UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034220
Receipt number R000038667
Scientific Title Early discharge and Prognostic community Outcomes for Psychiatric inpatients in Japan: A longitudinal study (ePOP-J study)
Date of disclosure of the study information 2018/11/01
Last modified on 2024/03/25 09:05:20

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Basic information

Public title

Early discharge and Prognostic community Outcomes for Psychiatric inpatients in Japan: A longitudinal study (ePOP-J study)

Acronym

ePOP-J

Scientific Title

Early discharge and Prognostic community Outcomes for Psychiatric inpatients in Japan: A longitudinal study (ePOP-J study)

Scientific Title:Acronym

ePOP-J

Region

Japan


Condition

Condition

Mental/psychiatric illness

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the factors which are related to readmission at one years follow-up from discharge among patients with mental illness who discharge within 12 months of the index admission.

Basic objectives2

Others

Basic objectives -Others

Testing associations between the variables

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Readmission during 12-months follow-up assessment

Key secondary outcomes

Quality of life (EQ-5D-5L)
Perception of disabilities
Self-agency
Length of hospital stay
Human relationship
Employment
Symptom
Function
Problematic behavior


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

60 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with diagnosis of psychiatric disorders who admit to acute psychiatric wards between 1st October, 2018 and 31st March, 2019.

Key exclusion criteria

1) Inpatients with diagnosis of non-psychiatric disorders (e.g. epilepsy)
2) Inpatients,those aged less than 20 years or greater than 60 years
3) Hospitalisation for particular treatment (e.g. ECT, hospitalisation for medical examination, psychiatric testimony)
4) Inpatients who are expected to immediately change the hospital or department
5) Inpatients who are expected to receive psychiatric treatment outside of participating hospitals or their affiliated medical institutions.

Target sample size

624


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Watanabe

Organization

Chiba University

Division name

Center for Forensic Mental Health

Zip code

260-0856

Address

Inohana 1-8-1, Chuoh-ku, Chiba-shi

TEL

043-226-2586(2539)

Email

hwata@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Sosei
Middle name
Last name Yamaguchi

Organization

National Center of Neurology and Psychiatry

Division name

Department of Community Mental Health & Law, National Institute of Mental Health

Zip code

187-8553

Address

4-1-1 Ogawa-Higashi, Kodaira, Tokyo

TEL

042-346-2039

Homepage URL

https://e-pop.jp/

Email

sosei.yama@ncnp.go.jp


Sponsor or person

Institute

Center for Forensic Mental Health, Chiba University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labor and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Graduate School of Medicine and School of Medicine, Chiba University

Address

1-8-1, Inohana, Chuo-ku, Chiba city, Chiba

Tel

043-222-7171

Email

inohana-rinri@office.chiba-u.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

2018 Year 11 Month 01 Day


Related information

URL releasing protocol

https://doi.org/10.1186/s13033-019-0298-3

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

611

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Analysis in progress

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

2018 Year 09 Month 15 Day

Date of IRB

2018 Year 09 Month 19 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2021 Year 09 Month 30 Day

Date of closure to data entry

2022 Year 05 Month 31 Day

Date trial data considered complete

2023 Year 05 Month 31 Day

Date analysis concluded



Other

Other related information

1. Assessment timing
1) Admission
2) Discharge
3) 6 months after discharge from the index admission
4) 12 months after discharge from the index admission

2. Contents of assessments
1) Admission
- Demographic and Diagnostic information
- Hospitalisation
- Employment
- Relationship
- Symptoms
- Functions
- Problematic behaviour and risk
- Prescription
- QOL
- Self-agency
- Perception of disabilities
- Past utilisation of services
- Weight and Body mass index

2) Discharge
- Diagnostic information
- Treatment during hospitalisation
- Days of hospitalisation
- Employment
- Relationship
- Symptoms
- Functions
- Problematic behaviour and risk
- Prescription
- QOL
- Self-agency
- Perception of disabilities
- Satisfaction with the hospitalisation
- Subjective relationship with family
- Past utilisation of services
- Weight and body mass index

3) 6-months follow-up
- Treatment in outpatient care
- Hospitalisation
- Employment
- Relationship
- Symptoms
- Functions
- Problematic behaviour and risk
- Prescription
- QOL
- Self-agency
- Perception of disabilities
- Satisfaction with outpatient services
- Subjective relationship with family
- Past utilisation of services
- Weight and body mass index

4) 12-months follow-up
- Treatment in outpatient care
- Hospitalisation
- Employment
- Relationship
- Symptoms
- Functions
- Problematic behaviour and risk
- Prescription
- QOL
- Self-agency
- Perception of disabilities
- Satisfaction with outpatient services
- Subjective relationship with family
- Past utilisation of services
- Weight and body mass index

3. Other assessments
1) Organisation information
2) Condition of community resources using ReMHRAD database
3) Costs of treatment and social services in three hospital sites


Management information

Registered date

2018 Year 09 Month 20 Day

Last modified on

2024 Year 03 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038667


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name