- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Thomas Caruso, MD, PhD
- Numer telefonu: 650-723-5728
- E-mail: tjcaruso@stanford.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Amrita Narang, MD
- Numer telefonu: (650) 721-2250
- E-mail: anarang@stanford.edu
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Determine the acceptability the tablet-based game among solid transplant patient.
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Evaluate the usability of the tablet-based game among solid transplant patient using System Usability Scale (SUS)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Thomas Caruso, MD, PhD, Stanford University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 87110
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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