UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057018 |
|---|---|
| Receipt number | R000065165 |
| Scientific Title | Effects of positive social interaction program on psychological well-being among older adults with cognitive impairment : a pilot randomized controlled trial |
| Date of disclosure of the study information | 2025/02/13 |
| Last modified on | 2025/02/13 18:28:46 |
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Basic information
Public title
Effects of positive social interaction program on psychological well-being among older adults with cognitive impairment
Acronym
Positive social interaction program on psychological well-being
Scientific Title
Effects of positive social interaction program on psychological well-being among older adults with cognitive impairment : a pilot randomized controlled trial
Scientific Title:Acronym
Positive social interaction program on psychological well-being among older adults with cognitive impairment: a pilot RCT
Region
| Japan |
Condition
Condition
mild cognitive impairment to mild dementia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effects of the Positive Interaction Program, which integrates positive emotions and positive social interactions, on the psychological well-being of older adults with cognitive impairments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological well-being (PERMA-Profiler Japanese version)
Key secondary outcomes
Quality of life(DEMQOL, WHO-5 Japanese translation), psychological status (UCLA Loneliness Scale Japanese 3-item version, items related to psychological status), social network (LSNS-6), lifestyle (extent of smiling and going out)
Feasibility assessment
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: The positive interaction program is conducted about one hour per week for 3 months (12 sessions)
Interventions/Control_2
Control group: Living life as usual
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)(a) 65 years and over, (b)general cognitive decline (from mild cognitive impairment (MCI) to mild dementia) (Mini Mental State Examination scored between 20 to 27), (c) a possible tendency to depressive symptoms (Geriatric Depression Scale 15 item version scored at one or more)
2) living in Aichi Prefecture (including those using day-care services)
3) able to go out once a week
4) able to sit for at least 30 minutes
5) willingness and ability to provide written informed consent
Key exclusion criteria
1)those who are taking antidepressants or anti-anxiety medication or undergoing psychotherapy due to a serious mental illness
2) those with a poor prognosis due to a progressive illness such as cancer
3) those with severe aphasia or who are unable to speak or read Japanese
4)those with severe visual or hearing impairment
5)those with severe cognitive impairment
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Sangyoon |
| Middle name | |
| Last name | Lee |
Organization
Obu Center for Dementia Care Research and Practice
Division name
Department of Research
Zip code
4740037
Address
3-294 Hantsuki-cho, Obu, Aichi, 4740037, Japan
TEL
0562-44-5551
sylee@dcnet.gr.jp
Public contact
Name of contact person
| 1st name | Sangyoon |
| Middle name | |
| Last name | Lee |
Organization
Obu Center for Dementia Care Research and Practice
Division name
Department of Research
Zip code
4740037
Address
3-294 Hantsuki-cho, Obu, Aichi, 4740037, Japan
TEL
0562-44-5551
Homepage URL
sylee@dcnet.gr.jp
Sponsor or person
Institute
Obu Center for Dementia Care Research and Practice
Institute
Department
Personal name
Funding Source
Organization
The Japan foundation for Aging and Health
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Social welfare coporation, Jinshikai
Address
3-287 Hanzuki-cho, Obu City, Aich, 4740037, Japan
Tel
0562-46-8420
zinshi-h@ma.medias.ne.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 | 02 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 28 | 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 | 02 | Month | 13 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065165
