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How accurate are home blood pressure monitors used by patients?

Accuracy of patient-owned blood pressure monitors compared to Omron PA350 monitor checker

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12562576
Enrollment
385
Registered
2016-03-17
Start date
2016-02-11
Completion date
Unknown
Last updated
2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Primary Care

Interventions

Eligible patients are sent a letter asking 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 p

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The inclusion criteria to receive the one page survey are: Patients on the hypertension register. The additional inclusion criteria for the monitor testing element: 1. Patients owning blood pressure monitors used at home 2. Participant is willing to take part in the study

Exclusion criteria

Exclusion criteria: Exclusion criteria for the monitor testing element: 1. Unable to provide consent 2. Patients who do not use home blood pressure monitors 3. Housebound patients who are unable to arrange for their monitor to be dropped off at the practice

Design outcomes

Primary

MeasureTime frame
Blood pressure monitor accuracy is determined by recording the proportion of devices with <3mmHg error compared to reference device (PA 350) at all BP ranges.

Secondary

MeasureTime frame
1. Mean, standard deviation, median and interquartile range of mean absolute error (MAE) – i.e. the mean difference between the values reported by the test device and reference device over the pressure ranges tested. 2. Association between mean absolute error and: 1. Number of usages of device 2. Length of time in service of device 3. Validation status of device 4. Recommended retail price of device

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026