About this trial
A randomised controlled trial for comparison of real-world feasibility and clinical outcomes of two different methods of home blood pressure monitoring Participants aged 18 years or over with diagnosed and treated hypertension (including via lifestyle interventions) that is not controlled (i.e. in-clinic measurement is 140/90 mmHg or greater) will be recruited from hypertension hospital clinics
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Established diagnosis of hypertension
Uncontrolled hypertension defined as office blood pressure ≥140/90mmHg.
Patients who are pharmacologically treated for their hypertension should have been on stable medication for at least 4 weeks.
Disqualifiers
Patients with stage III hypertension with office blood pressure ≥180/120mmHg or it is unsafe to keep them in the study, in the opinion of the investigators.
Individuals with diagnosed atrial fibrillation.
Patients with significant arrhythmias such as SVT (Supraventricular tachycardia) or any rhythm that has significant impact on their BP, poor perfusion, pregnancy, pre-eclampsia, deformities or abnormalities which may prevent proper application of a BP cuff, or skin disorders (anaemia, jaundice, rosacea, psoriasis, acute acne, and erythropoietic protoporphyria)
Participants who are unwilling to undertake self-monitoring or lacking capacity.
Trial design
Parallel
Treatments tested in this trial
Lifelight
DeviceContactless Vital Signs Measurement via RPPG
Blood Pressure Cuff
DeviceStandard Blood Pressure Cuff Digital
Treatment groups
Trial outcomes
Primary outcomes
Blood Pressure Measurement Non Inferiority
Demonstrate non-inferiority of Lifelight® HBPM compared to cuff-based HBPM for achieving blood pressure control. (5 mmHg non-inferiority margin)
Secondary outcomes
Adherance to Blood Pressure Measurement
Determine acceptability and adherence of Lifelight® for HBPM in comparison to cuff-based HBPM methods.
Sponsors and contacts
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Xim Limited
Lead sponsor
Barts & The London NHS Trust
Collaborator
Mind Over Matter Medtech Ltd
Collaborator
Health Innovation Wessex
Collaborator