UMIN-CTR Clinical Trial

Basic information
Public title	Multimodal care communication training study for physicians in acute care hospitals.
Acronym	Humanitude study for physicians
Scientific Title	Multimodal care communication training study for physicians in acute care hospitals.
Scientific Title:Acronym	Multimodal care communication training study for physicians in acute care hospitals.
Region	Japan

Condition
Condition	physician
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of changes in communication skills and empathy toward patients by a multimodal care communication education course for physicians working in an acute care hospital
Basic objectives2	Others
Basic objectives -Others	Analyzing the communication skill with patients by artificial intelligence.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Empathy for patients
Key secondary outcomes	Video analysis of the communication by 1st and 3rd person camera Burn-out of the work

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	Watch 1 hour of educational video once a week for a total of 4 times and obtain weekly bedside training
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Physicians working at an acute care hospital
Key exclusion criteria	Person who was not able to give the written conscent
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Miwako Middle name Last name Honda
Organization	National Hospital Organization Tokyo Medical Center
Division name	Division of Geriatric Research
Zip code	1520021
Address	2-5-1 Higashigaoka, Meguro, Tokyo
TEL	03-3411-0111
Email	honda-1@umin.ac.jp

Public contact
Name of contact person	1st name Masaki Middle name Last name Kobayashi
Organization	National Hospital Organization Tokyo Medical Center
Division name	Division of Geriatric Research
Zip code	1520021
Address	2-5-1 Higashigaoka, Meguro, Tokyo, Japan
TEL	03-3411-0111
Homepage URL
Email	kobayashi@tmcgrc.org

Sponsor
Institute	National Hospital Organization Tokyo Medical Center
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Hospital Organization Tokyo Medical Center
Address	2-5-1 Higashigaoka, Meguro, Tokyo, Japan
Tel	03-3411-0111
Email	honda@tmcgrc.org

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 21 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	2020 Year 10 Month 21 Day
Date of IRB	2020 Year 10 Month 27 Day
Anticipated trial start date	2020 Year 10 Month 27 Day
Last follow-up date	2025 Year 09 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	2021 Year 05 Month 21 Day
Last modified on	2021 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050586