UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062282 |
|---|---|
| Receipt number | R000071276 |
| Scientific Title | Effects of an outing-promotion intervention on behavioral and psychological symptoms of dementia (BPSD) among group home residents: a facility-stratified, pair-matched, randomized controlled trial |
| Date of disclosure of the study information | 2026/07/20 |
| Last modified on | 2026/07/20 21:48:34 |
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Basic information
Public title
Effects of an outing-promotion intervention on behavioral and psychological symptoms of dementia (BPSD) among group home residents: a facility-stratified, pair-matched, randomized controlled trial
Acronym
Outing promotion for BPSD reduction trial
Scientific Title
Effects of an outing-promotion intervention on behavioral and psychological symptoms of dementia (BPSD) among group home residents: a facility-stratified, pair-matched, randomized controlled trial
Scientific Title:Acronym
Outing promotion for BPSD reduction trial
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a staff-delivered outing-promotion intervention on the occurrence of behavioral and psychological symptoms of dementia (BPSD) among residents of group homes, using a randomized controlled design, and to evaluate the trajectory of BPSD occurrence during the post-intervention observation period.
Basic objectives2
Others
Basic objectives -Others
Verification of the effectiveness of a non-pharmacological intervention and exploration of the trajectory of effects after intervention discontinuation
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
BPSD occurrence rate derived from routine care records (weekly proportion of resident-days with documented BPSD). Assessment: operational baseline period (May 15-31, 2025) and post-baseline period (June 1 to December 31, 2025).
Key secondary outcomes
Outing rate (weekly proportion of resident-days with documented outings; adherence measure)
Change in Hasegawa Dementia Scale-Revised (HDS-R) scores (t1 to t2)
Trajectory of BPSD occurrence and between-group differences during the post-intervention observation period (January 1 to May 31, 2026)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group: Outing promotion. Care staff actively encouraged residents to go outdoors (walks, shopping, outdoor activities, etc.). The intervention period was from May 15 to December 31, 2025. The intervention was discontinued from January 1, 2026, followed by an observation period under usual care. Because an electronic care-record system was introduced simultaneously with the start of the intervention, no pre-intervention record data exist; the first two weeks of the intervention period (May 15 to 31, 2025) were defined as the operational baseline.
Interventions/Control_2
Control group: Usual care without specific outing promotion.
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
Residents with dementia living in the three participating group home units (dementia group homes) as of April 2025.
Key exclusion criteria
Residents with planned discharge at the time of allocation, etc.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Hara |
Organization
Yokohama City University
Division name
School of Economics and Business Administration
Zip code
2360027
Address
22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872131
hara.koj.vv@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Hara |
Organization
Yokohama City University
Division name
School of Economics and Business Administration
Zip code
2360027
Address
22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872131
Homepage URL
hara.koj.vv@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Koji Hara
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Hakkei Campus, Yokohama City University
Address
22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel
045-787-2354
sangaku@yokohama-cu.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
認知症対応型共同生活介護事業所3施設（非公開）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 20 | 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
24
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
| 2025 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 09 | Month | 30 | Day |
Other
Other related information
This trial was registered retrospectively because the principal investigator was not fully aware of the trial registration requirement at study initiation. Allocation was performed on April 19, 2025, and the procedure is preserved as a dated internal document. The primary outcome and analysis approach were described in the interim analysis report of January 2026. Following the interim analysis based on care records during the intervention period (May to December 2025), the intervention was discontinued in January 2026, and observation under usual care has continued thereafter.
Management information
Registered date
| 2026 | Year | 07 | Month | 20 | Day |
Last modified on
| 2026 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071276
