UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048358 |
|---|---|
| Receipt number | R000055112 |
| Scientific Title | The Database Construction for Solution Development to Changes in Well-being and Daily Life Problems with Cognitive Function Decline. |
| Date of disclosure of the study information | 2022/07/12 |
| Last modified on | 2024/08/11 15:29:40 |
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Basic information
Public title
The Database Construction for Solution Development to Changes in Well-being and Daily Life Problems with Cognitive Function Decline.
Acronym
The Database Construction for Solution Development to Changes in Well-being and Daily Life Problems with Cognitive Function Decline.
Scientific Title
The Database Construction for Solution Development to Changes in Well-being and Daily Life Problems with Cognitive Function Decline.
Scientific Title:Acronym
The Database Construction for Solution Development to Changes in Well-being and Daily Life Problems with Cognitive Function Decline.
Region
| Japan |
Condition
Condition
Patients with Major Neurocognitive Disorder, Mild Neurocognitive Disorder, and Subjective Cognitive Impairment.
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For those who meet the criteria of dementia or mild cognitive impairment or have subjective cognitive impairment, we will explore how quality of life (QOL), wellbeing, and life difficulties change with changes in cognitive function. And to explore the factors that influence them, and to build a database to create medical and non-medical services that make it easier for those with cognitive decline to live.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Cognitive function evaluation, well-being, and scores for life problems.
Key secondary outcomes
Qualitative examination of life problems by interview survey, exploratory verification by machine learning, generation of predictive model.
Creating algorithms that combine digital data with machine learning
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
18 years old or over
2) Able to obtain written informed consent to participate in this study (or able to obtain consent from Legally authorized representative)
3) Patients diagnosed as Major Neurocognitive Disorder, Mild Neurocognitive Disorder with the diagnostic criteria of DSM-5, or Subjective Cognitive Impairment.
4) Those who fall under any of the following (1) to (4).
(1) Patients who visited Keio University Hospital, collaborating institutions (Tokyo Medical and Dental University Hospital, Shonan Keiiku Hospital, Kawasaki City Kawasaki Hospital, Yokohama Municipal Stroke and Neurospine Center) or research collaborating institutions for the main complaint of dementia-related symptoms such as forgetfulness
(2) Elderly people (regardless of whether they have dementia or not) living in the community who learned about the study through lectures, study information sessions organized by the research team, dementia cafes, and recruitment advertisements placed in various places and who wish to participate.
(3) Members of organizations such as SILVER HUMAN RESOURCE CENTER who expressed their willingness to participate in the research
(4) Participating in research on "Steps toward the co-creation of a future in which we live well with dementia: Difficulty, ingenuity, purpose, and joy in the lives of people with dementia"
Key exclusion criteria
1)Difficult answering face-to-face and self-administered evaluation scales
2) Other reasons that investigators judge it is inappropriate to include into the study
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Mimura |
Organization
Keio university
Division name
Center for Preventive Medicine
Zip code
160-8582
Address
35 Shinanomachi Shinjuku Tokyo
TEL
03-5363-3829
mimura@a7.keio.jp
Public contact
Name of contact person
| 1st name | Toshiro |
| Middle name | |
| Last name | Horigome |
Organization
Keio university school of medicine
Division name
Neuropsychiatric department
Zip code
160-8582
Address
35 Shinanomachi Shinjuku Tokyo
TEL
03-5786-0006
Homepage URL
toshirou.ho@keio.jp
Sponsor or person
Institute
Keio university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
COI-NEXT
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Medical and Dental University
Tokyo Institute of Technology
Institute of Physical and Chemical Research
Shonan Keiiku Hospital
Kawasaki Municipal Hospital
Ajinomoto Food Manufacturing Co., Ltd
Yokohama Brain and Spine Center
FrontAct Co., Ltd.
i2medical LLC
Name of secondary funder(s)
Mitsui Sumitomo Insurance Company, Limited
MS&AD InterRisk Research & Consulting,Inc.
Ajinomoto Food Manufacturing Co.,Ltd
Grants-in-Aid for Scientific Research and for Early-Career Scientists
IRB Contact (For public release)
Organization
Research Ethics Committee of Keio University, School of Medicine
Address
35 Shinanomachi Shinjuku Tokyo
Tel
0353633503
med-rinri-jimu@adst.keio.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
慶應義塾大学（東京都）
東京医科歯科大学（東京都）
東京工業大学（東京都）
理化学研究所（埼玉県）
湘南慶育病院（神奈川県）
川崎市立川崎病院(神奈川県)
メモリークリニックお茶の水（東京都）
横浜市立脳卒中・神経脊椎センター(神奈川県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Research design
Observational study
2. Recruitment
Patients(n=700) who fall under 1) to 4) below are interviewed by a psychologist. The content of the interview includes cognitive function, peripheral symptoms, and daily life problems.
Patients who agree their consent are conducted a qualitative survey on the details of daily life, problems in daily life and their ingenuity, and happiness based on recorded interviews.
For selection criteria, see Eligibility.
3. Outcomes
1) Main outcomes
Cognitive function tests
Psychiatric and peripheral symptom assessment
QOL assessment
Activities of daily living assessment
Sleep assessment
Questionnaire about problems related to meals and transportation
2) Sub outcomes
Interviews about problems related to meals and transportation
3)Sub outcomes
Moving and Driving Category
Cognitive function test
Driving Behavior Questionnaire
Head MRI
Evaluation of driving in a real car
Driving safety evaluation
Driving aptitude test
Meals and food categories
photo information about meals
self-administered questionnaire(Meal&Food)
Oral Function Assessment
Sleep and Housing Category
Acquisition of biometric information by wearable devices
Management information
Registered date
| 2022 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055112
