UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054116 |
|---|---|
| Receipt number | R000061793 |
| Scientific Title | An evaluation of the enhanced multidisciplinary care program for the patients of the patioents with Parkison's disease and Parkison's syndrome |
| Date of disclosure of the study information | 2024/04/15 |
| Last modified on | 2024/04/16 16:54:17 |
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Basic information
Public title
An evaluation of the enhanced multidisciplinary care program for the patients of the patioents with Parkison's disease and Parkison's syndrome
Acronym
An evaluation of the enhanced multidisciplinary care program for the patients of the patioents with Parkison's disease and Parkison's syndrome
Scientific Title
An evaluation of the enhanced multidisciplinary care program for the patients of the patioents with Parkison's disease and Parkison's syndrome
Scientific Title:Acronym
An evaluation of the enhanced multidisciplinary care program for the patients of the patioents with Parkison's disease and Parkison's syndrome
Region
| Japan |
Condition
Condition
Parkinson's disease and Parkinson's syndrome
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We develope and introduce the enhanced multidisciplinary care program for the patients with Parkinson's disease and syndrome. The efficacy of the program will be prospectively evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the Quality of life
Key secondary outcomes
All items measured before the intervention, after 6 motnths and 1 year
Motor symptoms (UPDRS)
Non motor symptoms (UPDRS)
Status of the multi multidisciplinary care
Neuropsychological tests
Bathel Index
Details of Medication
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
We coprehensively and regulary evaluate the clinical symptoms, medioction, home enviroment, etc of each patient. Then, we introduce 'the enhanced multidisciplinary care program' that main interventions are reviced according to each need.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who meet Parkison's disease criteria for 2015 International Parkinson and Movement Disorder Society
Those who meet dementia with Lewy bodies criteria for Fourth consensus report of the DLB Consortium
Those who are diagnosed with the other Parkison's syndrome (Vascular Parkison's synrome, Progressive Supranuclear Palsy, Corticobasal degeneration, Multiple System Atrophy, etc)
Those who can underestand the informed consent
Key exclusion criteria
Those who have Past medical history of Psychiatoric disease
Those who complicate organic brain diseases (include cerebral infarction) except the concerned disease, and take medicines that affect the central nervous system
Those who are pregnant, or breastfeeding
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Ito |
Organization
Osaka Metropolitan University Hospital
Division name
Department of Neurology
Zip code
545-8586
Address
1-5-7, Asahimachi, Abeno-ku, Osaka City
TEL
06-6645-3889
a21337r@omu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Ito |
Organization
Osaka Metropolitan University Hospital
Division name
Department of Neurology
Zip code
545-8586
Address
1-5-7, Asahimachi, Abeno-ku, Osaka City
TEL
06-6645-3889
Homepage URL
a21337r@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
SUPER COURT
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Graduate School of Medicine, OsakaMetropolitan University
Address
1-2-7-6, Asahimachi, Abeno-ku, Osaka City
Tel
06-6645-3456
gr-a-knky-ethics@omu.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 | 04 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 | 04 | Month | 11 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061793
| 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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