All studies
RecruitingNAINTERVENTIONAL

Safety of AI-Powered Virtual Assistant in Outpatient Management of Heart Failure

This research is investigating if a new virtual assistant called SIRIO-HF can make a real difference for people who have recently been diagnosed with heart failure and have just left the hospital. We're testing if this assistant can help manage their condition at home, potentially reducing the number of extra doctor's appointments and the overall burden on the healthcare system. The main goals are to see if it helps consistently improve care and if patients are happy with it, all while making sure it's completely safe and doesn't affect the quality of their care.

At a glance

Status
Recruiting
Phase
NA
Sponsor
East and North Hertfordshire NHS Trust
Enrolment target
60
Start
07 May 2024
Estimated completion
13 Sep 2027

What is this study about?

Heart failure is a condition where your heart isn't pumping blood as well as it should. This study is for people who have recently been diagnosed with heart failure and have just come home from the hospital. The main idea is to see if a special computer program, like a virtual assistant called SIRIO-HF, can help look after you at home. This assistant is designed to help manage your condition and provide guidance.

We want to find out if using this virtual assistant can reduce how often you need to visit the doctor or hospital. It could also help make sure everyone gets a similar, good standard of care. We'll also be checking if people using the assistant are generally happy with it. Most importantly, we will be carefully monitoring to ensure that using this assistant is just as safe as usual care and that the quality of your overall care is not affected.

This is a 'pilot' study, which means it's a smaller, early test to see if the idea works well and is safe before thinking about larger studies in the future. Your involvement could help us understand new ways to support people living with heart failure.

Key takeaways

  • This study explores a new virtual assistant for heart failure care.
  • It's for people recently diagnosed and discharged from hospital.
  • Aims to reduce clinic visits and improve care satisfaction.
  • Focuses on safety and quality of care.
  • You will receive either the virtual assistant alongside usual care, or usual care alone.

Who may be eligible?

To join this study, you must be at least 18 years old. You also need to have been recently diagnosed with heart failure and have shown certain symptoms (doctors describe these as 'New York Heart Association class II-III symptoms') around the time you left the hospital.

There are also some reasons why you might not be able to join. For example, if you already know you've had heart failure for a long time, this study might not be suitable for you. Also, if you have other very serious health problems that might make it hard for you to follow the study's instructions, or if you have another condition like severe lung disease that causes similar symptoms to heart failure, you wouldn't be able to take part.

People with memory problems, such as dementia, or who are already involved in another medical study that involves receiving a new treatment, would also not be able to join this particular 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.

  1. Are you 18 years old or older?
  2. Have you recently been diagnosed with heart failure?
  3. Have you just left the hospital after your heart failure diagnosis?
  4. Do you not have a long history of heart failure?
  5. Do you not have severe memory problems like dementia?
Answer every question to see your result.

What does participation involve?

If you take part, you'll be randomly put into one of two groups. One group will use the SIRIO-HF virtual assistant alongside their usual care, and the other group will continue with their standard medical care. We won't know which group you're in, and neither will you at first. You'll likely have your usual medical appointments and check-ups, and we'll gather information about your health and how you're feeling over time. The study will last for a certain period, and we will let you know the exact length if you are suitable to take part. There are no new medications given as part of this study.

Potential risks and benefits

Taking part in a study like this might offer the benefit of trying a new approach to managing your heart failure, which could potentially mean fewer clinic visits if it works well. However, as with any new technology, there could be unexpected issues or technical problems with the virtual assistant. Our priority is your safety and quality of care, so we will be carefully monitoring everyone involved. Remember, you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • East and North Hertfordshire NHS Trust
    Verified postcode
    Stevenage, United Kingdom· Recruiting

Common questions

What is a 'virtual assistant'?

A virtual assistant is like a computer program or app that can help provide information and support, similar to an online helper, to assist you with managing your heart failure.

Will this study change my current heart failure treatment?

No, this study is looking at an additional tool (the virtual assistant) alongside your usual care. Your doctor will still manage your main heart failure treatment.

Do I have to live near the hospital to join?

The study is for people managing their heart failure at home after being discharged. Specific requirements will be discussed with you, but the aim is often to reduce clinic visits.

How long will I be in the study?

The exact duration will be explained if you are invited to join. Pilot studies tend to be for a shorter period to test the initial idea.

What happens if I don't like using the virtual assistant?

You are free to leave the study at any time, for any reason, without affecting your regular medical care. Your comfort with the study is important.

How to find out more

Joshua H Leader, MBChB, BSc

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Safety of AI-Powered Virtual Assistant in Outpatient Managem…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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