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

NCT07042334 | Recruiting

• 3 other identifiers: IRB_001793791K12TR00441323SCEFIA1154397
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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

Transition-age Youth; Transition to Adult Care; Serious Games; Congenital Heart Defect; Congenital Heart Disease in Adolescence; Patient Centered Care

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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%.

  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%.

  1.5 month

• Acceptability

  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.

  1-month

Secondary Outcomes (3)

• Appointment Worry and Preparedness

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

• Transition Readiness Questionnaire (TRAQ)

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

• CHD Knowledge Scale (Transition Readiness)

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

Other Outcomes (12)

• Learning Objective Comprehension

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

• PROMIS Anxiety

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

• STARx Transition Readiness Questionnaire

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

Study Arms (1)

Serious Game

EXPERIMENTAL

Receive serious game to build transition readiness skills

Behavioral: Serious game for transition readiness

Interventions

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.

Serious Game

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS): collaborator
• University of Utah: lead
• American Heart Association: collaborator

Study Sites (1)

Primary Children's Hospital and University of Utah Health

Salt Lake City, Utah, 84108, United States

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Rebecca Delaney, PhD

CONTACT

18012132557; rebecca.delaney@hsc.utah.edu

William Petty

CONTACT

william.petty@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 29, 2025
• Study Start: January 22, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-01

Locations

US (1)