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

Type2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994095
• Other study ID #: HUM00073693
• Status: Completed
• Phase: N/A
• First received: December 12, 2016
• Last updated: December 14, 2016
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type2 Diabetes

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PACIC score	Quality of Diabetes Care Received	Six months	No