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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035614
Receipt No. R000040574
Scientific Title Evaluation of hemodynamics (blood pressure, pulse) and prediction of dynamic change using wearable device.
Date of disclosure of the study information 2019/04/01
Last modified on 2020/02/21

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Basic information
Public title Evaluation of hemodynamics (blood pressure, pulse) and prediction of dynamic change using wearable device.
Acronym Monitoring using wearable devices
Scientific Title Evaluation of hemodynamics (blood pressure, pulse) and prediction of dynamic change using wearable device.
Scientific Title:Acronym Monitoring using wearable devices
Region
Japan

Condition
Condition Chronic diseases and dialysis patients (chronic renal failure)
Classification by specialty
Medicine in general Cardiology Nephrology
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Understanding hemodynamics and predicting fluctuation
Basic objectives2 Others
Basic objectives -Others Establishment of stabilization index of hemodynamic status
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Monitoring of blood pressure and pulse
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Chronic disease patients
Interventions/Control_2 Dialysis patient
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patient in hospital
Key exclusion criteria Research participation non-consent
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Takehito
Middle name
Last name Kobayashi
Organization Saitama Medical University
Division name General international medicine
Zip code 350-0495
Address 38 Monohongo, Monoyama-Cho, Iruma-gun, Saitama, JPN
TEL 0492761667
Email kobatake@saitama-med.ac.jp

Public contact
Name of contact person
1st name Takehito
Middle name
Last name Kobayashi
Organization Saitama Medical University
Division name General international medicine
Zip code 350-0495
Address 38 Monohongo, Monoyama-Cho, Iruma-gun, Saitama, JPN
TEL 0492761667
Homepage URL
Email kobatake@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical University
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 Saitama Medical University IRB
Address Iruma, Moroyama, Morohongo 38Department of Respiratory Medicine
Tel 0492761354
Email kobatake@saitama-med.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
2019 Year 04 Month 01 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
2019 Year 01 Month 21 Day
Date of IRB
2018 Year 07 Month 01 Day
Anticipated trial start date
2019 Year 04 Month 01 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

Management information
Registered date
2019 Year 01 Month 22 Day
Last modified on
2020 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040574

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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