UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038048 |
|---|---|
| Receipt number | R000043370 |
| Scientific Title | Influence of doing a subject-chosen activity on functioning in long-term inpatients with schizophrenia: a randomised controlled trial |
| Date of disclosure of the study information | 2019/09/18 |
| Last modified on | 2019/09/18 22:36:08 |
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Basic information
Public title
Investigating whether doing a subject-chosen activity improves initiative actions and psychiatric symptoms in long-term inpatients with schizophrenia
Acronym
Investigating whether doing a subject-chosen activity improves initiative actions and psychiatric symptoms in long-term inpatients with schizophrenia
Scientific Title
Influence of doing a subject-chosen activity on functioning in long-term inpatients with schizophrenia: a randomised controlled trial
Scientific Title:Acronym
Influence of doing a subject-chosen activity on functioning in long-term inpatients with schizophrenia: a randomised controlled trial
Region
| Japan |
Condition
Condition
Schizophrenia spectrum disorders
Classification by specialty
| Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study was to examine the hypothesis that performing a subject-chosen activity would improve functioning in long-term inpatients with schizophrenia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
The Japanese version of the Rehabilitation Evaluation Hall and Baker (REHAB)
REHAB was assessed during a week before and after intervention.
Key secondary outcomes
The Japanese version of the Global Assessment of Functioning (GAF) Scale
The Japanese version of the Positive and Negative Syndrome Scale (PANSS)
GAF and PANSS were assessed during the two weeks before and after intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention 1_Participants performed at least one subject-chosen activity per week in occupational therapy during twenty-seven weeks. "Subject-chosen activity" means that participants indicated that they wanted to do, in an interview using the Canadian Occupational Performance Measure (COPM).
Interventions/Control_2
Control 1_Participants performed at least one therapist-chosen activity per week in occupational therapy during twenty-seven weeks as an usual treatment. "Therapist-chosen activity" were chosen by occupational therapists in an interview as usual treatment without COPM and participants performed it with participants' consent.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(a) diagnosis of schizophrenia, as defined by the International Statistical Classification of Diseases (10th Revision); (b) hospitalization for more than a year on April 2016; (c) no difficulty in communicating because of their symptoms; (d) no plan for being discharged.
Key exclusion criteria
None.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tomoe |
| Middle name | |
| Last name | Ebisu |
Organization
Kobe University Graduate School of Health Sciences
Division name
Rehabilitation Science
Zip code
654-0154
Address
Tomogaoka 7-10-2, Suma-ku, Kobe, Hyogo 654-0142, Japan
TEL
+81-78-796-4504
tmetme1152@gmail.com
Public contact
Name of contact person
| 1st name | Tomoe |
| Middle name | |
| Last name | Ebisu |
Organization
Kobe University Graduate School of Health Sciences
Division name
Rehabilitation Science
Zip code
654-0154
Address
Tomogaoka 7-10-2, Suma-ku, Kobe, Hyogo 654-0142, Japan
TEL
+81-78-796-4504
Homepage URL
tmetme1152@gmail.com
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
the Utsumi Jijin Medical Corp Arima Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Utsumi Jijin Medical Corp Arima Hospital
Address
Shimoyamaguchi 1637-5, Yamaguchi-cho, Nishinomiya, Hyogo 651-1412, Japan
Tel
+81-78-904-0721
ot@arimahp.or.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
| 2019 | Year | 09 | Month | 18 | 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
73
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Unpublished. Now, we are working to publish.
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
| 2016 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 28 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 18 | Day |
Last modified on
| 2019 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043370
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| Registered date | File name |
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