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Clinical Trials/NCT01003340
NCT01003340
Completed
Not Applicable

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

Montefiore Medical Center1 site in 1 country188 target enrollmentJuly 2009
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Montefiore Medical Center
Enrollment
188
Locations
1
Primary Endpoint
mean number of asthma symptom days
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
December 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marina Reznik

principal investigator

Montefiore Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

mean number of asthma symptom days

Time Frame: baseline and every 8 weeks during the 12-months study period

average of asthma symptom days

Secondary Outcomes

  • 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)

Study Sites (1)

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