UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044128 |
|---|---|
| Receipt number | R000050322 |
| Scientific Title | Anxiety to SARS-CoV-2 vaccine in patients with autoimmune liver disease and effect of information sharing |
| Date of disclosure of the study information | 2021/05/07 |
| Last modified on | 2025/11/11 09:57:18 |
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Basic information
Public title
Anxiety to SARS-CoV-2 vaccine in patients with autoimmune liver disease and effect of information sharing
Acronym
Anxiety to SARS-CoV-2 vaccine in patients with autoimmune liver disease
Scientific Title
Anxiety to SARS-CoV-2 vaccine in patients with autoimmune liver disease and effect of information sharing
Scientific Title:Acronym
Anxiety to SARS-CoV-2 vaccine in patients with autoimmune liver disease
Region
| Japan |
Condition
Condition
Autoimmune liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Appropriate provision of information about COVID19 and vaccines to SARS-CoV-2 reduces anxiety to the vaccination.
Basic objectives2
Others
Basic objectives -Others
Reduction of anxiety by information sharing
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Information sharing improves objective parameter of anxiety to the vaccination.
Key secondary outcomes
Effect of information sharing to decision of vaccine receiving.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Providing information about COVID19 and vaccines to SARS-CoV-2
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient with autoimmune liver disease
With informed assent to be participant in this study
Key exclusion criteria
Without informed assent to be participant in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Takikawa |
Organization
Iwate Medical University
Division name
Division of Hepatology, Department of Internal Medicine
Zip code
0283694
Address
Idaidori 1-1-1, Yahaba cho, Iwate
TEL
0196515111
ytakikaw@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Kakisaka |
Organization
Iwate Medical University
Division name
Division of Hepatology, Department of Internal Medicine
Zip code
0283694
Address
Idaidori 1-1-1, Yahaba cho, Iwate
TEL
0196515111
Homepage URL
keikaki@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University
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
Iwate Medical University
Address
Idaidori 1-1-1, Yahaba cho, Iwate
Tel
0196515111
kenkyujosei@j.iwate-med.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
| 2021 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/kanzo/62/10/62_613/_pdf/-char/ja
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/kanzo/62/10/62_613/_pdf/-char/ja
Number of participants that the trial has enrolled
58
Results
Fifteen patients with primary biliary cholangitis, 18 with autoimmune hepatitis, and 7 with other autoimmune liver diseases were employed. Among the 34 patients with chronic hepatitis, the median age was 62 years, and 33 were female. After sharing information about COVID19 vaccination, the number of patients intending to "receive the vaccine" increased from 23 to 34, while those reporting "very anxious" decreased from 29 to 14.
Results date posted
| 2025 | Year | 11 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Outpatients with autoimmune liver disease who attend to an indicated hospital.
Participant flow
After obtaining informed consent, patients with autoimmune liver disease who attended as outpatients were consecutively employed.
Adverse events
NA
Outcome measures
Questionnaire and visual analog scale for vaccine-related anxiety.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2021 | 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
| 2021 | Year | 05 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050322
