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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02994095
Other study ID # HUM00073693
Secondary ID
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


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
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