Asthma Self-Management For Adolescents (ASMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01069991
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : February 12, 2013
New York City Council Speaker's Fund
Information provided by (Responsible Party):
David Evans PhD, 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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Patient education group Behavioral: Wait list control group Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Educating Adolescents To Preventively Manage Their Asthma
Study Start Date : January 2002
Actual Primary Completion Date : April 2006
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Quality of life [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Emergency department visits for asthma [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01069991

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
New York City Council Speaker's Fund
Principal Investigator: David Evans, PhD Columbia University

Responsible Party: David Evans PhD, Professor of Emeritus of Clinical Sociomedical Sciences (In Pediatrics) & Special Lecturer, Columbia University Identifier: NCT01069991     History of Changes
Other Study ID Numbers: AAAB2642
R18HL67268 ( Other Grant/Funding Number: New York City Council Speaker's Fund )
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by David Evans PhD, Columbia University:
Patient Education

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases