VISION-RWE (Real World Evaluation)
Research type
Research Study
Full title
Real World Evaluation of Lifelight®: A contactless vital signs monitor for self-monitoring blood pressure and its comparison to standard of care : The VISION-RWE study
IRAS ID
321955
Contact name
Laurence Pearce
Contact email
Sponsor organisation
Xim Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 30 days
Research summary
The VISION-RWE study aims to test whether a novel software-based blood pressure (BP) monitor called Lifelight is as good as the conventional method of home blood pressure monitoring for helping people with high BP keep their blood pressure at safe levels. Lifelight allows patients to monitor their blood pressure contactlessly, without needing to do any calibration and using only their smartphone. The conventional method is a popular upper-arm blood pressure cuff and monitor.
Study participants (18 yrs & older) will be patients with high blood pressure who are not at target for their blood pressure control. 500 participants will be recruited and monitored at William Harvey Clinical Research Centre, Barts Health NHS Trust. 250 participants will be provided Lifelight and the other 250 will be provided a standard blood pressure cuff and monitor. They will be asked to use these devices to monitor their blood pressure for at least 1 week each month, lasting for 6 months. They will be seen in the clinic 3 times (at the beginning, after 3 months and after 6 months) as part of the study for study nurses to evaluate if their blood pressure control is improving by self-monitoring as they progress through the study.
Participants will note down the home blood pressure measurements they make in between these clinic visits in a paper diary. They will also record their experiences of using the traditional cuff-based blood pressure monitor or smartphone app assigned to them, details about any GP visits, hospital admissions etc that they have while they are in the study in this same diary. They will complete questionnaires about their quality of life, lifestyle and blood pressure monitoring habits in a questionnaire booklet on 3 occasions. Some participants using Lifelight will be invited to have an interview about their experiences in the study.REC name
London - Dulwich Research Ethics Committee
REC reference
24/LO/0528
Date of REC Opinion
29 Aug 2024
REC opinion
Further Information Favourable Opinion