UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054417 |
|---|---|
| Receipt number | R000062155 |
| Scientific Title | Video Vignette study on cultural differences in communication between physicians and critically ill patients |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/05/16 23:14:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study of Cultural Differences in Communication between Doctors and Critically Ill Patients
Acronym
Communication Studies with Critically Ill Patients
Scientific Title
Video Vignette study on cultural differences in communication between physicians and critically ill patients
Scientific Title:Acronym
Video Vignette Study with Critically Ill Patients
Region
| Japan |
Condition
Condition
Serious Illness (Cancer, COPD, Heart Failure, or End-Stage Kidney Disease) and Caregivers
Classification by specialty
| Medicine in general | Cardiology | Hematology and clinical oncology |
| Nephrology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test whether clinical communication methods tailored to the Japanese context can better stabilize the emotions of Japanese patients and their families.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
STAI-JYZ of pre and post-watching video vignette
Key secondary outcomes
PSQ-J
Video Reality Rating
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
A group to watch a video recording of a conversation that does not use a communication technique with severely ill patients (NURSE) (control)
Interventions/Control_2
A group to watch a video recording of a conversation structured based on the original NURSE
Interventions/Control_3
A group to watch a video recording of a conversation structured based on the Japanese version NURSE
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
Patients or their family members suffering from any of the Serious Illnesses (Cancer, COPD, Heart Failure, End-Stage Renal Disease) are eligible. The criteria for inclusion were outpatients or their family members with a history of any of the above diseases and a history of hospitalization, or currently hospitalized patients or their family members whose condition is currently stable and mentally stable.
The rationale for including Serious Illness was that these are progressive diseases and may become similar to the video cases in the future, making them more interesting to evaluate.
The rationale for including the patient's family was that in Japan, patients' explanations are often given to their families, and family care is an important medical issue.
Key exclusion criteria
Non-Japanese speaker
Cognitive impairment
Mental unstableness
Clinically inappropriate, determined by the researchers
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Tadayuki |
| Middle name | |
| Last name | Hashimoto |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of General Medicine
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki, Osaka
TEL
072-683-1221
tadayuki.hashimoto@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Tadayuki |
| Middle name | |
| Last name | Hashimoto |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of General Medicine
Zip code
569-8686
Address
2-7 Daigakumachi, Takatsuki, Osaka
TEL
072-683-1221
Homepage URL
tadayuki.hashimoto@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Tadayuki Hashimoto
Funding Source
Organization
None
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
Itabashi Chuo Medical Center
Address
2 Chome-12-7 Azusawa, Itabashi City, Tokyo
Tel
03-3967-1181
yusukeyasumoto108@gmail.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
| 2024 | Year | 06 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 05 | Month | 16 | Day |
Last modified on
| 2024 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062155
