- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07609303
Feeding the Flame, One Day at a Time: Design and Acceptability of a Serious Game to Support Medication Adherence and Education for Pediatric Solid Organ Transplant Patients (Mystic Wizard)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Thomas Caruso, MD, PhD
- Numéro de téléphone: 650-723-5728
- E-mail: tjcaruso@stanford.edu
Sauvegarde des contacts de l'étude
- Nom: Amrita Narang, MD
- Numéro de téléphone: (650) 721-2250
- E-mail: anarang@stanford.edu
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- Between age 7-17
- History of solid organ transplantation
- Current admission in inpatient unit
- Able to understand and interact with a tablet-based game in English
Exclusion Criteria:
- Legal guardian not present to obtain consent
- Child with a significant neurological condition, or major developmental disability
- Child with active infection of the face or hand
- History of severe motion sickness
- Severe visual or motor impairment limiting gameplay participation
- Acute medical instability
- Major surgery within the last 48 hours
- Inability to understand English
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Determine the acceptability the tablet-based game among solid transplant patient.
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Evaluate the usability of the tablet-based game among solid transplant patient using System Usability Scale (SUS)
Délai: Immediately after intervention
|
Usability of the tablet-based game will be assessed using Usability and Acceptability Scale (UAS), which is a 8 item 5-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree with 40 indicating highest usability of the tool.
|
Immediately after intervention
|
|
To assess participants' intrinsic motivation and psychological needs satisfaction (autonomy, competence, relatedness, presence) while using the intervention
Délai: 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
|
|
To assess participants' overall engagement with the digital intervention
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Thomas Caruso, MD, PhD, Stanford University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 87110
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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