Real World Evaluation of Lifelight®: A contactless vital signs monitor for selfmonitoring blood pressure

Research question: Is Lifelight® non-inferior to a home blood pressure cuff for helping people with diagnosed hypertension to control their blood pressure? Background: Cardiovascular disease (CVD) is the most common cause of mortality. Blood pressure (BP) is the best single physiological indicator to control to reduce CVD risk.

Home blood pressure monitoring (HBPM) can help improve BP, however, 45.8% of hypertensive patients do not own a BP cuff. Of those who do, few use the cuffs frequently or correctly. Lifelight® is the world s first contactless medical device for measuring BP and other vital signs.

Its contactless and software nature means it overcomes the issues of conventional methods for measuring vital signs that currently make regular HBPM difficult or unappealing.

Its advantages means people with hypertension may monitor their BP more frequently and thus be more likely to control it to safe levels. Aims and Objectives: Collect real-world data to test the feasibility of Lifelight® for clinically effective HBPM.

The study's primary endpoint is to demonstrate non-inferiority of Lifelight® in comparison to a BP cuff for controlling BP within 3 months. With these data, minor improvements will be made to the app.

Additionally, test the feasibility of the methodology used to assess the clinical effectiveness of Lifelight®, including the process for engaging patients and the public in the research. The insights gained will inform plans for a future randomised control trial.

Methods: Real-world, two-arm non-inferiority feasibility study called VISION-RWE in which 5 GP surgeries and 5 pharmacies will recruit 350 people diagnosed with hypertension.

The study will generate data to assess the clinical effectiveness, adherence, acceptability, quality of life, and practical feasibility of HBPM using Lifelight® compared to a popular, standard-of-care BP cuff. In an alternating fashion, participants will be allocated to either 1. HBPM using a cuff for 3 months and then using Lifelight® for 3 months, or 2.

HBPM using Lifelight® for 3 months and then using a cuff for 3 months. BP at baseline, after 3 months and after 6 months will be compared.

Questionnaire data inputted by participants into the app at regular intervals will inform the study secondary endpoints.

Timelines: 24-month project in which the first 9 months will prepare for VISION-RWE, the next 6 months will deliver the study, and the final 9 months will maximise study impact.

Impact and Dissemination: Peer-reviewed publications in prominent journals will include a study protocol publication and a study results publication.

A PPI methodologies publication will present novel insights on the process for engaging patients and the public in community-based health technology research.

With input from the Barts PPI team, the VISION-RWE website, social media, newsletter and case study materials will regularly disseminate study progress and outcomes in lay terms.

Data emerging from VISION-RWE will refine understanding of the health economics for the NHS to make Lifelight® available to patients with diagnosed hypertension (7 million in the UK).

The potential avoided costs to health and social care is estimated (with assumptions) to be £58 million over 10-years.