Asthma Self-Management For Adolescents

Phase 2

Completed

• Conditions: Asthma
• Interventions: Behavioral: Patient education group; Behavioral: Wait list control group

• Registration Number: NCT01069991
• Lead Sponsor: Columbia University

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.

Detailed Description

Five public high schools from areas in New York City with high asthma rates will be enrolled in the study. In each school, we will identify students with asthma using a brief, self-administered survey that asks questions about current symptoms of wheeze, persistent cough, chest tightness, night waking, and past diagnosis of asthma. Eligible students will have the program explained to them individually. Caregivers of students who express interest in the program will be contacted to obtain written, informed consent. An equal number of students in each school will be randomly assigned to the immediate intervention group and to a control group that will receive the program 12 months later. Students assigned to the immediate intervention group will take part in three group workshops to learn about the chronic nature of asthma, how to control asthma by monitoring symptoms and using medicines consistently, and how to take preventive management steps using environmental control strategies and a written treatment plan from their physician as a guide for adjusting their medicines. They will also receive individual coaching by a health educator to assess how the students are doing and feeling, help them interpret their symptoms and responses to medication, and encourage them to take the next steps to control asthma. Before the visit we will have asthma specialist physicians on our staff make a telephone call to the student's physician to alert them that the student will make a visit, that the student will bring symptoms diaries, and to encourage the physician to review the diaries, prescribe according to NHLBI guidelines, and provide a written treatment plan. The intervention for each student will last three months. During the follow up year, no educational contact will be made with control group students, families, or physicians. Following completion of the study 12 months later, these students will be offered the same intervention provided to the immediate intervention group.

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2006-04
• Study Completion: 2007-02
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-11
• Last Update Posted: 2013-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

• 9th or 10th grade high school student
• diagnosed moderate to severe persistent asthma
• used physician prescribed asthma medicine in past 12 months

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient education group	Patient education group	Patient education program delivered to high school students with persistent asthma.
Wait list control group	Wait list control group	Control students received no intervention until the one year follow up period was completed.

Primary Outcome Measures

Name	Time	Method
Quality of life	One year

Secondary Outcome Measures

Name	Time	Method
Emergency department visits for asthma	One year

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States