A Community Health Worker Home Intervention to Improve Pediatric Asthma Outcomes

Asthma Clinical Trial

Official title:

A Randomized Controlled Trial of a Community Health Worker Home-Based Asthma Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003340
• Other study ID #: 07-10-360
• Secondary ID: CG-120837-N
• Status: Completed
• Phase: N/A
• First received: October 27, 2009
• Last updated: February 13, 2018
• Start date: July 2009
• Est. completion date: December 2013

Study information

• Verified date: February 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
United States	Montefiore Medical Group- CHCC	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	American Lung Association

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean number of asthma symptom days	average of asthma symptom days	baseline and every 8 weeks during the 12-months study period
Secondary	adherence to Inhaled Corticosteroid	survey evaluating medication adherence	baseline, 4 weeks, 8 weeks, and 12 weeks after beginning of intervention
Secondary	asthma-related Emergency Department visits	number of ED visits	baseline, 3-, 6- and 12-months follow-up
Secondary	parental asthma knowledge and management behaviors	survey evaluating asthma knowledge and management behavior	baseline, 3-, 6- and 12-months follow-up