UMIN-CTR Clinical Trial

Public title

Reduction of Uncontrolled Hypertension by Remote Monitoring and Telemedicine (REMOTE) Study

Acronym

Reduction of Uncontrolled Hypertension by Remote Monitoring and Telemedicine (REMOTE) Study

Scientific Title

Reduction of Uncontrolled Hypertension by Remote Monitoring and Telemedicine (REMOTE) Study

Scientific Title:Acronym

Reduction of Uncontrolled Hypertension by Remote Monitoring and Telemedicine (REMOTE) Study

Region

Japan

Condition

hypertension

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Benefits and efficacy of telemonitoring and telemedicine are reported for various health conditions in recent years, and in Japan, the application of telemedicine is becoming allowed for wider circumstances. Nevertheless, large-scale randomized clinical trial on the use of telemonitoring and telemedicine has not been reported from Japan, and it is unclear whether telemonitoring and telemedicine would provide comparable or better blood pressure control, quality of life, cost benefits, and/or prognosis compared to conventional hypertension treatment with office visits and patient self-report of blood pressure. Therefore, this study aimed to compare standard medical care, face-to-face care with blood pressure telemonitoring, and telemedicine with time-to-control of blood pressure as the primary outcome.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

time-to-control of blood pressure

Key secondary outcomes

Rate of blood pressure control, quality of life (EQ-5D), adherence (Morisky score), types and amounts of antihypertensive medication, medical costs, major adverse cardiovascular events, indices of atherosclerosis, serum creatinine, urinary protein, adverse events.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Control group

Interventions/Control_2

Telemonitoring group

Interventions/Control_3

Telemedicine group

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

80

years-old

>

Gender

Male and Female

Key inclusion criteria

Uncontrolled hypertension (home blood pressure >= 135/85 mmHg)
Untreated or antihyperntensive medication unchanged for >= 4 weeks
Capable of measuring blood pressure at home
Owns and capable of using smartphone or equivalent device
Able to give written informed consent

Key exclusion criteria

Unable to measure home blood pressure
Pregnant women and those expecting to become pregnant
Cardiovascular events within 6 months
History of coma due to hyper or hypoglycemia
Type 1 diabetes with inadequate glycemic control
Diabetic patients on insulin
Chronic kidney disease with eGFR < 30 mL/min/1.73m2
Secondary hypertension excluding non-operative primary aldosteronism
Sleep apnea with indication for positive airway pressure treatment
Atrial fibrillation
Scheduled for operation or intervention
Psychiatric conditions including alcoholism and substance abuse
Serious medical condition
Subject of other clinical trial
Judged unfit by the investigators

Target sample size

444

Name of lead principal investigator

1st name
Middle name
Last name	Junichi Yatabe

Organization

Tokyo Women's Medical University

Division name

Department of Internal Medicine II, Endocrinology and Hypertension

Zip code

Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan

TEL

+81333538111

Email

jyatabe@endm.twmu.ac.jp

Name of contact person

1st name
Middle name
Last name	Junichi Yatabe

Organization

Tokyo Women's Medical University

Division name

Department of Internal Medicine II, Endocrinology and Hypertension

Zip code

Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan

TEL

+81333538111

Homepage URL

Email

jyatabe@endm.twmu.ac.jp

Institute

Tokyo Women's Medical University
Department of Internal Medicine II, Endocrinology and Hypertension

Institute

Department

Personal name

Organization

PORT, INC.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

YES

Study ID_1

170803

Org. issuing International ID_1

Tokyo Women's Medical University

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京女子医科大学病院
ＴＭクリニック西新宿

Date of disclosure of the study information

2017

Year

10

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

Preinitiation

Date of protocol fixation

2017

Year

08

Month

29

Day

Date of IRB

Anticipated trial start date

2017

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

08

Month

31

Day

Last modified on

2017

Year

10

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033113