UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047816 |
|---|---|
| Receipt number | R000054514 |
| Scientific Title | The effect of multimodal non-pharmacological Intervention on older people with dementia in nursing home: A Randomized controlled trial |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2023/11/20 09:18:32 |
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Basic information
Public title
The effect of combined activity interventions for older people with dementia in nursing homes: A Randomized controlled trial
Acronym
The effect of combined activity interventions for older people with dementia in nursing homes
Scientific Title
The effect of multimodal non-pharmacological Intervention on older people with dementia in nursing home: A Randomized controlled trial
Scientific Title:Acronym
The effect of multimodal non-pharmacological Intervention on older people with dementia in nursing home
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the improvement effects of multimodal non-pharmacological interventions on cognitive decline for older people with dementia in nursing homes using a randomized controlled trial design.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to examine the improvement effects of multimodal non-pharmacological interventions on activities of daily living and behavioral and psychological symptom of dementia for older people with dementia in nursing homes using a randomized controlled trial design.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
COGNISTAT Five (memory, constructional ability, and orientation): Conducted pre-intervention, 2 months post-intervention, and 2 months follow-up.
Key secondary outcomes
ABC dementia scale (global cognitive function, activities of daily living and behavioral and psychological symptom of dementia): Conducted every week from the start of the intervention to the end of follow-up for 4 months.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention group will receive a multimodal non-pharmacological intervention combining exercise, cognitive training, and activities of daily living training three times a week for 30-40 minutes per session (10 minutes per intervention) for two months.
Interventions/Control_2
The control group will receive usual care for 2 months.
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, moderate or severe 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
40
Research contact person
Name of lead principal investigator
| 1st name | Kyosuke |
| Middle name | |
| Last name | Yorozuya |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
476-8588
Address
2-172 Fukinodai, Tokai, Aichi
TEL
0526016000
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 Rehabilitation and Care
Zip code
476-8588
Address
2-172 Fukinodai, Tokai, Aichi
TEL
0526016000
Homepage URL
yorozuya@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
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
0526016000
tsutsui@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
| 2022 | Year | 06 | 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
40
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
| 2022 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 06 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 20 | Day |
Last modified on
| 2023 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054514
