UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060474 |
|---|---|
| Receipt number | R000069188 |
| Scientific Title | Randomized controlled trial on the effectiveness of a messenger app-based(LINE) intervention program for promoting psychosocial well-being among community-dwelling older adults |
| Date of disclosure of the study information | 2026/01/27 |
| Last modified on | 2026/01/27 03:15:49 |
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Basic information
Public title
Effectiveness of a LINE-based intervention program for promoting psychosocial well-being among community-dwelling older adults
Acronym
LINE-based Health Program
Scientific Title
Randomized controlled trial on the effectiveness of a messenger app-based(LINE) intervention program for promoting psychosocial well-being among community-dwelling older adults
Scientific Title:Acronym
LINE-PSW Trial
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to develop a messenger app based intervention program to promote psychosocial well being among community dwelling older adults and to evaluate its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Life satisfaction will be assessed at three time points: at baseline, immediately after the intervention, and one month after the intervention.
Key secondary outcomes
K6 psychological distress scale,Loneliness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
[Intervention group] An 8-week psychosocial health promotion program. It consists of face-to-face sessions held every 2 to 3 weeks and the promotion of social interaction via the LINE app.
Interventions/Control_2
[Control group] Participants will receive a health-related booklet at the beginning of the study and will be instructed to maintain their usual daily activities.
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.Owning a smartphone, having experience with the LINE app, and being capable of exchanging messages.
3.Native Japanese speakers.
4.Capable of understanding the study's purpose and procedures, and providing written informed consent.
5.Capable of independent mobility and attending face-to-face programs.
Key exclusion criteria
1.Individuals requiring long-term care (Level 1 or higher) according to the Japanese Long-term Care Insurance system.
2.Individuals currently receiving treatment for psychiatric disorders.
3.Individuals who are institutionalized or hospitalized.
4.Individuals with organic brain disorders, including dementia.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Morita |
Organization
Science Tokyo
Division name
Department of Public Health Nursing
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5337
morita.phn@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Ayami |
| Middle name | |
| Last name | Odaira |
Organization
Science Tokyo
Division name
Department of Public Health Nursing
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5337
Homepage URL
ns220001@tmd.ac.jp
Sponsor or person
Institute
Science Tokyo
Institute
Department
Personal name
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
Science Tokyo
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-3726-1111
pr.info@adm.isct.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
| 2026 | Year | 01 | Month | 27 | 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
| 2026 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | 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
| 2026 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069188
