UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055850 |
|---|---|
| Receipt number | R000062931 |
| Scientific Title | Comparison between 3D Printing Models and Virtual Reality as Educational Methods for Adult Congenital Heart Disease Patients |
| Date of disclosure of the study information | 2024/10/22 |
| Last modified on | 2024/10/22 11:23:07 |
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Basic information
Public title
Comparison between 3D Printing Models and Virtual Reality in Educating Adult Congenital Heart Disease Patients
Acronym
Use of 3D Printing Model and Virtual Reality in Adult Congenital Heart Disease Patient Education
Scientific Title
Comparison between 3D Printing Models and Virtual Reality as Educational Methods for Adult Congenital Heart Disease Patients
Scientific Title:Acronym
Use of Advanced Imaging in Adult Congenital Heart Disease Patient Education
Region
| Japan |
Condition
Condition
adult congenital heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study's primary purpose is to support adult congenital heart disease patients to be more self-advocate and live a higher quality of life by improving their understanding of their heart condition.
Basic objectives2
Others
Basic objectives -Others
The current study compares participants' assessments of 3D-printed models and virtual reality (VR) to improve their knowledge about their heart condition. In addition, the study will assess whether this educational program of 3D printing and VR will enhance participants' understanding.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
After the study participants have received both educational programs using 3D printing models and VR, they will be asked to answer a questionnaire. The questionnaire will ask ten questions about which program was more effective in improving their understanding of their health conditions. The questionnaire was previously used in a study for health care professionals to compare the two imaging modalities for presurgical planning and physician education.
Key secondary outcomes
The study will assess the change in participants' knowledge between before and after the two educational programs.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
All participants will undergo educational programs using 3D printing models and VR, explaining their heart conditions and anatomies in detail. Half of the participants will undergo the VR educational program first. The other half will undergo the 3D printing model educational program first.
Interventions/Control_2
The other half will undergo the educational program, first using the 3D printing model.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The adult congenital heart disease patients who meet the criteria below will be eligible.
1) Patients with complex congenital heart disease anatomy. Here, we refer to complex congenital heart disease anatomy as those that require cardiac surgery at an early stage to address cyanosis. It includes atrioventricular septal defect (AVSD), Tetralogy of Fallot, Truncus arteriosus, Ebstein anomaly, Transposition of the great arteries, congenitally corrected transposition of the great arteries (ccTGA), single ventricle physiology, and hypoplastic left heart syndrome (HLHS).
Key exclusion criteria
1) Syndromic patients, including those with trisomy 21 and 22q11.2 deletion
2) Those who are not able to speak or read either Japanese or English
3) Patients who have pacemakers implanted and have not undergone cardiac CT or MRI scanning in the past 5 years
4) Those who are pregnant
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kodaira |
Organization
Keio University Hospital
Division name
Department of Cardiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5843-6702
mskodaira@keio.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kodaira |
Organization
Keio University Hospital
Division name
Department of Cardiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5843-6702
Homepage URL
mskodaira@keio.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062931
