UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058057 |
|---|---|
| Receipt number | R000066348 |
| Scientific Title | Examining the Minimal Important Change in the Japanese Version of the Occupational Self Assessment and the Occupational Self Assessment-Short Form |
| Date of disclosure of the study information | 2025/06/02 |
| Last modified on | 2025/06/02 20:44:52 |
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Basic information
Public title
Examining the Minimal Important Change in the Japanese Version of the Occupational Self Assessment and the Occupational Self Assessment-Short Form
Acronym
Examining the Minimal Important Change in the Japanese Version of the Occupational Self Assessment and the Occupational Self Assessment-Short Form
Scientific Title
Examining the Minimal Important Change in the Japanese Version of the Occupational Self Assessment and the Occupational Self Assessment-Short Form
Scientific Title:Acronym
Examining the Minimal Important Change in the Japanese Version of the Occupational Self Assessment and the Occupational Self Assessment-Short Form
Region
| Japan |
Condition
Condition
older adults living in the community
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the minimal important change in the Japanese version of the Occupational Self Assessment among community-dwelling older adults in Japan
Basic objectives2
Others
Basic objectives -Others
To examine the minimal important change in the Occupational Self Assessment-Short Form among community-dwelling older adults in Japan
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Occupational Self Assessment in Japanese version
Occupational Self Assessment-Short form
Key secondary outcomes
Dementia Assessment Sheet in Community-based Integrated Care System - 21 items
Transition Index
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
Independent in activities of daily living
DASC-21 score of 30 or less and able to communicate
Consent to the study
First-time administration of OSA and OSA-SF after participation in the community-based activities
Key exclusion criteria
Difficulty in verbal communication
Certification of long-term care level 1 or higher
Lack of permission to participate from the organizer of the community-based activities
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Kikuchi |
Organization
Graduate School of Human Health Sciences, Tokyo Metropolitan University
Division name
Department of Occupational Therapy
Zip code
116-0012
Address
7-2-10 Higashi-Oku, Arakawa-ku, Tokyo
TEL
03-3819-1211
ykikuchi.1993@gmail.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Kikuchi |
Organization
Graduate School of Human Health Sciences, Tokyo Metropolitan University
Division name
Department of Occupational Therapy
Zip code
116-0012
Address
7-2-10 Higashi-Oku, Arakawa-ku, Tokyo
TEL
03-3819-1211
Homepage URL
ykikuchi.1993@gmail.com
Sponsor or person
Institute
Graduate School of Human Health Sciences, Tokyo Metropolitan University
Institute
Department
Personal name
Yusuke Kikuchi
Funding Source
Organization
JSPS KAKEN
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
Arakawa Campus Research Ethics Committee, Tokyo Metropolitan University
Address
7-2-10 Higashi-Oku, Arakawa-ku, Tokyo
Tel
03-3819-1211
a-rinri@jmj.tmu.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 | 06 | Month | 02 | 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
| 2025 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 11 | Month | 30 | Day |
Other
Other related information
Recruitment Process
1) Site managers will be informed of the study using a request letter, and written consent will be obtained with a handwritten signature.
2) Posters will be displayed at the site, and participants will be accepted based on voluntary sign-up.
3) The research team will contact interested individuals, explain the study using the information sheet, consent form, and withdrawal form, and ensure voluntary participation.
4) Consent will be obtained after at least one day, confirmed by handwritten signature.
Research Methods
1. Study Design
This study aims to identify the Minimal Important Change (MIC) in the Japanese versions of the OSA and OSA-SF using an anchor-based method.
2. Anchor Method
The Transition Index will serve as the anchor, asking participants to rate changes in activity difficulty on a 7-point scale.
3. Data Collection
Assessments will be conducted at two time points: baseline and two months later. The research team will not intervene in the site programs. Demographics and DASC-21 will also be collected.
4. Measures
Baseline: OSA, OSA-SF, demographics, DASC-21
Follow-up: OSA, OSA-SF, Transition Index, DASC-21
5. Data Analysis
Participants will be grouped as improved or unchanged based on the Transition Index; deteriorated cases will be excluded. Change scores in OSA and OSA-SF will be predictors in logistic regression. MIC will be estimated using ROC analysis and the Youden index. Group imbalance will be adjusted using a correction formula.
Management information
Registered date
| 2025 | Year | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066348
