Tokyo, Dec. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060070) titled 'Effectiveness Evaluation Study of a Participatory Art Program for Living Well with Dementia' on Dec. 13.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Condition:
Condition - Dementia, Mild Cognitive Impairment (MCI), Healthy Older Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to examine the effects of a participatory, inclusive art program, in which people with and without dementia can jointly participate, on mental health through a randomized controlled trial (RCT).
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Intervention group: A participatory clinical art program designed to be accessible for people with dementia, combined with peer meetings for persons with dementia. Group sessions will be conducted for 120 minutes per session, 6 sessions over approximately 3 months.
Interventions/Control_2 - Control group: Health education (attention control). Lectures on general health topics delivered by healthcare professionals. Frequency and duration matched to the intervention group.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1.Individuals with dementia, mild cognitive impairment (MCI), or subjective memory concerns, residing in the community (including those living outside Chiyoda City but receiving care at medical institutions within the ward).
2.Ability to provide written informed consent for participation in this study.
Key exclusion criteria - 1.Individuals currently undergoing acute treatment for psychiatric or physical illness
2.In the case of persons with dementia, when family members do not consent to their participation
3.Individuals deemed inappropriate for inclusion in this study by the principal investigator, for example due to the severity of dementia symptoms making participation in the program difficult
Target Size - 66
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 11 Month 17 Day
Date of IRB - 2025 Year 09 Month 03 Day
Anticipated trial start date - 2025 Year 11 Month 17 Day
Last follow-up date - 2026 Year 10 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067783
Disclaimer: Curated by HT Syndication.