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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028937
Receipt No. R000033113
Scientific Title Reduction of Uncontrolled Hypertension by Remote Monitoring and Telemedicine (REMOTE) Study
Date of disclosure of the study information 2017/10/01
Last modified on 2017/10/17

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Basic information
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
Condition hypertension
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
Organization PORT, INC.
Organization
Division
Category of Funding Organization Profit organization
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 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
Institutions 東京女子医科大学病院
TMクリニック西新宿

Other administrative information
Date of disclosure of the study information
2017 Year 10 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 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
Other related information

Management information
Registered date
2017 Year 08 Month 31 Day
Last modified on
2017 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033113

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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