UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047860 |
|---|---|
| Receipt number | R000054563 |
| Scientific Title | A multicenter randomized controlled study to evaluate the effectiveness to share monitoring of daily symptoms between patients and physicians in the treatment of Parkinson's disease |
| Date of disclosure of the study information | 2022/05/25 |
| Last modified on | 2025/11/14 16:43:11 |
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Basic information
Public title
A multicenter randomized controlled study to evaluate the effectiveness to share monitoring of daily symptoms between patients and physicians in the treatment of Parkinson's disease
Acronym
SHARE-PD
Scientific Title
A multicenter randomized controlled study to evaluate the effectiveness to share monitoring of daily symptoms between patients and physicians in the treatment of Parkinson's disease
Scientific Title:Acronym
SHARE-PD
Region
| Japan |
Condition
Condition
Parkinson's Disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to Verify how the data obtained from a wearable device, a smartphone and its application are used by physicians to affect the patient's condition and medical practice during the 6-month study period.
Basic objectives2
Others
Basic objectives -Others
Medical usefulness
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MDS-UPDRS Total Score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Using a wearable device, a smartphone and its application during the 6-month
Interventions/Control_2
Regular medical care
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. The participant has been diagnosed with Parkinson's disease on the basis of the International Parkinson and Movement Disorder Society (MDS) and has motor/non-motor symptoms that require clinically complex management.
2. The participant is capable of operating each device used in this study, and understanding and complying with protocol requirements, in the opinion of the investigator.
3. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
4. The participant is aged 20 years or older at the time of informed consent.
5. The participant is capable of visiting the outpatient clinic during the evaluation period.
Key exclusion criteria
1. The participant has metal allergy.
2. The participant has cognitive impairment that, in the opinion of the investigator, would interfere with the ability to report on symptoms and function.
3. The participant has unstable Parkinson's disease and comorbidities that would make outpatient visits difficult, in the opinion of the investigator.
4. The participant is judged by the investigator as being ineligible for any other reason.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Genko |
| Middle name | |
| Last name | Oyama |
Organization
Juntendo University Hospital
Division name
Department of Neurology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
g_oyama@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Izutsu |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medical Office
Zip code
103-0023
Address
1-1,Nihonbashi-Honcho 2-Chome,Chuo-ku,Tokyo
TEL
03-3278-2111
Homepage URL
miwa.izutsu@takeda.com
Sponsor or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
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
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3 -1 -3 Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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
| 2022 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
TBD
Publication of results
Unpublished
Result
URL related to results and publications
TBD
Number of participants that the trial has enrolled
110
Results
In total, 110 subjects were registered in the present study. Four subjects were excluded because of withdrawal of informed consent (one patient) or discontinuation before Week 0 (three subjects); therefore, 106 subjects (device group: 52 subjects; regular medical care group: 54 subjects) were included in the FAS. The mean observation periods in the device group and the regular medical care group were 214.7 days and 212.2 days, respectively.
Results date posted
| 2025 | Year | 11 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Inclusion Criteria :
1. The participant has been diagnosed with Parkinson's disease on the basis of the International Parkinson and Movement Disorder Society (MDS) and has motor/non-motor symptoms that require clinically complex management.
2. The participant is capable of operating each device used in this study, and understanding and complying with protocol requirements, in the opinion of the investigator.
3. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
4. The participant is aged 20 years or older at the time of informed consent.
5. The participant is capable of visiting the outpatient clinic during the evaluation period.
Exclusion Criteria:
1. The participant has metal allergy.
2. The participant has cognitive impairment that, in the opinion of the investigator, would interfere with the ability to report on symptoms and function.
3. The participant has unstable Parkinson's disease and comorbidities that would make outpatient visits difficult, in the opinion of the investigator.
4. The participant is judged by the investigator as being ineligible for any other reason.
Participant flow
At the start of the observation period, eligible patients were randomly assigned to the device group or the regular medical care group in a 1:1 ratio using a permuted block design and stratified according to physician and medical practice (face-to-face vs online consultation). All patients visited the study site and underwent tests, observations, and assessments at the start of the observation period (Week -4 - Week 0), start of the treatment period(Week 0), and at Weeks 4, 8, 12, 16, 20, and 24. Patients assigned to the smart device group were loaned an Apple Watch (series 4, 5, or 6)and iPhone 11 Pro at week0 and wore the devices as much as possible, except during sleeping and bathing.
Monitoring of daily activities and symptoms via the devices was recorded using MONIPAD* (Registered trademark, Takeda Pharmaceutical Co. Ltd, Japan). Data collected included tremor, dyskinesia, step count, falls, number and duration of wearing-off episodes, and time spent wearing the device. Data were automatically uploaded to a secure, cloud-based storage platform accessible to the treating physician through the Healthcare Total Management Platform (HTMP)dashboard. Physicians incorporated these data into their medical care, which involved sharing and discussing the information with patients during study site visits. Patients in both groups received standard disease management (ie, medications, neurological adjunctive therapies, and regular monitoring).
Adverse events
N.A.
Outcome measures
Patient demographics:
In total, 110 subjects were registered in the present study. Four subjects were excluded because of withdrawal of informed consent (one patient) or discontinuation before Week 0 (three subjects); therefore, 106 subjects (device group: 52 subjects; regular medical care group: 54 subjects) were included in the FAS. The mean observation periods in the device group and the regular medical care group were 214.7 days and 212.2 days, respectively. In the FAS population, the demographic characteristics were similar between the two groups. In the two groups, > 70% of the subjects were between 50 and 69 years old. The majority of subjects in the "on period" were of Hoehn & Yahr stage 2, and the largest number of subjects in the "off period" were classified as Hoehn & Yahr stage 3.
Primary endpoint:
In the device group, the MDS-UPDRS total score significantly decreased from Week 0 to Week 24 (-6.0 ; p < 0.0001), and that in the regular medical care group significantly increased (5.7; p = 0.0004). In the ANCOVA with the baseline measurement included as a covariate, the mean change in the MDS-UPDRS total score was significantly smaller in the device group than in the regular medical care group (-11.1; 95% CI, -15.2 to -7.1; p < 0.0001).
Device data:
Data obtained from the application. The mean wear time between Week 0 and Week 24 was 744.1 min per day.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2022 | Year | 05 | Month | 25 | Day |
Last modified on
| 2025 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054563
