UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059603 |
|---|---|
| Receipt number | R000068168 |
| Scientific Title | Examining the Impact of Personal Relevance to Health on the Effectiveness of Motor-Function Feedback: A Randomized Controlled Trial Among Community-Dwelling Adults |
| Date of disclosure of the study information | 2025/11/04 |
| Last modified on | 2025/10/31 14:34:35 |
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Basic information
Public title
How the Way of Communicating Motor Function Results Affects How People Perceive Health: A Study for Community Residents
Acronym
Motor Function Feedback Study
Scientific Title
Examining the Impact of Personal Relevance to Health on the Effectiveness of Motor-Function Feedback: A Randomized Controlled Trial Among Community-Dwelling Adults
Scientific Title:Acronym
PR, Feedback RCT
Region
| Japan |
Condition
Condition
No specific disease
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To empirically examine, among community-dwelling adults, whether the impact of differences in feedback content for motor function assessment-specifically, the presence versus absence of clinical implications on acceptance of the evaluation results and on personal relevance (PR) differs by PR level (high vs. low).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perceived importance of the feedback results immediately after the motor function self-assessment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Presenting the results of a motor function self-assessment with clinical implications regarding future care needs.
Interventions/Control_2
Presenting the results of a motor function self-assessment without clinical implications regarding future care needs.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Community-dwelling adults aged 60 years and older who are enrolled in the National Health Insurance or the Latter-Stage Elderly Health Insurance system, and are able to respond to web-based questionnaires using a smartphone or personal computer.
Key exclusion criteria
Individuals certified as Care Level 3-5 under Japan's Long-Term Care Insurance (LTCI) system.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Ozaka |
Organization
Fukushima Medical University
Division name
Shirakawa Center for General Medicine
Zip code
961-0005
Address
2-1 Kamiyajiro, Toyochi, Shirakawa-shi, Fukushima, Japan
TEL
0248-22-2211
z7ded76922644@gmail.com
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Nishioka |
Organization
Kansai University
Division name
Graduate School of Psychology
Zip code
564-8680
Address
3-3-35 Yamate-cho, Suita-shi, Osaka, Japan
TEL
06-6368-1121
Homepage URL
k579694@kansai-u.ac.jp
Sponsor or person
Institute
Shirakawa Kosei General Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
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
Shirakawa Kosei General Hospital
Address
2-1 Kamiyajiro, Toyochi, Shirakawa-shi, Fukushima 961-0005, Japan
Tel
0248-22-2211
yamada-s@shirakawa-kosei.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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 31 | 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=R000068168
