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Clinical Trials/NCT02460718
NCT02460718
Completed
Not Applicable

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

Weill Medical College of Cornell University0 sites424 target enrollmentFebruary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Weill Medical College of Cornell University
Enrollment
424
Primary Endpoint
LDL cholesterol
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
February 2012
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Monika M. Safford

Professor

Weill Medical College of Cornell University

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

Outcomes

Primary Outcomes

LDL cholesterol

Time Frame: Change in LDL cholesterol in 12 month

measured using finger stick, spectrophotometer to measure LDL cholesterol

depressive symptoms

Time Frame: change in depressive symptoms at 12 months

self-report using Patient Health Questionnaire 8 (PHQ8)

Glycated hemoglobin (A1c)

Time Frame: Change in A1c in 12 months

fingerstick, point-of-care a1c test

Blood pressure

Time Frame: Change in blood pressure measure in 12 months

Measured using digital automated blood pressure monitor

diabetes self-care behaviors questionnaire

Time Frame: Change in diabetes self-care behaviors at 12 months

aspects of diabetes self-management such as taking medications as directed, self-report of exercise, and eating behaviors

patient activation

Time Frame: change in patient activation in 12 months

self-report using the 13 item Patient Activation Measure (PAM13)

quality of life

Time Frame: Change in quality of life measures at 12 months

self-report using Short form-1 (SF1), and Euroquol (EQ-5D)

Secondary Outcomes

  • body mass index(change in BMI in 12 months)
  • composite measure of healthcare utilization(Change in health care utilization in 12 months)
  • diabetes knowledge(change in diabetes knowledge in 12 months)
  • trust in physicians(change in trust in physicians in 12 months)

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