UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055484 |
|---|---|
| Receipt number | R000062739 |
| Scientific Title | What Are the Key Elements of Dementia Preparedness? -A Qualitative Study Toward Developing a Dementia Preparedness Program. |
| Date of disclosure of the study information | 2024/09/11 |
| Last modified on | 2025/07/11 10:14:59 |
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Basic information
Public title
What Are the Key Elements of Dementia Preparedness? -A Qualitative Study Toward Developing a Dementia Preparedness Program."
Acronym
What Are the Key Elements of Dementia Preparedness? -A Qualitative Study.
Scientific Title
What Are the Key Elements of Dementia Preparedness? -A Qualitative Study Toward Developing a Dementia Preparedness Program.
Scientific Title:Acronym
What Are the Key Elements of Dementia Preparedness? -A Qualitative Study."
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify what are the key factors to prepare for dementia
Basic objectives2
Others
Basic objectives -Others
Elements to be included in a dementia preparedness program
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Important Factors to Prepare for 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A. Persons with dementia who applied after seeing the Opportunity Act or the Research Cooperation flyer
1: have a diagnosis of dementia, and those with mild dementia, i.e., those with a Clinical Dementia Rating of Stage 0.5 or Stage 1 before the start of the interview.
2: Family members who can be present during the interview.
3: The subjects and their surrogates (family members) who gave their consent to the study after the study was explained to them.
*The male/female ratio should be adjusted so that it is between 40% and 60%.
B. Family caregivers who have applied for the study after reading the Kikan Method or the flyer for research cooperation
1: Those who are caring for a family member with dementia.
2: Those who agreed to cooperate in the research after the research was explained to them.
*The male/female ratio will be adjusted so that it is between 40% and 60%.
*The ratio of male and female participants shall be adjusted so that the ratio of male and female participants is between 40% and 60%.
C. Professionals who support persons with dementia who have applied for the study after reading the resource guide or the research cooperation flyer.
1: Those with at least 10 years of experience in dementia support
2: Those who have professional qualifications in medical/caregiving/welfare, etc.
3: Those who have given their consent to cooperate in the research after the research has been explained to them.
The ratio of male to female participants should be adjusted so that it is between 40% and 60%.
The ratio of men to women should be adjusted so that the ratio of men to women is between 40% and 60%.
Key exclusion criteria
A. Persons with dementia
1: Persons with significant depressive symptoms, i.e., those who score 10 or more on the Geriatric Depression Scale before the interview begins.
2: Other subjects deemed inappropriate by the principal investigator
B. Family caregivers
1: Subjects with significant depressive symptoms, i.e., those who scored 10 or more on the GDS before the start of the interview.
2: Others whom the principal investigator judges to be inappropriate as subjects.
C. Professionals who support the person with dementia
1: Other subjects who are judged as inappropriate by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Risa |
| Middle name | |
| Last name | OTSUKA |
Organization
Shinshu university
Division name
School of health sciences
Zip code
3908621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2401
2r022otsuka4@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Otsuka |
Organization
Shinshu university
Division name
School of health sciences
Zip code
3908621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263372401
Homepage URL
2r022otsuka4@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu university
Institute
Department
Personal name
Funding Source
Organization
Shinshu university
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
Shinshu university
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263372401
2r022otsuka4@shinshu-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 | 09 | Month | 11 | 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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Qualitative analysis of what people with dementia, family members, and professionals should know before they develop dementia, surveyed through semi-structured interviews.
Management information
Registered date
| 2024 | Year | 09 | Month | 11 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062739
