NCT00660322

Brief Summary

Asthma is the most common chronic disease of childhood and a major cause of morbidity in the United States. If asthma symptoms are controlled, a child with asthma can stay well and lead a normal life. Daily use of inhaled steroids controls symptoms and reduces morbidity and emergent health care utilization in children with persistent asthma, and is safe for long-term use. However, inhaled steroids are underused in community asthma care. The Telephone Asthma Program (TAP) is a series of brief, telephone calls with a trained coach to help the parent manage the child's asthma care. The coach will teach self-management skills, help the parent to use the child's asthma medicines effectively, provide support and remind the parent to go for follow-up care with the pediatrician. We hypothesized that the Telephone Asthma Program will reduce the incidence of acute exacerbations of asthma that require emergent care, improve the quality of life of children with asthma and their parents, and increase the daily use of inhaled steroids in children with persistent asthma. We evaluated the Telephone Asthma Program in a randomized controlled trial involving 362 children aged 5 to 12 years old cared for by community pediatricians. Eligible children were randomized to the TAP program or usual care by their pediatrician.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
362

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Jan 2004

Typical duration 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

January 1, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
Last Updated

April 17, 2008

Status Verified

April 1, 2008

Enrollment Period

2 years

First QC Date

April 15, 2008

Last Update Submit

April 15, 2008

Conditions

Asthma

Keywords

AsthmaTelemedicineRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • Parental asthma-related quality of life

    one year

  • Urgent care events for asthma

    One year

Study Arms (2)

Control

NO INTERVENTION

Families assigned to the control arm will receive usual asthma care from the child's primary care provider.

Intervention

EXPERIMENTAL

The Telephone Asthma Program and usual care.

Behavioral: Telephone Asthma Program

Interventions

Telephone Asthma ProgramBEHAVIORAL

The parent will have access to a trained asthma coach for 12 months. The coach will call the parents at mutually convenient times (up to 12 times a year) to work on 4 targeted asthma behaviors: 1. Using asthma controller medications as prescribed 2. Having and Asthma Action Plan available to all who may need it. 3. Using asthma rescue medications with the child's first symptoms. 4. Having a collaborative relationship with the child's primary care provider that includes asthma check-ups at least twice a year.

Intervention

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Physician diagnosis of asthma for at least a year
  • At least one acute exacerbation of asthma in past 12 months that required a visit to the emergency department, hospitalization or an unscheduled office visit for acute care and/or a course of oral steroids.
  • Taking daily controller medications or symptoms consistent with persistent asthma

You may not qualify if:

  • No phone
  • Unable to speak English
  • Child has another disease that requires regular monitoring by pediatrician
  • A sibling is already enrolled in the study
  • Child's primary asthma provider is an asthma specialist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

  • Garbutt J, Bloomberg G, Banister C, Sterkel R, Epstein J, Bruns J, Swerczek L, Wells S. What constitutes maintenance asthma care? The pediatrician's perspective. Ambul Pediatr. 2007 Jul-Aug;7(4):308-12. doi: 10.1016/j.ambp.2007.03.007.

    PMID: 17660103BACKGROUND

  • Garbutt JM, Banister C, Highstein G, Sterkel R, Epstein J, Bruns J, Swerczek L, Wells S, Waterman B, Strunk RC, Bloomberg GR. Telephone coaching for parents of children with asthma: impact and lessons learned. Arch Pediatr Adolesc Med. 2010 Jul;164(7):625-30. doi: 10.1001/archpediatrics.2010.91.

    PMID: 20603462DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jane Garbutt, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 17, 2008

Study Start

January 1, 2004

Primary Completion

January 1, 2006

Study Completion

June 1, 2007

Last Updated

April 17, 2008

Record last verified: 2008-04

Locations

US(1)