UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056649 |
|---|---|
| Receipt number | R000064333 |
| Scientific Title | Petit Volunteer for Loneliness Alleviation in Older Adults (PetitVOLA): A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/01/07 |
| Last modified on | 2026/01/26 09:27:49 |
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Basic information
Public title
Petit Volunteer for Loneliness Alleviation in Older Adults (PetitVOLA)
Acronym
Petit Volunteer for Loneliness Alleviation in Older Adults (PetitVOLA)
Scientific Title
Petit Volunteer for Loneliness Alleviation in Older Adults (PetitVOLA): A Randomized Controlled Trial
Scientific Title:Acronym
Petit Volunteer for Loneliness Alleviation in Older Adults (PetitVOLA): A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the benefits of petit volunteer activity (PetitVOLA) as a sustainable program for preventing loneliness by establishing an Ikigai volunteer system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Loneliness
Key secondary outcomes
Social isolation, life satisfaction, physical function, cognitive function, psychological status, Lifestyle
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Volunteer in nursing care homes for 2-3 hours per day at least once a week for 3 months.
Interventions/Control_2
Control group: lead a normal life for 3 months
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) completed baseline assessments
2) living in the target area
3) aged over 65 years
4) capable of operating a smartphone
5) able to travel to nursing care homes (on foot, by bicycle, private vehicle or public transportation)
6) able to attend the prescribed training and continue to implement the intervention
7) willingness and ability to provide written informed consent
Key exclusion criteria
1) certified long-term care insurance
2) current or history of psychiatric disorders (epilepsy, depression, schizophrenia, bipolar disorder)
3) cognitive decline at baseline (MMSE < 21 points)
4) slow gait speed (<1.0 m/s) at baseline
5) score of less than 28 points on the University of California, Los Angeles Loneliness Scale (UCLA-LS) version3
6) regularly volunteering within the past 6 months
7) currently working more than 5 days a week
8) did not take the required training
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shimada |
Organization
National Center for Geriatrics and Gerontology
Division name
Center for Geriatrics and Social Science
Zip code
474-8511
Address
7-430 Morioka-cho, Obu city, Aichi
TEL
0562-87-1285
shimada@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Shimoda |
Organization
National Center for Geriatrics and Gerontology
Division name
Center for Geriatrics and Social Science
Zip code
474-8511
Address
7-430 Morioka-cho, Obu city, Aichi
TEL
0562-44-5651
Homepage URL
tshimoda@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
National Center for Geriatrics and Gerontology; Research and Medical Division
Address
7-430 Morioka-cho Obu Aichi Japan
Tel
0562-46-2311
yaday@ncgg.go.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 | 01 | Month | 07 | 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
De-identified individual participant data will not be publicly available but may be shared with qualified researchers upon reasonable request. Data will become available after publication of the main results.
IPD sharing Plan description
De-identified individual participant data (including baseline characteristics and outcome measures) will not be publicly available but may be shared with qualified researchers upon reasonable request. Requests should be directed to the principal investigator and will be considered on a case-by-case basis, subject to approval by the National Center for Geriatrics and Gerontology ethics committee and data access policies. Data will become available after publication of the main results.
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 07 | 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
| 2025 | Year | 01 | Month | 07 | Day |
Last modified on
| 2026 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064333
