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A Community Health Worker Home Intervention to Improve Pediatric Asthma Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01003340
Recruitment Status : Completed
First Posted : October 28, 2009
Last Update Posted : January 24, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Asthma Behavioral: Wee Wheezers

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of a Community Health Worker Home-Based Asthma Intervention
Study Start Date : July 2009
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Wee Wheezers asthma education
6 lesson asthma education delivered at home by Community Health Workers
Behavioral: Wee Wheezers
The intervention, Wee Wheezers, modified to the needs of the targeted population will include 6 bi-weekly 1 hour educational home visits conducted by Community Health Workers at homes of children with persistent asthma
Other Name: Wee Wheezers at Home

Outcome Measures

Primary Outcome Measures :
  1. mean number of asthma symptom days [ Time Frame: baseline and every 8 weeks during the 12-months study period ]

Secondary Outcome Measures :
  1. adherence to Inhaled Corticosteroid [ Time Frame: baseline, 4 weeks, 8 weeks, and 12 weeks after beginning of intervention ]
  2. asthma-related Emergency Department visits [ Time Frame: baseline, 3-, 6- and 12-months follow-up ]
  3. parental asthma knowledge and management behaviors [ Time Frame: baseline, 3-, 6- and 12-months follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003340

United States, New York
Montefiore Medical Group- CHCC
Bronx, New York, United States, 10451
Sponsors and Collaborators
Montefiore Medical Center
American Lung Association
Principal Investigator: Marina Reznik, MD, MS Montefiore Medical Center
More Information

Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01003340     History of Changes
Other Study ID Numbers: 07-10-360
First Posted: October 28, 2009    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: December 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Montefiore Medical Center:
community health workers
home intervention

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases