UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040953
Receipt number 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 2023/07/18 10:49:16

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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 or person

Institute

Juntendo University

Institute

Department

Personal name



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

https://cardio.jmir.org/2023/1/e45230

Publication of results

Published


Result

URL related to results and publications

https://cardio.jmir.org/2023/1/e45230

Number of participants that the trial has enrolled

64

Results

Blood pressure control status and safety did not differ between the intervention and control groups. In-person visits at 6-month intervals may cause a societal cost reduction and improve patient satisfaction during video-based telemedicine.

Results date posted

2023 Year 07 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The mean age of participants was 54.5 (SD 10.3) years, and 60.9% (39/64) of the participants were male. Patient characteristics, including diabetes, dyslipidemia, smoking, alcohol drinking, and family history of hypertension, did not significantly differ between the 2 groups. However, the use of antihypertensive medication was significantly different between these groups.

Participant flow

Physicians recruited the patients during their first in-person visits. After recruitment by a physician, each patient spoke with a clinical research assistant who used an explanatory document to outline the study to the patient. The originally planned patient enrollment period was 3 months, but the COVID-19 pandemic led to some delays; hence, the patient enrollment period was extended to 8 months. The registration period for the first half group (3 clinics) was from May 29, 2020, to January 31, 2021, and that for the second half group (5 clinics) was from July 31, 2020, to March 31, 2021. Notably, the follow-up period for both groups was 6 months. Follow-up was planned for the 3rd and 6th months after patient enrollment. Overall, 31 and 33 patients were included in the intervention and control groups, respectively. However, 1 patient in the control group dropped out of the study before the 3-month visit after withdrawing consent.

Adverse events

There were no adverse events in either group.

Outcome measures

The primary end point of the study was the change in systolic blood pressure (6-month value - baseline value). Secondary end points were the treatment continuation rate at 6 months, patient satisfaction ratings (Ministry of Health, Labor, and Welfare [MHLW] survey for behavior at the outpatient visit [Question 15], and EuroQol 5 Dimensions 5 Level [EQ-5D-5L]), a health economic evaluation, and a safety evaluation (adverse events). Furthermore, we examined whether the patient attended in-person visits for hypertension management outside the scheduled timing.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

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 09 Month 30 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

2023 Year 07 Month 18 Day



Link to view the page

Value
https://center6.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