Tokyo, April 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061278) titled 'How does small-group recreation affect social interaction in daily life for older adults with dementia?' on April 16.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Tokushukai Medical Corporation, Geriatric Health Services Facility Ajisai

Condition: Condition - Alzheimer's disease Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: Interventions/Control_1 - Small-group recreational activities Interventions/Control_2 - Observation only

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 Size - 5

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069544

Disclaimer: Curated by HT Syndication.