UMIN-CTR Clinical Trial

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

hypertension, chronic hear disease, post-cerebrovascular diorder

Classification by specialty

Medicine in general

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

AMED

Institute

Department

Personal name

Organization

AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

06

Month

18

Day

Last modified on

2016

Year

06

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022639