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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025372
Receipt No. R000029170
Scientific Title Comparison of antihypertensive medical care using telemedicine vs. conventional therapy
Date of disclosure of the study information 2016/12/25
Last modified on 2016/12/21

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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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 01 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
2016 Year 12 Month 22 Day
Last modified on
2016 Year 12 Month 21 Day


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

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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