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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022783
Receipt No. R000022639
Scientific Title The effect of tele-monitoring on post-cerebrovascular disoreder and cardiac disease patients at home care seeting
Date of disclosure of the study information 2016/07/01
Last modified on 2016/06/18

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Basic information
Public title The effect of tele-monitoring on post-cerebrovascular disoreder and cardiac disease patients at home care seeting
Acronym The effect of tele-monitoring on post-cerebrovascular disoreder and cardiac disease patients at home care seeting
Scientific Title The effect of tele-monitoring on post-cerebrovascular disoreder and cardiac disease patients at home care seeting
Scientific Title:Acronym The effect of tele-monitoring on post-cerebrovascular disoreder and cardiac disease patients at home care seeting
Region
Japan

Condition
Condition hypertension, chronic hear disease, post-cerebrovascular diorder
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To testify the effect of tele-monitoring on frequency of home visit, medical condition and prognosis at home care setting
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes re-admittance due to exacerbation of heart failure, cerebrovascular disease and other cardiovascular events, and death within 9 months after intervention
Key secondary outcomes NYHA grade
BNP or NT-proBNP level
cerebrovascular disease and other cardiovascular related medicine and its dose
frequency of emergent doctor visit and doctor call
blood pressure, pulse rate, respiratory rate
satisfaction of patients, family and medical staff

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 telemonitoring with vital sign sensor and sleep sensor
Interventions/Control_2 without telemonitoring with vital sign sensor and sleep sensor
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) Patients provided with regular visit by the physician at least twice every month
2) Patients at risk for any of the cerebral or cardiovascular diseases as below
(1) Patients with previous or current history of hypertension
(2) Patients with grade II, III or IV heart failure (New York Heart Association (NYHA) severity classification), BNP over 100 pg/mL or NT-proBNP over 400 pg/mL)
(3) Patients with previous history of cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage for more than 3 months prior to enrollment
3) Patients with written informed consent to participate obtained from subjects or representatives
Key exclusion criteria 1) Patients with cancer.
2) Patients with a previous history of coronary artery disease, vascular disease, cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage within 3 months prior to enrollment
3) Patients with a >=50% increase in serum creatinine within 3 months prior to enrollment
4) Patients on hormone replacement therapy with estrogen (estrogenic hormone products)
5) Patients who participated in another clinical study or clinical trial in the six months prior to enrollment
6) Patients judged inappropriate for this study by the physicians in charge
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuaki Isobe
Organization Tokyo Medical and Dental University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-5-45 Yusima, Bunkyo-ku, Tokyo
TEL 03-5803-5951
Email isobemi.cvm@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinsuke Muto
Organization Tetsuyu Institute Medical Corporation
Division name President
Zip code
Address 4-25-5 Sengoku, Bunkyo-ku, Tokyo
TEL 050-3784-2001
Homepage URL
Email shinsuke.muto@you-homeclinic.or.jp

Sponsor
Institute AMED
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 07 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 No longer recruiting
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 18 Day
Last modified on
2016 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022639

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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