UMIN-CTR Clinical Trial

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