How accurate are home blood pressure monitors used by patients?

Completed

• Conditions: Topic: Primary Care; Subtopic: Primary Care; Disease: All Diseases; Circulatory System; Hypertension

• Registration Number: ISRCTN12562576
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-17
• Study Completion: 2016-12-31
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 385

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br>2. Association between mean absolute error and:<br>1. Number of usages of device<br>2. Length of time in service of device<br>3. Validation status of device<br>4. Recommended retail price of device