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

Diabetes Mellitus Clinical Trial

— ENCOURAGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460718
• Other study ID #: T0808270039
• Status: Completed
• Phase: N/A
• First received: May 29, 2015
• Last updated: March 9, 2016
• Start date: February 2009
• Est. completion date: February 2012

Study information

• Verified date: March 2016
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin (A1c)	fingerstick, point-of-care a1c test	Change in A1c in 12 months	No
Primary	Blood pressure	Measured using digital automated blood pressure monitor	Change in blood pressure measure in 12 months	No
Primary	LDL cholesterol	measured using finger stick, spectrophotometer to measure LDL cholesterol	Change in LDL cholesterol in 12 month	No
Primary	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	No
Primary	depressive symptoms	self-report using Patient Health Questionnaire 8 (PHQ8)	change in depressive symptoms at 12 months	No
Primary	quality of life	self-report using Short form-1 (SF1), and Euroquol (EQ-5D)	Change in quality of life measures at 12 months	No
Primary	patient activation	self-report using the 13 item Patient Activation Measure (PAM13)	change in patient activation in 12 months	No
Secondary	body mass index	weight measured using digital scale, height measured using stadiometer	change in BMI in 12 months	No
Secondary	diabetes knowledge	assessed using the Spoken Knowledge in Low Literacy in Diabetes Scale	change in diabetes knowledge in 12 months	No
Secondary	trust in physicians	assessed using the Trust in Physicians Scale	change in trust in physicians in 12 months	No
Secondary	composite measure of healthcare utilization	self-report by participant, number of times utilized healthcare services	Change in health care utilization in 12 months	No