Can TElemedicine System Replace Doctor Consultations to Achieve Non-inferior Blood Pressure in Patients With Controlled Hypertension
Recruiting
N/AInterventional Study
Hypertension
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
364 (estimated)
Sponsor
Chinese University of Hong Kong · Other
Who this trial is looking for
This trial is looking for adults with high blood pressure who are already managing their condition with medication. Participants will use a telemedicine system to help monitor their blood pressure and may have fewer in-person visits with their doctor.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with high blood pressure.
I am taking medication for high blood pressure.
My blood pressure is well-controlled outside of the doctor's office.
I can read basic Chinese.
I have used a mobile app in the past year.
I am between 18 and 80 years old.
You may not be able to join if
I cannot provide informed consent.
I do not want to measure my blood pressure at home.
I have certain health issues that prevent me from using blood pressure monitoring.
I have a severe mental illness that affects my ability to use the system.
I have other serious health conditions that need regular check-ups.
I am not expected to live for more than one year.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility Criteria
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 …
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.
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