UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062865 |
|---|---|
| Receipt number | R000071952 |
| Scientific Title | A Feasibility Study of an Online Health Promotion Occupational Therapy Program for Community-Dwelling Older Adults |
| Date of disclosure of the study information | 2026/09/12 |
| Last modified on | 2026/09/10 05:52:16 |
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Basic information
Public title
A Feasibility Study of an Online Health Promotion Occupational Therapy Program for Community-Dwelling Older Adults
Acronym
Online Health Promotion OT Program
Scientific Title
A Feasibility Study of an Online Health Promotion Occupational Therapy Program for Community-Dwelling Older Adults
Scientific Title:Acronym
Online Health Promotion OT Program
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the feasibility of delivering a Model of Human Occupation (MOHO)-based program in an online format to community-dwelling older adults.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Completion rate: The proportion of participants who participate through the 15th and final session of the program. Assessed at the end of the program.
Key secondary outcomes
Recruitment rate, participation rate, reasons for absence, participant satisfaction, health-related quality of life (SF-36), and occupational balance (OBQ-J) will be assessed. Recruitment and participation rates will be calculated at the end of the recruitment period, and reasons for absence will be recorded throughout the program. The SF-36 and OBQ-J will be assessed before and after the intervention, and participant satisfaction will be assessed at the end of the program.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
An online Model of Human Occupation (MOHO) program will be delivered to community-dwelling older adults in groups of approximately eight participants using the voice call and group functions of the LINE application. The program will be conducted according to a standardized manual and will consist of 15 weekly 60-minute sessions. Each session will combine lectures and exercises addressing components of MOHO, including interests, habits, roles, and environment. The exercises will provide participants with opportunities to reflect on their daily lives and share relevant experiences with other participants. During the final three sessions, participants will identify specific activities or roles they would like to incorporate into their daily lives, try them in their actual daily lives, and share their experiences and reflections.
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
1.Community-dwelling older adults aged 65 years or older
2.Individuals who are independent in activities of daily living
3.participating in a health promotion program provided by the local municipality
4.Individuals who meet at least one of the five criteria for social frailty: decreased frequency of going out, not visiting friends, not feeling helpful to friends or family, living alone, or not talking with someone every day
5.Individuals who are able to use the LINE application
Key exclusion criteria
1.Individuals who have difficulty participating in the online program due to problems with the internet environment, visual or hearing function, or other related factors.
2.Individuals who are judged by the researcher to be unable to participate safely in the program.
3.Individuals who have no prior experience using the LINE application.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Minami |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences
Zip code
1168551
Address
7-2-10Higashioku, Arakawa-ku, Tokyo, Japan
TEL
0338191211
minami-yuji@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Minami |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Human Health Sciences
Zip code
1168551
Address
7-2-10Higashioku, Arakawa-ku, Tokyo, Japan
TEL
0338191211
Homepage URL
minami-yuji@ed.tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Yuji Minami
Funding Source
Organization
None
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
Research Ethics Committee, Arakawa Campus, Tokyo Metropolitan University
Address
7-2-10Higashioku, Arakawa-ku, Tokyo, Japan
Tel
0338191211
minami-yuji@ed.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
東京都立大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 12 | 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
| 2006 | Year | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | 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
Management information
Registered date
| 2026 | Year | 09 | Month | 10 | Day |
Last modified on
| 2026 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071952
