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A Community Health Worker Home Intervention to Improve Pediatric Asthma Outcomes

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wee Wheezers
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring asthma, children, community health workers, home intervention

Eligibility Criteria

2 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Group- CHCC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Wee Wheezers asthma education

Arm Description

6 lesson asthma education delivered at home by Community Health Workers

Outcomes

Primary Outcome Measures

mean number of asthma symptom days
average of asthma symptom days

Secondary Outcome Measures

adherence to Inhaled Corticosteroid
survey evaluating medication adherence
asthma-related Emergency Department visits
number of ED visits
parental asthma knowledge and management behaviors
survey evaluating asthma knowledge and management behavior

Full Information

First Posted
October 27, 2009
Last Updated
February 13, 2018
Sponsor
Montefiore Medical Center
Collaborators
American Lung Association
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1. Study Identification

Unique Protocol Identification Number
NCT01003340
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
American Lung Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, children, community health workers, home intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wee Wheezers asthma education
Arm Type
Experimental
Arm Description
6 lesson asthma education delivered at home by Community Health Workers
Intervention Type
Behavioral
Intervention Name(s)
Wee Wheezers
Other Intervention Name(s)
Wee Wheezers at Home
Intervention Description
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
Primary Outcome Measure Information:
Title
mean number of asthma symptom days
Description
average of asthma symptom days
Time Frame
baseline and every 8 weeks during the 12-months study period
Secondary Outcome Measure Information:
Title
adherence to Inhaled Corticosteroid
Description
survey evaluating medication adherence
Time Frame
baseline, 4 weeks, 8 weeks, and 12 weeks after beginning of intervention
Title
asthma-related Emergency Department visits
Description
number of ED visits
Time Frame
baseline, 3-, 6- and 12-months follow-up
Title
parental asthma knowledge and management behaviors
Description
survey evaluating asthma knowledge and management behavior
Time Frame
baseline, 3-, 6- and 12-months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Reznik, MD, MS
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Group- CHCC
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22505947
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.
Results Reference
result
PubMed Identifier
24131031
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.
Results Reference
result
PubMed Identifier
24336438
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.
Results Reference
result

Learn more about this trial

A Community Health Worker Home Intervention to Improve Pediatric Asthma Outcomes

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