School-based Asthma Therapy: Stage 2 Effectiveness Study (SBAT)

This study has been completed.
Sponsor:
Collaborators:
Halcyon Hill Foundation
Information provided by (Responsible Party):
Jill Halterman, University of Rochester
ClinicalTrials.gov Identifier:
NCT01175369
First received: June 23, 2010
Last updated: December 9, 2013
Last verified: August 2013
Results First Received: January 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition: Asthma
Intervention: Behavioral: School-based Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Usual Care Usual asthma care
School-based Care The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).

Participant Flow:   Overall Study
    Usual Care     School-based Care  
STARTED     265     265  
COMPLETED     263     260  
NOT COMPLETED     2     5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Usual Care Usual asthma care
School-based Care The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
Total Total of all reporting groups

Baseline Measures
    Usual Care     School-based Care     Total  
Number of Participants  
[units: participants]
  265     265     530  
Age  
[units: participants]
     
<=18 years     265     265     530  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  7.2  ± 1.9     7.1  ± 2.0     7.1  ± 1.9  
Gender  
[units: participants]
     
Female     118     104     222  
Male     147     161     308  
Region of Enrollment  
[units: participants]
     
United States     265     265     530  



  Outcome Measures

1.  Primary:   Number of Symptom Free Days   [ Time Frame: Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February) ]

2.  Secondary:   Cotinine Level   [ Time Frame: 2 month and approximately 9 month (end of school year) follow-up assessments ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Cost Effectiveness of the Intervention   [ Time Frame: approximately 9 months (length of school year) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Additional Asthma Morbidity Outcomes   [ Time Frame: 1-9 months (Monthly Follow-up assessments) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Dr. Jill Halterman
Organization: University of Rochester
phone: 5852755798
e-mail: jill_halterman@urmc.rochester.edu


Publications of Results:
Other Publications:


Responsible Party: Jill Halterman, University of Rochester
ClinicalTrials.gov Identifier: NCT01175369     History of Changes
Obsolete Identifiers: NCT00296998
Other Study ID Numbers: 12308, 1R01HL079954-01A1
Study First Received: June 23, 2010
Results First Received: January 14, 2013
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board