A Community Health Worker Home Intervention to Improve Pediatric Asthma Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Montefiore Medical Center
Sponsor:
Collaborator:
American Lung Association
Information provided by (Responsible Party):
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01003340
First received: October 27, 2009
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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 Intervention
Asthma
Behavioral: Wee Wheezers

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of a Community Health Worker Home-Based Asthma Intervention

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • mean number of asthma symptom days [ Time Frame: baseline and every 8 weeks during the 12-months study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adherence to Inhaled Corticosteroid [ Time Frame: baseline, 4 weeks, 8 weeks, and 12 weeks after beginning of intervention ] [ Designated as safety issue: No ]
  • asthma-related Emergency Department visits [ Time Frame: baseline, 3-, 6- and 12-months follow-up ] [ Designated as safety issue: No ]
  • parental asthma knowledge and management behaviors [ Time Frame: baseline, 3-, 6- and 12-months follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: July 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   2 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003340

Contacts
Contact: Marina Reznik, MD, MS 718-741-2494 mreznik@montefiore.org
Contact: Philip O Ozuah, MD. PhD 718-741-2499 pozuah@montefiore.org

Locations
United States, New York
Montefiore Medical Group- CHCC Recruiting
Bronx, New York, United States, 10451
Contact: Marina Reznik, MD, MS    718-741-2494    mreznik@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
American Lung Association
Investigators
Principal Investigator: Marina Reznik, MD, MS Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01003340     History of Changes
Other Study ID Numbers: 07-10-360
Study First Received: October 27, 2009
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014