UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054518 |
|---|---|
| Receipt number | R000060115 |
| Scientific Title | Verification sudy of the practical protocol of home-visit rehabilitation for person with dementia |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/05/30 17:51:10 |
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Basic information
Public title
Verification study of the practical protocol of home-visit rehabilitation for person with dementia
Acronym
VST-HRPD
Scientific Title
Verification sudy of the practical protocol of home-visit rehabilitation for person with dementia
Scientific Title:Acronym
VST-HRPD
Region
| Japan |
Condition
Condition
Alzheimer type dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the usefulness of the practical protocol of home-visit rehabilitation for person with dementia by randomly controlled comparison study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of days staying at home
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
home-visit rehabilitation with the practical protocol
Interventions/Control_2
home-visit rehabilitation without the practical protocol
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosed with Alzheimer's type dementia and FAST score of 3 ~ 6
Living at home and have a familiar caregiver
Key exclusion criteria
Physical disability requiring aid for indoor daily life (independence degree of daily living for the disabled elderly as B or C)
Cognitive decline requiring permanent support (independence degree of daily living for the demented elderly as IIIb,IV,or M)
With neurological deficits or structural brain abnormalities(i.e. Parkinson's disease, vascular dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, head trauma)
Psychiatric symptoms, irritability, or behavioral abnormalities( i.e.major depression, bipolar disorder (defined by DSM-V))
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Niimi |
Organization
The University of Tokyo Hospital
Division name
Unit for Early and Exploratory Clinical Development
Zip code
113-8655
Address
7-3-1Hongo, Bunkyo-ku, Tokyo
TEL
0358009113
niimiy-crc@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Niimi |
Organization
The University of Tokyo Hospital
Division name
Unit for Early and Exploratory Clinical Development
Zip code
113-8655
Address
7-3-1Hongo, Bunkyo-ku, Tokyo
TEL
0358009113
Homepage URL
niimiy-crc@h.u-tokyo.ac.jp
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
MHLW
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
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
0358410818
ethics@m.u-tokyo.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
| 2024 | 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
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
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 05 | Month | 30 | Day |
Last modified on
| 2024 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060115
