Tokyo, July 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062282) titled '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' on July 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Yokohama City University
Condition:
Condition - Dementia
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
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 Size - 24
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071276
Disclaimer: Curated by HT Syndication.