School-based Approaches to Help Pre-teens Manage Asthma

Asthma Clinical Trial

— DMSP  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217776
• Other study ID #: 288
• Secondary ID: R01HL068654-04
• Status: Completed
• Phase: N/A
• First received: September 19, 2005
• Last updated: January 16, 2013
• Start date: February 2003
• Est. completion date: January 2009

Study information

• Verified date: January 2013
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1292
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Open Airways Educational Intervention

• Peer Asthma Action Educational Intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Care Use Data	health care use will be self reported in the telephone interviews with parents at baseline, 12 months and 24 months.	At Baseline, 12 month and 24 months	No