UMIN-CTR Clinical Trial

Basic information
Public title	A preliminary study of the effects of multimodal non-pharmacological interventions for older people with dementia in nursing homes
Acronym	Multimodal non-pharmacological intervention for older people with dementia
Scientific Title	A preliminary study of the effects of multimodal non-pharmacological interventions for older people with dementia in nursing homes
Scientific Title:Acronym	Multimodal non-pharmacological intervention for older people with dementia
Region	Japan

Condition
Condition	Dementia
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to preliminarily examine the maintenance and improving effects of multimodal non-drug interventions on cognitive dysfunction in older people with dementia in nursing home.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Global cognitive function measured by cognitive function tests (ABC dementia scale and COGNISTAT Five) and specific cognitive functions such as memory, orientation, and constitutive ability.
Key secondary outcomes	Behavioral and psychological symptoms of dementia and activities of daily living measured by the ABC Dementia Scale.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Participants spend the first two months as usual. Participants then receive multimodal non-pharmacological interventions that combine exercise, cognitive training, and activities of daily living training three times a week for two months at a frequency of 30 minutes per session (10 minutes per intervention).
Interventions/Control_2
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	1) Older people over 65 years old. 2) Persons with mild or moderate cognitive decline. 3) Those who can communicate and can carry out inspections using questionnaires. 4) A person who has obtained consent from the person (a person who has also obtained consent from his / her family if the doctor deems it necessary). 5) Those who have or are suspected of having Alzheimer's disease.
Key exclusion criteria	1) Persons with severe behavioral disorders or medical requirements. 2) Persons with severe visual or hearing impairment. 3) Those who refuse to participate in the research. 4) Those who have cerebrovascular dementia, frontotemporal dementia, Lewy body dementia, and other secondary dementia who have not been diagnosed with Alzheimer's dementia. 5) Those who do not understand the purpose of the research.
Target sample size	3

Research contact person
Name of lead principal investigator	1st name Kyosuke Middle name Last name Yorozuya
Organization	Seijoh University
Division name	Faculty of Care and Rehabilitation
Zip code	476-8588
Address	2-172 Fukinodai, Tokai, Aichi
TEL	0526016000
Email	yorozuya@seijoh-u.ac.jp

Public contact
Name of contact person	1st name Kyosuke Middle name Last name Yorozuya
Organization	Seijoh University
Division name	Faculty of Care and Rehabilitation
Zip code	476-8588
Address	2-172 Fukinodai, Tokai, Aichi
TEL	0526016000
Homepage URL
Email	yorozuya@seijoh-u.ac.jp

Sponsor
Institute	Seijoh University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Research Ethics Committee of Seijoh University
Address	2-172 Fukinodai, Tokai, Aichi
Tel	052-601-6000
Email	fujita@seijoh-u.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

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 01 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
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	Completed
Date of protocol fixation	2021 Year 10 Month 25 Day
Date of IRB	2021 Year 10 Month 25 Day
Anticipated trial start date	2021 Year 11 Month 01 Day
Last follow-up date	2022 Year 05 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 25 Day
Last modified on	2022 Year 05 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052338