UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061195 |
|---|---|
| Receipt number | R000070027 |
| Scientific Title | Development of a Simplified Goal-Setting Diary for Long-Term Care Prevention Services |
| Date of disclosure of the study information | 2026/04/13 |
| Last modified on | 2026/04/08 10:41:25 |
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Basic information
Public title
Development of a Simplified Goal-Setting Diary for Long-Term Care Prevention Services
Acronym
Development of a Simplified Goal-Setting Diary for Long-Term Care Prevention Services
Scientific Title
Development of a Simplified Goal-Setting Diary for Long-Term Care Prevention Services
Scientific Title:Acronym
Development of a Simplified Goal-Setting Diary for Long-Term Care Prevention Services
Region
| Japan |
Condition
Condition
community-dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the reliability and validity of the scores for the "Effort" and "Satisfaction" items in the simplified goal-setting diary.
Basic objectives2
Others
Basic objectives -Others
Examination of the reliability and validity of a goal-setting diary as an assessment tool in long-term care prevention.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Scores for "Effort" and "Satisfaction" from the simplified goal-setting diary will be collected over a two-week period. To evaluate the test-retest reliability, these scores will be re-collected one week after the completion of the diary entries.
Key secondary outcomes
To evaluate criterion-related validity, the Canadian Occupational Performance Measure (COPM) scores will be collected at baseline and after two weeks.
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
-Individuals capable of attending an "Elderly Salon" (community-based social space) at least once a week.
-Individuals with a rank of I or II on the "Degree of Independence in Daily Living for the Elderly with Dementia."
-Individuals capable of completing the daily diary entries independently.
Key exclusion criteria
Individuals with an acute disease currently receiving treatment (e.g., bone fractures, infectious diseases, etc.).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Katsuma |
| Middle name | |
| Last name | Ikeuchi |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and Welfare
Zip code
723-0053
Address
1-1 Gakuen-cho, Mihara-city, Hiroshima
TEL
0848-60-1175
ikeuchi@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Katsuma |
| Middle name | |
| Last name | Ikeuchi |
Organization
Prefectural University of Hiroshima
Division name
Faculty of Health and Welfare
Zip code
723-0053
Address
1-1 Gakuen-cho, Mihara-city, Hiroshima
TEL
0848-60-1175
Homepage URL
ikeuchi@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Katsuma Ikeuchi
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Prefectural University of Hiroshima
IRB Contact (For public release)
Organization
Prefectural University of Hiroshima
Address
1-1 Gakuen-cho, Mihara-city, Hiroshima
Tel
0848-60-1175
ikeuchi@pu-hiroshima.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
| 2026 | Year | 04 | 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
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants will maintain their usual daily activities while completing the simplified goal-setting diary daily for two weeks. Researchers will collect the scores for the "Effort" and "Satisfaction" items from the diaries to analyze their reliability and validity.
Management information
Registered date
| 2026 | Year | 04 | Month | 08 | Day |
Last modified on
| 2026 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070027
