Serious GamesNCT07042334
Aim 3: Pilot Study of a Serious Game to Promote Transition Readiness Skills
A study testing Serious game for transition readiness in people with Serious Games and Transition-age Youth, run by University of Utah at 1 site in United States.
Trial summary
This study involves testing a new video game designed to support adolescents with congenital heart disease (CHD) in preparing to manage their health independently. The game aims to teach essential skills such as communicating with healthcare providers, understanding medical information, and managing appointments and… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Serious Games, Transition-age Youth, Transition to Adult Care
- What is being tested?
- Serious game for transition readiness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with congenital heart disease, their parent, and their clinician
Who cannot join
- -Significant visual or cognitive impairment that would impede their ability to play the game and/or complete the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Primary Children's Hospital and University of Utah Health
Salt Lake City, Utah, 84108
About this study
This study involves testing a new video game designed to support adolescents with congenital heart disease (CHD) in preparing to manage their health independently. The game aims to teach essential skills such as communicating with healthcare providers, understanding medical information, and managing appointments and medications. This small pilot study will evaluate the game's usability, acceptability, and its impact on participants' confidence and preparedness for managing their heart care. Feedback will be collected from adolescent participants, their parents, and healthcare providers, and the study will examine how the game influences communication during clinical visits.
- Conditions
- Serious Games, Transition-age Youth, Transition to Adult Care, Congenital Heart Defect, Congenital Heart Disease in Adolescence, Patient Centered Care
- Being tested
- Serious game for transition readiness
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious game for transition readinessBehavioural
The serious game is an interactive narrative fiction game in which players guide a character through a hospital setting, making choices that simulate real-life healthcare scenarios. The game is designed to improve skills such as communication with healthcare providers, understanding medical information, and managing appointments and medications. No drugs or medical devices are used in this intervention.
| Study group | Role | What they receive |
|---|---|---|
| Serious Game | Experimental | Receive serious game to build transition readiness skills Receives: Behavioral: Serious game for transition readiness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of game logins
Metadata metrics from players interaction with the game will be collected, including the number of game logins. The higher the number the more engagement with the game.
Measured: 1 month
Length of time spent on game
Metadata metrics from players interaction with the game will be collected, including the amount of time spent (i.e., minutes) on the game. The greater the amount of time the more engagement with the game.
Measured: 1 month
Game sections completed
Metadata metrics from players interaction with the game will be collected including the number of game sections that are completed. The higher the number indicates more engagement with the game.
Measured: 1 month
Recruitment of participants in the study
A percentage will be calculated from the number of participants approached and number of participants who enrolled. Sufficient recruitment is equal to or greater than 60%.
Measured: 1-month
Retention of participants
Retention of participants will be assessed by calculating a percentage from the number who enrolled and number who completed the study. Sufficient retention will be greater than or equal to 60%.
Measured: 1.5 month
Acceptability and Usability
After completing the intervention, participants will be asked to complete questionnaires about their satisfaction and usability of the game (e.g., system usability scale (SUS). On the SUS, responses are from 1 to 5 for each item and greater scores indicate higher acceptability.
Measured: 1-month
Secondary outcomes (3)
Appointment Worry and Preparedness
Five item measure developed by study team that asks participants to rate how worried and prepared they feel for their appointment
Measured: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)
Transition Readiness Questionnaire (TRAQ)
TRAQ is a validated scale indicating baseline transition readiness skills across: medication management, tracking health concerns, and communication Higher scores indicate better readiness to independently manage care.
Measured: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)
CHD Knowledge Scale (Transition Readiness)
This validated scale evaluates transition readiness, including perceived knowledge of adolescents with CHD. Self reported knowledge questions are domain specific to CHD.
Measured: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start22 Jan 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious GamesStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Rebecca Delaney, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042334
- Sponsor's protocol ID
- IRB_00179379
- Other IDs
- 1K12TR004413, 23SCEFIA1154397
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aim 3: Pilot Study of a Serious Game to Promote Transition Readiness Skills
- ClinicalTrials.gov ID
- NCT07042334
- Acronym / sponsor ID
- IRB_00179379
- Conditions
- Serious Games, Transition-age Youth, Transition to Adult Care, Congenital Heart Defect, Congenital Heart Disease in Adolescence, Patient Centered Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- American Heart Association, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 29 Jun 2025 (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.
This study involves testing a new video game designed to support adolescents with congenital heart disease (CHD) in preparing to manage their health independently. The game aims to teach essential skills such as communicating with healthcare providers, understanding medical information, and managing appointments and medications. This small pilot study will evaluate the game's usability, acceptability, and its impact on participants' confidence and preparedness for managing their heart care. Feedback will be collected from adolescent participants, their parents, and healthcare providers, and the study will examine how the game influences communication during clinical visits.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serious Game | Experimental | Behavioral: Serious game for transition readinessReceive serious game to build transition readiness skills |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with congenital heart disease, their parent, and their clinician
Key exclusion criteria (1 listed)
- -Significant visual or cognitive impairment that would impede their ability to play the game and/or complete the study.
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 |
|---|---|---|
| Serious game for transition readinessThe serious game is an interactive narrative fiction game in which players guide a character through a hospital setting, making choices that simulate real-life healthcare scenarios. The game is designed to improve skills such as communication with healthcare providers, understanding medical information, and managing appointments and medications. No drugs or medical devices are used in this intervention. | Behavioural | Serious Game |
Primary outcome
Number of game logins
Time frame: 1 month
Metadata metrics from players interaction with the game will be collected, including the number of game logins. The higher the number the more engagement with the game.
Length of time spent on game
Time frame: 1 month
Metadata metrics from players interaction with the game will be collected, including the amount of time spent (i.e., minutes) on the game. The greater the amount of time the more engagement with the game.
Game sections completed
Time frame: 1 month
Metadata metrics from players interaction with the game will be collected including the number of game sections that are completed. The higher the number indicates more engagement with the game.
Recruitment of participants in the study
Time frame: 1-month
A percentage will be calculated from the number of participants approached and number of participants who enrolled. Sufficient recruitment is equal to or greater than 60%.
Retention of participants
Time frame: 1.5 month
Retention of participants will be assessed by calculating a percentage from the number who enrolled and number who completed the study. Sufficient retention will be greater than or equal to 60%.
Acceptability and Usability
Time frame: 1-month
After completing the intervention, participants will be asked to complete questionnaires about their satisfaction and usability of the game (e.g., system usability scale (SUS). On the SUS, responses are from 1 to 5 for each item and greater scores indicate higher acceptability.
3 secondary outcomes
Appointment Worry and Preparedness
Time frame: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)
Transition Readiness Questionnaire (TRAQ)
Time frame: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)
CHD Knowledge Scale (Transition Readiness)
Time frame: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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 Serious game for transition readiness in people with Serious Games and Transition-age Youth, run by University of Utah at 1 site in United States.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of game logins (time frame: 1 month). The study lists 6 primary outcomes in all. 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 27 Oct 2026.