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

BACKGROUND: Hypertension is the most prevalent chronic condition and is the leading cause of cardiovascular diseases, imposing enormous burdens on the healthcare system. Although telemedicine may provide improved blood pressure (BP) monitoring and control, it remains unclear whether it could replace face-to-face consultations for patients with optimal BP control. Thus, the primary objective of this study is to investigate whether participants assigned to the telemedicine group show non-inferior BP control compared to the usual care group at 12 months. METHODS: This randomised controlled trial (RCT) will involve 364 patients receiving anti-HT medications who have well-controlled BP on out-of-office BP measurements, including HBPM or ambulatory blood pressure measurements (ABPM). Participants will be randomised to either the telemedicine (HealthCap) group or usual care (control) group (1:1). Patients in the intervention group will measure and transmit their 7-day home BP measurements (HBPM) to the physician's office. The medications will be refilled without consultation when optimal control (<135/85 mmHg for patients without comorbidities and <130/80 mmHg for patients with comorbidities that increase cardiovascular risk) and safety questions are confirmed. Nevertheless, if any of the answers in the safety questions are positive or the HBPM mean is suboptimal, patients will have consultations as planned. Investigators will be blinded to the randomisation sequence and allocation. The primary outcome is the daytime ABPM systolic BP at 12 months. Secondary outcomes include HT treatment adherence, self-efficacy, number of visits to primary care clinics where they have clinical follow-up, health care utilisation other than general outpatient clinics (GOPCs) in both arms at baseline, 6 months, and 12 months. Acceptability will be assessed through interviews with the telemedicine study participants and the physician. DISCUSSION AND SIGNIFICANCE: This trial will examine whether patients in the telemedicine group would have non-inferior BP control compared to patients in the usual care group. It has the potential to change clinical practice and have important research implications because patients with optimal BP can monitor their BP through a telemedicine system and will have fewer frequent clinical visits. This will empower primary care and allow effective and safe allocation of scarce medical resources to patients in need. Moreover, it will save patients time because of the long wait to see doctors and collect medications in GOPCs. It is also encouraging the engagement of patients in their health because they will play a proactive role in managing their chronic illnesses. TRIAL REGISTRATION: ClinicalTrials.gov NCT06524180. Registered on July 29, 2024. https://clinicaltrials.gov/study/NCT06524180?term=NCT06524180&rank=1#more-information .