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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038262
Receipt No. R000043616
Scientific Title A cross-sectional study of dementia in people with intellectual disability in Japan
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/10

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Basic information
Public title A cross-sectional study of dementia in people with intellectual disability in Japan
Acronym A cross-sectional study of dementia in people with intellectual disability
Scientific Title A cross-sectional study of dementia in people with intellectual disability in Japan
Scientific Title:Acronym A cross-sectional study of dementia in people with intellectual disability
Region
Japan

Condition
Condition intellectual disability
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to investigate the prevalence of dementia among people with intellectual disability. And, the caregivers of the subjects answer a questionnaire to evaluate the symptoms associated with dementia.
Basic objectives2 Others
Basic objectives -Others Evaluating the usefulness of the dementia screening tool for people with intellectual disability.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Prevalence of dementia by age
Key secondary outcomes 1. Demography (age, sex, diagnosis)
2. Diagnosis of dementia
3. Type of dementia
4. Dementia symptoms (Memory, Executive Function, Behavioral and Psychological Symptoms of Dementia, Activity of Daily Living, Adaptability)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Doctors perform a medical examination and diagnose the presence or absence of dementia.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients using the supporting facilities for people with intellectual disabilities that collaborate this research in November 1, 2019.
2.Patients with intellectual disability
3.Legal representatives of patients fully understand this study and give written informed consent for the participation in this study. (If the patient has ability to understand this study and to give written informed consent to participate in this study, both the patient and his/her legal representative give written informed consent. )
Key exclusion criteria Patients who are not appropriate for participation in this study because of their health condition as judged by the doctor.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Ryozo
Middle name
Last name Kuwano
Organization Asahigawa Medical Welfare Center
Division name Asahigawaso Research Institute
Zip code 703-8555
Address 866, Gion, Kita-ku, Okayama, 703-8555, Japan.
TEL 086-207-2035
Email ryosun@jidouin.jp

Public contact
Name of contact person
1st name Ryozo
Middle name
Last name Kuwano
Organization Asahigawa Medical Welfare Center
Division name Asahigawaso Research Institute
Zip code 703-8555
Address 866, Gion, Kita-ku, Okayama, 703-8555, Japan.
TEL 086-207-2035
Homepage URL
Email ryosun@jidouin.jp

Sponsor
Institute Asahigawa Medical Welfare Center
Institute
Department

Funding Source
Organization 1. The Nippon Foundation
2. Asahigawasou
3. Okayama University
5. Japan Society for the Promotion of Science/MEXT(Japan)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
Tel 086-235-6503
Email mae6605@adm.okayama-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 R1002
Org. issuing International ID_1 Asahigawa Medical Welfare Center, Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 侑愛荘(北海道),ワークショップまるやま荘(北海道),新生園(北海道),明生園(北海道),更生園(千葉県),あすなろの郷(茨城県),国立のぞみの園(群馬県),ひのき荘(群馬県),かつら荘(群馬県),あすなろ荘(群馬県),さわら荘(群馬県),みのわ育成園(群馬県),こがね荘(群馬県),赤穂精華園(兵庫県),丹南精明園(兵庫県),三木精愛園(兵庫県),あゆみ苑成人寮(広島県),吉野川育成園(徳島県),青葉園(佐賀県),若木園(佐賀県)

Other administrative information
Date of disclosure of the study information
2019 Year 11 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 10 Month 23 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2020 Year 11 Month 01 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 10 Month 10 Day
Last modified on
2019 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043616

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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