UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037564 |
|---|---|
| Receipt number | 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 | 2023/02/01 11:52:56 |
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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
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
tabitaka@health.nop.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
76
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
No longer recruiting
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
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 31 | Day |
Last modified on
| 2023 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042821
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
