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

NCT ID: NCT02549495

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 168 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2019-06-30

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.

Conditions

Hypertension; Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard University

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Daniel Palazuelos

Associate Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrick M Newman, MD

Role: STUDY_DIRECTOR

Brigham and Women's Hospital

Daniel Palazuelos, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Worster DT, Franke MF, Bazua R, Flores H, Garcia Z, Krupp J, Maza J, Palazuelos L, Rodriguez K, Newman PM, Palazuelos D. Observational stepped-wedge analysis of a community health worker-led intervention for diabetes and hypertension in rural Mexico. BMJ Open. 2020 Mar 8;10(3):e034749. doi: 10.1136/bmjopen-2019-034749.

Reference Type: RESULT

PMID: 32152172 (View on PubMed)

Newman PM, Franke MF, Arrieta J, Carrasco H, Elliott P, Flores H, Friedman A, Graham S, Martinez L, Palazuelos L, Savage K, Tymeson H, Palazuelos D. Community health workers improve disease control and medication adherence among patients with diabetes and/or hypertension in Chiapas, Mexico: an observational stepped-wedge study. BMJ Glob Health. 2018 Feb 15;3(1):e000566. doi: 10.1136/bmjgh-2017-000566. eCollection 2018.

Reference Type: RESULT

PMID: 29527344 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2013P000711

Identifier Type: -

Identifier Source: org_study_id