- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thomas Caruso, MD, PhD
- Phone Number: 650-723-5728
- Email: tjcaruso@stanford.edu
Study Contact Backup
- Name: Amrita Narang, MD
- Phone Number: (650) 721-2250
- Email: anarang@stanford.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between age 7-14
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determine the acceptability the tablet-based game among solid transplant patient.
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the usability of the tablet-based game among solid transplant patient using System Usability Scale (SUS)
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Caruso, MD, PhD, Stanford University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 87110
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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