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临床试验/NCT01067092
NCT01067092已完成不适用

MATCH: The Mexican-American Trial of Community Health Workers

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2005年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
144
试验地点
2
主要终点
% of persons with blood pressure less than 130/80

研究概览

简要总结

The MATCH study (Mexican-American Trial of Community Health Workers) tests the hypothesis that the use of indigenous Community Health Workers (CHWs), recruited from the target community and trained to provide culturally appropriate diabetes education, can promote pro-active self-management among inner-city dwelling Mexican-Americans with Type 2 diabetes mellitus. The study aims are to demonstrate that a CHW, compared to an attention control, will: 1) result in improvement in short term physiologic outcomes (Hemoglobin A1c levels and blood pressure), and 2) result in increased frequency of self-management behaviors (daily self blood-glucose monitoring, medication adherence, adherence to diet and physical activity recommendations). The study design is a single site, partially blinded, randomized controlled trial of 144 patients with Type 2 diabetes mellitus.

Eligibility criteria include a diagnosis of Type 2 diabetes, residence in target community areas in the Chicago area, and Mexican or Mexican-American ethnic heritage. Participants are randomized to either an experimental group receiving 36 home visits over a two year period in which a CHW delivered diabetes education and self-management skills training, or to an attention control consisting of 36 bilingual diabetes education newsletters covering the same curriculum as the CHWs. The curriculum covers recommended diabetes self-management behaviors including glucose self-monitoring, responding to abnormal blood glucose levels, working effectively with health care providers, medication adherence, foot care, daily physical activity, and reducing fat content of diet. CHWs also deliver training in behavioral skills of self-monitoring, environmental restructuring, engagement of social support, stress management, and problem-solving skills to facilitate the self-management activities. Consistent delivery of the CHW intervention is documented by audiotapes and Documentation of Intervention worksheets.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Diagnosis of type 2 diabetes mellitus
  • Taking at one oral medication daily to control diabetes
  • Self-identified as Mexican or Mexican-American
  • Resident in target community within Chicago, Berwyn, or Cicero, Illinois.

排除标准

  • Diabetes controlled with diet or insulin only
  • Advanced end-organ complications, including: end-stage renal disease, stroke with paresis, Congestive Heart Failure (NYHA class 3 or 4), or other major end-organ complication of diabetes
  • Receiving treatment for a major psychiatric disorder (i.e. schizophrenia)
  • Are unable to understand and give informed consent in either English or Spanish
  • Live in a household with someone who is already a randomized study participant or know of family members who are already study participants.
  • Have lived in Mexico for more than four months in the past two years, or are anticipating extended travel to Mexico in the next year.
  • Are under the age of 18

结局指标

主要结局

% of persons with blood pressure less than 130/80

时间窗: 2 years

Hemoglobin A1c

时间窗: 2 years

次要结局

  • Summary of Diabetes Self-Care Activities(2 years)
  • Medication adherence(2 years)
  • Daily self-blood glucose monitoring(2 years)

研究者

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

Steven K. Rothschild, MD

Associate Professor

Rush University Medical Center

研究点 (2)

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