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
|Condition or disease|
|Hypertension Diabetes Mellitus, Type 2|
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.
|Study Type :||Observational|
|Actual Enrollment :||174 participants|
|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|
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
- 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
- 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
- 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
- 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
- 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.
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
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02130|
|Study Director:||Patrick M Newman, MD||Brigham and Women's Hospital|
|Principal Investigator:||Daniel Palazuelos, MD, MPH||Brigham and Women's Hospital|