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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: ENCOURAGE Study

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 424
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; 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; 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; This intervention tested the effects of a peer coaching program plus brief diabetes education versus brief diabetes education alone on diabetes outcomes.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: University of Alabama at Birmingham

Publications and helpful links

General Publications

• Cherrington AL, Khodneva Y, Richman JS, Andreae SJ, Gamboa C, Safford MM. Impact of Peer Support on Acute Care Visits and Hospitalizations for Individuals With Diabetes and Depressive Symptoms: A Cluster-Randomized Controlled Trial. Diabetes Care. 2018 Dec;41(12):2463-2470. doi: 10.2337/dc18-0550. Epub 2018 Oct 29.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: May 29, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimate): June 2, 2015

Study Record Updates

• Last Update Posted (Estimate): March 10, 2016
• Last Update Submitted That Met QC Criteria: March 9, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: pragmatic clinical trial; diabetes mellitus; peer support
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: T0808270039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will stay at UAB