Clinical trial NCT01069991: Asthma Self-Management For Adolescents
Official title: Educating Adolescents To Preventively Manage Their Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Adolescents
Patient Education
Schools
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: New York City Council Speaker's Fund
First posted: 2010-02-17
Enrollment: 345
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Quality of life
timeFrame: One year
Secondary outcomes:
measure: Emergency department visits for asthma
timeFrame: One year
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: David Evans, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.