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Asthma Self-Management For Adolescents (ASMA)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Patient education group
Wait list control group
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring Asthma, Adolescents, Patient Education, Schools

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient education group

Wait list control group

Arm Description

Patient education program delivered to high school students with persistent asthma.

Control students received no intervention until the one year follow up period was completed.

Outcomes

Primary Outcome Measures

Quality of life

Secondary Outcome Measures

Emergency department visits for asthma

Full Information

First Posted
February 16, 2010
Last Updated
February 11, 2013
Sponsor
Columbia University
Collaborators
New York City Council Speaker's Fund
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1. Study Identification

Unique Protocol Identification Number
NCT01069991
Brief Title
Asthma Self-Management For Adolescents
Acronym
ASMA
Official Title
Educating Adolescents To Preventively Manage Their Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
New York City Council Speaker's Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Adolescents, Patient Education, Schools

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
345 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient education group
Arm Type
Experimental
Arm Description
Patient education program delivered to high school students with persistent asthma.
Arm Title
Wait list control group
Arm Type
Experimental
Arm Description
Control students received no intervention until the one year follow up period was completed.
Intervention Type
Behavioral
Intervention Name(s)
Patient education group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wait list control group
Intervention Description
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 Measure Information:
Title
Quality of life
Time Frame
One year
Secondary Outcome Measure Information:
Title
Emergency department visits for asthma
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Evans, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15582346
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.
Results Reference
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Asthma Self-Management For Adolescents

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