Evaluating the use of a Remote Tele-home Monitoring and Management Hypertension Program for Patients Receiving Virtual Care: A Pilot Randomized Controlled Trial

OHSN-REB #20210851-01H

ClinicalTrials.gov ID: NCT05300503 

This innovative single-center randomized controlled pilot study addresses the challenges of managing hypertension (HTN) in the virtual care era. HTN is the leading cause of death and disability worldwide, significantly increasing the risk of cardiovascular disease. The COVID-19 pandemic accelerated the shift to virtual care, limiting access to reliable blood pressure (BP) monitoring and creating barriers to effective HTN management. Heart Institute patients who meet eligibility criteria and provide informed consent will be randomized (1:1) to one of the two study arms: (1) interactive BP monitor and enrollment in the Telehome Monitoring Program, or (2) usual care by their clinician. Participants who are are in the interventional arm will be provided with the telehome monitoring equipment to transmit their BP readings to the Heart Institute nursing team for real-time management over a 3-month duration. The nurses adjust BP medications based on advanced medical directives every 2 weeks if needed. Those in usual care will continue their usual day to day activities and take their current medication as directed, but are encouraged to track their BP daily and record any symptoms they may be feeling for the 3-month duration. Participants are seen for clinic appointments at the 3-month timepoint upon completion of study group, and again at 6-months to assess maintenance of intervention effects.

The primary outcome measure is the results of 24-hour ambulatory BP test completed by all participants at baseline, 3-months, and 6-months. This measure will provide insight on the change in BP response in both study arms at baseline versus the 3-month timepoint following completion of the intervention. The 24-hour ambulatory BP test will be repeated again at the 6-month mark to assess if there is maintenance of the intervention effects over time. 

Secondary goals focus on reducing healthcare utilization, preventing adverse cardiovascular events, and demonstrating the cost-effectiveness of this scalable intervention. The study leverages cutting-edge technology to create a practical, patient-centered solution for hypertension management, aiming to enhance long-term health outcomes and reduce the burden of hypertension across Canada.