Clinical trial NCT02460718: ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama
Official title: ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus
peer support
pragmatic clinical trial
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2015-06-02
Enrollment: 424
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycated hemoglobin (A1c)
timeFrame: Change in A1c in 12 months
measure: Blood pressure
timeFrame: Change in blood pressure measure in 12 months
measure: LDL cholesterol
timeFrame: Change in LDL cholesterol in 12 month
measure: diabetes self-care behaviors questionnaire
timeFrame: Change in diabetes self-care behaviors at 12 months
measure: depressive symptoms
timeFrame: change in depressive symptoms at 12 months
measure: quality of life
timeFrame: Change in quality of life measures at 12 months
measure: patient activation
timeFrame: change in patient activation in 12 months
Secondary outcomes:
measure: body mass index
timeFrame: change in BMI in 12 months
measure: diabetes knowledge
timeFrame: change in diabetes knowledge in 12 months
measure: trust in physicians
timeFrame: change in trust in physicians in 12 months
measure: composite measure of healthcare utilization
timeFrame: Change in health care utilization in 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.