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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026098
Receipt No. 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 2018/02/14

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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
Middle name
Last name Kayano YOTSUMOTO
Organization Kobe University Graduate School
Division name Department of Health Sciences
Zip code
Address 7-10-2 Tmogaoka Suma-ku, Kobe
TEL 078-796-4590
Email yotumoto@kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masami Ito
Organization Kobe University Graduate School
Division name general affairs department
Zip code
Address 7-10-2 Tmogaoka Suma-ku, Kobe
TEL 078-796-4502
Homepage URL
Email syomu2@ams.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Health Sciences
Institute
Department

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
Address
Tel
Email

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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
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
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
2018 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029990

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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