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

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

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Behavioral: Pilot Study

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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PACIC score	Quality of Diabetes Care Received	Six months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• do Valle Nascimento TM, Resnicow K, Nery M, Brentani A, Kaselitz E, Agrawal P, Mand S, Heisler M. A pilot study of a Community Health Agent-led type 2 diabetes self-management program using Motivational Interviewing-based approaches in a public primary care center in Sao Paulo, Brazil. BMC Health Serv Res. 2017 Jan 13;17(1):32. doi: 10.1186/s12913-016-1968-3.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (ESTIMATE): December 15, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 15, 2016
• Last Update Submitted That Met QC Criteria: December 14, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: HUM00073693

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data set available on request.