Teen Asthma Project (TAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyekyun Rhee, University of Rochester
ClinicalTrials.gov Identifier:
NCT01161225
First received: July 9, 2010
Last updated: December 9, 2014
Last verified: December 2014
Results First Received: December 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Supportive Care
Condition: Asthma
Interventions: Behavioral: Peer-assisted asthma self-management program
Behavioral: Adult-led asthma self-management program

  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
Intervention Group This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
Control Group This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
Peer Leader Group Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.

Participant Flow:   Overall Study
    Intervention Group     Control Group     Peer Leader Group  
STARTED     59     53     14  
COMPLETED     45     44     12  
NOT COMPLETED     14     9     2  



  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
Intervention Group This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
Control Group This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
Peer Leader Group Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
Total Total of all reporting groups

Baseline Measures
    Intervention Group     Control Group     Peer Leader Group     Total  
Number of Participants  
[units: participants]
  59     53     14     126  
Age  
[units: years]
Mean (Standard Deviation)
  15.31  (1.36)     14.97  (1.29)     18.28  (1.90)     15.50  (1.71)  
Gender  
[units: participants]
       
Female     33     31     11     75  
Male     26     22     3     51  
Region of Enrollment  
[units: participants]
       
United States     59     53     14     126  



  Outcome Measures
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1.  Primary:   Pediatric Asthma Quality of Life Questionnaire (PAQLQ)   [ Time Frame: 9 months post camp ]

2.  Primary:   Asthma Control Questions   [ Time Frame: 9 months post camp ]

3.  Secondary:   Asthma Self-Efficacy   [ Time Frame: 9 months post camp ]

4.  Secondary:   Illness Management Survey   [ Time Frame: 9 months post camp ]

5.  Secondary:   Attitude Toward Illness Scale   [ Time Frame: 9 months post camp ]

6.  Secondary:   Asthma Knowledge Questionnaire   [ Time Frame: 9 months post camp ]

7.  Secondary:   Forced Expiratory Volume in 1 Second (FEV1) % Predicted   [ Time Frame: 9 months post camp ]

8.  Secondary:   Health Care Utilization Events   [ Time Frame: 9-months postcamp ]


  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: Hyekyun Rhee
Organization: University of Rochester Medical Center
phone: 5852763775
e-mail: hyekyun_rhee@urmc.rochester.edu


Publications of Results:
Other Publications:

Responsible Party: Hyekyun Rhee, University of Rochester
ClinicalTrials.gov Identifier: NCT01161225     History of Changes
Other Study ID Numbers: R21NR009837
Study First Received: July 9, 2010
Results First Received: December 2, 2014
Last Updated: December 9, 2014
Health Authority: United States: Institutional Review Board