres, E. A., Tiwari, A., Movsas, S., Carrasquillo, I., & Zonszein, J. (2015). Underutilization of Diabetes Education. Experience in an Urban Teaching Hospital in The Bronx. J Diabetes Metab Syndr Disord, 2(005).
Zhang Y, Cui Y, Shen M, Zhang J, Liu B, Dai M, Chen L, Han D, Fan Y, Zeng Y, Li W, Lin F, Li S, Chen X, Pan P; medical team from Xiangya Hospital to support Hubei, China. Association of diabetes mellitus with disease severity and prognosis in COVID-19: A retrospective cohort study. Diabetes Res Clin Pract. 2020 Jul;165:108227. doi: 10.1016/j.diabres.2020.108227. Epub 2020 May 22.
Primary Completion
September 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 22, 2023
Record last verified: 2023-02
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Source: ClinicalTrials.gov.
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