UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049749 |
|---|---|
| Receipt number | R000056665 |
| Scientific Title | A Study on Caregiving Behaviors of Home Caregivers of Elderly People with Dementia and Elderly People in Need of Care |
| Date of disclosure of the study information | 2022/12/13 |
| Last modified on | 2024/03/11 17:20:25 |
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Basic information
Public title
A Study on Caregiving Behaviors of Home Caregivers of Elderly People with Dementia and Elderly People in Need of Care
Acronym
A Study on Caregiving Behaviors of Home Caregivers of Elderly People with Dementia and Elderly People in Need of Care
Scientific Title
A Study on Caregiving Behaviors of Home Caregivers of Elderly People with Dementia and Elderly People in Need of Care
Scientific Title:Acronym
A Study on Caregiving Behaviors of Home Caregivers of Elderly People with Dementia and Elderly People in Need of Care
Region
| Japan |
Condition
Condition
Home Caregivers
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between subjective caregiving perceptions and caregiving behaviors of home caregivers of elderly people with dementia and elderly people who need care, and objective data on caregivers' physical activity
Basic objectives2
Others
Basic objectives -Others
Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pulse rate
Caregiver burden
Positive appraisal
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Those caring for elderly people with dementia (SMQ; Short-Memory Questionnaire 16) or elderly people who need nursing care (certified as needing nursing care)
2)Aged 18 years or older
3)Caring for an elderly person with dementia or in need of care at home for at least 5 hours a week as a primary caregiver
4)Fully understand the content of the research and consent can be obtained in writing
Key exclusion criteria
1) When the attending physician or facility administrator clinically determines that the elderly person with dementia or the elderly person in need of nursing care who is being cared for has a serious life-threatening disease or is in the terminal stage (a period when the disease is not likely to be cured and death is expected within a few weeks to six months)
2) When it is determined by the attending physician and facility administrator that the elderly person being cared for has a serious illness that would be life-threatening to the caregiver
3) Other cases in which the person in charge of the joint research facility judges that it is difficult to carry out this research (for example, sudden deterioration of the condition of the elderly person with dementia or the elderly person requiring care, admission of the elderly person with dementia or the elderly person requiring care to an institution, deterioration of the health condition of the caregiver, etc.)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Kajiwara |
Organization
Japanese Red Cross Kyushu International College of Nursing
Division name
Faculty of Nursing
Zip code
811-4157
Address
1-1 Asty Munakata, Fukuoka
TEL
0940-35-7001
k-kajiwara@jrckicn.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Kajiwara |
Organization
Japanese Red Cross Kyushu International College of Nursing
Division name
Faculty of Nursing
Zip code
811-4157
Address
1-1 Asty Munakata, Fukuoka
TEL
0940-35-7001
Homepage URL
k-kajiwara@jrckicn.ac.jp
Sponsor or person
Institute
Japanese Red Cross Kyushu International College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee for Epidemiological Studies at Japanese Red Cross Kyushu International College of Nursing
Address
1-1 Asty Munakata, Fukuoka
Tel
0940-35-7001
keiri@jrckicn.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
| 2022 | Year | 12 | Month | 13 | 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
| 2022 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research design: cross-sectional study
A self-administered questionnaire will be used to investigate the burden of caregiving and positive perceptions. In addition, physical activity will be measured using equipment.
Management information
Registered date
| 2022 | Year | 12 | Month | 12 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056665
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
