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Completed

NCT Number: NCT02994095

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

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.

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Key information

Conditions

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pilot Study

Behavioral

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

Primary outcomes

  1. PACIC score

    Time frame: Six months

    Quality of Diabetes Care Received

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 15, 2016
Registry last updated
Dec 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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