Condition category
Circulatory System
Date applied
17/03/2016
Date assigned
17/03/2016
Last edited
14/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The heart is responsible for pumping blood around the body to deliver oxygen-rich blood. In order to do this a certain amount of pressure is needed in the blood vessels, but if this pressure is too high, then it puts a great strain on the arteries and heart. This is called hypertension (high blood pressure), which is very common and often long-term (chronic). Many people with hypertension are unaware of it, as it rarely causes any noticeable symptoms. If left untreated however, it dramatically increases the risk of heart disease, kidney disease and stroke, earning it the nickname of the “silent killer”. It is therefore very important to monitor these people in order to ensure that they do not develop these complications. There is a wide range of blood pressure monitors available for use at home, although it is not known how accurate the measurements are. The aim of this study is to find out how well home blood pressure monitors work at measuring blood pressure.

Who can participate?
Adults with high blood pressure who own a home blood pressure monitor.

What does the study involve?
Participants are sent a letter by their GP practice asking if they would like to have their home blood pressure monitor tested for accuracy. Those who respond are asked to drop off their blood pressure monitor to their practice on a prearranged day. Monitors are tested and returned to participants, complete with testing results, within 2 weeks. The study team tests the patients’ blood pressure monitors using the OMRON PA350 digital BP tester (a specialised piece of equipment designed to measure how accurately blood pressure monitors can measure pressure). Monitors are inflated following a standard process as recommended by each monitor manufacturer and the British Hypertension Society. Monitors that have a 3mmHg or greater difference from the PA350 reading at any blood pressure level are rated as having failed. The study team also assess whether cuffs are working properly.

What are the possible benefits and risks of participating?
Participants will benefit from learning how accurate their home blood pressure monitor is and so it can be replaced if it is inaccurate. There are no direct risks of taking part, although some participants may find it difficult not having their monitor available while it is being tested.

Where is the study run from?
The testing takes place at the University of Birmingham and participants are recruited from GP practices in the Midlands (UK)

When is the study starting and how long is it expected to run for?
February 2016 to December 2016

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr James Hodgkinson
j.a.hodgkinson@bham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr James Hodgkinson

ORCID ID

Contact details

University of Birmingham
Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 1214 148842
j.a.hodgkinson@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20163

Study information

Scientific title

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

Acronym

ACCU-RATE

Study hypothesis

Primary aim:
To determine how accurate are home digital upper arm and wrist blood pressure monitors.

Secondary aims:
1. To find out which digital blood pressure monitors are currently used by patients
2. How well they perform;
3. Is there any evidence of decreasing accuracy over time, or with greater usage, or by validation status, or cost (recommended retail price) of device

Ethics approval

15/NW/0828

Study design

Non-randomised diagnostic accuracy study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Primary Care; Subtopic: Primary Care; Disease: All Diseases

Intervention

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 practice on a prearranged day. Monitors will be tested and returned to participants with results within 2 weeks.

The procedure will be to test patients’ blood pressure (BP) monitors using the OMRON PA350 digital BP tester. Monitors will be inflated following a standard process as recommended by each monitor manufacturer and the British Hypertension Society, with a pass rate of +/- 3mmHg or less from the PA350 reading.

Intervention type

Other

Phase

Drug names

Primary outcome measures

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

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

Overall trial start date

11/02/2016

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 385; UK Sample Size 385

Participant 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

Recruitment start date

11/02/2016

Recruitment end date

31/10/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
Department of Primary Care & General Practice Primary Care Clinical Sciences Building Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Department of Primary Care & General Practice
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication of study findings (at the aggregate level) in a peer reviewed journal, and at an academic conference (most likely SAPC). All participants will receive the full results for their own monitor, and a copy of the overall (aggregate) results if they wish.

Intention to publish date

31/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Verified study information with principal investigator.