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Vitaliti Continuous Vital Signs Monitor User-Testing Protocol: VERDICT-2

The VERDICT-2 study is looking at a new device called the Vitaliti Continuous Vital Signs Monitor. This device is worn on the body and can constantly check important health signs like your heart rate, breathing, and temperature. We're testing it with people who have recently had surgery and are now recovering at home. We also want to hear from their family members who might be helping them, and the doctors and nurses looking after them. The main goal is to find out how well people accept the device, what their experience is like using it, and if it's comfortable to wear. We also want feedback on how it fits into the healthcare routine. The aim is to improve care after surgery by using technology that can give real-time health updates to medical staff, potentially helping to spot problems early.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
Hamilton Health Sciences Corporation
Enrolment target
45
Start
01 Jun 2024
Estimated completion
01 Sep 2024
Surgery

What is this study about?

Imagine leaving the hospital after surgery, but still having a 'guardian angel' watching over your health from afar. That's a bit like what the Vitaliti Continuous Vital Signs Monitor aims to do. This study is testing a new wearable device that can keep an eye on your key health numbers, sometimes called 'vital signs,' all the time, even when you're at home. These vital signs include things like your blood pressure, how quickly your heart is beating (pulse), your breathing speed, your body temperature, and the amount of oxygen in your blood.

After surgery, some people can face challenges, and it's sometimes hard to notice a problem developing until it's more serious. This new technology is designed to automatically collect your health information and, if needed, alert your healthcare team in real-time. This could help doctors and nurses spot potential issues earlier, possibly preventing a return to the hospital or an emergency visit. It's similar to how technology has made surgery itself safer and better over the years.

The VERDICT-2 study is all about trying out this new Vitaliti device with real people. We want to know what it's like to wear it every day after surgery. We'll be asking people who've had surgery, their family members who support them, and the nurses and doctors involved in their care about their experiences. Your feedback will be really important in helping us understand if this device is easy and comfortable to use, and how it could best fit into the way we look after patients once they leave the hospital.

Key takeaways

  • This study tests a new wearable device for monitoring vital signs after surgery.
  • It aims to understand how easy it is to use for patients, families, and healthcare staff.
  • Participation involves wearing the device and sharing your experiences.
  • Your feedback will help improve care for future surgical patients.
  • You can stop taking part at any time without affecting your medical care.

Who may be eligible?

This study is looking for people aged 45 or older who are having a non-heart-related surgery under general anaesthetic or a regional numbing injection. You should expect to stay in the hospital for at least two nights after your operation. To join, you also need to meet one of a few health conditions, such as having a history of heart disease or stroke, or have several risk factors like needing major surgery or having high blood pressure.

We also need to make sure you can understand what the device does and can talk to the research team. If you have severe allergies to sticky plasters, use a hearing aid or cochlear implant, or have difficulties that would prevent you from using the device or completing surveys, you unfortunately won't be able to take part.

Family members or carers can also take part if they are over 18, live with the patient or are closely involved in their recovery, and can understand and communicate well. We're also inviting nurses and doctors from Hamilton Health Sciences who look after patients around the time of surgery to join.

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 45 years old or older?
  2. Are you having a non-heart surgery where you'll stay in hospital for at least two nights afterwards?
  3. Do you have a history of conditions like heart disease, stroke, or several risk factors for heart problems?
  4. Do you feel you can understand and communicate about using a new device?
  5. Are you able to wear something with adhesive on your skin?
  6. Do you or your family member live with the patient or help with their recovery (for carer participants)?
Answer every question to see your result.

What does participation involve?

Taking part in this study means you would wear the Vitaliti device after your surgery. We will ask you and your family member (if they're also participating) to share your experiences and provide feedback on how easy and comfortable the device is to use. This will involve completing some surveys and potentially having conversations or interviews with the research team. Doctors and nurses will also give their feedback on working with the device.

The main steps are: agreeing to take part by signing a consent form, using the device as instructed, and then giving your opinions on it. There are no extra hospital visits specifically for this study beyond your usual post-surgery care. We are interested in your experience during your recovery period at home. The exact total duration of your involvement will be discussed with you, but it focuses on your post-surgical recovery.

Potential risks and benefits

A potential benefit of taking part is contributing to the development of new technology that could significantly improve care for future surgical patients, by allowing earlier detection of potential problems after surgery. For individuals, there isn't a direct medical benefit as the device is being tested for user experience, but some might find comfort in the continuous monitoring. As with any device worn on the skin, there's a small risk of skin irritation from adhesives. You can choose to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • McMaster University
    Verified postcode
    Hamilton, Canada

Common questions

What is the Vitaliti device?

It's a wearable device that continuously monitors your vital signs like heart rate, breathing, and temperature after surgery.

Who can take part in this study?

Adults aged 45 or over having certain non-heart surgeries, plus their family members and healthcare staff.

Will this device change my surgery or recovery?

No, the study is about testing the device's usability, not your surgical treatment. Your medical care will remain the same.

What do I need to do if I join?

You'll wear the device after surgery and share your feedback on how it feels and works through surveys or interviews.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care.

How to find out more

Official trial record

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 "Vitaliti Continuous Vital Signs Monitor User-Testing Protoco…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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