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

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Behavioral: Pilot Study

• Registration Number: NCT02994095
• Lead Sponsor: University of Michigan

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.

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 Timeline

• Study Start: 2014-03
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2016-12
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-14
• Last Update Submitted: 2016-12-14
• Study First Posted: 2016-12-15
• Last Update Posted: 2016-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Adult patients with T2 diabetes who received care at the primary care center
• A1c>7.0% in prior six months

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Exclusion Criteria

• Age> 75
• being pregnant
• having terminal health condition or other conditions that would impede participation such as dementia and mental illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single intervention arm	Pilot Study	Trained CHAs in Motivational Interviewing in pilot study

Primary Outcome Measures

Name	Time	Method
PACIC score	Six months	Quality of Diabetes Care Received