NCT00399984

Brief Summary

Inhaled corticosteroids taken on a daily basis have been proven to be the most effective treatment for children with persistent asthma. However, many pediatricians still do not prescribe daily corticosteroids to their asthmatic patients; this can lead to poor health outcomes among asthmatic children. This study will evaluate an interactive medical education program that focuses on improving pediatricians' asthma management skills and on encouraging increased corticosteroid use among their patients with asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Apr 2004

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

5.2 years

First QC Date

November 13, 2006

Last Update Submit

June 11, 2013

Conditions

Keywords

Continuing Medical Education

Outcome Measures

Primary Outcomes (2)

  • Changes in physician knowledge, attitudes, and self-reported behavior

    1-3 years

  • Changes in patient asthma outcomes (both measured on a yearly basis)

    1-3 years

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Asthma Education Program

2

NO INTERVENTION

Interventions

interactive seminars regarding daily inhaled corticosteroids

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pediatricians must meet all of the following criteria:
  • Graduate of a pediatric residency program in the United States
  • In active medical practice for at least 4 half-day sessions, with 40% clinical effort in general pediatrics
  • At least 54 children with asthma in their patient population
  • Parents of pediatric asthma patients must meet all of the following criteria:
  • Parent or guardian of a pediatric patient that meets patient eligibility criteria
  • Able to identify that the participating physician is the child's primary care pediatrician
  • Provides most asthma management or is the adult who normally takes the child to the doctor
  • Pediatric patients must meet all of the following criteria:
  • Older than 4 years of age (to decrease the likelihood that the child has bronchiolitis)
  • Younger than 16 years of age (to ensure that during all 3 years of the evaluation part of the study, the child will be younger than 20 years of age)
  • Diagnosis of asthma made by a physician using commonly accepted clinical criteria
  • No other chronic disorders that have pulmonary complications (e.g., sickle cell disease, tuberculosis, acquired immune deficiency syndrome \[AIDS\], cystic fibrosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michael D. Cabana, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 15, 2006

Study Start

April 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 13, 2013

Record last verified: 2013-06

Locations