NCT02460718

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
424

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

3 years

First QC Date

May 29, 2015

Last Update Submit

March 9, 2016

Conditions

Keywords

diabetes mellituspeer supportpragmatic clinical trial

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (4)

  • body mass index

    change in BMI in 12 months

  • diabetes knowledge

    change in diabetes knowledge in 12 months

  • trust in physicians

    change in trust in physicians in 12 months

  • composite measure of healthcare utilization

    Change in health care utilization in 12 months

Study Arms (2)

control group

NO INTERVENTION

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.

Encourage study

EXPERIMENTAL

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

Interventions

ENCOURAGE StudyBEHAVIORAL

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

Encourage study

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • or older in age, diagnosed with diabetes, under the care of a doctor

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 29, 2015

First Posted

June 2, 2015

Study Start

February 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 10, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Data will stay at UAB