UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028708 |
|---|---|
| Receipt number | R000032863 |
| Scientific Title | A cross-sectional study of dementia in people with intellectual disability |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2019/08/19 16:02:32 |
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Basic information
Public title
A cross-sectional study of dementia in people with intellectual disability
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
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
YES
Objectives
Narrative objectives1
This study aims to investigate the prevalence of dementia among people with intellectual disability, and to evaluate the frequency of the symptoms associated with dementia.
Basic objectives2
Others
Basic objectives -Others
Evaluating the reliability and the validity of the dementia screening tool for intellectual disability used abroad.
Trial characteristics_1
Trial characteristics_2
Developmental phase
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
Dynamic allocation
Institution consideration
Blocking
Concealment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients using the target welfare facilities in Okayama prefecture managed by collaborative research institutes in November 1, 2017.
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
500
Research contact person
Name of lead principal investigator
| 1st name | Seishi |
| Middle name | |
| Last name | Terada |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Neuropsychiatry
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL
086-235-7246
terada@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Seishi |
| Middle name | |
| Last name | Terada |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Neuropsychiatry
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL
086-235-7246
Homepage URL
terada@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Okayama University
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
Asahigawasou
Asahigawasou Research Institute
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
旭川荘（岡山県）
Other administrative information
Date of disclosure of the study information
| 2017 | 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
493
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
| 2017 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 17 | Day |
Last modified on
| 2019 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032863
