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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02549495
• Other study ID #: 2013P000711
• Status: Completed
• Start date: March 2013
• Est. completion date: June 2019

Study information

• Verified date: October 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: June 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes Mellitus, Type 2
• Hypertension
• Noncommunicable Diseases

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Harvard University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay	Every-three months, until one year after all communities receive intervention
Primary	Systolic blood pressure	Systolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure monitor	Every-three months, until one year after all communities receive intervention
Secondary	Adherence to daily medications	Self-reported medication adherence as measured by 5-day recall, 30-day recall and response to Likert-style questions	Every-three months, until one year after all communities receive intervention
Secondary	Diastolic blood pressure	Diastolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure	Every-three months, until one year after all communities receive intervention
Secondary	Disease control	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.	Every-three months, until one year after all communities receive intervention