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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037719
Receipt No. R000043023
Scientific Title Survey of caregivers of people with dementia: About caregivers' flail and care stress status
Date of disclosure of the study information 2019/12/01
Last modified on 2019/08/19

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Basic information
Public title Survey of caregivers of people with dementia: About caregivers' flail and care stress status
Acronym Survey of caregivers of people with dementia: About caregivers' flail and care stress status
Scientific Title Survey of caregivers of people with dementia: About caregivers' flail and care stress status
Scientific Title:Acronym Survey of caregivers of people with dementia: About caregivers' flail and care stress status
Region
Japan

Condition
Condition Caregiver of Dementia
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Due to the aging of dementia caregivers, it is expected that physical fitness decline will be a serious problem. Elderly people who are experiencing mental and physical deterioration due to aging may have further increased mental stress and decreased activity. This time, focusing on the flail of dementia caregivers, we will clarify the relationship with care stress.
Basic objectives2 Others
Basic objectives -Others Nursing care survey
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes caregiver frailty (J-CHS, basic checklist)
Key secondary outcomes Caregiver depression, social isolation, duration of care
Dementia severity in patients with dementia

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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects were primary caregivers of persons with dementia age 65 and older. Dementia caregivers are those who do not need financial assistance. In the case of dementia patients, caregivers were used.
Key exclusion criteria We excluded patients with dementia and primary caregivers who have motor dysfunction in depression, schizophrenia, or stroke, and those who have more than 5 medications for dementia caregivers.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Yamamoto
Organization Kochi Medical School University
Division name Department of Rehbilitation center
Zip code 783-8505
Address Oko-choKohasu,Nankoku,Kochi,Japan
TEL 088-880-2490
Email yamaya.soccer22@gmail.com

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Yamamoto
Organization Kochi Medical School University
Division name Department of Rehbilitation center
Zip code 783-8505
Address Oko-choKohasu,Nankoku,Kochi,Japan
TEL 088-880-2490
Homepage URL
Email yamaya.soccer22@gmail.com

Sponsor
Institute Kochi Medical School University
Institute
Department

Funding Source
Organization Nothing
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 Kochi Medical School University
Address Oko-choKohasu,Nankoku,Kochi,Japan
Tel 088-880-2490
Email yamaya.soccer22@gmail.com

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
2019 Year 12 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation test

Management information
Registered date
2019 Year 08 Month 19 Day
Last modified on
2019 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043023

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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