A Community Health Worker Home Intervention to Improve Pediatric Asthma Outcomes
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- mean number of asthma symptom days [ Time Frame: baseline and every 8 weeks during the 12-months study period ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Marina Reznik, MD, MS | 718-741-2494 | mreznik@montefiore.org |
| Contact: Philip O Ozuah, MD. PhD | 718-741-2499 | pozuah@montefiore.org |
| 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 | |
| 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 Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013