Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059600) titled 'The influence of picture books on older people and readers' on Oct. 31.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Fukushima Medical University
Condition:
Condition - Dementia, Mild Cognitive Impairment
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Examining the effects of using picture books in older people with cognitive decline and readers.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The participants receive 60 minutes of individualized activity using a picture book a at once.
Interventions/Control_2 - The participants receive 60 minutes of individualized activity no using a picture book a at once.
Eligibility:
Age-lower limit - 65
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - The study participants comprise older people aged 65 years and older at cooperating study sites who meet all inclusion criteria and do not meet any exclusion criteria. The inclusion criteria were a Mini Mental State Examination(MMSE)s' score of 27 or less or those diagnosed with MCI or dementia by a physician and those who agreed to participate in this study.
Key exclusion criteria - Exclusion criteria were defined as individuals with severe cognitive impairment (MMSE < 10) or those unable to communicate verbally.
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 31 Day
Date of IRB - 2025 Year 09 Month 24 Day
Anticipated trial start date - 2025 Year 11 Month 21 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068184
Disclaimer: Curated by HT Syndication.
