Accu-rate
Research type
Research Study
Full title
How accurate are home blood pressure monitors used by patients?
IRAS ID
127686
Contact name
James Hodgkinson
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
The primary aim of this research is to determine how accurate are home digital upper arm and wrist blood pressure monitors.
Secondary aims:
To find out which digital blood pressure monitors are currently used by patients; how well they perform; is there any evidence of decreasing accuracy over time, or with greater usage, or by validation status, or cost (recommended retail price) of device.The primary outcome measure is the proportion of monitors with <3mmHg error (indicating accuracy) compared to a reference device throughout testing.
The population to be recruited from is people are on the hypertension register who use home BP monitors.
According to QOF data 2011/2012 the prevalence of people with hypertension is 13.5%. Therefore per 7000 patients we expect 945 (approximately) to be on the hypertension register. Of these patients we assume 30% to self monitor their blood pressure at home. From a previous study (TASMIN-SR) it was found that 24% of patients recruited into the trial used a home blood pressure monitor, and rates of self-monitoring have increased subsequently.
Practices will be recruited through the CRN-PC. Once recruited, computer searches of practice clinical computer systems will be run to identify patients who are on the hypertension register. Searches will be conducted by practice staff, with support and assistance from a researcher from the University of Birmingham or CRN-PC. The GP will remove from the list patients that would be inappropriate (e.g. those suffering from terminal illness). They are unlikely to know for sure who is self-monitoring.
The practice will then send a letter asking eligible patients if they are interested in having their monitor tested for accuracy. Those who respond (by telephone or post) will be asked to drop off their monitor to the practice on a prearranged day. Monitors will be tested and returned to participants with results within 2 weeks.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0828
Date of REC Opinion
9 Nov 2015
REC opinion
Further Information Favourable Opinion