NCT00860834

Brief Summary

Parents of children with asthma must work with their child's pediatrician to ensure that their child's asthma is managed well. Asthma coaches are one way to facilitate and support the relationship between parents and pediatricians. This study will evaluate whether access to a 12-month telephone asthma coaching program for parents is an effective way to improve asthma outcomes in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
984

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Aug 2008

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

August 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2014

Completed
Last Updated

October 3, 2018

Status Verified

October 1, 2018

Enrollment Period

4.8 years

First QC Date

March 10, 2009

Last Update Submit

October 1, 2018

Conditions

Asthma

Keywords

Consumer ParticipationTelephone Coaching Program

Outcome Measures

Primary Outcomes (3)

  • Asthma control

    Measured at Months 12 and 24

  • Asthma-related quality of life

    Measured at Months 12 and 24

  • Urgent care events

    Measured at Months 12 and 24

Secondary Outcomes (2)

  • Adherence to guideline-recommended asthma maintenance care behaviors

    Measured at Months 12 and 24

  • Cost effectiveness

    Measured at Months 12 and 24

Study Arms (2)

1

EXPERIMENTAL

Pediatricians and parents of children with asthma will participate in the asthma coaching program.

Behavioral: Asthma Coaching Program

2

ACTIVE COMPARATOR

Children of parents enrolled in the study will receive usual asthma care from their pediatrician.

Behavioral: Usual Care

Interventions

Asthma Coaching ProgramBEHAVIORAL

Parents will have access to an asthma coach for 12 months. Telephone calls between parents and coaches will occur anywhere from once a week to once a month.

1
Usual CareBEHAVIORAL

Children of parents enrolled in the study will receive the normal asthma care that their pediatricians usually provide.

2

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Affiliated with St. Louis Children's Hospital and/or Washington University in St. Louis
  • Provides asthma care for at least 40 asthmatic children from the target population
  • Has a child who is between 3 and 12 years old with persistent asthma and who is cared for by a study pediatrician

You may not qualify if:

  • Spends less than 50% of their time in general pediatrics
  • Is an asthma specialist (allergist or pulmonary specialist)
  • Another physician in their practice is participating in the study
  • Their asthmatic child is less than 3 years old or is 13 years or older at the time of study entry
  • Their child has not had a physician diagnosis of asthma before study entry
  • Their child has a significant comorbid condition
  • Cannot speak English
  • Does not have a phone

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 JM, Highstein G, Yan Y, Strunk RC. Partner randomized controlled trial: study protocol and coaching intervention. BMC Pediatr. 2012 Apr 2;12:42. doi: 10.1186/1471-2431-12-42.

    PMID: 22469168BACKGROUND

  • Garbutt JM, Yan Y, Highstein G, Strunk RC. A cluster-randomized trial shows telephone peer coaching for parents reduces children's asthma morbidity. J Allergy Clin Immunol. 2015 May;135(5):1163-70.e1-2. doi: 10.1016/j.jaci.2014.09.033. Epub 2014 Oct 30.

    PMID: 25445827DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jane M. Garbutt, MB, ChB

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Robert Strunk, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 10, 2009

First Posted

March 12, 2009

Study Start

August 1, 2008

Primary Completion

May 3, 2013

Study Completion

May 3, 2014

Last Updated

October 3, 2018

Record last verified: 2018-10

Locations

US(1)