Novel pulse device for diagnosis of PAD (NOTEPAD)
Research type
Research Study
Full title
Innovative photoplethysmography technology for rapid non-invasive assessment of peripheral arterial disease in primary care (NOTEPAD)
IRAS ID
164338
Contact name
John Allen
Contact email
Sponsor organisation
R&D Officer
Duration of Study in the UK
1 years, 5 months, 15 days
Research summary
Peripheral arterial disease (PAD) is common affecting about 5% of western populations aged 55 and 74 years. PAD can cause leg pain and may cause ulcers or gangrene. Patients are about six times more likely to suffer a heart attack or stroke than those without the condition. Detecting PAD early allows its risk factors to be controlled but currently there are no devices which general practitioners can easily use to diagnose PAD. The Ankle Brachial Pressure Index (ABPI) test has been recommended but is time consuming and few healthcare professionals have been properly trained in the technique.
This study will test a newly developed PAD detector device called MPPG which is comfortable for patients and easy to use in any clinical setting. Pilot studies have indicated that it substantially agrees with the currently recommended ABPI assessments and this study hopes to show that the MPPG is as good if not better than ABPI in a GP clinic setting.
To do this the study will comprise of 2 parts. The first will assess the diagnostic performance of MPPG. Patients will be recruited from within GP practices and will attend an appointment where both an MPPG and ABPI assessment will be performed. Data from both assessments will then be analysed by the research team.
Patients recruited will include both patients with PAD and matched controls – it is important to include matched controls as we need to ensure that the MPPG machine can detect those without PAD as well as those with PAD.
The qualitative component of the study will explore views of the MPPG through interviews with patients and general practice staff. Patients will be asked about their experience and the acceptability of the device and staff about feasibility and ease of use of the device, and views on the training in the use of MPPG. The training sessions will be observed. Staff will also be observed using the device with their and the patient’s consent.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
14/NE/1238
Date of REC Opinion
13 Jan 2015
REC opinion
Further Information Favourable Opinion