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Asthma Learning Project (ALP)

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ClinicalTrials.gov Identifier: NCT00874900
Recruitment Status : Unknown
Verified July 2011 by Seattle Children's Hospital.
Recruitment status was:  Recruiting
First Posted : April 3, 2009
Last Update Posted : July 8, 2011
Sponsor:
Information provided by:
Seattle Children's Hospital

Tracking Information
First Submitted Date  ICMJE April 1, 2009
First Posted Date  ICMJE April 3, 2009
Last Update Posted Date July 8, 2011
Study Start Date  ICMJE December 2008
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2009)
Child Knowledge [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2009)
Child Knowledge
Change History Complete list of historical versions of study NCT00874900 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2009)
Locus of control [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2009)
Locus of control
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Asthma Learning Project
Official Title  ICMJE Asthma Learning Project: Randomized Trial of a Computerized Asthma Game in a Pediatric Emergency Department
Brief Summary

The purpose of this study is to determine the effect on knowledge and behavior of playing an educational asthma computer game during a pediatric Emergency Department (ED) asthma visit among children ages 7 - 15 years. The ED cares for a high-risk population of children who have difficulty accessing preventive care well. The addition of a computer game to usual asthma emergency care could be a simple, effective, enjoyable way to improve patients' asthma knowledge, beliefs, and management practices. This project has the potential to lead to larger studies evaluating the benefit of education with and without behavioral interventions such as motivational interviewing.

This project plans to implement and evaluate the use of a goal setting activity and the educational asthma computer game, "Quest for the Code" (Starlight Starbright Children's FoundationTM), in the ED of Seattle Children's Hospital. In a randomized trial of Spanish and English speaking children ages 7 - 15 years receiving ED care for their asthma, the investigators will evaluate the effects of the game on children's asthma knowledge, attitudes, and behaviors.

The investigators aim to compare the change in asthma knowledge and locus of control after 3 months, for children who play the computerized asthma game, versus those who receive standard care in the ED. The investigators will also compare changes in asthma severity and activity limitations over 3 months, for children who play the asthma game without goal-setting, children who playing the game with goal-setting, and children who receive standard care.

Overall, the investigators hypothesize that educational asthma game play by pediatric patients with acute asthma will improve asthma knowledge, compared with standard care.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Other: Educational game
    "Quest for the Code" is an educational asthma computer game. Participants randomized to this intervention will have access to the game for a minimum of one hour while receiving treatment in the Seattle Children's Emergency Department.
  • Other: Educational game + motivational interview
    "Quest for the Code" is an educational asthma computer game. Participants randomized to this intervention will have access to this game for a minimum of one hour while receiving treatment in the Seattle Children's Emergency Department (ED).Before leaving the ED, participants in this group will have a brief asthma goal setting activity using motivational interview techniques.
  • Other: Motivational interview
    Participant randomized to this group will receive standard care for the treatment of their asthma, including an education asthma booklet developed by Seattle Children's. Before leaving the ED, participants in this group will have a brief asthma goal setting activity using motivational interview techniques.
Study Arms  ICMJE
  • Experimental: Game
    Intervention: Other: Educational game
  • Experimental: Game + Activation
    Intervention: Other: Educational game + motivational interview
  • No Intervention: Booklet
  • Experimental: Booklet + Activation
    Intervention: Other: Motivational interview
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 2, 2009)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2013
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 7 - 15 years, inclusive.
  • Patient has a history of asthma or asthma-like symptoms on at least 1 occasion, occurring at least 3 months prior to the current episode (may be verbal per patient/caregiver).
  • Patient is presenting to the ED for an acute asthma exacerbation of any type or severity.
  • Available for phone call or mail questionnaire in 2 weeks and 3 months.
  • Parent able to read English or Spanish.
  • Child able to understand spoken English or Spanish.
  • Child able to use a computer and mouse or stylus.
  • Provider believes the patient is likely to remain in ED for at least one hour.
  • Informed consent by parent and assent from child

Exclusion Criteria:

  • Child has previously participated in this study.
  • Child has a hearing impairment uncompensated for by assistive listening devices.
  • Significant mental disorder or cognitive impairment that the parent believes would preclude competent informed assent or game play.
  • Child has a baseline motor disorder and the parent is unable to assist using a mouse and keyboard
  • Child has significant medial conditions that have a pulmonary component, in addition to their asthma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00874900
Other Study ID Numbers  ICMJE ALP12526
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julie Brown, MD, MPH, Seattle Children's Hospital
Study Sponsor  ICMJE Seattle Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julie Brown, MD, MPH Seattle Children's
PRS Account Seattle Children's Hospital
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP