UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055565 |
|---|---|
| Receipt number | R000063305 |
| Scientific Title | The Effect of an Occupational Therapy Program on Health Related Quality of Life for Elderly Residents in the Community Multiple pre and post comparative studies |
| Date of disclosure of the study information | 2024/09/21 |
| Last modified on | 2025/09/21 09:11:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Effect of an Occupational Therapy Program on Health-Related Quality of Life for Elderly Residents in the Community
Acronym
The Effect of an Occupational Therapy Program on Health-Related Quality of Life for Elderly Residents in the Community
Scientific Title
The Effect of an Occupational Therapy Program on Health Related Quality of Life for Elderly Residents in the Community
Multiple pre and post comparative studies
Scientific Title:Acronym
The Effect of an Occupational Therapy Program on Health Related Quality of Life for Elderly Residents in the Community
Multiple pre and post comparative studies
Region
| Japan |
Condition
Condition
Disuse syndrome
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effect of an occupational therapy program on HRQOL of elderly people living in the community.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
MOS 36-Item Short-Form Health Survey (SF-36) Japanese version (3 and 6 months after intervention)
Key secondary outcomes
Self completed Occupational Performance Index,Frenchay Activities Index,3 and 6 months after intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Subjects in the experimental group will be administered the program three times for three months.
(1) In the recognition of factors that support current health, the occupational therapist provides individual feedback on each person's condition and listens to specific tasks using the Activities of Daily Living Listening Sheet regarding the current. (2) In the group occupation for continued occupation participation, participants will be divided into small groups to discuss what is necessary to continue the occupation. Specific methods and activities will be discussed. (3) In the presentation of efforts, each individual presents the occupation, its value, and necessary efforts. The occupational therapists will explain what they admire in each other's occupation and what can be reflected in future activities.
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
Those who usually participate in community-based activities Those who are not certified as requiring support or nursing care and who give their consent to cooperate in the research
Key exclusion criteria
Those with a diagnosis that affects cognitive function, such as dementia or mental illness.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Aoyagi |
Organization
Shizuoka college of medical care science
Division name
Department of Occupational Therapy
Zip code
4340041
Address
2000 Hiraguchi, Hamamatsu City, Hamamatsu, Shizuoka, Japan
TEL
0535851551
aoyagi.ot511201@gmail.com
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Aoyagi |
Organization
Shizuoka college of medical care science
Division name
Department of Occupational Therapy
Zip code
4340041
Address
2000 Hiraguchi, Hamamatsu City, Hamamatsu, Shizuoka, Japan
TEL
0535851551
Homepage URL
aoyagi.ot511201@gmail.com
Sponsor or person
Institute
Shizuoka college of medical care science
Institute
Department
Personal name
Aoyagi Shota
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of St.Seirei Christopher University
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu City, Shizuoka Prefecture
Tel
053-439-1400
rinri@seirei.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
| 2024 | Year | 09 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 08 | 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
| 2024 | Year | 09 | Month | 20 | Day |
Last modified on
| 2025 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063305
