UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038189 |
|---|---|
| Receipt number | R000043521 |
| Scientific Title | Study to make a community for people with dementia and other challenges to live with dignity |
| Date of disclosure of the study information | 2019/10/03 |
| Last modified on | 2022/10/10 17:36:52 |
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Basic information
Public title
Takashimadaira Study: To realize living with dignity for people with dementia
Acronym
Takashimadaira Study: Dementia
Scientific Title
Study to make a community for people with dementia and other challenges to live with dignity
Scientific Title:Acronym
People with dementia Living with dignity
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Real world experience of community dwelling people with dementia
Basic objectives2
Others
Basic objectives -Others
Clinical dementia rating
Cognitive ability
Social needs
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL
Key secondary outcomes
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
MMSE<24
Key exclusion criteria
refusal to be included
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Okamura |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Promoting Independence of the Elderly
Zip code
173-0015
Address
Itabashi-ku, Sakae-cho, 35-2
TEL
03-3964-3241
t.okamura.jp@gmail.com
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Okamura |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Promoting Independence of the Elderly
Zip code
173-0015
Address
Itabashi-ku, Sakae-cho, 35-2
TEL
03-3964-3241
Homepage URL
t.okamura.jp@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of TMIG
Address
Itabashi-ku, Sakae-cho, 35-2
Tel
03-3964-3241
naomi_hasegawa@tmghig.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 03 | 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
89
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Now analyzing.
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
Main results already published
Date of protocol fixation
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
A visiting survey to conduct a in-depth interview
Management information
Registered date
| 2019 | Year | 10 | Month | 02 | Day |
Last modified on
| 2022 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043521
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/08/31 | 5yearsoutcome.sav |
