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| ID | Type | Description | Link |
|---|---|---|---|
| 1K12TR004413 | U.S. NIH Grant/Contract | View source | |
| 23SCEFIA1154397 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serious Game | Experimental | Receive serious game to build transition readiness skills |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit) |
| Transition Readiness Questionnaire (TRAQ) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit) |
| PROMIS Anxiety |
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Delaney, PhD | Contact | 18012132557 | rebecca.delaney@hsc.utah.edu | |
| William Petty | Contact | william.petty@hsc.utah.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Children's Hospital and University of Utah Health | Recruiting | Salt Lake City | Utah | 84108 | United States |
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|
| 1-month |
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. |
| Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit) |
| 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. | Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit) |
The validated PROMIS scale evaluates anxiety in its 8-item form. All items are scored 1-5, with higher scores indicating greater anxiety |
| Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit) |
| 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 | Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit) |
| 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 | Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit) |
| Quality of Life- Patient Reported | A validated scale that measures teen quality of life for those with heart conditions. Items are scaled 1-4, and higher scores indicate lower quality of life. | Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit) |
| Patient Engagement | Developed by the study team with items to measure engagement with their cardiologist during their appointment. | Post-intervention survey (given or sent within 1 week post-clinic visit) |
| Parent-reported transition readiness and knowledge | Using the GotTransition Framework, this measure assesses parent-reported transition readiness perceptions. | Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit) |
| Parent-reported appointment worry and preparedness | Developed by study team. Measures worry and preparedness for vistits in young adults | Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit) |
| Parent-reported STARx | The STARx scale is an independently validated scale measuring parent-reported pediatric 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 last two subscales are used at the second time point | Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit) |
| Parent-reported patient engagement | Developed by the study team with items to measure engagement with care after the game. | Post-intervention survey (given or sent within 1 week post-clinic visit) |
| Parent-reported quality of life | A validated scale that measures teen quality of life for those with heart conditions. Items are scaled 1-4, and higher scores indicate a lower quality of life. | Baseline and Post-intervention survey (given or sent within 1 week post-clinic visit) |
| Clinician-reported patient engagement | Developed by the study team. Measures clinician-reported patient engagement during a study visit after playing the game. | Post-intervention survey (given or sent within 1 week post-clinic visit) |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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