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Clinical Trials/NCT02549495
NCT02549495
Completed
N/A

Evaluation of a Community Health Worker Intervention on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico

Brigham and Women's Hospital1 site in 1 country168 target enrollmentMarch 1, 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hypertension
Sponsor
Brigham and Women's Hospital
Enrollment
168
Locations
1
Primary Endpoint
Change in Hemoglobin A1c
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

This study evaluates the effectiveness of community health workers when added to routine care for patients with diabetes and high blood pressure in rural clinics in Chiapas, Mexico. It does so by recording information on adherence to therapy, blood pressure and hemoglobin A1c while a non-governmental organization working in Mexico trains and introduces a community health worker program.

Detailed Description

Compañeros en Salud (CES), an affiliate project of Partners in Health, has been working in the rural Sierra of Chiapas, Mexico since February 2012. CES works in partnership with the local Ministry of Health to rehabilitate and staff existing government primary care clinics. Each community's clinic is staffed by one CES project physician year-round. CES activities span the range of allopathic medicine, but the focus of the project is in the prevention, detection, diagnosis and management of non-communicable diseases (NCDs) such as diabetes and hypertension. CES currently operates in several rural communities with catchment areas of approximately 1,500 - 2,500 people. Routine care for NCDs is based on national guidelines and consists of monthly in-clinic visits by primary care physicians. Over 9 months in 2014 and again over 6 months in 2016, CES will introduce a community health worker program called "Acompañantes" to its project communities to augment care of patients with NCDs. Acompañantes are lay health workers and members of the community who bridge the gap between project clinics and patients, improving understanding of NCDs, their treatments, and adherence to therapy. The introduction of Acompañantes to communities is planned in a once-every-three-months fashion, the most rapid roll-out logistically feasible for CES. The investigators' project will document their experience over this time, and for one year after introduction of the Acompañantes program to all seven study communities, by documenting adherence to therapy, hemoglobin a1c, and blood pressure at every-three month intervals over this time frame.

Registry
clinicaltrials.gov
Start Date
March 1, 2013
End Date
June 1, 2019
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniel Palazuelos

Associate Physician

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

  • Formal diagnosis of Type II Diabetes Mellitus, Stage I or II Hypertension or both
  • Daily medications required for patient's condition
  • Residence and receipt of therapy within the study catchment area
  • Age greater than or equal to 18 years.

Exclusion Criteria

  • Known or suspected secondary hypertension
  • Known or suspected Type 1 diabetes
  • Pregnancy
  • Chronic use of glucocorticoids.

Outcomes

Primary Outcomes

Change in Hemoglobin A1c

Time Frame: Baseline, 23 months

Change in percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay

Change in Systolic Blood Pressure

Time Frame: Baseline, 23 months

Change in Systolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure monitor

Secondary Outcomes

  • Change in Adherence to Daily Medications(One year after all communities receive intervention)
  • Change in Diastolic Blood Pressure(Baseline, 23 months)
  • Disease Control(One year after all communities receive intervention)

Study Sites (1)

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