UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038262 |
|---|---|
| Receipt number | 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 | 2023/04/13 09:25:29 |
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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
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
ryosun@jidouin.jp
Sponsor or person
Institute
Asahigawa Medical Welfare Center
Institute
Department
Personal name
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
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
1966
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
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 23 | Day |
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
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 10 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043616
