UMIN-CTR Clinical Trial

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	Ethical Committee for Clinical Research of Hiroshima University
Address	Kasumi 1-2-3 Minami-ku, Hiroshima, Japan
Tel	0822571947
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049505