UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040193 |
|---|---|
| Receipt number | R000045831 |
| Scientific Title | Evaluating the social function of people with dementia under the COVID-19 epidemic by the Japanese version of the social functioning in dementia scale |
| Date of disclosure of the study information | 2020/04/18 |
| Last modified on | 2024/04/21 13:47:19 |
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Basic information
Public title
Evaluating the social function of people with dementia under the COVID-19 epidemic
by the Japanese version of the social functioning in dementia scale
Acronym
Evaluating the social function of people with dementia under the COVID-19 epidemic
Scientific Title
Evaluating the social function of people with dementia under the COVID-19 epidemic
by the Japanese version of the social functioning in dementia scale
Scientific Title:Acronym
Evaluating the social function of people with dementia under the COVID-19 epidemic
Region
| Japan |
Condition
Condition
People with mild cognitive impairment or people with mild dementia
Classification by specialty
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We carry out SF-DEM for people with dementia and family caregivers by SF-DEM-J under the COVID-19 epidemic, and evaluate the decline in their social function.
Basic objectives2
Others
Basic objectives -Others
In addition, one year after the recruitment, and if the epidemic has not converged at that time, it will be evaluated again at the time of convergence, and the social functions at the time of social crisis and in normal times will be compared.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Reliability and validity of SF-DEM-J
Key secondary outcomes
We validate the correlation between Section 1-3 total of SF-DEM and MMSE, GDS, and each section of SF-DEM with conventional neuropsychological tests, and correlation with Clinical Dementia Rating score (CDR) of community activitiy. Regression analysis is performed on how the items of Neuropsychiatric Inventory (NPI) and Instrumental Activities of Daily Living Scale (IADL) are related.
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
People with mild cognitive impairment or people with mild dementia.
There are family caregivers who are contacted at least once a week, are over 20 years old, and are not accompanied by dementia or mental illness.
Key exclusion criteria
People with mild cognitive impairment or people with mild dementia or family caregiver cannot answer the first three questions in SF-DEM
If people with mild cognitive impairment or people with mild dementia has a severe mental illness
If people with mild cognitive impairment or people with mild dementia is suffering from a severe medical disorder or if cognitive decline due to drugs is suspected
If the family caregiver has dementia or a severe mental illness
When the attending physician determines that the family caregiver is inappropriate
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyama |
| Middle name | |
| Last name | Kenji |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
565-0871
Address
D3, 2-2, Yamadaoka, Suita-city, Osaka
TEL
0668793051
yosiyama@psy.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyama |
| Middle name | |
| Last name | Kenji |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
565-0871
Address
D3, 2-2, Yamadaoka, Suita-city, Osaka Japan
TEL
0668793051
Homepage URL
yosiyama@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Psychiatry, Osaka University Graduate School of Medicine
Address
D3, 2-2, Yamadaoka, Suita-city, Osaka Japan
Tel
0668793051
yosiyama@psy.med.osaka-u.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
第二大阪警察病院精神科神経科、大阪大学医学部附属病院精神科神経科、日本生命病院精神科神経科
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000040193
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38462968/
Number of participants that the trial has enrolled
103
Results
The scale's interrater reliability was excellent and test-retest reliability was substantial. Content validity was confirmed for the caregiver-rated SF-DEM-J, and convergent validity was moderate. Caregiver-rated SF-DEM-J was associated with apathy, irritability, loneliness, and cognitive impairment. The total score of caregiver-rated SF-DEM-J and the score of Section 2, "communication with others," significantly improved at 6-8 months of follow-up.
Results date posted
| 2024 | Year | 04 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We interviewed people with mild cognitive impairment (MCI) and mild dementia and their caregivers during June 2020-March 2021 to validate patient- and caregiver-rated SF-DEM-J and compared their scores at baseline (April 2020 to May 2020) and at 6-8 months (January 2021 to March 2021) during a time of tighter COVID-19 restrictions.
Participant flow
We interviewed people with mild cognitive impairment (MCI) and mild dementia and their caregivers during June 2020-March 2021 to validate patient- and caregiver-rated SF-DEM-J and compared their scores at baseline (April 2020 to May 2020) and at 6-8 months (January 2021 to March 2021) during a time of tighter COVID-19 restrictions.
Adverse events
None
Outcome measures
The SF-DEM-J is acceptable as a measure of social function in MCI and mild dementia. Our results show that the social functioning of people with dementia, especially communicating with others, improved during the COVID-19 pandemic, probably as a result of adaptation to the restrictive life.
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
We evaluate the validity and reliability of SF-DEM by SF-DEM-J under the COVID-19 epidemic.
We also verify the agreement between SF-DEM people with MCI or mild dementia and SF-DEM family caregivers.
Since it is presumed that social activities and hobby activities will be impaired under the COVID-19 epidemic, SF-DEM-J under the COVID-19 epidemic will be conducted for patients and family caregivers, and SF- By verifying the reliability and validity of DEM-J, and by seeing the correlation between SF-DEM-J items and the conventional neuropsychological tests, we examine which of the core symptoms of illness and BPSD cause social decline towards people with mild cognitive impairment and mild dementia.
Management information
Registered date
| 2020 | Year | 04 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045831
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