AsthmaDMSPNCT00217776
School-based Approaches to Help Pre-teens Manage Asthma
A study testing Open Airways Educational Intervention and Peer Asthma Action Educational Intervention in people with Asthma, run by University of Michigan.
Trial summary
This random trial will deploy 2 interventions and a control group with eleven and twelve year old, low income, African American students in middle schools in Detroit, MI. The goals are to determine if 1) a self-management program focused on pre-teen capabilities designed for middle schools produces desired outcomes… Read more about this study
- Who is it for?
- Ages 11 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Open Airways Educational Intervention and Peer Asthma Action Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,292 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Jan 2009
- Phase
- Interventional
- 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 11 to 12 years
- All sexes
- No healthy volunteers
- Child
Children identified for this research will be a sample of 6th grade students enrolled in 19 public middle schools in Detroit, Michigan who meet the following criteria: 1) attend a participating school, 2) be 11-12 years old at the time of entry into the study (enrolled in 6th grade) and 3) based on NAEPP guidelines (a) have a diagnosis of asthma and have active asthma symptoms and/or have received a prescription for asthma medications in the last year, or (b) report the presence of 3 of 5 non-exercise related asthma symptoms in the last year on five or more occasions, or (c) report two or more exercise related asthma symptoms in the past year on five or more occasions, or (d) have a severity classification of persistent disease (mild, moderate, severe) based on night time questions, and 4) have returned a signed parental consent form.
About this study
This random trial will deploy 2 interventions and a control group with eleven and twelve year old, low income, African American students in middle schools in Detroit, MI. The goals are to determine if 1) a self-management program focused on pre-teen capabilities designed for middle schools produces desired outcomes, and 2) if the program, enhanced by a peer component, improves upon outcomes. Outcomes of interest are symptom experience, quality of life, self-management, and school grades.
Read the detailed description
BACKGROUND:
To date, no data provide information on the effects of middle school based interventions for pre-teens with asthma or the advantages of an approach that recognizes the importance of peer influence on pre-teen's asthma behavior. Interventions to reach low income minority populations are particularly needed.
DESIGN NARRATIVE:
If only one primary outcome is to be specified, it would be asthma morbidity, as evident in asthma symptoms. Data to assess outcomes will be collected at baseline, and 12 and 24 months post program through parent interviews and student surveys.
Additional primary outcomes listed in the protocol include: Asthma related quality of life, disease management behavior and academic performance.
Secondary outcomes include: peer support, school attendance, physical activity, health care use, and smoking behavior.
- Conditions
- Asthma
- Being tested
- Open Airways Educational Intervention, Peer Asthma Action Educational Intervention
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Airways Educational InterventionBehavioural
Also called A 6 week asthma educational self management program for middle school students.
Peer Asthma Action Educational InterventionBehavioural
Also called Peer Asthma Action Educational Intervention is a peer led training program for children in multiple grades teaching them about asthma and asthma management.
| Study group | Role | What they receive |
|---|---|---|
| Open Airways Educational Intervention | Active comparator | Children in this arm will receive the Open Airways educational program which is an evidenced based asthma educational program for children, developed by the investigator. Receives: Behavioral: Open Airways Educational Intervention |
| Open Airways and Peer Asthma Action Intervention Education | Active comparator | Children in this arm will receive BOTH the Open Airways asthma education program and the Peer Asthma Action education program. Receives: Behavioral: Open Airways Educational Intervention; Behavioral: Peer Asthma Action Educational Intervention |
| Control Arm | No intervention | Children in the Control Arm will be interviewed in person at baseline, 12 month and 24 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Care Use Data
health care use will be self reported in the telephone interviews with parents at baseline, 12 months and 24 months.
Measured: At Baseline, 12 month and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,292 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Noreen M. Clark, University of Michigan
- Investigators
- Noreen M. Clark, PhD, Principal investigator, University of Michigan School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217776
- Sponsor's protocol ID
- 288
- Other IDs
- R01HL068654-04
- Acronym
- DMSP
- Status last verified
- Jan 2013
- First submitted
- 19 Sep 2005
- Last updated
- 17 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School-based Approaches to Help Pre-teens Manage Asthma
- ClinicalTrials.gov ID
- NCT00217776
- Acronym / sponsor ID
- DMSP / 288
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,292 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 Sep 2005 (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.
This random trial will deploy 2 interventions and a control group with eleven and twelve year old, low income, African American students in middle schools in Detroit, MI. The goals are to determine if 1) a self-management program focused on pre-teen capabilities designed for middle schools produces desired outcomes, and 2) if the program, enhanced by a peer component, improves upon outcomes. Outcomes of interest are symptom experience, quality of life, self-management, and school grades.
Detailed description
BACKGROUND:
To date, no data provide information on the effects of middle school based interventions for pre-teens with asthma or the advantages of an approach that recognizes the importance of peer influence on pre-teen's asthma behavior. Interventions to reach low income minority populations are particularly needed.
DESIGN NARRATIVE:
If only one primary outcome is to be specified, it would be asthma morbidity, as evident in asthma symptoms. Data to assess outcomes will be collected at baseline, and 12 and 24 months post program through parent interviews and student surveys.
Additional primary outcomes listed in the protocol include: Asthma related quality of life, disease management behavior and academic performance.
Secondary outcomes include: peer support, school attendance, physical activity, health care use, and smoking behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Airways Educational Intervention | Active comparator | Behavioral: Open Airways Educational InterventionChildren in this arm will receive the Open Airways educational program which is an evidenced based asthma educational program for children, developed by the investigator. |
| Open Airways and Peer Asthma Action Intervention Education | Active comparator | Behavioral: Open Airways Educational Intervention, Behavioral: Peer Asthma Action Educational InterventionChildren in this arm will receive BOTH the Open Airways asthma education program and the Peer Asthma Action education program. |
| Control Arm | No intervention | –Children in the Control Arm will be interviewed in person at baseline, 12 month and 24 months. |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Open Airways Educational InterventionAlso: A 6 week asthma educational self management program for middle school students. | Behavioural | Open Airways Educational Intervention, Open Airways and Peer Asthma Action Intervention Education |
| Peer Asthma Action Educational InterventionAlso: Peer Asthma Action Educational Intervention is a peer led training program for children in multiple grades teaching them about asthma and asthma management. | Behavioural | Open Airways and Peer Asthma Action Intervention Education |
Primary outcome
Health Care Use Data
Time frame: At Baseline, 12 month and 24 months
health care use will be self reported in the telephone interviews with parents at baseline, 12 months and 24 months.
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 17 Jan 2013.
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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.
Noreen M. Clark, PhD principal investigator
University of Michigan School of Public Health
Questions about this trial
What is this clinical trial studying?
A study testing Open Airways Educational Intervention and Peer Asthma Action Educational Intervention in people with Asthma, run by University of Michigan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Health Care Use Data (time frame: At Baseline, 12 month and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2013.