A Pilot Randomized Clinical Trial (RCT) to Examine the Benefits of a Culturally Adapted Peer Support and Self-Management Intervention to Improve Glycemic Control in African Americans
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- University of Wisconsin, Madison
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Change in blood glucose (hemoglobin A1C)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of the study is to gather input about the value of adding a newly developed diabetes self-management program to an existing diabetes self-management program. Participants will self-identify as African-American/Black with type 2 diabetes, and prescribed a diabetes medication. Participants can expect to be in the study for 6 months.
Detailed Description
Both programs utilized in this study focus on topics such as diet, exercise, and stress. Both programs offer ideas to manage diabetes symptoms, discuss appropriate exercises, provide guidance on healthy eating, review the use of medicine, and offer tips on communicating with healthcare providers and voicing concerns to family members. The new program is culturally-tailored for African Americans and focuses on helping patients take their medicines as prescribed. The purpose of this research study is to evaluate this newly developed combined diabetes self-management program.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Between 18-90 years old
- •Self-identify as African-American
- •Diagnosis of Type 2 diabetes
- •Able to speak/read English
- •Self-report having a primary care provider who prescribes one diabetes medication
- •Diagnosed with diabetes for ≥1 year at point of care
- •Will reside in the geographical area throughout the study period
- •Self-reported nonadherence on the DOSE-nonadherence survey
- •≥7.5% A1C
Exclusion Criteria
- •Self-reported bipolar or personality disorders, schizophrenia, Alcohol and Other Drug Abuse (AODA), dementia
- •Older adults who have a history of severe hypoglycemia requiring medical assistance or glucagon administration
- •Participating in another lifestyle or medication adherence program
Outcomes
Primary Outcomes
Change in blood glucose (hemoglobin A1C)
Time Frame: Baseline, 2 months, 6 months
The hypothesis is that there will be a more significant change in mean A1C, which is clinically meaningful, for participants in Peers EXCEL as compared to those in HLWD.
Secondary Outcomes
- Feasibility of intervention(Baseline, 2 months, 6 months)
- Medication adherence(Baseline, 2 months, 6 months)
- Acceptability of intervention(Baseline, 2 months, 6 months)
- Adherence to Refills and Medicines Scale for Diabetes (ARMS-D) Score(Baseline, 2 months, 6 months)