A Community Health Worker Home Intervention to Improve Pediatric Asthma Outcomes

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: Wee Wheezers

• Registration Number: NCT01003340
• Lead Sponsor: Montefiore Medical Center

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Wee Wheezers asthma education	Wee Wheezers	6 lesson asthma education delivered at home by Community Health Workers

Primary Outcome Measures

Name	Time	Method
mean number of asthma symptom days	baseline and every 8 weeks during the 12-months study period	average of asthma symptom days

Secondary Outcome Measures

Name	Time	Method
adherence to Inhaled Corticosteroid	baseline, 4 weeks, 8 weeks, and 12 weeks after beginning of intervention	survey evaluating medication adherence
parental asthma knowledge and management behaviors	baseline, 3-, 6- and 12-months follow-up	survey evaluating asthma knowledge and management behavior
asthma-related Emergency Department visits	baseline, 3-, 6- and 12-months follow-up	number of ED visits

Trial Locations

Locations (1)

Montefiore Medical Group- CHCC; 🇺🇸 Bronx, New York, United States