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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044128
Receipt No. 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 2021/05/07

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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
Email 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
Email keikaki@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 58
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
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
2021 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050322

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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