UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026098 |
|---|---|
| Receipt number | R000029990 |
| Scientific Title | Effect of decision-making to social function of people with schizophrenia in the day program |
| Date of disclosure of the study information | 2017/02/11 |
| Last modified on | 2023/02/06 19:30:44 |
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Basic information
Public title
Effect of decision-making to social function of people with schizophrenia in the day program
Acronym
Effect of decision-making to social function of people with schizophrenia in the day program
Scientific Title
Effect of decision-making to social function of people with schizophrenia in the day program
Scientific Title:Acronym
Effect of decision-making to social function of people with schizophrenia in the day program
Region
| Japan |
Condition
Condition
schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A purpose of this study is to clarify whether improve a social function by providing an opportunity of periodical self-determination for a person from authority of long term place of the day program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
GAF(Global Assessment of Functioning scale);baseline and after intervention(3 month later)
Key secondary outcomes
RAS(Recovery Assessment Scale)and PANSS(Positive and Negative Syndrome Scale);baseline and after intervention(3 month later)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention: Participants sets and writes his/her goal in daily activities in the sheet once a week, within 5 min each, for 3 months.
Interventions/Control_2
Control:usual treatment(in the day program)
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.People with schizophrenia who are users more than a year in day program in Fukuoka.
2.Day program users who is above 18 and under 65 years old.
3.Day program users who attend regularly more than twice a week.
4.Users who did consent to participate in research.
Key exclusion criteria
1.Users who lack of ability of consent to participate in research.
2.Users who staff concern aggravation after participate in research.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kayano |
| Middle name | |
| Last name | YOTSUMOTO |
Organization
Kobe University Graduate School
Division name
Department of Health Sciences
Zip code
654-0142
Address
7-10-2 Tmogaoka Suma-ku, Kobe
TEL
078-796-4590
yotumoto@kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Masami |
| Middle name | |
| Last name | Ito |
Organization
Kobe University Graduate School
Division name
general affairs department
Zip code
6540142
Address
7-10-2 Tmogaoka Suma-ku, Kobe
TEL
078-796-4502
Homepage URL
syomu2@ams.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Health Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe university
Address
7-10-2 Tmogaoka Suma-ku, Kobe
Tel
078-796-4590
yotumoto@kobe-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
| 2017 | Year | 02 | Month | 11 | 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
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 11 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029990
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
