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 2024/03/21 11:39:51

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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

Email

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


Email

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

Email

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


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

No longer recruiting

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

2024 Year 03 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054563


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name