Study of telemedicine in the treatment of hyperetension

JRCT ID: jRCT1022220042

Registered date:08/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hypertension
• Date of first enrollment: 28/01/2023
• Target sample size: 234
• Study type: Interventional

Intervention(s)

Intervention 1: Monitoring staff will refer to the transmitted electromagnetic records from time to time, and send information such as frequency of measurements and advice on medical care via text chat.
Intervention 2: Monitoring staff will refer to the transmitted electromagnetic records from time to time and send information such as frequency of measurements and medical advice via text chat. The online physician will refer to the transmitted home blood pressure data from time to time and provide online medical care when he/she decides that antihypertensive measures should be strengthened or weakened.

Outcome(s)

• Primary Outcome: Percentage of patients achieving antihypertensive goal (mean morning and night systolic blood pressure <125 mmHg) based on average home systolic blood pressure for 7 days from the last day of 6 months after enrollment.

Secondary Outcome

(1) Average systolic blood pressure at home for the first 7 days of the month (by morning and night)
(2) Home diastolic blood pressure averages for the first 7 days of the month (by morning and night)
(3) Difference (amount of change) between home systolic blood pressure averages for the first 7 days of the study and for the last 7 days of the study 6 months after enrollment
(4) Interval between visits to the hospital
(5) Weight and activity level
(6) Treatment details
(7) Side effects and adverse events (self-reported)
(8) Various blood and urine laboratory tests

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

(1) Men and women between the ages of 40 and 75 at the time consent is obtained
(2) Patients with persistent hypertension (home systolic blood pressure averaging 135 mmHg or higher for all 5 days, confirmed by blood pressure diary)
(3) Untreated for more than 4 weeks or prescription has not been changed for more than 4 weeks
(4) Able to measure blood pressure at home
(5) Own a smartphone with access to the Telemedies application
(6) Have written consent

Exclude criteria

(1) Patients who cannot measure their blood pressure at home
(2) Patients who have been diagnosed with heart failure, angina pectoris, or post-myocardial infarction
(3) Patients with bilateral carotid artery stenosis or main cerebral artery occlusion
(4) Patients with chronic kidney disease (eGFR < 60 mL/min/1.73 m2) with urine protein negative (< 0.15 g/gCr in urine at any time)
(5) Pregnant women
(6) Plasma aldosterone concentration (CLEIA method)/plasma renin activity ratio >= 200 (except for patients diagnosed with idiopathic aldosteronism)
(7) Patients with secondary hypertension (except for patients diagnosed with idiopathic aldosteronism and patients with primary aldosteronism after treatment for aldosterone-producing adenomas)
(8) Patients with atrial fibrillation
(9) Patients with drug dependence or psychiatric disorders
(10) Patients participating in other clinical trials
(11) Patients with other serious diseases
(12) Other patients deemed inappropriate as subjects by the principal investigator.

Related Information

• Primary Sponsor: Hashimoto Shigeatsu
• Secondary Sponsor: Yatabe Junichi