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| ID | Type | Description | Link |
|---|---|---|---|
| A561000 | Other Identifier | UW Madison | |
| PHARM/PHARMACY | Other Identifier | UW Madison | |
| Protocol Version 02/20/2023 | Other Identifier | UW Madison |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Living with Diabetes (HLWD) | Active Comparator | 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. |
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| Peers EXCEL | Experimental | Participants will have an 8-week self-management program, and will participate in phone calls with a peer for the remaining 4 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peers LEAD | Behavioral | Two group session focusing on beliefs about medicines and diabetes, discrimination/mistrust, and communication with providers, and 2 peer-based phone calls from Ambassadors to occur weekly for weeks 3-8, then bi-weekly for weeks 9-12. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olayinka Shiyanbola, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| HLWD | Behavioral | Weekly group sessions for two months. Sessions will last up to 2.5 hours and focus on a different diabetes self-management topic. |
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| Baseline, 2 months, 6 months |
| 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 |
| 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 |
| 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 |
| D004700 | Endocrine System Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |