UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045706
Receipt number R000052167
Scientific Title The effect of an Empathy training program in the Medical Care and Supervision Act in Japan
Date of disclosure of the study information 2021/11/01
Last modified on 2024/04/21 00:09:51

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Basic information

Public title

The effect of an Empathy training program in the Medical Care and Supervision Act in Japan

Acronym

The effect of an Empathy training program in the Medical Care and Supervision Act in Japan

Scientific Title

The effect of an Empathy training program in the Medical Care and Supervision Act in Japan

Scientific Title:Acronym

The effect of an Empathy training program in the Medical Care and Supervision Act in Japan

Region

Japan


Condition

Condition

Schizophrenia

Classification by specialty

Psychiatry Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To reveal the effect of an Empathy training program

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Multi-dimensional Empathy Scale

Key secondary outcomes

Rosenberg self esteem Scale
Life Assessment Scale for the Mentally Ill


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

An Empathy training program

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Schizophrenia

Key exclusion criteria

Dementia

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Minoru
Middle name
Last name Ishizaki

Organization

National Hospital Oganization Simofusa Psychiatric Center

Division name

Nursing department

Zip code

266-0007

Address

578, Hetacho, Chiba Shi Midori Ku, Chiba Ken,

TEL

043-291-1221

Email

ishizaki.minoru.zd@mail.hosp.go.jp


Public contact

Name of contact person

1st name Minoru
Middle name
Last name Ishizaki

Organization

National Hospital Oganization Simofusa Psychiatric Center

Division name

Nursing department

Zip code

266-0007

Address

578, Hetacho, Chiba Shi Midori Ku, Chiba Ken,

TEL

043-291-1221

Homepage URL


Email

ishizaki.minoru.zd@mail.hosp.go.jp


Sponsor or person

Institute

National Hospital Oganization Simofusa Psychiatric Center

Institute

Department

Personal name



Funding Source

Organization

National Hospital Oganization Simofusa Psychiatric Center

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

National Hospital Oganization Simofusa Psychiatric Center

Address

578, Hetacho, Chiba Shi Midori Ku, Chiba Ken,

Tel

043-291-1221

Email

ishizaki.minoru.zd@mail.hosp.go.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 11 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

Terminated

Date of protocol fixation

2021 Year 09 Month 24 Day

Date of IRB

2021 Year 09 Month 24 Day

Anticipated trial start date

2021 Year 11 Month 01 Day

Last follow-up date

2023 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

2021 Year 10 Month 08 Day

Last modified on

2024 Year 04 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052167