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

NCT ID: NCT07042334

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-22

Study Completion Date

2026-08-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Serious Game

Receive serious game to build transition readiness skills

Group Type EXPERIMENTAL

Serious game for transition readiness

Intervention Type 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.

Interventions

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Serious game for transition readiness

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Delaney

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Primary Children's Hospital and University of Utah Health

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rebecca Delaney, PhD

Role: CONTACT

18012132557

Facility Contacts

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Rebecca K Delaney, PhD

Role: primary

801-213-2557

Other Identifiers

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1K12TR004413

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23SCEFIA1154397

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB_00179379

Identifier Type: -

Identifier Source: org_study_id

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