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

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Halcyon Hill Foundation
Information provided by (Responsible Party):
Jill Halterman, University of Rochester
ClinicalTrials.gov Identifier:
NCT01175369
First received: June 23, 2010
Last updated: July 25, 2014
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 
Overall Participants Analyzed 
[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 reported.   Anticipated Reporting Date:   No text entered.  

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


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 ( US NIH Grant/Contract Award Number )
Study First Received: June 23, 2010
Results First Received: January 14, 2013
Last Updated: July 25, 2014