UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037719 |
|---|---|
| Receipt number | 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 02:30:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yamaya.soccer22@gmail.com
Sponsor or person
Institute
Kochi Medical School University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
