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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name