UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043820 |
|---|---|
| Receipt number | R000049505 |
| Scientific Title | The effectiveness of support to prevent COVID-19 infection and decline in cognitive and physical function for care givers of elderly people with dementia |
| Date of disclosure of the study information | 2021/04/02 |
| Last modified on | 2022/08/22 10:12:02 |
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Basic information
Public title
The effectiveness of support to prevent COVID-19 infection and decline in cognitive and physical function for care givers of elderly people with dementia
Acronym
Efficacy of COVID-19 infection prevention support for caregivers of elderly people with dementia
Scientific Title
The effectiveness of support to prevent COVID-19 infection and decline in cognitive and physical function for care givers of elderly people with dementia
Scientific Title:Acronym
Efficacy of COVID-19 infection prevention support for caregivers of elderly people with dementia
Region
| Japan |
Condition
Condition
Healthy people (family members of an elderly people with dementia)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to educate family members of people with dementia about prevention of infection according to the symptoms and ADL of the person with dementia, cognitive and physical deterioration, and to provide information about preparedness in COVID-19 by care managers. Also, we evaluate the effectiveness of the intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Care burden: Zarit Caregiver Burden Interview (1 month, 2 months and 3 months after registration)
Key secondary outcomes
1. Depression: Patient Health Questionnaire-9 (1 month, 2 months and 3 months after registration)
2. Fear of COVID-19 infection: The Fear of COVID-19 Scale (1 month, 2 months and 3 months after registration)
3. Qualitative evaluation of interventions and educational materials (1 month, 2 months and 3 months after registration)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Educational intervention using an educational material
Interventions/Control_2
Observation
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
A family member living with an elderly people with dementia
Key exclusion criteria
1. The person living apart from an elderly people with dementia
2. The person has been diagnosed with dementia
3. The person for whom educational intervention was judged to be difficult in discussions between the researcher and the care manager
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Ishii |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Medicine for Integrated Approach to Social Inclusion
Zip code
734-8553
Address
Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
TEL
0822572018
sishii76@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Kazawa |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Medicine for Integrated Approach to Social Inclusion
Zip code
734-8553
Address
Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
TEL
0822572018
Homepage URL
kkazawa@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Medicine for Integrated Approach to Social Inclusion, Graduate School of Biomedical and Health Sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Japanese Council of Senior Citizens Welfare Service
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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
Tel
0822571947
iryo-seisaku@office.hiroshima-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
53
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
| 2021 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 08 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 02 | Day |
Last modified on
| 2022 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049505
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
