Smartwatch monitoring for atrial fibrillation after stroke—The Pulsewatch Study: Protocol for a multiphase randomized controlled trial

• Published in: Cardiovascular digital health journal 2021-08, Vol.2 (4), p.231-241
• Main Authors: Dickson, Emily L., Ding, Eric Y., Saczynski, Jane S., Han, Dong, Moonis, Majaz, Fitzgibbons, Timothy P., Barton, Bruce, Chon, Ki, McManus, David D.
• Format: Article
• Language: English
• Subjects: Atrial fibrillation; Commercial wearable device; Photoplethysmography; Stroke; Study Design/Research Method
• ISSN: 2666-6936; 2666-6936
• DOI: 10.1016/j.cvdhj.2021.07.002

Atrial fibrillation (AF) is a common heart rhythm disorder that elevates stroke risk. Stroke survivors undergo routine heart rhythm monitoring for AF. Smartwatches are capable of AF detection and potentially can replace traditional cardiac monitoring in stroke patients. The goal of Pulsewatch is to assess the accuracy, usability, and adherence of a smartwatch-based AF detection system in stroke patients. The study will consist of two parts. Part I will have 6 focus groups with stroke patients, caretakers, and physicians, and a Hack-a-thon, to inform development of the Pulsewatch system. Part II is a randomized clinical trial with 2 phases designed to assess the accuracy and usability in the first phase (14 days) and adherence in the second phase (30 days). Participants will be randomized in a 3:1 ratio (intervention to control) for the first phase, and both arms will receive gold-standard electrocardiographic (ECG) monitoring. The intervention group additionally will receive a smartphone/smartwatch dyad with the Pulsewatch applications. Upon completion of 14 days, participants will be re-randomized in a 1:1 ratio. The intervention group will receive the Pulsewatch system and a handheld ECG device, while the control group will be passively monitored. Participants will complete questionnaires at enrollment and at 14- and 44-day follow-up visits to assess various psychosocial measures and health behaviors. Part I was completed in August 2019. Enrollment for Part II began September 2019, with expected completion by the end of 2021. Pulsewatch aims to demonstrate that a smartwatch can be accurate for real-time AF detection, and that older stroke patients will find the system usable and will adhere to monitoring.