AsthmaNCT03613675
Acceptability of Video Games to Promote Asthma Education and Self-management in Children
A study testing Video games in people with Asthma, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Video games
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2019to 10 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged 8-12 years inclusively
- with physician-diagnosed asthma
- who are on a daily controller medication
- who understand French or English.
Who cannot join
- chronic respiratory conditions other than asthma
- cardiovascular diseases
- neuromuscular disorders
- developmental delay.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Conditions
- Asthma
- Being tested
- Video games
- Keywords
- video games
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video gamesDevice
The 4 videos games consists of:
- Asthmonaut, a desktop game in which the child navigates through different scenarios and interacts with nine characters to learn about asthma symptoms and management (30 minutes)
- Lung Launcher, a mobile game in which the character encounters different asthma triggers (customizable to the child) and the child has to find the correct preventive method to address each trigger (4 minutes)
- Asthma Heroes, a desktop game where the player interacts with several characters to learn about their symptoms, treatment and context, and collects objects to help them manage their asthma (30 minutes)
- Bloïd, a mobile game where the player uses a pressure sensor as an input device to guide a spacecraft and destroy meteorites in its path (4 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Video games | Experimental | All participants will be asked to play 4 video games. Receives: Device: Video games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gaming experience, relevance for end-user, and areas of improvement of the games
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.
Measured: Immediately after playing the games (same day)
Secondary outcomes (1)
Asthma knowledge
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).
Measured: Immediately after playing the games (same day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start15 Jan 2019
- Primary completion10 Mar 2019
- Study completion10 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be asked to play 4 video games on asthma.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Concordia University, Montreal
- Responsible party
- Principal investigator, Sze Man Tse, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613675
- Sponsor's protocol ID
- 2019-2075
- Status last verified
- Oct 2022
- First submitted
- 27 Jul 2018
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of Video Games to Promote Asthma Education and Self-management in Children
- ClinicalTrials.gov ID
- NCT03613675
- Acronym / sponsor ID
- 2019-2075
- Conditions
- Asthma
- Keywords
- video games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Concordia University, Montreal
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 10 Mar 2019 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be asked to play 4 video games on asthma.
| Arm | Type | Receives |
|---|---|---|
| Video games | Experimental | Device: Video gamesAll participants will be asked to play 4 video games. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- aged 8-12 years inclusively
- with physician-diagnosed asthma
- who are on a daily controller medication
- who understand French or English.
Key exclusion criteria (4 listed)
- chronic respiratory conditions other than asthma
- cardiovascular diseases
- neuromuscular disorders
- developmental delay.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video gamesThe 4 videos games consists of: * Asthmonaut, a desktop game in which the child navigates through different scenarios and interacts with nine characters to learn about asthma symptoms and management (30 minutes) * Lung Launcher, a mobile game in which the character encounters different asthma triggers (customizable to the child) and the child has to find the correct preventive method to address each trigger (4 minutes) * Asthma Heroes, a desktop game where the player interacts with several characters to learn about their symptoms, treatment and context, and collects objects to help them manage their asthma (30 minutes) * Bloïd, a mobile game where the player uses a pressure sensor as an input device to guide a spacecraft and destroy meteorites in its path (4 minutes). | Device | Video games |
Primary outcome
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.
1 secondary outcome
Asthma knowledge
Time frame: Immediately after playing the games (same day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video games in people with Asthma, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gaming experience, relevance for end-user, and areas of improvement of the games (time frame: Immediately after playing the games (same day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.