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School-based Approaches to Help Pre-teens Manage Asthma (DMSP)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Noreen M. Clark, University of Michigan
ClinicalTrials.gov Identifier:
NCT00217776
First received: September 19, 2005
Last updated: January 16, 2013
Last verified: January 2013
History of Changes

September 19, 2005
January 16, 2013
February 2003
January 2009   (final data collection date for primary outcome measure)
Health Care Use Data [ Time Frame: At Baseline, 12 month and 24 months ] [ Designated as safety issue: No ]
health care use will be self reported in the telephone interviews with parents at baseline, 12 months and 24 months.
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Complete list of historical versions of study NCT00217776 on ClinicalTrials.gov Archive Site
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School-based Approaches to Help Pre-teens Manage Asthma
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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.

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.
Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Behavioral: Open Airways Educational Intervention
    Other Name: A 6 week asthma educational self management program for middle school students.
  • Behavioral: Peer Asthma Action Educational Intervention
    Other Name: Peer Asthma Action Educational Intervention is a peer led training program for children in multiple grades teaching them about asthma and asthma management.
  • Active Comparator: Open Airways Educational Intervention
    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.
    Intervention: Behavioral: Open Airways Educational Intervention
  • Active Comparator: Open Airways and Peer Asthma Action Intervention Education
    Children in this arm will receive BOTH the Open Airways asthma education program and the Peer Asthma Action education program.
    Interventions:
    • Behavioral: Open Airways Educational Intervention
    • Behavioral: Peer Asthma Action Educational Intervention
  • No Intervention: Control Arm
    Children in the Control Arm will be interviewed in person at baseline, 12 month and 24 months.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1292
January 2009
January 2009   (final data collection date for primary outcome measure)

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.
Both
11 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00217776
288, R01HL068654-04
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Noreen M. Clark, University of Michigan
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Noreen M. Clark, PhD University of Michigan School of Public Health
University of Michigan
January 2013

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