Asthma Self-Management For Adolescents

Asthma Clinical Trial

— ASMA  

Official title:

Educating Adolescents To Preventively Manage Their Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069991
• Other study ID #: AAAB2642
• Secondary ID: R18HL67268
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2010
• Last updated: February 11, 2013
• Start date: January 2002
• Est. completion date: February 2007

Study information

• Verified date: February 2013
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: February 2007
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	New York City Council Speaker's Fund

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		One year	No
Secondary	Emergency department visits for asthma		One year	No