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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013958
Receipt No. R000016258
Scientific Title Reliability and validity of the Specific Levels of Functioning Scale (SLOF) Japanese version
Date of disclosure of the study information 2014/05/14
Last modified on 2017/08/21

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Basic information
Public title Reliability and validity of the Specific Levels of Functioning Scale (SLOF) Japanese version
Acronym Reliability and validity of the Specific Levels of Functioning Scale (SLOF) Japanese version
Scientific Title Reliability and validity of the Specific Levels of Functioning Scale (SLOF) Japanese version
Scientific Title:Acronym Reliability and validity of the Specific Levels of Functioning Scale (SLOF) Japanese version
Region
Japan

Condition
Condition schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examined the reliability and validity of the Japanese version of the Specific Levels of Functioning Scale (SLOF).
Basic objectives2 Others
Basic objectives -Others Individuals with schizophrenia show impairment in various aspects of daily lives. The Specific Levels of Functioning Scale(SLOF) by Schneider et al. was developed to measure the behavioral functioning and daily living skills of patients with schizophrenia. We examined the reliability and validity of the Japanese version of the SLOF.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Neurocognitive function: BACS-J (Brief Assessment of Cognitive function in Schizophrenia Japanese version)
Social function: UPSA-B (Japanese version)
Real-world functonal outcome: SLOF(Specific Levels of Functioning Assessment)Japanese version, SFS(Social Functioning Scale) Japanese version
Key secondary outcomes Psychiatric symptoms: PANSS(Positive and Negative Syndrome Scale)
Social cognitive function: Hinting task Japanese version, SCSQ-J(Social Cognition Screening Questionnaire Japanese version)
Meta cognitive function: BCIS-J(Beck Cognitive Insight Scale Japanese version)
Global function: GAF(Global Assessment of Functioning)
Premorbid intellectual funton: JART(Japanese Adult Reading Test)
Backgroud factors: age, sex, dominat hand, schooling history, family history, morbidity period, recurrence, administration, complications, past history, ECT, medication

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria The patient who
(1)is diagnosed as schizophrenia by using DSM-4-TR
(2)is outpatient
(3)is 20 years old and over and under 60 years old
(4)has family or caregiver who can assess his/her real-world functional outcome
(5)can understand the aim and contents of this study and agree with this study.
Key exclusion criteria The patient who
(1)have severe cerebral organic disease or brain injury, now or before.
(2)alcohol or substance use disorder (exclude caffein or nicotine use).
(3)who diagnosed as axis-2 of DSM-4-TR(personality disorder or mental retardation).
(4)is regarded as inappropriate for this study by the researcher.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidehito Niimura
Organization School of Medicine, Keio University
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-5363-3829
Email niimura-hide@nifty.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidehito Niimura
Organization School of Medicine, Keio University
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-5363-3829
Homepage URL
Email niimura-hide@nifty.ne.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Japanese Foundation for Neuroscience and Mental Health
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor National Center of Neurology and Psychiatry
Department of Psychiatry, Hokkaido University Graduate School of Medicine
Department of Neuropsychiatry, School of Medicine, Sapporo Medical University
Department of Psychiatry, School of Medicine, Tokyo Women's Medical University
Department of Psychiatry, School of Medicine, Showa University
Department of Psychiatry, School of Medicine, Nara Medical University
Department of Neuropsychiatry, School of Medicine, Kansai Medical University
Hizen Psychiatric Center
Department of Neuropsychiatry, School of Medicine, Oita University
Department of Psychiatry, School of Medicine, University of Occupational and Environmental Health
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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2014 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 16 Day
Last follow-up date
2014 Year 06 Month 30 Day
Date of closure to data entry
2014 Year 07 Month 15 Day
Date trial data considered complete
2014 Year 08 Month 01 Day
Date analysis concluded
2015 Year 07 Month 31 Day

Other
Other related information Sumiyoshi T, Nishida K, Niimura H, Toyomaki A, Morimoto T, Tani M, Inada K, Ninomiya T, Hori H, Manabe J, Katsuki A, Kubo T, Koshikawa Y; Shirahama M, Kohno K, Kinoshita T, Kusumi I, Iwanami A, Ueno T, Kishimoto T, Terao T, Nakagome K: Validation of the Specific Level of Function Scale: Japanese version; Relation to cognitive insight. Schizophrenia Research: Cognition 6: 9-14, 2016

Management information
Registered date
2014 Year 05 Month 14 Day
Last modified on
2017 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016258

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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