UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040263 |
|---|---|
| Receipt number | R000045928 |
| Scientific Title | Changes of problem behaviors through recreational therapy:Effects of recreational programs held at monitoring zone of closed ward |
| Date of disclosure of the study information | 2020/04/28 |
| Last modified on | 2020/12/07 15:18:34 |
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Basic information
Public title
Changes of problem behaviors through recreational therapy:Effects of recreational programs held at monitoring zone of closed ward
Acronym
Effects of recreational therapy at monitoring zone
Scientific Title
Changes of problem behaviors through recreational therapy:Effects of recreational programs held at monitoring zone of closed ward
Scientific Title:Acronym
Effects of recreational therapy at monitoring zone
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve the psychopathology and social function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rehabilitation Evaluation of Hall and Baker(REHAB)
Key secondary outcomes
1)Changes of patients'talk contents and facilal expressions,2)Brief Psychiatric Raing Scale(BPRS)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Recreational therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Long-term hospitalized patients for more than five years who have stayed at monitoring zone for more than one year
Key exclusion criteria
Hospitalized patients for less than five years whose stay at monitoring zone for less than one year
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Hidaka |
| Middle name | |
| Last name | Naomi |
Organization
Sawa Hospital
Division name
Nursing Division
Zip code
561-0803
Address
1-9-1Siroyama,Toyonaka City,Oosaka,Japan,561-0803
TEL
06-8685-1211
nur@hokuto-kai.com
Public contact
Name of contact person
| 1st name | Hidaka |
| Middle name | |
| Last name | Naomi |
Organization
Sawa Hospital
Division name
Nursing Division
Zip code
561-0803
Address
1-9-1Siroyama,Toyonaka City,Oosaka,Japan,561-0803
TEL
06-8685-1211
Homepage URL
nur@hokuto-kai.com
Sponsor or person
Institute
Sawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Sawa Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee,Social medical corporation Hokutokai
Address
1-9-1Siroyama,Toyonaka City,Oosaka,Japan,561-0803
Tel
06-6865-1211
clin-res@hokuto-kai.com
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
| 2020 | Year | 04 | Month | 28 | 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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 28 | Day |
Last modified on
| 2020 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045928
