UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013958 |
|---|---|
| Receipt number | 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 14:46:58 |
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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
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
niimura-hide@nifty.ne.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016258
