Type 2 Diabetes Clinical Trial
Official title:
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
Verified date | November 2023 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | November 14, 2023 |
Est. primary completion date | October 2, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in blood glucose (hemoglobin A1C) | 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. | Baseline, 2 months, 6 months | |
Secondary | Medication adherence | 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. | Baseline, 2 months, 6 months | |
Secondary | Feasibility of intervention | Participants will complete validated surveys to assess diabetes-health beliefs, patient self-efficacy/activation, and patient-provider communication quality. | Baseline, 2 months, 6 months | |
Secondary | Acceptability of intervention | Interviews and focus groups will be conducted with participants, ambassadors and HLWD leaders respectively to get feedback on their intervention experiences. | Baseline, 2 months, 6 months | |
Secondary | Adherence to Refills and Medicines Scale for Diabetes (ARMS-D) Score | The ARMS-D has a total possible range of scores from 11-44, with higher scores indicating increased problems with medication adherence. | Baseline, 2 months, 6 months |
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