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Completed

NCT Number: NCT02460718

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ENCOURAGE Study

Behavioral

This intervention tested the effects of a peer coaching program plus brief diabetes education versus brief diabetes education alone on diabetes outcomes.

Primary outcomes

  1. Glycated hemoglobin (A1c)

    Time frame: Change in A1c in 12 months

    fingerstick, point-of-care a1c test

  2. Blood pressure

    Time frame: Change in blood pressure measure in 12 months

    Measured using digital automated blood pressure monitor

  3. LDL cholesterol

    Time frame: Change in LDL cholesterol in 12 month

    measured using finger stick, spectrophotometer to measure LDL cholesterol

  4. 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

  5. depressive symptoms

    Time frame: change in depressive symptoms at 12 months

    self-report using Patient Health Questionnaire 8 (PHQ8)

  6. 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)

  7. patient activation

    Time frame: change in patient activation in 12 months

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

Secondary outcomes

  1. body mass index

    Time frame: change in BMI in 12 months

    weight measured using digital scale, height measured using stadiometer

  2. diabetes knowledge

    Time frame: change in diabetes knowledge in 12 months

    assessed using the Spoken Knowledge in Low Literacy in Diabetes Scale

  3. trust in physicians

    Time frame: change in trust in physicians in 12 months

    assessed using the Trust in Physicians Scale

  4. composite measure of healthcare utilization

    Time frame: Change in health care utilization in 12 months

    self-report by participant, number of times utilized healthcare services

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • University of Alabama at Birmingham

Registry information

Acronym: ENCOURAGE

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 2, 2015
Registry last updated
Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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