NCT01003340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

4.4 years

First QC Date

October 27, 2009

Last Update Submit

February 13, 2018

Conditions

Asthma

Keywords

asthmachildrencommunity health workershome intervention

Outcome Measures

Primary Outcomes (1)

  • mean number of asthma symptom days

    average of asthma symptom days

    baseline and every 8 weeks during the 12-months study period

Secondary Outcomes (3)

  • adherence to Inhaled Corticosteroid

    baseline, 4 weeks, 8 weeks, and 12 weeks after beginning of intervention

  • asthma-related Emergency Department visits

    baseline, 3-, 6- and 12-months follow-up

  • parental asthma knowledge and management behaviors

    baseline, 3-, 6- and 12-months follow-up

Study Arms (1)

Wee Wheezers asthma education

EXPERIMENTAL

6 lesson asthma education delivered at home by Community Health Workers

Behavioral: Wee Wheezers

Interventions

Wee WheezersBEHAVIORAL

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

Also known as: Wee Wheezers at Home
Wee Wheezers asthma education

Eligibility Criteria

Age2 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • children with other chronic pulmonary diseases (e.g, cystic fibrosis, bronchopulmonary dysplasia) or presence of tracheostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Group- CHCC

The Bronx, New York, 10451, United States

Location

Related Publications (3)

  • 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.

    PMID: 22505947RESULT

  • 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.

    PMID: 24131031RESULT

  • 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.

    PMID: 24336438RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Marina Reznik, MD, MS

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 28, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 15, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)