- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03613675
Acceptability of Video Games to Promote Asthma Education and Self-management in Children
Asthma is a chronic lung disease affecting over 800,000 Canadian children. Knowing how to avoid asthma triggers, to take care of one's health, and to know when and why to do one's treatment can help prevent asthma crises, and have a better quality of life.
Games in health can make the management of asthma easier by helping the child better understand his condition, his triggers, and manage his asthma by himself. Games also offer a personalized experience, where players can receive feedback about their learning. However, few studies explored the use of games in childhood asthma.
This study will test 4 games for children with asthma. Through different characters and scenarios, the goals of the games are to help the child with asthma to better recognize and manage his asthma triggers and symptoms. The objectives of this study are:
- Evaluate the acceptability of these games in children with asthma
- Gather feedback on the games to guide future development
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T1C5
- CHU Sainte-Justine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Along with a parent, children
- aged 8-12 years inclusively
- with physician-diagnosed asthma
- who are on a daily controller medication
- who understand French or English.
Exclusion Criteria: children with
- chronic respiratory conditions other than asthma
- cardiovascular diseases
- neuromuscular disorders
- developmental delay.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video games
All participants will be asked to play 4 video games.
|
The 4 videos games consists of:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gaming experience, relevance for end-user, and areas of improvement of the games
Time Frame: Immediately after playing the games (same day)
|
This is a qualitative outcome which includes the quality of the interface as assessed by the player, the gaming experience, its relevance for the end-user, and areas of improvement.
This will be assessed through a questionnaire and a focus group.
|
Immediately after playing the games (same day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma knowledge
Time Frame: Immediately after playing the games (same day)
|
This includes retention of key messages and whether the games respond to the families' knowledge gaps.
Knowledge transfer will be assessed through a questionnaire administered to the child before and after the gaming experience.
This questionnaire contains 16 true or false questions and 5 questions with short answers on asthma.
The maximal score on this questionnaire is 25 (range 0-25).
|
Immediately after playing the games (same day)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-2075
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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