UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055887 |
|---|---|
| Receipt number | R000063763 |
| Scientific Title | The Relationship Between Family Caregivers' Help-Seeking for Behavioral and Psychological Symptoms of Dementia in Elderly Patients, Dementia Stigma, and Caregiving Burden |
| Date of disclosure of the study information | 2024/10/21 |
| Last modified on | 2025/10/22 17:55:13 |
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Basic information
Public title
The Relationship Between Family Caregivers' Help-Seeking for Behavioral and Psychological Symptoms of Dementia in Elderly Patients, Dementia Stigma, and Caregiving Burden
Acronym
The Relationship Between Help-Seeking, Stigma, and Caregiver Burden in Dementia Caregivers
Scientific Title
The Relationship Between Family Caregivers' Help-Seeking for Behavioral and Psychological Symptoms of Dementia in Elderly Patients, Dementia Stigma, and Caregiving Burden
Scientific Title:Acronym
The Relationship Between Help-Seeking, Stigma, and Caregiver Burden in Dementia Caregivers
Region
| Japan |
Condition
Condition
Dementia and family caregiver
Classification by specialty
| Neurology | Psychosomatic Internal Medicine | Geriatrics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the relationship between help-seeking, dementia stigma, and caregiver burden among family caregivers for BPSD in elderly people with dementia.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to clarify the relationship between help-seeking, dementia stigma, and caregiver burden among family caregivers for BPSD in elderly people with dementia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Behavioral and psychological symptoms of dementia
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals aged 65 years or older with a diagnosis of dementia and their primary caregivers.
Key exclusion criteria
Those who did not agree to participate in the study. Primary caregivers who have difficulty answering questionnaires (information on elderly people with dementia will also be collected from primary caregivers using observational scales, etc.).
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Kyosuke |
| Middle name | |
| Last name | Yorozuya |
Organization
Seijoh university
Division name
Faculty of Rehabilitation and Care
Zip code
476-8588
Address
2-172 Fukinodai, Tokai, Aichi
TEL
0526016000
yorozuya.kyosuke@gmail.com
Public contact
Name of contact person
| 1st name | Kyosuke |
| Middle name | |
| Last name | Yorozuya |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
476-8588
Address
2-172 Fukinodai, Tokai, Aichi
TEL
0526016000
Homepage URL
yorozuya.kyosuke@gmail.com
Sponsor or person
Institute
Seijoh university
Institute
Department
Personal name
Funding Source
Organization
The Taiyo Life Welfare Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of Seijoh University
Address
2-172 Fukinodai, Tokai, Aichi
Tel
0526016000
tsutsui@seijoh-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
| 2024 | Year | 10 | Month | 21 | 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
43
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will examine cross-sectionally and longitudinally the relationship between BPSD in older people with dementia and psychosocial factors such as help-seeking, dementia stigma, and caregiver burden by their families.
Management information
Registered date
| 2024 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063763
