UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059622 |
|---|---|
| Receipt number | R000068051 |
| Scientific Title | Development of a psychological well-being scale to contribute to the development and improvement of dementia prevention programs: A content validity study |
| Date of disclosure of the study information | 2025/11/04 |
| Last modified on | 2025/10/31 14:29:03 |
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Basic information
Public title
Development of a psychological well-being scale to contribute to the development and improvement of dementia prevention programs: A content validity study
Acronym
Development of a psychological well-being scale to contribute to the development and improvement of dementia prevention programs: A content validity study
Scientific Title
Development of a psychological well-being scale to contribute to the development and improvement of dementia prevention programs: A content validity study
Scientific Title:Acronym
Development of a psychological well-being scale to contribute to the development and improvement of dementia prevention programs: A content validity study
Region
| Japan |
Condition
Condition
Older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a psychological well-being scale for dementia prevention programs, select items with good content validity that measure positive aspects.
Basic objectives2
Others
Basic objectives -Others
content validity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Level of agreement on the final items obtained through a Delphi survey
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 60 or older who participate in dementia prevention classes, dementia cafes, or meetings for people with dementia
2. Organizers or staff of dementia cafes or meetings for people with dementia
3. Professionals (doctors, nurses, occupational therapists, etc.) who have been involved in the practice or research of dementia prevention classes, dementia cafes, or meetings for people with dementia for 5 years or more
Key exclusion criteria
None
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | KAMIMURA |
Organization
Shinshu University
Division name
School of health sciences
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano Pref. Japan
TEL
09041088417
tkamimu@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | KAMIMURA |
Organization
Shinshu University
Division name
School of health sciences
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto, Nagano Pref. Japan
TEL
0263-37-2395
Homepage URL
tkamimu@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 JAPAN
Tel
0263-37-2574
mdrinri@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
| 2025 | Year | 11 | Month | 04 | 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
| 2025 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Design] Non-interventional cross-sectional study
[Research Outline]
To create an item pool for the psychological well-being scale under development, we will conduct semi-structured interviews in addition to a literature review. Interview participants will be recruited from older adults interested in dementia and dementia prevention, as well as individuals actively involved in creating community spaces for people with dementia and their families, or in activities that incorporate the voices of those affected. Participation will be limited to those who provide informed consent.
Next, we will extract items with high content validity from the item pool developed based on interviews and other sources. Using the Delphi method, we will consult with physicians, nurses, occupational therapists, and others engaged in dementia prevention practice to determine the evaluation items.
The interviews and Delphi method will be conducted in accordance with the criteria outlined in the COSMIN methodology for assessing the content validity of PROMs, specifically the Instructions for evaluating the content validity of PROMs.
Management information
Registered date
| 2025 | Year | 11 | Month | 02 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068051
