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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension, Diabetes Mellitus, Type 2

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Diabetes or Hypertension<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |