UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036792 |
|---|---|
| Receipt number | R000041832 |
| Scientific Title | Predictive factors associated with the subjective well-being of the caregivers of the people living with dementia in Japan |
| Date of disclosure of the study information | 2019/05/19 |
| Last modified on | 2023/05/29 12:09:20 |
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Basic information
Public title
Predictive factors associated with the subjective well-being of the caregivers of the people living with dementia in Japan
Acronym
Predictive factors associated with the subjective well-being of the caregivers of the people living with dementia in Japan
Scientific Title
Predictive factors associated with the subjective well-being of the caregivers of the people living with dementia in Japan
Scientific Title:Acronym
Predictive factors associated with the subjective well-being of the caregivers of the people living with dementia in Japan
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the level of the subjective well-being and the predictive factors associated with subjective well-being among the caregivers of the people living with dementia in Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction With Life Scale, Flourishing scale, Scale of Positive and Negative Experience, WHO-5
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The professional caregivers of people living with dementia at nursing homes.
Key exclusion criteria
General staffs not involved in the care for the people with dementia.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Ssdo |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-(0)3-5363-3971
mitsusado@keio.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Ninomiya |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-(0)3-5363-3971
Homepage URL
akira-ninomiya@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
KUMON INSTITUTE OF EDUCATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
+81-(0)3-3353-1211
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 19 | 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
2272
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to the time required for data cleaning
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Self-administered questionnaires were collected at the beginning of the study, 6 and 12 months later, respectively.
Data cleaning is currently underway.
Management information
Registered date
| 2019 | Year | 05 | Month | 19 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041832
