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A Pilot Study of a Community Health Agent-led Diabetes Self-Management Program

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT02994095
Collaborator
(none)
57
Enrollment
1
Arm
9
Duration (Months)

Study Details

Study Description

Brief Summary

This was a pilot study to assess the feasibility and acceptability of training Community Health Agents in Motivational Interviewing in real-life primary care centers.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pilot Study
 N/A

Detailed Description

Rates of noncommunicable diseases (NCDs) such as type 2 diabetes are escalating in low and middle-income countries such as Brazil. Scalable primary care-based interventions are needed to improve self-management and clinical outcomes of adults with diabetes. This pilot study examines the feasibility, acceptability, and outcomes of training community health agents (CHAs) in Motivational Interviewing (MI)-based counseling for patients with poorly controlled diabetes in a primary care center in São Paulo, Brazil.

Nineteen salaried CHAs participated in 32 hours of training in MI and behavioral action planning. With support from booster training sessions, they used these skills in their regular monthly home visits over a 6 month period with 57 diabetes patients with baseline HbA1cs > 7.0%. The primary outcome was patients' reports of the quality of diabetes care as measured by the Portuguese version of the Patient Assessment of Chronic Illness Care (PACIC) scale. Secondary outcomes included changes in patients' reported diabetes self-management behaviors and in A1c, blood pressure, cholesterol and triglycerides. CHAs' fidelity to and experiences with the intervention were also assessed.

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Pilot Study of a Community Health Agent-led Diabetes Self-Management Program Using Motivational Interviewing-based Approaches in a Public Primary Care Center in São Paulo, Brazil
Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single intervention arm

Trained CHAs in Motivational Interviewing in pilot study

Behavioral: Pilot Study
Trained community health agents used Motivational Interviewing-based counseling and action planning in monthly home visits with adults with diabetes

Outcome Measures

Primary Outcome Measures

  1. PACIC score [Six months]

    Quality of Diabetes Care Received

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Adult patients with T2 diabetes who received care at the primary care center

  • A1c>7.0% in prior six months

Exclusion Criteria:

  • Age> 75

  • being pregnant

  • having terminal health condition or other conditions that would impede participation such as dementia and mental illness

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Michigan

Investigators

  • Principal Investigator: Michele Heisler, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mary Ellen Michele Heisler, Professor, University of Michigan
ClinicalTrials.gov Identifier:
NCT02994095
Other Study ID Numbers:
  • HUM00073693
First Posted:
Dec 15, 2016
Last Update Posted:
Dec 15, 2016
Last Verified:
Dec 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Diabetes Mellitus

Study Results

No Results Posted as of Dec 15, 2016