- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01003340
A Community Health Worker Home Intervention to Improve Pediatric Asthma Outcomes
February 13, 2018 updated by: Marina Reznik, Montefiore Medical Center
A Randomized Controlled Trial of a Community Health Worker Home-Based Asthma Intervention
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
188
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Bronx, New York, United States, 10451
- Montefiore Medical Group- CHCC
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 9 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Wee Wheezers asthma education
6 lesson asthma education delivered at home by Community Health Workers
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mean number of asthma symptom days
Time Frame: baseline and every 8 weeks during the 12-months study period
|
average of asthma symptom days
|
baseline and every 8 weeks during the 12-months study period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adherence to Inhaled Corticosteroid
Time Frame: baseline, 4 weeks, 8 weeks, and 12 weeks after beginning of intervention
|
survey evaluating medication adherence
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baseline, 4 weeks, 8 weeks, and 12 weeks after beginning of intervention
|
asthma-related Emergency Department visits
Time Frame: baseline, 3-, 6- and 12-months follow-up
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number of ED visits
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baseline, 3-, 6- and 12-months follow-up
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parental asthma knowledge and management behaviors
Time Frame: baseline, 3-, 6- and 12-months follow-up
|
survey evaluating asthma knowledge and management behavior
|
baseline, 3-, 6- and 12-months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marina Reznik, MD, MS, Montefiore Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Reznik M, Ozuah PO. Measurement of inhaled corticosteroid adherence in inner-city, minority children with persistent asthma by parental report and integrated dose counter. J Allergy (Cairo). 2012;2012:570850. doi: 10.1155/2012/570850. Epub 2012 Mar 15.
- Reznik M, Silver EJ, Cao Y. Evaluation of MDI-spacer utilization and technique in caregivers of urban minority children with persistent asthma. J Asthma. 2014 Mar;51(2):149-54. doi: 10.3109/02770903.2013.854379. Epub 2013 Oct 22.
- Reznik M, Jaramillo Y, Wylie-Rosett J. Demonstrating and assessing metered-dose inhaler-spacer technique: pediatric care providers' self-reported practices and perceived barriers. Clin Pediatr (Phila). 2014 Mar;53(3):270-6. doi: 10.1177/0009922813512521. Epub 2013 Dec 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
October 27, 2009
First Submitted That Met QC Criteria
October 27, 2009
First Posted (Estimate)
October 28, 2009
Study Record Updates
Last Update Posted (Actual)
February 15, 2018
Last Update Submitted That Met QC Criteria
February 13, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-10-360
- CG-120837-N (Other Grant/Funding Number: American Lung Association)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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