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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorUniversity of Utah

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Serious GameExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 month
2

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.

Time frame
1 month
3

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.

Time frame
1 month
4

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%.

Time frame
1-month

Secondary outcomes

1

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

Time frame
Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)
2

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.

Time frame
Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)
3

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.

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

Other outcomes

1

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

Time frame
Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)
2

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

Time frame
Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)
3

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

Time frame
Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit)
4

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

American Heart Association

Collaborator

National Center for Advancing Translational Sciences (NCATS)

Collaborator