Serious Game to Promote Transition Readiness Skills for Patients With Congenital Heart Disease

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07042334
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-19
• Last Update Submitted: 2025-06-19
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29
• Study Start: 2025-08-01
• Primary Completion: 2026-08
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of game logins	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	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	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	1-month	A percentage will be calculated from the number of participants approached and number of participants who enrolled to report on recruitment. Sufficient recruitment is equal to or greater than 60%.
Retention of participants	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	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.

Trial Locations

Locations (1)

Primary Children's Hospital and University of Utah Health; 🇺🇸 Salt Lake City, Utah, United States