UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052268 |
|---|---|
| Receipt number | R000048455 |
| Scientific Title | Exploratory study on understanding the health and living conditions of single Elderly People in the COVID-19 pandemic |
| Date of disclosure of the study information | 2023/09/21 |
| Last modified on | 2023/09/21 13:30:33 |
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Basic information
Public title
Exploratory study on understanding the health and living conditions of single Elderly People in the COVID-19 pandemic
Acronym
Exploratory study on understanding the health and living conditions of single Elderly People in the COVID-19 pandemic
Scientific Title
Exploratory study on understanding the health and living conditions of single Elderly People in the COVID-19 pandemic
Scientific Title:Acronym
Exploratory study on understanding the health and living conditions of single Elderly People in the COVID-19 pandemic
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effectiveness of the intervention and to test the psychological and physical effectiveness of the intervention by randomly assigning the elderly living alone with mild dementia to two groups: with and without intervention by a robot to support the elderly living alone with mild dementia.
Basic objectives2
Others
Basic objectives -Others
To test the of changes in well-being in elderly people living alone with mild dementia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
well-being
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Live with the robot for 2 months
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elderly with mild dementia living alone
Key exclusion criteria
Elderly people living alone with dementia who were stopped from being included in this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuyo |
| Middle name | |
| Last name | Nomura |
Organization
Osaka Metropolitan University
Division name
Urban Rejilience Research Center
Zip code
558-8585
Address
3-3-138 Sugimoto, Sumiyoshi-ku, Osaka
TEL
06-6605-2913
nomura@omu.ac.jp
Public contact
Name of contact person
| 1st name | Yasuyo |
| Middle name | |
| Last name | Nomura |
Organization
Osaka Metropolitan University
Division name
Urban Rejilience Research Center
Zip code
558-8585
Address
3-3-138 Sugimoto, Sumiyoshi-ku, Osaka
TEL
0666052913
Homepage URL
nomura@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University
Address
3-3-138 Sugimoto, Sumiyoshi-ku, Osaka
Tel
0666052913
nomura@omu.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
| 2023 | Year | 09 | Month | 21 | 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
50
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
| 2020 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 21 | Day |
Last modified on
| 2023 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048455
