Clinical trial NCT01003340: A Community Health Worker Home Intervention to Improve Pediatric Asthma Outcomes
Official title: A Randomized Controlled Trial of a Community Health Worker Home-Based Asthma Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
children
community health workers
home intervention
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: American Lung Association
First posted: 2009-10-28
Enrollment: 188
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: mean number of asthma symptom days
timeFrame: baseline and every 8 weeks during the 12-months study period
Secondary outcomes:
measure: adherence to Inhaled Corticosteroid
timeFrame: baseline, 4 weeks, 8 weeks, and 12 weeks after beginning of intervention
measure: asthma-related Emergency Department visits
timeFrame: baseline, 3-, 6- and 12-months follow-up
measure: parental asthma knowledge and management behaviors
timeFrame: baseline, 3-, 6- and 12-months follow-up
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Group- CHCC
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Marina Reznik, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.