UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053949 |
|---|---|
| Receipt number | R000061578 |
| Scientific Title | A Japanese Multicenter Prospective Study of Prognosis in Late-Stage Parkinson's Disease (a National Hospital Organization Network collaborative study) |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/03/23 11:43:02 |
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Basic information
Public title
A Study of Prognosis in Late-Stage Parkinson's Disease in Japan
Acronym
Prognosis in Late-Stage Parkinson's Disease
Scientific Title
A Japanese Multicenter Prospective Study of Prognosis in Late-Stage Parkinson's Disease (a National Hospital Organization Network collaborative study)
Scientific Title:Acronym
A Japanese Prospective Study of Prognosis in Late-Stage Parkinson's Disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess motor function, cognitive function, nutritional status, quality of life, and care status in patients with late-stage Parkinson's disease. In addition, functional prognosis, life expectancy, and the occurrence of associated adverse events (pneumonia, fractures, complications requiring hospitalization, and institutionalization) will be prospectively studied for 18 months. The relationship between prognosis and baseline characteristics will also be examined.
Basic objectives2
Others
Basic objectives -Others
Changes in the MDS-UPDRS, Hoehn and Yahr stage, and Schwab and England ADL scale from baseline
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the MDS-UPDRS, Hoehn and Yahr stage, and Schwab and England ADL scale from baseline to 18 months
Key secondary outcomes
1) Baseline
Motor function, Cognitive function, Nutritional status, Treatment, Quality of life of the patient/family, use of long-term care insurance, level of care required, care burden, utilization of social resources, Frequency of falls, history of fractures
2) Prognosis
Survival/death, pneumonia, fractures, complications requiring hospitalization (excluding pneumonia and fractures), institutionalization (first time only), cognitive function, quality of life, burden of care, changes in care setting during 18 months.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who met all of the following criteria were enrolled :
1) Patients diagnosed with clinically-established PD according to the International Parkinson and Movement Disorder Society (MDS) criteria
2) Patients who had been diagnosed with PD for at least 7 years
3) Patients with "Hoehn and Yahr stage IV or V" or "less than 50% on the Schwab and England scale" at the time of admission
4) Patients who were managed as outpatients for PD treatment or hospitalized within 14 days
5) Patients with a caregiver able to cooperate with the survey and who can objectively assess the patient if the patient is homebound
6) Patients whose condition has been stable for the past 14 days
7) Patients who provided written consent for inclusion in this study by the patient or a surrogate
Key exclusion criteria
Patients who fall under any of the following categories were excluded:
1) Patients admitted for treatment of complications
2) Patients transferred from an acute care hospital
3) Patients judged by the principal investigator or research coordinator to be inappropriate for participation in this study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Ikuko |
| Middle name | |
| Last name | Aiba |
Organization
National Hospital Organization Higashinagoya National Hospital
Division name
Department of Neurology
Zip code
465-8620
Address
5-101, Umemorizaka, Meito-ku, Nagoya, 465-8620, Japan
TEL
052-801-1151
ikukoaiba0401@gmail.com
Public contact
Name of contact person
| 1st name | Ikuko |
| Middle name | |
| Last name | Aiba |
Organization
National Hospital Organization Higashinagoya National Hospital
Division name
Department of Neurology
Zip code
465-8620
Address
5-101, Umemorizaka, Meito-ku, Nagoya, 465-8620, Japan
TEL
052-801-1151
Homepage URL
ikukoaiba0401@gmail.com
Sponsor or person
Institute
National Hospital Organization Higashinagoya National Hospital
Institute
Department
Personal name
Ikuko Aiba
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Central Research Ethics Committee
Address
2-5-21, Higashigaoka, Meguro-ku, Tokyo, 152-8621, Japan
Tel
+81-3-5712-5075
700-kenkyu@mail.hosp.go.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 | 03 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2024 | Year | 03 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061578
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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