A multicentre trial to assess the validity of the Kardia six-lead hand-held ECG in psychiatry
This study aims to make heart checks easier for people on certain mental health medications. Some medications can affect the heart, so regular heart tracings (ECGs) are important. Traditional ECGs can be difficult for some, especially if they feel anxious or find it hard to lie still or undress. This study investigates a new, small device called Kardia 6L. You just place your fingers on it and touch your knee or ankle. We want to see if this new device works as well as the standard hospital ECG in mental health services. Our goal is to improve safety, reduce clinic visits, and make the experience better for patients.
At a glance
What is this study about?
When you take certain medicines for your mental health, doctors sometimes need to check how your heart is working. This is usually done with a heart tracing called an ECG (electrocardiogram). A standard ECG involves sticking small pads on your chest, wrists, and ankles, and you need to lie still. For some people, this can be uncomfortable or difficult, especially if they are feeling unwell, anxious, or don't like to undress.
This study is looking at a new, handheld device called Kardia 6L. It's about the size of a credit card, and you can get a heart tracing by simply placing your fingers on it and touching your knee or ankle. The results are then sent to a phone via Bluetooth. We believe this new device could make it much easier for people to get the heart checks they need, which means fewer trips to the doctor, less waiting, and a more comfortable experience overall.
We've already seen that this new device works well in hospital heart clinics. Now, we want to find out how well it works for people in mental health services. By finding a simpler way to do these important heart checks, we hope to improve patient safety and make sure everyone gets the care they need without extra stress or delays.
Key takeaways
- This study is testing an easier way to get heart checks for people on mental health medication.
- It compares a new, small device (Kardia 6L) with the standard hospital heart test (ECG).
- Taking part involves one short visit to have two heart tests and answer two questions.
- There are no new medicines or risks involved in this study.
- Your participation could help make heart checks better and simpler for many patients in the future.
Who may be eligible?
This study is open to adults aged 18 and over who have been prescribed or are about to be prescribed certain medications for mental health conditions, called antipsychotics. This includes people whether they are staying in hospital or seeing doctors in a clinic.
Unfortunately, you won't be able to join the study if you are under 18 years old. Also, if you aren't able to give your consent (permission) to take part and there isn't a family member or close friend who can advise on your behalf, or if that person feels you wouldn't want to participate, then you also won't be able to join this study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been prescribed or are you about to be prescribed an antipsychotic medication?
- Can you provide your own permission to join the study?
- If you can't, is there a close family member or friend who can advise on your behalf and thinks you'd want to join?
What does participation involve?
If you decide to take part, you'll first be asked for your permission. We will then ask for some personal details and your health history, which will be gathered from your medical notes and by talking to you. We'll also measure your height and weight. You will then have two heart tracings: first, a standard hospital ECG, and very soon after (within 2 minutes), an ECG using the new Kardia 6L device. A specially trained nurse or research assistant will carry out these tests. They will note how long each test takes. After the tests, you'll be asked two simple questions about which machine you would prefer to use again and why. This is a one-off visit, and the whole process should not take too much time.
Potential risks and benefits
Locations (9)
- Leeds and York Partnership NHS Foundation TrustCity onlyLeeds, England
- Tees, Esk and Wear Valleys NHS Foundation TrustCity onlyDarlington, England
- Kent and Medway Mental Health NHS TrustCity onlyMaidstone, England
- Essex Partnership University NHS Foundation TrustApproximateWickford, England
- Humber Teaching NHS Foundation TrustCity onlyHull, England
- Bradford District Care NHS Foundation TrustCity onlyShipley, England
- Cambridgeshire and Peterborough NHS Foundation TrustCity onlyCambridge, England
- Surrey and Borders Partnership NHS Foundation TrustCity onlyLeatherhead, England
- Hampshire and Isle of Wight Healthcare NHS Foundation TrustCity onlySouthampton, England
Common questions
What is an ECG?
An ECG is a simple, painless test that checks your heart's electrical activity. It shows how fast your heart is beating and if it's beating normally.
Why do people taking mental health medication need ECGs?
Some mental health medications can affect your heart, so doctors use ECGs to make sure your heart is healthy enough to take them safely.
Will I have to take any new medicines in this study?
No, you will not be given any new medicines or treatments as part of this study. It's only about comparing two ways of doing a heart tracing.
How long will my involvement in the study last?
Your involvement in the study will only be for one visit, where you will have the heart tests and answer a couple of questions.
What happens to my information?
Your information will be kept confidential and used to understand how well the new heart monitor works. It will help improve care for others.
How to find out more
Nazya Azam
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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