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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037564
Receipt No. R000042821
Scientific Title Effects of rehabilitation based on process analysis of daily activity for dementia in community-dwlling older adults with dementia
Date of disclosure of the study information 2019/07/31
Last modified on 2020/08/06

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Basic information
Public title Effects of rehabilitation based on process analysis of daily activity for dementia in community-dwlling older adults with dementia
Acronym Effects of rehabilitation based on process analysis of daily activity for dementia in community-dwlling older adults with dementia
Scientific Title Effects of rehabilitation based on process analysis of daily activity for dementia in community-dwlling older adults with dementia
Scientific Title:Acronym Effects of rehabilitation based on process analysis of daily activity for dementia in community-dwlling older adults with dementia
Region
Japan

Condition
Condition dementia
Classification by specialty
Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To egamine that effects of rehabilitation based on process analysis of daily activity for dementia in community-dwlling older adults with dementia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Process Analysis of Daily activity for Dementia
Key secondary outcomes Physical Self-Maintenance Scale
Lawton Instrumental Activities of Daily Living Scale
Hyogo Activity of dairy living Scale
Mini-mental State Examination
J-ZBI8
DBD13
Satisfaction
Performance

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver Other
Interventions/Control_1 Participants will be received to combined interventions for ADL independence (use of remaining cognitive function, skill training, environment support, support and education for families, etc.) for 40 minute, once a week, for 3 months.
Interventions/Control_2 Participants will be received to usual care for 40 minute, once a week, for 3 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 community-dwelling older adults with dementia or mild cognitive impairment
Key exclusion criteria Persons with ADL impairment due to remarkable orthopedic disease, neurological disease and sensory organ disease etc
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Tabira
Organization Kagoshima University
Division name Faculty o Medicine, School of Health Science
Zip code 890-8520
Address 8-35-1, Sakuragaoka, Kagoshima
TEL 0992756780
Email tabitaka@health.nop.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name Takayuki
Middle name
Last name Tabira
Organization Kagoshima University
Division name Faculty o Medicine, School of Health Science
Zip code 890-8520
Address 8-35-1, Sakuragaoka, Kagoshima
TEL 0992756780
Homepage URL
Email tabitaka@health.nop.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University
Institute
Department

Funding Source
Organization Grants-in-aid for Scientific Research, Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Japanese Association of Occupational Therapists

IRB Contact (For public release)
Organization Kagoshima Uniersity Hospital Ethical Committee
Address 8-35-1, Sakuragaoka, Kagoshima
Tel 0992756692
Email kufsyomu@kuas.kagoshima-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
2019 Year 07 Month 31 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 Enrolling by invitation
Date of protocol fixation
2019 Year 05 Month 01 Day
Date of IRB
2019 Year 06 Month 13 Day
Anticipated trial start date
2019 Year 07 Month 20 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 31 Day
Last modified on
2020 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042821

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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