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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046103
Receipt No. 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

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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
Email 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
Email takahashi.hiroshi.ce@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Tottori Medical Center (Clinical research division)
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052621

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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