Asthma Self-Management For Adolescents

NCT ID: NCT01069991

Last Updated: 2013-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 345 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2007-02-28

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Patient education group

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

Group Type: EXPERIMENTAL

Patient education group

Intervention Type: BEHAVIORAL

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.

Wait list control group

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

Group Type: EXPERIMENTAL

Wait list control group

Intervention Type: BEHAVIORAL

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

Interventions

Patient education group

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.

Intervention Type: BEHAVIORAL

Wait list control group

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York City Council Speaker's Fund

UNKNOWN

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

David Evans PhD

Professor of Emeritus of Clinical Sociomedical Sciences (In Pediatrics) & Special Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Evans, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15582346 (View on PubMed)

Other Identifiers

R18HL67268

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AAAB2642

Identifier Type: -

Identifier Source: org_study_id