Asthma Self-Management For Adolescents (ASMA)

This study has been completed.
Sponsor:
Collaborator:
New York City Council Speaker's Fund
Information provided by (Responsible Party):
David Evans PhD, Columbia University
ClinicalTrials.gov Identifier:
NCT01069991
First received: February 16, 2010
Last updated: February 11, 2013
Last verified: February 2013

February 16, 2010
February 11, 2013
January 2002
April 2006   (final data collection date for primary outcome measure)
Quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01069991 on ClinicalTrials.gov Archive Site
Emergency department visits for asthma [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Asthma Self-Management For Adolescents
Educating Adolescents To Preventively Manage Their Asthma

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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.
  • 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.
  • Experimental: Patient education group
    Patient education program delivered to high school students with persistent asthma.
    Intervention: Behavioral: Patient education group
  • Experimental: Wait list control group
    Control students received no intervention until the one year follow up period was completed.
    Intervention: Behavioral: Wait list control group
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
345
February 2007
April 2006   (final data collection date for primary outcome measure)

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
Both
13 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01069991
AAAB2642, R18HL67268
No
David Evans PhD, Columbia University
Columbia University
New York City Council Speaker's Fund
Principal Investigator: David Evans, PhD Columbia University
Columbia University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP