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Trial record 1 of 1 for:    NCT02994095
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A Pilot Study of a Community Health Agent-led Diabetes Self-Management Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02994095
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : December 15, 2016
Information provided by (Responsible Party):
Mary Ellen Michele Heisler, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Behavioral: Pilot Study Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : March 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Single intervention arm
Trained CHAs in Motivational Interviewing in pilot study
Behavioral: Pilot Study
Trained community health agents used Motivational Interviewing-based counseling and action planning in monthly home visits with adults with diabetes

Primary Outcome Measures :
  1. PACIC score [ Time Frame: Six months ]
    Quality of Diabetes Care Received

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02994095

Sponsors and Collaborators
University of Michigan
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Principal Investigator: Michele Heisler, MD University of Michigan
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mary Ellen Michele Heisler, Professor, University of Michigan Identifier: NCT02994095    
Other Study ID Numbers: HUM00073693
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data set available on request.
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases