UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061278 |
|---|---|
| Receipt number | R000069544 |
| Scientific Title | Effects of Small-Group Recreation for Older Adults with Moderate to Severe Dementia: An analysis of social proximity and interaction in daily life |
| Date of disclosure of the study information | 2026/04/16 |
| Last modified on | 2026/04/15 17:13:19 |
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Basic information
Public title
How does small-group recreation affect social interaction in daily life for older adults with dementia?
Acronym
A Study on Recreation and Social Interaction among Older Adults with Dementia
Scientific Title
Effects of Small-Group Recreation for Older Adults with Moderate to Severe Dementia: An analysis of social proximity and interaction in daily life
Scientific Title:Acronym
Evaluation of Interpersonal Proximity Changes in Dementia Recreation (ABA' Design)
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine how small-group recreational activities influence interpersonal distance and patterns of social engagement in daily life among older adults with moderate to severe dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in interpersonal relationships in daily life are evaluated through direct observation during free-time periods (30 minutes each in the morning and afternoon).
Proximity behavior is defined as being within 1.2 meters, maintained for at least 5 seconds, with reciprocal interaction present. Observations are recorded using a 5 minute interval time-sampling method (12 samples per day).
The quality of proximity is assessed using a simplified Dyadic Code, classifying interactions during proximity as Positive, Neutral, or Negative.
For comparison, two non-participants living in the same environment are observed using the same procedures and treated as pseudo-controls.
Key secondary outcomes
Quality of activities (A-QOA), Psychological and Behavioral Symptoms (BPSD+Q), Cognitive Function (HDS-R)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Small-group recreational activities
Interventions/Control_2
Observation only
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) Residents of the dementia ward in the facility.
2) Aged 65 years or older.
3) Diagnosed with Alzheimer's disease by a physician.
4) A score of 15 or below on the Hasegawa Dementia Scale-Revised (HDS-R).
5) Able to move within shared spaces independently or with distal supervision.
6) The primary daytime activity location is the shared space (not the private room).
7) Not belonging to any existing small-group activity program.
8) No planned discharge at the start of the study.
9) After receiving sufficient explanation about the study, participants who provide voluntary assent and whose proxy provides informed consent; if the participant's capacity to consent is judged insufficient, inclusion is based on proxy consent alone.
Key exclusion criteria
1) Deemed unsuitable for participation by the attending physician.
2) Due to sensory impairments, the attending physician or a nurse, care worker, or therapist not involved in the study judged that the participant had marked difficulty engaging in conversation at a normal speaking volume, recognizing others' positions or facial expressions, or establishing reciprocal interaction, making participation in small-group activities or observation of interpersonal interactions inappropriate.
3) Presence of cognitive impairment caused by conditions other than Alzheimer's disease, or a medical history strongly suggesting such causes (e.g., cerebrovascular disease, Parkinson's disease, normal-pressure hydrocephalus, severe psychiatric disorders).
4) Proxy consent could not be obtained.
5) Any other case deemed inappropriate for inclusion by the principal investigator.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Ikeda |
Organization
Tokushukai Medical Corporation, Geriatric Health Services Facility Ajisai
Division name
Rehabilitation
Zip code
421-0421
Address
3208-1, Hosoe, Makinohara City, Shizuoka, Japan
TEL
0548-23-0231
Ikedaayumi315@gmail.com
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Ikeda |
Organization
Tokushukai Medical Corporation, Geriatric Health Services Facility Ajisai
Division name
Rehabilitation
Zip code
421-0421
Address
3208-1, Hosoe, Makinohara City, Shizuoka, Japan
TEL
0548-23-0231
Homepage URL
Ikedaayumi315@gmail.com
Sponsor or person
Institute
Tokushukai Medical Corporation, Geriatric Health Services Facility Ajisai
Institute
Department
Personal name
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
The Tokushukai Group Ethics Committee
Address
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
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
医療法人徳洲会 介護老人保健施設あじさい（静岡県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 16 | 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 | 04 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational component examines the relationship between participation in small-group recreational activities and changes in interpersonal proximity and social engagement in daily life. Interpersonal proximity is recorded using a 5-minute interval time-sampling method, and the quality of interaction is coded as Positive, Neutral, or Negative. Two non-participants living in the same environment are observed as pseudo-controls for comparison.
Management information
Registered date
| 2026 | Year | 04 | Month | 16 | Day |
Last modified on
| 2026 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069544
