Peers EXCEL Trial to Improve Glycemic Control

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Peers LEAD
* Behavioral: HLWD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Living with Diabetes (HLWD)<br>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. | Behavioral: HLWD<br>* Weekly group sessions for two months. Sessions will last up to 2.5 hours and focus on a different diabetes self-management topic.<br>|
| Experimental: Peers EXCEL<br>Participants will have an 8-week self-management program, and will participate in phone calls with a peer for the remaining 4 months. | Behavioral: Peers LEAD<br>* 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.<br>Behavioral: HLWD<br>* Weekly group sessions for two months. Sessions will last up to 2.5 hours and focus on a different diabetes self-management topic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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African-American, medication adherence, diabetes self-management