UMIN-CTR Clinical Trial

Basic information
Public title	Verification of stress relief by introducing online visits to the restrictions on visits of COVID-19
Acronym	The effect of online visits to COVID-19
Scientific Title	Verification of stress relief by introducing online visits to the restrictions on visits of COVID-19
Scientific Title:Acronym	The effect of online visits to COVID-19
Region	Japan

Condition
Condition	hospitalized patient
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of stress relief effect by online visit
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective stress evaluation (questionnaire survey using POMS2 Japanese shortened version)
Key secondary outcomes	Objective stress evaluation (biological stress marker / vital signs)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Online visit
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	Inpatients and their families wishing to visit online
Key exclusion criteria	Patients who fall under any of the following are excluded from the target. 1.Patients who cannot obtain written consent 2.Other patients who are judged to be inappropriate as research subjects by the principal investigator.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Yamamoto
Organization	Jinseikai Kohnan Hospital
Division name	Surgery
Zip code	5203321
Address	Kohnan-cho Katsuragi 958, Koka, Shiga
TEL	0748-86-3131
Email	yhiroshi@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Yamamoto
Organization	Jinseikai Kohnan Hospital
Division name	Surgery
Zip code	5203321
Address	Kohnan-cho Katsuragi 958, Koka, Shiga
TEL	0748-86-3131
Homepage URL
Email	yhiroshi@belle.shiga-med.ac.jp

Sponsor
Institute	Jinseikai Kohnan Hospital
Institute
Department

Funding Source
Organization	Jinseikai Kohnan Hospital
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	Jinseikai Kohnan Hospital
Address	Kohnan-cho Katsuragi 958, Koka, Shiga
Tel	0748-86-3131
Email	yhiroshi@belle.shiga-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	仁生会甲南病院(滋賀県）

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 16 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	Completed
Date of protocol fixation	2020 Year 11 Month 12 Day
Date of IRB	2020 Year 11 Month 13 Day
Anticipated trial start date	2020 Year 11 Month 16 Day
Last follow-up date	2021 Year 03 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	2020 Year 11 Month 08 Day
Last modified on	2022 Year 02 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048379