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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043820
Receipt No. 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 2021/04/02

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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
Email 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
Email kkazawa@hiroshima-u.ac.jp

Sponsor
Institute Department of Medicine for Integrated Approach to Social Inclusion, Graduate School of Biomedical and Health Sciences, Hiroshima University
Institute
Department

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 Clinical research center in Hiroshima
Address Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
Tel 0822571752
Email protocol@cimr.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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Enrolling by invitation
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

Other
Other related information

Management information
Registered date
2021 Year 04 Month 02 Day
Last modified on
2021 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049505

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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