Can TElemedicine System Replace Doctor Consultations to Achieve Non-inferior Blood Pressure in Patients With Controlled Hypertension

Официальное название

Can TElemedicine System Replace Doctor Consultations to Achieve Non-inferior Blood Pressure in Patients With Controlled Hypertension (TEACH)? a Randomised Controlled Trial and Cost-minimization Analysis

Обзор

The goal of this clinical trial is to evaluate whether patients assigned to the telemedicine (HealthCap) group demonstrate non-inferior blood pressure (BP) control compared to patients in the usual care group at 12 months. The main question it aims to answer is: * Do participants in telemedicine group have non-inferior daytime ambulatory blood pressure readings at 12-month, compared to usual care group? * Do participants in telemedicine group have better HT treatment, higher self-efficacy, reduced number of visits to primary care clinics and similar health care utilisation other than GOPCs, compared to usual care group? Participant in telemedicine group will: * Receive reminders to measure 7-day home blood pressure before their index consultation. * Get their drug refilled automatically as well as have consultations deferred 16-18 weeks later, if their blood pressure is under optimal control. * Have consultations as scheduled, if their BP is suboptimal or any of the safety questions screen positive. Participants in control group will: * Have consultation with physicians every 16-18 weeks.

Вмешательства

• Устройство Telemedicine
  a mobile app and telemedicine platform to confirm good blood pressure control and may save doctor face-to-face consultation
• Другое Usual care
  Participants will be followed up as usual by face-to-face consultation with the doctors

Первичные конечные точки

• daytime systolic blood pressure [Срок оценки: from the enrollment at 12-months]

Вторичные конечные точки (12)

• Ambulatory blood pressure readings [Срок оценки: from enrollment at 6-month]
• Ambulatory blood pressure readings [Срок оценки: from enrollment at 12-month]
• Treatment adherence [Срок оценки: from enrollment at 6-month and 12-month]
• Self-efficacy [Срок оценки: from enrollment at 6 month and 12 month]
• Satisfaction with HealthCap [Срок оценки: from enrollment at 12 month]
• Acceptability [Срок оценки: from enrollment at 12-month]
• Health-related quality of life [Срок оценки: from enrollment at 6-month and 12-month]
• serum creatinine [Срок оценки: from enrollment at 12 month]
• Body weight [Срок оценки: from enrollment at 12 month]
• Height [Срок оценки: from enrollment at 12 month]
• Total cholesterol level [Срок оценки: from enrollment at 12 month]
• Total triglyceride level [Срок оценки: from enrollment at 12 month]

Критерии участия

Критерии включения

• (i) having a diagnosis of essential HT;
• (ii) on anti-HT medications;
• (iii) well-controlled HT on out-of-office BP measurements, including HBPM or ambulatory blood pressure measurements (ABPM) (measurement algorithm and details under methods). ABPM or HBPM are preferred to office BP due to their superior reproducibility and predictivity to cardiovascular outcomes. Furthermore, office BP misclassifies 30-40% of patients as having suboptimal BP control due to white-coat effect. From our pilot study, some patients with optimal BP are reluctant to undergo ABPM before recruitment into the RCT, and HBPM is more acceptable to these patients and is therefore included. According to local and international guidelines, optimal out-of-office daytime BP should be \<135/85 mmHg for patients without comorbidities and \<130/85 mmHg for patients with comorbidities that increase cardiovascular risk (i.e. stroke, ischaemic heart diseases, heart failure, diabetes mellitus (DM), and chronic kidney diseases) respectively;
• (iv) can read basic Chinese (language used in the HealthCap);
• (v) have used any mobile app (not HT-related) in the previous 1 year; and
• (vii) aged between 18-80.

Критерии исключения

• (i) cannot provide informed consent;
• (ii) unwillingness to conduct HBPM or repeated ABPM;
• (iii) relative contraindications to ABPM (i.e., diagnosed atrial fibrillation, nighttime workers, occupational drivers, or patients with bleeding tendencies);
• (iv) have severe mental illnesses that impair their ability to use HealthCap, including those diagnosed with schizophrenia, dementia, or as being actively suicidal;
• (v) a diagnosis of other acute or chronic diseases that need regular physical assessments and/or medication changes (e.g., suboptimally controlled DM \[e.g., glycosylated haemoglobin (HbA1c)≥7%\], depression requiring medications, active cancer); and (vi) predicted lifespan of \<1 year.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• HKW and NTEC GOPC — Гонконг

Публикации

• Ng SN, Yip BH, Wang S, Leung M, Choi SYK, Leung SY, Han JJ, Tsui WW, Lai SY, Chan L, Mihailidou AS, McManus RJ, Sy J, Lee EK. Can TElemedicine system replace doctor consultations to Achieve non-inferior blood pressure in patients with Controlled Hypertension (TEACH)? Study protocol for a randomised controlled trial. Trials. 2025 Dec 8;27(1):31. doi: 10.1186/s13063-025-09350-3. PMID 41361824

Идентификаторы

NCT: NCT06524180 · 2023.525

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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