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Asthma Learning Project (ALP)

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational game
Educational game + motivational interview
Motivational interview
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seattle Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

Experimental

Arm Label

Game

Game + Activation

Booklet

Booklet + Activation

Arm Description

Outcomes

Primary Outcome Measures

Child Knowledge

Secondary Outcome Measures

Locus of control

Full Information

First Posted
April 1, 2009
Last Updated
July 7, 2011
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00874900
Brief Title
Asthma Learning Project
Acronym
ALP
Official Title
Asthma Learning Project: Randomized Trial of a Computerized Asthma Game in a Pediatric Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Game
Arm Type
Experimental
Arm Title
Game + Activation
Arm Type
Experimental
Arm Title
Booklet
Arm Type
No Intervention
Arm Title
Booklet + Activation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Educational game
Intervention Description
"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.
Intervention Type
Other
Intervention Name(s)
Educational game + motivational interview
Intervention Description
"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.
Intervention Type
Other
Intervention Name(s)
Motivational interview
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child Knowledge
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Locus of control
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Brown, MD, MPH
Phone
206-987-4016
Email
julie.brown@seattlechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Brown, MD, MPH
Organizational Affiliation
Seattle Children's
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Asthma Learning Project

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