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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040953
Receipt No. R000046687
Scientific Title Usefulness of telemedicine in hypertensive outpatients: Cluster randomized controlled trial
Date of disclosure of the study information 2020/07/31
Last modified on 2020/06/30

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Basic information
Public title Usefulness of telemedicine in hypertensive outpatients: Cluster randomized controlled trial
Acronym Usefulness of telemedicine in hypertensive outpatients: Cluster randomized controlled trial
Scientific Title Usefulness of telemedicine in hypertensive outpatients: Cluster randomized controlled trial
Scientific Title:Acronym Usefulness of telemedicine in hypertensive outpatients: Cluster randomized controlled trial
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is verification of the need for face-to-face medical treatment once every three months, which is a requirement for online medical fees.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in systolic blood pressure (value after 6 months vs baseline)
Key secondary outcomes Patient satisfaction and economic analysis in medicine

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Intervention group: Telemedicine at the 3rd month from the baseline.
Interventions/Control_2 Control group: Face-to-face outpatient service at the 3rd month from the baseline.
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) Adult patients receiving outpatient telemedicine and adult patients who will start outpatient telemedicine
(2) Adult patients who have been diagnosed with essential hypertension and are prescribed antihypertensive drugs for 3 months or more
(3) Adult patients with stable hypertension and co-morbidities (no change in prescription of antihypertensive drug for 3 months)
(4) Adult patients who can visit the clinic 3 and 6 months after registration
(5) Those who have taken a sufficient explanation to participate in this research, and have a sufficient understanding and consent
Key exclusion criteria (1) Patients with drug allergy
(2) Pregnant patients
(3) Patients who can not undertaken telemedicine, such as those with visual impairment
(4) Patients with end stage renal failure
(5) Cancer receiving chemotherapy
(6) Patients with chronic respiratory disease such as obstructive pulmonary disease with home oxygen therapy
(7) Patients participating in other clinical trials
(8) Patients who need frequent outpatient visit such as blood tests
(9) Patients who the principal investigator and co-investigators judged to be medically or scientifically inappropriate to participate in the study
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Yuji
Middle name
Last name Nishizaki
Organization Juntendo University
Division name Medical Technology Innovation Center
Zip code 113-8431
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email ynishiza@juntendo.ac.jp

Public contact
Name of contact person
1st name Yuji
Middle name
Last name Nishizaki
Organization Juntendo University
Division name Medical Technology Innovation Center
Zip code 113-8431
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email ynishiza@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University Hospital Ethics Committee
Address 3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
Tel 03-5802-1584
Email kenkyu5858@juntendo.ac.jp

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 ・大林クリニック(栃木県)
・九段下駅前ココクリニック(東京都)
・外房こどもクリニック(千葉県)
・赤坂おだやかクリニック(東京都)
・おだやかライフ内科クリニック(埼玉県)
・南砂町おだやかクリニック(東京都)
・中野島糖尿病クリニック(神奈川県)
・長尾医院(広島県)

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 31 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
2020 Year 04 Month 08 Day
Date of IRB
2020 Year 05 Month 29 Day
Anticipated trial start date
2020 Year 05 Month 29 Day
Last follow-up date
2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 06 Month 30 Day
Last modified on
2020 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046687

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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