UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025372 |
|---|---|
| Receipt number | 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 | 2021/01/31 16:01:15 |
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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
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
jyatabe@endm.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029170
