Asthma in Central Texas Project

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01676896
First received: August 24, 2012
Last updated: March 18, 2015
Last verified: March 2015
Results First Received: December 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor)
Condition: Asthma
Interventions: Behavioral: Asthma in-school class
Behavioral: Asthma Day Camp
Behavioral: Health Promotion in-school class

  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
Asthma In-school Class

Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.

Asthma in-school class

Asthma Day Camp

The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.

Asthma Day Camp

Health Promotion In-school Class

The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.

Health Promotion in-school class


Participant Flow:   Overall Study
    Asthma In-school Class     Asthma Day Camp     Health Promotion In-school Class  
STARTED     96     96     100  
COMPLETED     84     89     81  
NOT COMPLETED     12     7     19  
Withdrawal by Subject                 12                 7                 19  



  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
Asthma In-school Class

Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.

Asthma in-school class

Asthma Day Camp

The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.

Asthma Day Camp

Health Promotion In-school Class

The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.

Health Promotion in-school class

Total Total of all reporting groups

Baseline Measures
    Asthma In-school Class     Asthma Day Camp     Health Promotion In-school Class     Total  
Number of Participants  
[units: participants]
  96     96     100     292  
Age  
[units: participants]
       
<=18 years     96     96     100     292  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  8.77  ± 1.25     8.83  ± 1.21     8.86  ± 1.29     8.82  ± 1.25  
Gender  
[units: participants]
       
Female     43     37     26     106  
Male     53     59     74     186  
Region of Enrollment  
[units: participants]
       
United States     96     96     100     292  



  Outcome Measures
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1.  Primary:   Absenteeism, End of Study   [ Time Frame: 12 months ]

2.  Primary:   Quality of Life, End of Study   [ Time Frame: 12 months ]

3.  Primary:   Number of Days Hospitalized, During Study Year   [ Time Frame: 12 months ]

4.  Primary:   Emergency Department Visits, Study Year   [ Time Frame: 12 months ]

5.  Primary:   Number of Asthma Hospitalizations Pre-Study Year   [ Time Frame: 12 months ]

6.  Primary:   Absenteeism Pre-study Year   [ Time Frame: 12 months ]

7.  Primary:   Number of Days in Hospital for Asthma, Pre-Study Year   [ Time Frame: 12 months ]

8.  Primary:   Number of Asthma Hospital Stays, During Study Year   [ Time Frame: 12 months ]

9.  Primary:   Emergency Department Visits, Pre-study Year   [ Time Frame: 12 months ]

10.  Primary:   Quality of Life, Pre-study Year   [ Time Frame: 12 months ]

11.  Secondary:   Asthma Self-management, Time 4   [ Time Frame: 3 months ]

12.  Secondary:   Home Asthma Management, Time 4, End of Study   [ Time Frame: 3 months ]

13.  Secondary:   Metered Dose Inhaler Skill, Time 4   [ Time Frame: 3 month ]

14.  Secondary:   Medication Adherence, Time 4   [ Time Frame: 3 months ]

15.  Secondary:   Asthma Self-management, Time 3   [ Time Frame: 3 months ]

16.  Secondary:   Asthma Self-management, Time 2   [ Time Frame: 3 months ]

17.  Secondary:   Asthma Self-management, Time 1, Baseline   [ Time Frame: 3 months ]

18.  Secondary:   Home Asthma Management, Time 1, Baseline   [ Time Frame: 3 months ]

19.  Secondary:   Home Asthma Management, Time 2.   [ Time Frame: 3 months ]

20.  Secondary:   Home Asthma Management, Time 3   [ Time Frame: 3 months ]

21.  Secondary:   Metered Dose Inhaler Skill, Time 3   [ Time Frame: 3 month ]

22.  Secondary:   Metered Dose Inhaler Skill, Time 2   [ Time Frame: 3 month ]

23.  Secondary:   Metered Dose Inhaler Skill, Time 1   [ Time Frame: 3 month ]

24.  Secondary:   Medication Adherence, Time 1   [ Time Frame: 3 months ]

25.  Secondary:   Medication Adherence, Time 2   [ Time Frame: 3 months ]

26.  Secondary:   Medication Adherence, Time 3   [ Time Frame: 3 months ]

27.  Other Pre-specified:   Lung Inflammation, Time 4   [ Time Frame: 1 day ]

28.  Other Pre-specified:   Lung Inflammation, Time 1   [ Time Frame: 1 day ]

29.  Other Pre-specified:   Lung Inflammation, Time 2   [ Time Frame: 1 day ]

30.  Other Pre-specified:   Lung Inflammation, Time 3   [ Time Frame: 1 day ]


  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: Sharon Horner
Organization: UTexasAustin
phone: 512-471-7951
e-mail: shorner@mail.nur.utexas.edu


No publications provided


Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01676896     History of Changes
Other Study ID Numbers: R01NR007770, R01NR007770
Study First Received: August 24, 2012
Results First Received: December 3, 2014
Last Updated: March 18, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government