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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036830
Receipt No. R000041958
Scientific Title Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on patients with developmental disorder
Date of disclosure of the study information 2019/08/01
Last modified on 2019/05/23

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Basic information
Public title Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on patients with developmental disorder
Acronym Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on patients with developmental disorder
Scientific Title Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on patients with developmental disorder
Scientific Title:Acronym Effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation) on patients with developmental disorder
Region
Japan

Condition
Condition patients with developmental disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 effectiveness of cognitive rehabilitation (NEAR : Neuropsychological and Educational Approach to Cognitive Remediation)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Multi dimensional Scale for PDD and ADHD:MSPA, Achenbach System of Empirically Based Assessment Adult Self Report:ASR, Brief Assessment of Cognition in Schizophrenia: BACS, Self Efficacy for Community Life scale: SECL, Life Assessment Scale for Mental Ill: LASMI, and The Global Assessment of Functioning Scale: GAF after cognitive rehabilitation for 6 months
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 cognitive rehabilitation
Interventions/Control_2 twice a week, 6 months
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 it was judged a psychiatrist to patients with developmental disorder
Key exclusion criteria intelligence quotient more than 70 by Wechsler Adult Intelligence Scale- Third Edition,exclude dementia
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Ohno
Organization Kawasaki University of Medical Welfare
Division name Department of Occupational Therapy
Zip code 701-0193
Address 288, Matsushima, Kurashiki-city, Okayama 701-0193, Japan
TEL 086-462-1111
Email h-oono@mw.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Ohno
Organization Kawasaki University of Medical Welfare
Division name Department of Occupational Therapy
Zip code 701-0193
Address 288, Matsushima, Kurashiki-city, Okayama 701-0193, Japan
TEL 086-462-1111
Homepage URL
Email h-oono@mw.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki University of Medical Welfare Department of Occupational Therapy
Institute
Department

Funding Source
Organization Kawasaki University of Medical Welfare
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kawasaki University of Medical Welfare
Address 288, Matsushima, Kurashiki-city, Okayama 701-0193, Japan
Tel 086-462-1111
Email h-oono@mw.kawasaki-m.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 川崎医科大学付属病院(岡山県)

Other administrative information
Date of disclosure of the study information
2019 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2024 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 23 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041958

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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