Unique ID issued by UMIN | UMIN000040953 |
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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 |
Usefulness of telemedicine in hypertensive outpatients: Cluster randomized controlled trial
Usefulness of telemedicine in hypertensive outpatients: Cluster randomized controlled trial
Usefulness of telemedicine in hypertensive outpatients: Cluster randomized controlled trial
Usefulness of telemedicine in hypertensive outpatients: Cluster randomized controlled trial
Japan |
Hypertension
Cardiology |
Others
NO
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.
Safety,Efficacy
Confirmatory
Changes in systolic blood pressure (value after 6 months vs baseline)
Patient satisfaction and economic analysis in medicine
Interventional
Parallel
Randomized
Cluster
Open -no one is blinded
No treatment
2
Treatment
Other |
Intervention group: Telemedicine at the 3rd month from the baseline.
Control group: Face-to-face outpatient service at the 3rd month from the baseline.
20 | years-old | <= |
Not applicable |
Male and Female
(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
(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
70
1st name | Yuji |
Middle name | |
Last name | Nishizaki |
Juntendo University
Medical Technology Innovation Center
113-8431
2-1-1, Hongo, Bunkyo-ku, Tokyo
03-3813-3111
ynishiza@juntendo.ac.jp
1st name | Yuji |
Middle name | |
Last name | Nishizaki |
Juntendo University
Medical Technology Innovation Center
113-8431
2-1-1, Hongo, Bunkyo-ku, Tokyo
03-3813-3111
ynishiza@juntendo.ac.jp
Juntendo University
Ministry of Health, Labor and Welfare
Japanese Governmental office
Juntendo University Hospital Ethics Committee
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan
03-5802-1584
kenkyu5858@juntendo.ac.jp
NO
・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)
2020 | Year | 07 | Month | 31 | Day |
https://cardio.jmir.org/2023/1/e45230
Published
https://cardio.jmir.org/2023/1/e45230
64
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.
2023 | Year | 07 | Month | 18 | Day |
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.
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.
There were no adverse events in either group.
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.
Completed
2020 | Year | 04 | Month | 08 | Day |
2020 | Year | 05 | Month | 29 | Day |
2020 | Year | 05 | Month | 29 | Day |
2021 | Year | 09 | Month | 30 | Day |
2020 | Year | 06 | Month | 30 | Day |
2023 | Year | 07 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046687
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