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

NCT ID: NCT02994095

Last Updated: 2016-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-12-31

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.

Conditions

Type2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Single intervention arm

Trained CHAs in Motivational Interviewing in pilot study

Group Type: EXPERIMENTAL

Pilot Study

Intervention Type: BEHAVIORAL

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

Interventions

Pilot Study

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Mary Ellen Michele Heisler

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Heisler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

References

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.

Reference Type: DERIVED

PMID: 28086870 (View on PubMed)

Other Identifiers

HUM00073693

Identifier Type: -

Identifier Source: org_study_id