Evaluating the implementation of the blood pressure monitoring program based on smart wearable devices (BPMP-SWD) of intravenous thrombolysis for acute ischemic stroke: Protocol for a randomized controlled trial

Abstract Background It is recommended that blood pressure (BP) in patients with acute ischemic stroke (AIS) should be monitored closely before and until 24 hours after thrombolysis. The guideline adherence to BP monitoring in clinical practice can be influenced by a variety of factors. Interventions integrated with knowledge on influencing factors have been widely used to improve guideline adherence. Aim To evaluate if the BP monitoring program based on smart wearable devices (BPMP-SWD) can improve the adherence of intravenous thrombolytic (IVT) care in patients with AIS. Methods This study is a prospective, open-label, endpoint-blinded, single-center, randomized controlled trial, randomized in a 1:1 ratio to either the control or intervention group at a comprehensive stroke center. The BP in the control group will be monitored using a conventional bedside monitoring device and the intervention group will be monitored using a smart wearable device. The primary outcome is the guideline adherence to BP monitoring for IVT. The secondary outcomes include the feasibility, fidelity and acceptance of smart wearable devices. Based on pilot data, a total of 160 patients with AIS undergoing IVT will be recruited. Discussion This study may provide novel evidence on improving the adherence to intravenous thrombolytic BP monitoring and support the wider implementation of smart wearable devices-based intervention to promote evidence-based practice. Trial registration The Chinese Clinical Trial Registry ChiCTR2300069063 (Date of registration 03.06.2023)