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NCT Number: NCT07042334

Aim 3: Pilot Study of a Serious Game to Promote Transition Readiness Skills

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary Children's Hospital and University of Utah Health

Salt Lake City, Utah, 84108, United States

Location status: Recruiting

Location contact

Rebecca K Delaney, PhD

CONTACT

[email protected]

801-213-2557

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with congenital heart disease, their parent, and their clinician

Exclusion criteria

-Significant visual or cognitive impairment that would impede their ability to play the game and/or complete the study.

Treatment and study plan

Serious game for transition readiness

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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%.

  5. 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%.

  6. Acceptability

    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.

Secondary outcomes

  1. Appointment Worry and Preparedness

    Time frame: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)

    Five item measure developed by study team that asks participants to rate how worried and prepared they feel for their appointment

  2. Transition Readiness Questionnaire (TRAQ)

    Time frame: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)

    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.

  3. CHD Knowledge Scale (Transition Readiness)

    Time frame: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)

    This validated scale evaluates transition readiness, including perceived knowledge of adolescents with CHD. Self reported knowledge questions are domain specific to CHD.

Other outcomes

  1. Learning Objective Comprehension

    Time frame: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)

    This scale, developed by the study team evaluates comprehension of study-specific learning objectives. All items are scored 1-5, with higher scores indicating higher learning comprehension

  2. PROMIS Anxiety

    Time frame: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)

    The validated PROMIS scale evaluates anxiety in its 8-item form. All items are scored 1-5, with higher scores indicating greater anxiety

  3. STARx Transition Readiness Questionnaire

    Time frame: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)

    The STARx scale is an independently validated scale measuring pedatric patient ability to manage healthcare independently. Three subscales measure behavior, knowledge, and difficulty. All scales are measured 1-5 scale with an additional N/A option for certain questions. Higher scores indicate positive outcomes among the subscales. Only the second two subscales are used at the second time point

  4. Self-Efficacy

    Time frame: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)

    The General Self-Efficacy scale is a validated, self-reported scale on self-efficacy. Items are scored 1-4, with higher scores indicating greater self-efficacy

  5. Quality of Life- Patient Reported

    Time frame: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)

    A validated scale that measures teen quality of life for those with heart conditions. Items are scaled 1-4, and higher scores indicate lower quality of life.

  6. Patient Engagement

    Time frame: Post-intervention survey (given or sent within 1 week post-clinic visit)

    Developed by the study team with items to measure engagement with their cardiologist during their appointment.

  7. Parent-reported transition readiness and knowledge

    Time frame: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)

    Using the GotTransition Framework, this measure assesses parent-reported transition readiness perceptions.

  8. Parent-reported appointment worry and preparedness

    Time frame: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)

    Developed by study team. Measures worry and preparedness for vistits in young adults

  9. Parent-reported STARx

    Time frame: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)

    The STARx scale is an independently validated scale measuring parent-reported pediatric patient ability to manage healthcare independently. Three subscales measure behavior, knowledge, and difficulty. All scales are measured 1-5 scale with an additional N/A option for certain questions. Higher scores indicate positive outcomes among the subscales. Only the last two subscales are used at the second time point

  10. Parent-reported patient engagement

    Time frame: Post-intervention survey (given or sent within 1 week post-clinic visit)

    Developed by the study team with items to measure engagement with care after the game.

  11. Parent-reported quality of life

    Time frame: Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)

    A validated scale that measures teen quality of life for those with heart conditions. Items are scaled 1-4, and higher scores indicate a lower quality of life.

  12. Clinician-reported patient engagement

    Time frame: Post-intervention survey (given or sent within 1 week post-clinic visit)

    Developed by the study team. Measures clinician-reported patient engagement during a study visit after playing the game.

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Delaney, PhD

CONTACT

[email protected]

18012132557

William Petty

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • American Heart Association
  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2025
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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