Asthma Self-Management For Adolescents (ASMA)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Asthma |
Behavioral: Patient education group Behavioral: Wait list control group |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Educating Adolescents To Preventively Manage Their Asthma |
- Quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]
- Emergency department visits for asthma [ Time Frame: One year ] [ Designated as safety issue: No ]
| Enrollment: | 345 |
| Study Start Date: | January 2002 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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| Ages Eligible for Study: | 13 Years to 18 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | David Evans, PhD | Columbia University |
More Information
Publications:
| Responsible Party: | David Evans PhD, Professor of Emeritus of Clinical Sociomedical Sciences (In Pediatrics) & Special Lecturer, Columbia University |
| ClinicalTrials.gov Identifier: | NCT01069991 History of Changes |
| Other Study ID Numbers: | AAAB2642, R18HL67268 |
| Study First Received: | February 16, 2010 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Columbia University:
|
Asthma Adolescents Patient Education Schools |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013