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
  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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069991

Locations
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
Investigators
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 September 22, 2014