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 | 2024/09/21 22:56:24 |
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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)
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/
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
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
Published
Result
URL related to results and publications
https://doi.org/10.1007/s00127-024-02710-5
Number of participants that the trial has enrolled
609
Results
A total of 491 of 609 participants were followed for 12 months. Scores on patient-reported measures at discharge (T2) were not significantly associated with readmission. The interaction between readmission and time was significantly associated with the change in subjective disability scores. This association was not observed in models adjusted for all potential covariates.
Results date posted
| 2024 | Year | 09 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 08 | Month | 05 | Day |
Baseline Characteristics
Among the 491 participants retained for follow-up 12 months after their index admission (T4), approximately 58% were female, with an average age of 42.23 years (SD=10.70). Schizophrenia (59%), depression (14%), and bipolar disorder (13%) were the most prevalent diagnoses. Involuntary admissions accounted for 65% of index hospitalizations, and 40% of the participants had experienced a psychiatric hospitalization prior to the index admission.
Participant flow
During the recruitment period, a total of 4,603 patients were admitted to 21 psychiatric hospitals, out of which 2,093 were deemed eligible for participation. Among these eligible participants, 609 completed the initial evaluation at admission (T1), and 491 were retained throughout the 12-month follow-up period, resulting in an attrition rate of 19.4%.
Adverse events
None
Outcome measures
The primary exposure and outcome were readmission and quality of life. Patient-reported measures of personal agency, subjective disability, and satisfaction with inpatient care were also assessed. In addition, psychiatric symptoms, functioning, presence of physical illness and other relevant variables were evaluated.
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 | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038667
