AsthmaPhase 2ASMANCT01069991
Asthma Self-Management For Adolescents
A Phase 2 study testing Patient education group in people with Asthma, run by Columbia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- Patient education group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Feb 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 9th or 10th grade high school student
- diagnosed moderate to severe persistent asthma
- used physician prescribed asthma medicine in past 12 months
Who cannot join
- comorbidity with other diseases that affect lung function
- enrollment in special education classes for learning disabilities
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Patient education group, Wait list control group
- Keywords
- Asthma, Adolescents, Patient Education, Schools
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education groupBehavioural
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.
Wait list control groupBehavioural
No intervention was provided for this group until the one year study period was completed, and then the patient education intervention was provided.
| Study group | Role | What they receive |
|---|---|---|
| Patient education group | Experimental | Patient education program delivered to high school students with persistent asthma. Receives: Behavioral: Patient education group |
| Wait list control group | Experimental | Control students received no intervention until the one year follow up period was completed. Receives: Behavioral: Wait list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: One year
Secondary outcomes (1)
Emergency department visits for asthma
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startJan 2002
- Primary completionApr 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- New York City Council Speaker's Fund
- Responsible party
- Principal investigator, David Evans PhD, Columbia University
- Investigators
- David Evans, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069991
- Sponsor's protocol ID
- AAAB2642
- Other IDs
- R18HL67268
- Acronym
- ASMA
- Status last verified
- Feb 2013
- First submitted
- 16 Feb 2010
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15582346
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educating Adolescents To Preventively Manage Their Asthma
- ClinicalTrials.gov ID
- NCT01069991
- Acronym / sponsor ID
- ASMA / AAAB2642
- Conditions
- Asthma
- Keywords
- Asthma, Adolescents, Patient Education, Schools
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- New York City Council Speaker's Fund
- Study start
- Jan 2002
- Primary completion
- Apr 2006 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient education group | Experimental | Behavioral: Patient education groupPatient education program delivered to high school students with persistent asthma. |
| Wait list control group | Experimental | Behavioral: Wait list control groupControl students received no intervention until the one year follow up period was completed. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 9th or 10th grade high school student
- diagnosed moderate to severe persistent asthma
- used physician prescribed asthma medicine in past 12 months
Key exclusion criteria (2 listed)
- comorbidity with other diseases that affect lung function
- enrollment in special education classes for learning disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient education groupPatient 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. | Behavioural | Patient education group |
| Wait list control groupNo intervention was provided for this group until the one year study period was completed, and then the patient education intervention was provided. | Behavioural | Wait list control group |
Primary outcome
Quality of life
Time frame: One year
1 secondary outcome
Emergency department visits for asthma
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
- Background: PubMed 15582346Bruzzese 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.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Evans, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Patient education group in people with Asthma, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01069991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.