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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Hypertension

Treatments: Other: Usual care; Device: Telemedicine

Study type: Interventional

Funder types: Other

Identifiers

NCT06524180

2023.525

Details and patient eligibility

About

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.

Enrollment: 364 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (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.

Exclusion criteria

• (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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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364 participants in 2 patient groups

Telemedicine

Experimental group

Description:

Patients will be (i) given a validated HBPM device (ORMON HEM-7120) with appropriate cuff size, (ii) taught the HBPM technique, and (iii) taught to record HBPM readings using the HealthCap mobile app on their smartphones. Participants randomized to intervention will be reminded to take dual BP readings in the morning and evening for 1-2 weeks before the index consultation. These BP readings will be automatically sent to a computer at the clinic. When the HBPM mean is optimal (i.e., \<135/85 mmHg or \<130/80 mmHg \[for patients with cardiovascular diseases, renal diseases, and DM\]), other parameters will be checked using an online questionnaire. If no complaints are identified, the patient will have automatic drug refill and the physician appointment will be deferred for 16-18 weeks.

Treatment:

Device: Telemedicine

Usual care

Active Comparator group

Description:

Participants will continue receiving routine care, including anti-HT drug prescriptions, from their regular clinicians. In HK, patients with well-controlled HT are routinely seen every 16-18 weeks. Participants will also be given the same HBPM devices and taught the techniques. This is necessary because HBPM is a secondary outcome. According to the HK guidelines, all patients with HT are advised to regularly monitor their home BP, which can be considered as usual care.14 However, the patients will not be taught any BP measurement algorithm (such as that used in the telemedicine group). They will also be asked not to download or use any new HT mobile apps during the study period. In HK, all citizens have unlimited access to GOPCs and emergency departments for health problems. All participants are advised to seek medical help if BP becomes dangerously and persistently high (i.e. SBP ≥180 or DBP ≥110mmHg) or in case of any suspected medical emergencies.

Treatment:

Other: Usual care