UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039365
Receipt number R000043674
Scientific Title Investigating safe and effective communication when patients and clinicians use online video with family in decision-making process
Date of disclosure of the study information 2020/02/02
Last modified on 2021/06/02 10:59:02

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Basic information

Public title

Investigating safe and effective communication when patients and clinicians use online video with family in decision-making process

Acronym

Investigating safe and effective communication when patients and clinicians use online video with family in decision-making process

Scientific Title

Investigating safe and effective communication when patients and clinicians use online video with family in decision-making process

Scientific Title:Acronym

Investigating safe and effective communication when patients and clinicians use online video with family in decision-making process

Region

Japan


Condition

Condition

Medicine in general

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigating safe and effective communication when patients and clinicians use online video with family

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Decision conflict

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

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

Other

Interventions/Control_1

Patients and clinicians use online video communication with outside family in decision-making process.

Interventions/Control_2

Patients in control group do not use online video communication.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

We include hospitalized patients who are going to make a decision on their treatment.

Key exclusion criteria

We exclude patients who are not able to make a decision.

Target sample size

134


Research contact person

Name of lead principal investigator

1st name Tetsuro
Middle name
Last name Hayashi

Organization

National Hospital Organization Tokyo Medical Center

Division name

Department of clinical epidemiology

Zip code

152-0092

Address

2-5-1 Higashigaoka Meguro-ku, Tokyo

TEL

0334113130

Email

tetsuro1026@hotmail.com


Public contact

Name of contact person

1st name Tetsuro
Middle name
Last name Hayashi

Organization

National Hospital Organization Tokyo Medical Center

Division name

Department of clinical epidemiology

Zip code

152-0092

Address

2-5-1 Higashigaoka Meguro-ku, Tokyo

TEL

0334113130

Homepage URL


Email

tetsuro1026@hotmail.com


Sponsor or person

Institute

National Hospital Organization Tokyo Medical Center

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Government offices of other countries

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-ku, Tokyo

Tel

0334113130

Email

tetsuro1026@hotmail.com


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

2020 Year 02 Month 02 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

0

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

Terminated

Date of protocol fixation

2019 Year 11 Month 01 Day

Date of IRB

2019 Year 12 Month 02 Day

Anticipated trial start date

2020 Year 02 Month 01 Day

Last follow-up date

2021 Year 08 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 02 Month 02 Day

Last modified on

2021 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043674


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name