NCT00149500

Brief Summary

We will evaluate the effect of an eighteen-month asthma coaching intervention for parents/caregivers of children with asthma to reduce asthma morbidity. The primary objective is to determine if asthma coaching will significantly reduce asthma morbidity as measured by a reduction in the number of ED visits and hospitalizations for the children during the 18 months of active coaching and during the 18 months after the coaching stops. We will provide half of the subjects (parents/caregivers) with access to assistance from an asthma coach for 18 months (including 2 contacts with an asthma nurse during the first 6 months). The other half of the subjects will not have an asthma coach, but their children will have their usual routine care with their primary care providers. The nurse and coach will help the subjects learn more about caring for their children's asthma and improving interactions with the primary care providers for their children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
241

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Sep 2003

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

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

4.7 years

First QC Date

September 6, 2005

Last Update Submit

May 2, 2018

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • ER visits

    Documenting the number of ER visits per patient in the 18 month period.

    18 months

Study Arms (2)

Coaching group for lifestyle changes

EXPERIMENTAL

Patients received monthly phone calls with coaching for lifestyle changes over 2 years.

Behavioral: Coaching

Routine pediatric care

NO INTERVENTION

This group receives routine care with their pediatrician.

Interventions

CoachingBEHAVIORAL

Patients received monthly calls to assist in behavioral change relative to asthma care

Coaching group for lifestyle changes

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • A. The child of the parent/caregiver has a diagnosis of asthma made by a physician and reported by the parent, or diagnosis of asthma made during the ED visit if the child has experienced two previous wheezing episodes.
  • B. The child will undergo treatment during the enrollment ED visit for the current asthma exacerbation, as determined by the treating ED clinician. As a result, only parents/caregivers with children experiencing a significant wheezing episode will be entered into the study.
  • C. The child is 2-10 years of age (second birth date until, but not including, eleventh birth date).
  • D. The child has Medicaid or no medical insurance. This criterion permits easy identification and selection of low-income children/families, who are the target population for this proposal.
  • E. The parent/caregiver has a working telephone at home. F. The child attends one of the target practices (7 private practices and 5 federally funded clinics) for routine care.
  • G. The parent/caregiver and child live within the St. Louis metro area.

You may not qualify if:

  • A. The child attends a practice other than the target group. B. The parent/caregiver and child live outside of the St. Louis metro area. C. The child has a chronic illness other than asthma that manifests as wheezing or respiratory symptoms.
  • D. The parent/caregiver does not have a working telephone in home. E. The parent/caregiver is not able to effectively communicate in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Nelson KA, Highstein GR, Garbutt J, Trinkaus K, Fisher EB, Smith SR, Strunk RC. A randomized controlled trial of parental asthma coaching to improve outcomes among urban minority children. Arch Pediatr Adolesc Med. 2011 Jun;165(6):520-6. doi: 10.1001/archpediatrics.2011.57.

    PMID: 21646584DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Robert Strunk

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

September 1, 2003

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

May 8, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)