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临床试验/NCT02549495
NCT02549495已完成不适用

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

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2013年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
168
试验地点
1
主要终点
Change in Hemoglobin A1c

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Known or suspected secondary hypertension
  • Known or suspected Type 1 diabetes
  • Pregnancy
  • Chronic use of glucocorticoids.

结局指标

主要结局

Change in Hemoglobin A1c

时间窗: Baseline, 23 months

Change in percent glycated hemoglobin as measured by PTS diagnostics point-of-care assay

Change in Systolic Blood Pressure

时间窗: Baseline, 23 months

Change in Systolic blood pressure as measured by Omron HEM 7080IT electronic blood pressure monitor

次要结局

  • Change in Adherence to Daily Medications(One year after all communities receive intervention)
  • Change in Diastolic Blood Pressure(Baseline, 23 months)
  • Disease Control(One year after all communities receive intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Palazuelos

Associate Physician

Brigham and Women's Hospital

研究点 (1)

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