Advancing DSME/S and COVID-19 Prevention and Protection Through "emPOWERed to Change" Program

NCT04993326 | Withdrawn

• 1 other identifier: 1774297-1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type2 Diabetes; Covid19

Keywords

Diabetes Education, African Americans, COVID-19

Outcome Measures

Primary Outcomes (1)

• Type 2 Glycemic Control - HbA1c of 7% or less

  Achieve Glycemic control defined as an HbA1c of 7% or less

  12 weeks

Secondary Outcomes (2)

• Understanding of Diabetes Self-Management

  12 weeks

• Understand of COVID-19 Risks, Protection and Prevention

  12 weeks

Study Arms (2)

Intervention

OTHER

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)

Behavioral: emPOWERed To Change Program

Control

NO INTERVENTION

Usual Standard of Care as deemed by participants provider(s)

Interventions

emPOWERed To Change Program BEHAVIORAL

Online Diabetes Self-Management Education and Support along with COVID-19 prevention and protection (vaccination) education and resource information

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• and older African American, Male or Female, must be diagnosed with type 2 diabetes mellitus and be from MLK-OPC, no prior formal DSME/S program participation and must have internet access

You may not qualify if:

• Under 18 years of age, POC but not African American, not diagnosed with type 2 diabetes mellitus, not a patient of LAC DHS MLK-OPC facilities, not having internet access, had or receiving formal DSME/S program

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead

Related Publications (15)

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  PMID: 23798949 BACKGROUND

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  PMID: 32437224 BACKGROUND

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  BACKGROUND

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  PMID: 33269331 BACKGROUND

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  PMID: 30097421 BACKGROUND

• 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/

  BACKGROUND

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  BACKGROUND

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  PMID: 28249025 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

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  PMID: 27124817 BACKGROUND

• Public Policy Institute of California (2021). California's Digital Divide. https://www.ppic.org/publication/californias-digital-divide/

  BACKGROUND

• 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.

  PMID: 33230737 BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 32446795 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jay Vadgama, M.D.

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 6, 2021
• Study Start: January 10, 2022
• Primary Completion: September 30, 2022
• Study Completion: February 28, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share