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临床试验/NCT01003340
NCT01003340已完成不适用

A Randomized Controlled Trial of a Community Health Worker Home-Based Asthma Intervention

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2009年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
188
试验地点
1
主要终点
mean number of asthma symptom days

研究概览

简要总结

The investigators propose to test the hypothesis that a home-based asthma intervention, the Wee Wheezers program, delivered by the Community Health Workers and tailored to the needs of the investigators community, will improve anti-inflammatory medication adherence, parental asthma knowledge and management behaviors, which in turn will reduce asthma morbidity (defined as days with asthma symptoms) and health care utilization (defined as asthma-related Emergency Department visits) among low-income, minority children with persistent asthma in the Bronx.

详细描述

Asthma disproportionately burdens low-income inner city and minority children residing in inner cities. Daily use of inhaled corticosteroids (ICS) control symptoms and reduce asthma morbidity. Less then 50% of children with persistent asthma adhere to such therapy. Poor adherence to ICS medications is one of the major contributors to asthma morbidity. One way to reduce asthma disparities is to work in partnership with communities. Community Health Workers (CHWs) share the ethnic, cultural, social, and environmental experiences of the people in the community. Although, CHW home interventions have been successful in reducing asthma allergens, no studies using CHWs to deliver a previously identified evidence-based home intervention to improve ICS adherence and health outcomes in a population of inner-city, minority children with persistent asthma have been found. Objective: To evaluate the effectiveness of an evidence-based asthma home intervention, the Wee Wheezers program, tailored to the needs of the community and delivered by CHWs, in improving medication adherence, health outcomes and parental management behaviors among low-income, minority children with persistent asthma in the Bronx.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
2 Years 至 9 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •children 2-9 years of age with persistent asthma
  • •children being currently prescribed ICS in the Metered Dose Inhaler (MDI) form
  • •if the child is 2 years of age at the time of the recruitment, he/she must have at least two prior episodes of wheezing treated and reversible with beta-agonists
  • •primary caregiver speaks English or Spanish
  • •family has a phone.

排除标准

  • •children with other chronic pulmonary diseases (e.g, cystic fibrosis, bronchopulmonary dysplasia) or presence of tracheostomy

研究组 & 干预措施

Wee Wheezers asthma education

Experimental

6 lesson asthma education delivered at home by Community Health Workers

干预措施: Wee Wheezers (Behavioral)

结局指标

主要结局

mean number of asthma symptom days

时间窗: baseline and every 8 weeks during the 12-months study period

average of asthma symptom days

次要结局

  • parental asthma knowledge and management behaviors(baseline, 3-, 6- and 12-months follow-up)
  • asthma-related Emergency Department visits(baseline, 3-, 6- and 12-months follow-up)
  • adherence to Inhaled Corticosteroid(baseline, 4 weeks, 8 weeks, and 12 weeks after beginning of intervention)

研究者

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

Marina Reznik

principal investigator

Montefiore Medical Center

研究点 (1)

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