UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053410 |
|---|---|
| Receipt number | R000060953 |
| Scientific Title | A Prospective Observational Study Aimed at Comprehensive Assessment of Psychiatric Inpatients Based on Objective Data and Prescriptions for Reducing Long-Term Hospitalization |
| Date of disclosure of the study information | 2024/01/22 |
| Last modified on | 2024/01/22 12:14:50 |
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Basic information
Public title
A Prospective Observational Study Aimed at Comprehensive Assessment of Psychiatric Inpatients Based on Objective Data and Prescriptions for Reducing Long-Term Hospitalization
Acronym
A Prospective Observational Study Aimed at Comprehensive Assessment of Psychiatric Inpatients Based on Objective Data and Prescriptions for Reducing Long-Term Hospitalization
Scientific Title
A Prospective Observational Study Aimed at Comprehensive Assessment of Psychiatric Inpatients Based on Objective Data and Prescriptions for Reducing Long-Term Hospitalization
Scientific Title:Acronym
A Prospective Observational Study Aimed at Comprehensive Assessment of Psychiatric Inpatients Based on Objective Data and Prescriptions for Reducing Long-Term Hospitalization
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying the characteristics of long-term inpatients in Japanese psychiatric hospitals and reducing long-term hospitalization
Basic objectives2
Others
Basic objectives -Others
Regularly investigate sleep variables, clinical psychological test scores, and medication treatment guideline compliance rates in patients with schizophrenia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-Year Discharge Rate
Key secondary outcomes
sleep variables, clinical psychological test scores, and schizophrenia medication treatment guideline compliance rate
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) A diagnosis of schizophrenia (DSM-5)
(2) Hospitalized for more than 1 year consecutively
Key exclusion criteria
(1) Patients with complications of serious physical diseases
(2) Patients whom the principal investigator or attending physician determines to be unsuitable as subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Arai |
Organization
Kurita hospital
Division name
Department of psychiatry
Zip code
380-0921
Address
695 Kurita, Nagano City, Nagano Prefecture
TEL
026-226-1311
y-arai@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Arai |
Organization
Kurita hospital
Division name
Department of psychiatry
Zip code
380-0921
Address
695 Kurita, Nagano City, Nagano Prefecture
TEL
026-226-1311
Homepage URL
y-arai@shinshu-u.ac.jp
Sponsor or person
Institute
Kurita hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurita hospital
Address
695 Kurita, Nagano City, Nagano Prefecture
Tel
026-226-1311
y-arai@shinshu-u.ac.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
| 2024 | Year | 01 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As new content for the research purpose, we plan to conduct a one-week actigraphy test and a questionnaire survey every six months. Other data will be obtained from routine clinical data.
Management information
Registered date
| 2024 | Year | 01 | Month | 22 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060953
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
