- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Thomas Caruso, MD, PhD
- Número de teléfono: 650-723-5728
- Correo electrónico: tjcaruso@stanford.edu
Copia de seguridad de contactos de estudio
- Nombre: Amrita Narang, MD
- Número de teléfono: (650) 721-2250
- Correo electrónico: anarang@stanford.edu
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Determine the acceptability the tablet-based game among solid transplant patient.
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluate the usability of the tablet-based game among solid transplant patient using System Usability Scale (SUS)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thomas Caruso, MD, PhD, Stanford University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 87110
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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