Peers EXCEL Trial to Improve Glycemic Control
- Conditions
- Type 2 Diabetes
- Interventions
- Behavioral: Peers LEADBehavioral: HLWD
- Registration Number
- NCT05527847
- Lead Sponsor
- University of Wisconsin, Madison
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Peers EXCEL Peers LEAD Participants will have an 8-week self-management program, and will participate in phone calls with a peer for the remaining 4 months. Peers EXCEL HLWD Participants will have an 8-week self-management program, and will participate in phone calls with a peer for the remaining 4 months. Healthy Living with Diabetes (HLWD) HLWD Participants will have a 6-week self-management program, followed by the option to work with a Community Health Worker for the remaining 4 months.
- Primary Outcome Measures
Name Time Method Change in blood glucose (hemoglobin A1C) 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 Outcome Measures
Name Time Method Feasibility of intervention Baseline, 2 months, 6 months Participants will complete validated surveys to assess diabetes-health beliefs, patient self-efficacy/activation, and patient-provider communication quality.
Medication adherence Baseline, 2 months, 6 months The hypothesis is that there will be higher medication adherence for participants in Peers EXCEL as compared to those in HLWD. Self-reported medication adherence is measured using the 3-item Extent of Nonadherence domain in the Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) survey. This measure screens for nonadherence and is calculated by computing the mean of the 3 items (range of score is 1-5). Mean scores of 3 (i.e., scoring "1" on each of the 3 items) will be classified as nonadherent, while all mean scores \>3 will be classified as adherent.
Acceptability of intervention Baseline, 2 months, 6 months Interviews and focus groups will be conducted with participants, ambassadors and HLWD leaders respectively to get feedback on their intervention experiences.
Adherence to Refills and Medicines Scale for Diabetes (ARMS-D) Score Baseline, 2 months, 6 months The ARMS-D has a total possible range of scores from 11-44, with higher scores indicating increased problems with medication adherence.
Trial Locations
- Locations (1)
University of Wisconsin
🇺🇸Madison, Wisconsin, United States