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

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ClinicalTrials.gov Identifier: NCT02549495
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Harvard University
Information provided by (Responsible Party):
Daniel Palazuelos, 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.

Condition or disease
Hypertension Diabetes Mellitus, Type 2

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.

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Study Type : Observational
Actual Enrollment : 174 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of a Community Health Worker Intervention on Adherence to Therapy for Non-Communicable Chronic Disease in Chiapas, Mexico
Study Start Date : March 2013
Actual Primary Completion Date : April 2018
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with Diabetes or Hypertension
All patients in the seven study communities will receive the community health worker intervention provided by CES, as it is incorporated into the standard of care. However, they will receive the intervention at different points in time depending on which community they lived in, as community health worker programs can only be started at every-three-month intervals



Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: Every-three months, until one year after all communities receive intervention ]
    Percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay

  2. Systolic blood pressure [ Time Frame: Every-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 :
  1. Adherence to daily medications [ Time Frame: Every-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

  2. Diastolic blood pressure [ Time Frame: Every-three months, until one year after all communities receive intervention ]
    Diastolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure

  3. Disease control [ Time Frame: Every-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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with Diabetes Mellitus, Type 2, or Hypertension, taking daily therapy, living in one of seven study communities in rural Chiapas, Mexico.
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.

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 ClinicalTrials.gov identifier (NCT number): NCT02549495


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Brigham and Women's Hospital
Harvard University
Investigators
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Study Director: Patrick M Newman, MD Brigham and Women's Hospital
Principal Investigator: Daniel Palazuelos, MD, MPH Brigham and Women's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Palazuelos, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02549495    
Other Study ID Numbers: 2013P000711
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Chronic Disease
Noncommunicable Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes