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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034220
Receipt No. 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 2019/09/26

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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
Institute Center for Forensic Mental Health, Chiba University
Institute
Department

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
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
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
Date trial data considered complete
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
2019 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.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


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