UMIN-CTR Clinical Trial

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