NCT01069991

Brief Summary

The goal of this study is to help adolescents with asthma learn to control their illness and live without restrictions. We hypothesize that an intensive school-based asthma education program for students in 9th and 10th grade who have persistent asthma, together with asthma education for their primary care physicians, will improve the students' health status, quality of life, and ability to control their asthma through self-management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
345

participants targeted

Target at P75+ for phase_2 asthma

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_2 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

January 1, 2002

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

4.2 years

First QC Date

February 16, 2010

Last Update Submit

February 11, 2013

Conditions

Keywords

AsthmaAdolescentsPatient EducationSchools

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    One year

Secondary Outcomes (1)

  • Emergency department visits for asthma

    One year

Study Arms (2)

Patient education group

EXPERIMENTAL

Patient education program delivered to high school students with persistent asthma.

Behavioral: Patient education group

Wait list control group

EXPERIMENTAL

Control students received no intervention until the one year follow up period was completed.

Behavioral: Wait list control group

Interventions

Patient education delivered to high school students with persistent asthma in group and individual sessions. Academic detailing was also provided to the students' primary care providers.

Patient education group

No intervention was provided for this group until the one year study period was completed, and then the patient education intervention was provided.

Wait list control group

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • th or 10th grade high school student
  • diagnosed moderate to severe persistent asthma
  • used physician prescribed asthma medicine in past 12 months

You may not qualify if:

  • comorbidity with other diseases that affect lung function
  • enrollment in special education classes for learning disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • Bruzzese JM, Bonner S, Vincent EJ, Sheares BJ, Mellins RB, Levison MJ, Wiesemann S, Du Y, Zimmerman BJ, Evans D. Asthma education: the adolescent experience. Patient Educ Couns. 2004 Dec;55(3):396-406. doi: 10.1016/j.pec.2003.04.009.

    PMID: 15582346BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • David Evans, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Emeritus of Clinical Sociomedical Sciences (In Pediatrics) & Special Lecturer

Study Record Dates

First Submitted

February 16, 2010

First Posted

February 17, 2010

Study Start

January 1, 2002

Primary Completion

April 1, 2006

Study Completion

February 1, 2007

Last Updated

February 12, 2013

Record last verified: 2013-02

Locations