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

Study Overview
=================
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.

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

Conditions
-----------------
Type2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Pilot Study


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single intervention arm<br>Trained CHAs in Motivational Interviewing in pilot study | Behavioral: Pilot Study<br>* Trained community health agents used Motivational Interviewing-based counseling and action planning in monthly home visits with adults with diabetes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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