UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of antihypertensive medical care using telemedicine vs. conventional therapy
Acronym	Telemedicine comparison trial for hypertension
Scientific Title	Comparison of antihypertensive medical care using telemedicine vs. conventional therapy
Scientific Title:Acronym	Telemedicine comparison trial for hypertension
Region	Japan

Condition
Condition	Essential Hypertension
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Compare by achieved home blood pressure a conventional hypertensive medical care with telemedicine care using ICT-based non-face-to-face communication
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Home blood pressure after 1 year
Key secondary outcomes	1) Major adverse cardiovascular events (coronary events, hospitalization for heart failure, stroke, doubling of serum creatinine) 2) Adverse events 3) Vascular indices: Cardio-Ankle Vascular Index (CAVI), Augmentation Index (AI), Flow Mediated Dilation (FMD), Intima-Media Thickness (IMT), visceral fat area (DUALSCAN) 4) Laboratory data (blood and urine) 5) Questionnaires on quality of life and adherence

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Telemedicine group: after the initial assessment including a face-to-face interview, the participants will use network-attached sphigmomanometer to measure home blood pressure and consult physician by non-face-to-face communcation to adjust antihypertensive treatment for 12 months
Interventions/Control_2	Conventional therapy group will manually measure and record home blood pressure and visit clinics regularly to adjust antihypertensive treatment. The conventional therapy group will be compared to the intervention group after 1 year.
Interventions/Control_3
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Able to visit Tokyo Women's Medical University Hospital Department of Endocrinology and Hypertension for assessment 2) Wish to try non-face-to-face medical communication and telemedicine 3) Able to perform home blood pressure measurements 4) Age of 20 years or older at time of consent 5) Those with essential hypertension
Key exclusion criteria	1) Those who do not own a smartphone compatible with the telemedicine platform 2) Past history of coronary diseases 3) Those with diabetes mellitus, chronic kidney disease, history of stroke, or peripheral artery disease 4) Those classified as Category III according to the cardiovascular risk chart by Japan Atherosclerosis Society 5) Pregnant women and those with high possibility of becoming pregnant 6) Secondary hypertension, excluding idiopathic hyperaldosteronism and primary aldosteronism after adrenalectomy 7) Those judged by research administrator to be inappropriate for the study
Target sample size	450

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsuhiro Ichihara
Organization	Tokyo Women's Medical University
Division name	Department of Medicine II, Endocrinology and Hypertension
Zip code
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Email	atzichi@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 Medicine II, Endocrinology and Hypertension
Zip code
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Homepage URL	https://port-medical-bp.com/twmu-research
Email	jyatabe@endm.twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
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	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京女子医科大学病院（東京都）、TM内科クリニック西新宿（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 25 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	Completed
Date of protocol fixation	2016 Year 06 Month 14 Day
Date of IRB	2016 Year 06 Month 14 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 12 Month 22 Day
Last modified on	2021 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029170