UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050914 |
|---|---|
| Receipt number | R000058028 |
| Scientific Title | Examining the impact of video materials on digital subtraction angiography on the quality of medical care. |
| Date of disclosure of the study information | 2023/05/17 |
| Last modified on | 2024/04/29 20:44:22 |
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Basic information
Public title
Examining the impact of video materials on digital subtraction angiography on the quality of medical care.
Acronym
Examining the impact of video materials on digital subtraction angiography on the quality of medical care.
Scientific Title
Examining the impact of video materials on digital subtraction angiography on the quality of medical care.
Scientific Title:Acronym
Examining the impact of video materials on digital subtraction angiography on the quality of medical care.
Region
| Japan |
Condition
Condition
cerebrovascular disease
Classification by specialty
| Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine whether video-assisted educational materials can improve health literacy for patients undergoing digital subtraction angiography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HLS-14
Key secondary outcomes
HCAHPS
knowledge evaluation (5 questions)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients are needed preprocedural view of video material that explains digital subtraction angiography
Interventions/Control_2
Patients in the control group do not watch the video and are given an explanation of the test in a face-to-face informed consent session
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
| 30 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who will undergo first-time digital subtraction angiography at Okayama university hospital. The period from the approval by the Ethics Committee to December 31, 2025, is eligible.
Key exclusion criteria
Disagree to participate in this study inclusion
Digital subtraction angiography unexpectedly cancel
Patients whose native language is not Japanese
Patients who have had previous digital subtraction angiography
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | KENJI |
| Middle name | |
| Last name | SUGIU |
Organization
Okayama University Hospital
Division name
IVR Center, Neurological Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL
086-235-7336
ksugiu@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | YUKI |
| Middle name | |
| Last name | EBISUDANI |
Organization
Okayama University Hospital
Division name
Neurological Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL
086-235-7336
Homepage URL
yebis_murai@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
Tel
086-235-6503
mae6605@adm.okayama-u.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
| 2023 | Year | 05 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 24 | Day |
Last modified on
| 2024 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058028
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
