An Oxford trial to detect atrial fibrillation has been designed to include as many eligible people as possible, including those who rarely interact with the healthcare system or take part in clinical trials.
Working with 27 general practice surgeries, the AMALFI study, which is funded by the NIHR Oxford Biomedical Research Centre (BRC), has recruited more than 5,000 participants across the Thames Valley, West Midlands and West of England, which provides a diverse mix of geographical locations, including both urban and rural settings.
Its streamlined ‘light-touch’ design is aimed at making it as easy as possible for people to take part in the trial. The fact that there are no study visits – and therefore no need to travel – makes the study less onerous for people on low incomes, who are socially disadvantaged, those with mobility issues, those living in remote areas and people with caring responsibilities.
Atrial fibrillation (AF) is a heart condition that affects one in ten people over the age of 65. It causes an irregular and often abnormally fast heart rate, which may lead to dizziness or shortness of breath. However, there are sometimes no symptoms, and a person may be unaware they have the condition. People with AF are more at risk of having a stroke.
AMALFI (Active Monitoring for AtriaL FIbrillation), which is run by researchers at the University of Oxford’s Clinical Trial Service Unit (CTSU), the Division of Cardiovascular Medicine and the Nuffield Department of Primary Care Health Sciences, is investigating the possible benefits of screening people using a new Zio Patch monitor to detect AF.
Professor Louise Bowman, Chief Investigator of the AMALFI study, says: “Our overarching aim in designing the trial as we did was to address the simple question: is it worthwhile to carry out routine screening for undiagnosed atrial fibrillation on a population basis? If it is, it has to be achievable, so it has to be simple.
“We were investigating the scientific question about whether screening with the patch monitor has clinical benefit, but also the reality of will people actually do it? And they did.”
Potential participants were identified from primary care records; eligibility criteria were simply those aged over 65 with cardiovascular risk factors. Participation did not require a referral by healthcare staff or for the participant to attend a care appointment. All communication with the participants has been by post or telephone, to remove any barriers due to digital exclusion.
Professor Bowman (pictured left) noted that most of the recruitment took place during the COVID pandemic: “It was a trial that absolutely flew when most other trials were struggling because non-COVID trials in hospitals had to be halted as patients couldn’t get to hospital and nurses were deployed to other duties. AMALFI carried on and excelled in spite of the pandemic.”
“We wanted the trial to be as inclusive as possible, so there was no filtering. As long as they met the trial criteria in terms of age and medical conditions, they were invited. So, it was absolutely everybody – they didn’t have to be online, didn’t have to be of any particular ethnicity, didn’t have to travel.”
Those who agree to take part are sent the trial information by post, and once they have read it, can give their consent remotely. They are then posted the Zio patch device, which has clear instructions included so that they can put it on themselves, or ask someone to put it on for them.
Once they have finished with the device, they take it off, put it in a box that has been provided and post it back to the study team. When the data has been analysed, the results are sent back to the patient directly and a copy to the GP.
Dr Nick Jones is a GP in Oxford who helped to design and conduct the trial. A number of his patients participated in AMALFI. He says: “The study was deliberately designed to make it accessible. The majority of patients we have recruited don’t have to leave their home to take part. Recruitment is intentionally aimed at people who are at high risk of AF, who tend to be fairly frail, older people with other medical conditions. We hoped that designing the study this way would make it easier for people to take part.”
“It’s a very light-touch trial so it’s easy to participate if you live in a remote community. It’s unlike a lot of studies where there’s an emphasis on in-person assessments and follow-up.”
Participants who test negative for AF are simply notified by letter. Those who are diagnosed with AF might then be asked by their GP to come in for a face-to-face assessment and further tests.
Dr Jones says he had spoken to study participants who have been positive about the fact they found it was a very simple process, the patch was easy to use, and they liked the idea of being screened for a high-risk condition.
Dr Jones adds that the study design has been welcomed by busy GP surgeries: “Some studies ask a lot more of them. We purposefully tried to ensure that as much as possible went through the trial team – and that has a beneficial knock-on effect for patients.
“The practices that are often the busiest – in the areas of biggest deprivation – are often the least likely to want to take part in a very hands-on study. We really wanted this to be a study that would be good for their patients but that would not take up too much of their time, and that’s been really appreciated.”
Professor Bowman says one of the intentions of the trial was to inform a possible national screening programme for AF.
“If this trial is shown to be worthwhile, it would be lovely to think it could inform those kinds of decisions at a national level. That’s why we had to make it very simple and user-friendly, and not requiring lots of additional resources.”
Professor Barbara Casadei, the Oxford BRC’s Theme Lead for Cardiovascular Medicine, who co-leads the study, added: “AMALFI is a good example of how to obtain reliable evidence at low cost in a representative population with minimal interference in the participants’ family and working life.
“Not surprisingly, AMALFI has a higher-than-average percentage of female participants – around 50 percent – than is usually seen in cardiovascular trials (typically 20-30 percent). The streamlined design of AMALFI offers an inclusive and sustainable alternative to traditional randomised controlled trials.”