- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Thomas Caruso, MD, PhD
- Telefonnummer: 650-723-5728
- E-mail: tjcaruso@stanford.edu
Undersøgelse Kontakt Backup
- Navn: Amrita Narang, MD
- Telefonnummer: (650) 721-2250
- E-mail: anarang@stanford.edu
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Determine the acceptability the tablet-based game among solid transplant patient.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluate the usability of the tablet-based game among solid transplant patient using System Usability Scale (SUS)
Tidsramme: 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).
Tidsramme: 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.
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Thomas Caruso, MD, PhD, Stanford University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 87110
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Solid Organ Transplantation
-
Murdoch Childrens Research InstituteRekrutteringSolid Organ TransplantationAustralien
-
The Hospital for Sick ChildrenEnduring Hearts; University of Alberta/Stollery Children's HospitalAfsluttet
-
Rennes University HospitalRekruttering
-
Jennifer HarrisonAfsluttet
-
The Hospital for Sick ChildrenRekrutteringSolid Organ TransplantationCanada
-
Medical College of WisconsinAfsluttetSolid Organ TransplantationForenede Stater
-
University Hospital, GrenobleIkke rekrutterer endnuKunstig intelligens | Solid Organ Transplantation
-
University Health Network, TorontoIkke rekrutterer endnuSolid Organ Transplantation | Levertransplantation | Nyretransplantation | Hjertetransplantation
-
University of PittsburghRekrutteringKnoglemarvstransplantation | Solid Organ TransplantationForenede Stater
-
Peking University First HospitalPeking University People's Hospital; Peking University Third Hospital; Beijing... og andre samarbejdspartnereAfsluttetLangsigtet resultat | Ældre patienter | Epidural anæstesi | Solid Organ Cancer | Kirurgisk resektionKina
Kliniske forsøg med Mystic Wizard
-
University of PittsburghNational Institute of Mental Health (NIMH); Kaiser Foundation Research...Afsluttet
-
University of PittsburghNational Institute of Mental Health (NIMH); Kaiser Foundation Research...AfsluttetDepression | SelvmordstankerForenede Stater
-
Bradley HospitalNational Heart, Lung, and Blood Institute (NHLBI)Ikke rekrutterer endnu
-
Kaiser PermanenteHealthPartners Institute; OCHIN, Inc.AfsluttetHjerte-kar-sygdomme | Slag | HjerteanfaldForenede Stater
-
Kessler FoundationUniversity of Southern California; VA Office of Research and Development; Kessler Institute for Rehabilitation og andre samarbejdspartnereUkendt
-
HealthPartners InstituteEssentia HealthAfsluttet
-
University of Missouri-ColumbiaAfsluttetKronisk slagtilfældeForenede Stater
-
HealthPartners InstituteAfsluttet
-
HealthPartners InstituteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Aktiv, ikke rekrutterende
-
HealthPartners InstituteNational Heart, Lung, and Blood Institute (NHLBI)AfsluttetHjerte-kar-sygdomme | Rygning | Forhøjet blodtryk | Diabetes | Kardiovaskulær risikofaktor | Hyperlipidæmi