UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000056275 |
|---|---|
| Receipt number | R000064295 |
| Scientific Title | The study on the effectiveness of crisis plan in preventing compulsory admission in mental health care. |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2024/11/26 15:43:40 |
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Basic information
Public title
The study on the effectiveness of crisis plan in preventing compulsory admission in mental health care.
Acronym
The study on the effectiveness of crisis plan in preventing compulsory admission in mental health care.
Scientific Title
The study on the effectiveness of crisis plan in preventing compulsory admission in mental health care.
Scientific Title:Acronym
The study on the effectiveness of crisis plan in preventing compulsory admission in mental health care.
Region
| Japan |
Condition
Condition
Schizophrenia, Schizotypal disorders, Delusional disorders, Mood disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effevtiveness of crisis plans in preventing compulsory admissions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The occurrence rate of compulsory admission
Key secondary outcomes
The number of days compulsory admission
The number of voluntary admission
The insidence of self-harming and aggressive behavior
Japanese version of the UCLA loneliness scale
Japanese version of the Recovery Assessment Scale
Japanese version of the INSPIRE measure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Intervention through the development and utilization of crisis plans
Interventions/Control_2
Providing information about crisis plans
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
Inpatients in the acute care ward of a psychiatric hospital.
Patients with at least one psychiatric hospital admission in the past two years.
Patients who are able to understand the contents of the study and provide informed consent to participate.
Key exclusion criteria
Patients under 18 years old.
Pationts whom physicians in charge do not allow them to paticipate.
Patients who are unable to provide consent to participate in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Kanou |
Organization
Tohoku Fukushi University
Division name
Faculty of Comprehensive Social Welfare
Zip code
981-8522
Address
1-8-1 Kunimi, Aoba Ward, Sendai City, Miyagi, Japan
TEL
022-233-3111
s-kano@tfu.ac.jp
Public contact
Name of contact person
| 1st name | Shunuske |
| Middle name | |
| Last name | Kanou |
Organization
Tohoku Fukushi University
Division name
Faculty of Comprehensive Social Welfare
Zip code
981-8522
Address
1-8-1 Kunimi, Aoba Ward, Sendai City, Miyagi, Japan
TEL
022-223-3111
Homepage URL
s-kano@tfu.ac.jp
Sponsor or person
Institute
Tohoku Fukushi University
Institute
Department
Personal name
Funding Source
Organization
Scientific Research Grant Program by the Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku Fukushi University
Address
1-8-1 Kunimi, Aoba Ward, Sendai City, Miyagi, Japan
Tel
022-233-3111
soumu@tfu.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
| 2025 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 07 | 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
| 2024 | Year | 11 | Month | 26 | Day |
Last modified on
| 2024 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064295
