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

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 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


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

Value
https://center6.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