- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07609303
Pediatric Solid Organ Transplant Patient Engagement Using an Educational Tablet-Based Game(Mystic Wizard)
Pediatric Solid Organ Transplant Patient Engagement Using an Educational Tablet-Based Game: A Prospective, Mixed Methods Study
Children and teenagers who receive a solid organ transplant (such as a kidney, liver, or heart) must take medications every day to keep their new organ healthy. Taking these medications correctly and on time is one of the most important parts of staying well after a transplant, but it can be hard for young patients to understand why this matters and to keep up with their routines. Doctors and nurses usually teach patients about their transplant through conversations, which may not always be engaging or easy for kids to remember.
This study looks at a new way to help young transplant patients learn about their condition and their medications: an educational game played on a tablet. The purpose of the study is to find out what patients think of the game and how well it works for them. Researchers want to know whether young patients find the game acceptable and enjoyable, whether it is easy to use, whether it makes them feel motivated and capable, and how engaged they feel while playing.
To do this, patients will play the tablet game and then share their experiences. After playing, they will take part in a small group interview where they talk about what they liked, what was confusing, and whether the game helped them understand their transplant and medications. They will also fill out short questionnaires about how easy the game was to use and how engaging it felt.
The researchers' hypothesis is that pediatric solid organ transplant patients will find the educational tablet-based game acceptable, easy to use, and engaging, and that it will be a welcome and helpful tool for learning about their transplant care. The findings will help guide whether this kind of game could be used to support transplant education for children and teens.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Thomas Caruso, MD, PhD
- Numero di telefono: 650-723-5728
- Email: tjcaruso@stanford.edu
Backup dei contatti dello studio
- Nome: Amrita Narang, MD
- Numero di telefono: (650) 721-2250
- Email: anarang@stanford.edu
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Pediatric solid organ transplant recipient (e.g., liver, kidney, heart)
- Age 7-14 years
- Currently admitted to Lucile Packard Children's Hospital
- Able to understand and interact with a tablet-based game in English
- Parent or legal guardian available to provide consent
Exclusion Criteria:
- Significant cognitive impairment or developmental condition limiting ability to participate in gameplay or surveys
- Acute medical instability
- Severe visual, hearing, or motor impairment preventing interaction with the game
- Non-English speaking participant
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Solid organ transplant recipient
|
Mystic Wizards is a tablet-based serious game intervention designed to support medication understanding, self-efficacy, and health engagement among pediatric solid organ transplant recipients. The game uses a narrative fantasy framework in which players assume the role of a young wizard entrusted with a "Legacy Flame" representing their transplanted organ. Daily medications are represented as "potions" required to maintain the strength and stability of the Flame. The intervention includes short narrative sequences, interactive mini-games, visual feedback systems, and avatar customization features designed to reinforce medication routines and promote empowerment in a developmentally appropriate manner. Participants complete a single gameplay session lasting approximately 10-12 minutes on a tablet device during their inpatient hospitalization, followed by brief surveys and a semi-structured interview. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Determine the acceptability the tablet-based game among solid transplant patient.
Lasso di tempo: Immediately after intervention
|
Semi-structured focus group interviews conducted in person immediately after intervention.
Six core questions plus probing prompts assessing attitudes, opinions, and perceptions of the intervention experience
|
Immediately after intervention
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Evaluate the usability of the tablet-based game among solid transplant patient using System Usability Scale (SUS)
Lasso di tempo: Immediately after intervention
|
The system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a subjective assessments of usability. The measure is scored on a scale from 0 to 100 with 100 indicating higher usability. |
Immediately after intervention
|
|
To assess participants' intrinsic motivation and psychological needs satisfaction (autonomy, competence, relatedness, presence) while using the intervention using Player Experience of Needs Satisfaction (PENS).
Lasso di tempo: Immediately after intervention
|
The PENS scale is a validated, 21-item psychometric questionnaire used to assess participants' psychological experiences during gameplay.
Higher scores correlate with greater psychological satisfaction and long-term treatment adherence.
|
Immediately after intervention
|
|
To assess participants' overall engagement with the digital intervention (focused attention, perceived usability, aesthetic appeal, reward) using User Engagement Scale (UES) - Short.
Lasso di tempo: Immediately after intervention
|
User engagement will be measured by User Engagement Scale (UES) - Short.
This scale consists of 12 items that participants will respond to, reflecting their feelings and interactions with the application or platform.
Each item is rated on a Likert scale ranging from 1 to 5, where 1 indicates "strongly disagree" and 5 indicates "strongly agree."
|
Immediately after intervention
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Thomas Caruso, MD, PhD, Stanford University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 87110
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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