UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046103 |
|---|---|
| Receipt number | R000052621 |
| Scientific Title | An observational study to examine the usefulness and challenges of monitoring Parkinson's disease patients during hospitalization and at home using a digital device (amue link) |
| Date of disclosure of the study information | 2021/11/17 |
| Last modified on | 2021/11/17 20:58:34 |
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Basic information
Public title
An observational study to examine the usefulness and challenges of monitoring Parkinson's disease patients during hospitalization and at home using a digital device (amue link)
Acronym
An observational study to examine the usefulness and challenges of monitoring Parkinson's disease patients during hospitalization and at home using a digital device (amue link)
Scientific Title
An observational study to examine the usefulness and challenges of monitoring Parkinson's disease patients during hospitalization and at home using a digital device (amue link)
Scientific Title:Acronym
An observational study to examine the usefulness and challenges of monitoring Parkinson's disease patients during hospitalization and at home using a digital device (amue link)
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the usefulness and challenges of in-hospital and home-based monitoring using digital devices for Parkinson's disease patients.
Basic objectives2
Others
Basic objectives -Others
usefulness
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of digital device (amue link) measurement results related to motor function
Key secondary outcomes
Evaluation of digital device (amue link) measurement results correlated with on-off time of symptom diary record, PDQ-39, CSQ-8J and MDS-UPDRS
Comparison of digital device (amue link) measurement results before and after medication and rehabilitation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who have been diagnosed with Parkinson's disease according to standard diagnostic criteria
(2) Patients who have fully understood the explanatory document about this study and have given their consent to participate in the study
(3) Patients who are scheduled to be hospitalized for short-term intensive rehabilitation at Tottori Medical Center
(4) Patients who are receiving oral levodopa alone or in combination with other drugs
(5) Patients with diurnal variation of motor symptoms and off hours more than once a day (with or without dyskinesia)
(6) Adult males and females aged 20 years or older
Key exclusion criteria
(1) Subjects who are judged by the principal investigator or sub-investigator to have cognitive impairment that may affect the reporting of symptoms and functions
(2) A person who has a musculoskeletal disorder that affects the assessment of motor symptoms of Parkinson's disease
(3) The patient has an unstable comorbid condition
(4) Patients with severe hearing loss who have difficulty in speech
(5) Persons who use implantable medical devices such as cardiac pacemakers and defibrillators
(6) A person who is judged by the principal investigator or subordinate investigator to be unsuitable for participation in the research for other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takahashi |
Organization
National Hospital Organization Tottori Medical Center
Division name
Neurology
Zip code
689-0203
Address
876 Mitsu, Tottori-shi, Tottori
TEL
0857-59-1111
takahashi.hiroshi.ce@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takahashi |
Organization
National Hospital Organization Tottori Medical Center
Division name
Neurology
Zip code
689-0203
Address
876 Mitsu, Tottori-shi, Tottori
TEL
0857-59-1111
Homepage URL
takahashi.hiroshi.ce@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Tottori Medical Center (Clinical research division)
Institute
Department
Personal name
Funding Source
Organization
(None)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Tottori Medical Center Institutional Review Board
Address
876 Mitsu, Tottori-shi, Tottori
Tel
0857-59-1111
N@A
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
| 2021 | Year | 11 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 26 | 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
Prospective observational study
Management information
Registered date
| 2021 | Year | 11 | Month | 17 | Day |
Last modified on
| 2021 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052621
