UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028937 |
|---|---|
| Receipt number | 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 | 2025/04/23 17:24:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Junichi |
| Middle name | |
| Last name | Yatabe |
Organization
Tokyo Women's Medical University
Division name
Department of Internal Medicine II, Endocrinology and Hypertension
Zip code
162-8666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
+81333538111
jyatabe@endm.twmu.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Yatabe |
Organization
Tokyo Women's Medical University
Division name
Department of Internal Medicine II, Endocrinology and Hypertension
Zip code
162-8666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
+81333538111
Homepage URL
jyatabe@endm.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Department of Internal Medicine II, Endocrinology and Hypertension
Institute
Department
Personal name
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
Tokyo Women's Medical University
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan
Tel
+81333538111
jyatabe@fmu.ac.jp
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
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033113
