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Impact of Community Health Workers on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico

Completed
Conditions
Hypertension
Diabetes Mellitus, Type 2
Registration Number
NCT02549495
Lead Sponsor
Brigham and Women's Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
174
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Hemoglobin A1cEvery-three months, until one year after all communities receive intervention

Percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay

Systolic blood pressureEvery-three months, until one year after all communities receive intervention

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

Secondary Outcome Measures
NameTimeMethod
Adherence to daily medicationsEvery-three months, until one year after all communities receive intervention

Self-reported medication adherence as measured by 5-day recall, 30-day recall and response to Likert-style questions

Diastolic blood pressureEvery-three months, until one year after all communities receive intervention

Diastolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure

Disease controlEvery-three months, until one year after all communities receive intervention

Diabetes and/or hypertension control. Disease control among patients with hypertension was defined according to Mexican national guidelines: blood pressure \<140/90 mm Hg for patients with hypertension and no diabetes; blood pressure \<130/80 mm Hg for patients with hypertension and diabetes and blood pressure \< 150/90 mm Hg for patients over the age of 80. Disease control for patients with diabetes defined as glycated hemoglobin (HbA1c) \< 7% per national guidelines.

Trial Locations

Locations (1)

Brigham and Women's Hospital

🇺🇸

Boston, Massachusetts, United States

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