About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Serious game for transition readiness
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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%.
Secondary outcomes
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
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.
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.
Other outcomes
Learning Objective Comprehension
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
PROMIS Anxiety
The validated PROMIS scale evaluates anxiety in its 8-item form. All items are scored 1-5, with higher scores indicating greater anxiety
STARx Transition Readiness Questionnaire
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
Self-Efficacy
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
Sponsors and contacts
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University of Utah
Lead sponsor
American Heart Association
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator