UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of tele-monitoring on post-cerebrovascular disoreder and cardiac disease patients at home care seeting
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Mitsuaki Isobe
Organization	Tokyo Medical and Dental University
Division name	Department of Cardiovascular Medicine
Address	1-5-45 Yusima, Bunkyo-ku, Tokyo
TEL	03-5803-5951
Email	isobemi.cvm@tmd.ac.jp

Public contact
Name of contact person	Shinsuke Muto
Organization	Tetsuyu Institute Medical Corporation
Division name	President
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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