ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama

Study Overview
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Brief Summary
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It is unclear whether peer coaching is effective in minority populations living with diabetes in hard-to-reach, under resourced areas such as the rural South. We examined the effect of an innovative peer coaching intervention plus brief education vs. brief education alone on diabetes outcomes.

Detailed Description
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The purpose of this project was to provide robust evidence on the effectiveness of a peer support intervention in improving diabetes outcomes by conducting a group-randomized, controlled implementation trial of a volunteer peer support intervention. The study had three specific aims: Aim 1. In Phase I (months 0-8), to perform a qualitative needs assessment with peer advisors and health care providers to inform peer advisor roles and responsibilities (i.e., the intervention) and peer advisor recruitment strategies, curriculum and training; and patient recruitment plans. Aim 2. Also in Phase I, to pilot our collaboratively developed intervention and, based on pilot test results, to recruit and train peer advisors for the intervention, and begin patient recruitment. Aim 3. In Phase II (months 9-32), conduct the group randomized implementation trial and evaluate it using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.

Official Title
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ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: ENCOURAGE Study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 or older in age, diagnosed with diabetes, under the care of a doctor Exclusion Criteria: not community dwelling, less than 19 years old, pregnant, end-stage medical conditions with limited life expectancy, no access to telephone, does not speak english

Ages Eligible for Study
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Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Participants received 1-hour group diabetes education class covering diabetes basics, healthy eating, stress reduction, physical activity, social support, and how to get the most out of their doctors visit. Participants also received a diabetes report card showing their Hba1c, blood pressure, ldl cholesterol, and body weight. | |
| Experimental: Encourage study<br>Participants in the intervention arm were paired with a peer coach, interacting by telephone weekly for the first 8 weeks and then monthly for a total of 10 months. Participants also received 1-hour group diabetes education class covering diabetes basics, healthy eating, stress reduction, physical activity, social support, and how to get the most out of their doctors visit. Participants also received a diabetes report card showing their Hba1c, blood pressure, ldl cholesterol, and body weight. | Behavioral: ENCOURAGE Study<br>* This intervention tested the effects of a peer coaching program plus brief diabetes education versus brief diabetes education alone on diabetes outcomes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin (A1c) | fingerstick, point-of-care a1c test | Change in A1c in 12 months | 
| Blood pressure | Measured using digital automated blood pressure monitor | Change in blood pressure measure in 12 months | 
| LDL cholesterol | measured using finger stick, spectrophotometer to measure LDL cholesterol | Change in LDL cholesterol in 12 month | 
| diabetes self-care behaviors questionnaire | aspects of diabetes self-management such as taking medications as directed, self-report of exercise, and eating behaviors | Change in diabetes self-care behaviors at 12 months | 
| depressive symptoms | self-report using Patient Health Questionnaire 8 (PHQ8) | change in depressive symptoms at 12 months | 
| quality of life | self-report using Short form-1 (SF1), and Euroquol (EQ-5D) | Change in quality of life measures at 12 months | 
| patient activation | self-report using the 13 item Patient Activation Measure (PAM13) | change in patient activation in 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index | weight measured using digital scale, height measured using stadiometer | change in BMI in 12 months | 
| diabetes knowledge | assessed using the Spoken Knowledge in Low Literacy in Diabetes Scale | change in diabetes knowledge in 12 months | 
| trust in physicians | assessed using the Trust in Physicians Scale | change in trust in physicians in 12 months | 
| composite measure of healthcare utilization | self-report by participant, number of times utilized healthcare services | Change in health care utilization in 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, peer support, pragmatic clinical trial