RecruitingInterventional

Holistic approach for improving the care of people with multiple conditions after critical illness

This study is testing a new support program called HARMONISE for people who have been seriously ill and spent time in intensive care (ICU), especially those with other health problems. After leaving the hospital, many people face challenges like weakness, sadness, and memory issues. Currently, support varies across the UK. HARMONISE aims to help people with multiple health conditions smoothly move from hospital back home. We want to see if this program can be easily used in local communities and if patients and their families find it helpful. The study will compare those who get usual care with those who get the HARMONISE program, measuring things like physical and mental health. This could lead to better support for ICU survivors across the country.

At a glance

Status

Recruiting

Sponsor

Queen's University Belfast

Enrolment target

Start

05 Sep 2025

Estimated completion

01 Feb 2028

Sequalae of critical illness

What is this study about?

Many people who are very sick and spend time in an intensive care unit (ICU) need extra help when they go home. They might feel weak, sad, or have trouble with their memory. If someone also has other ongoing health problems, managing all of this can be even harder. Right now in the UK, the support people receive after leaving the ICU can be very different depending on where they live, and often there isn't much support available when they get back home. This can make their existing health problems worse and sometimes even lead to them needing to go back to the hospital.

Our team has created a special program called HARMONISE. It's designed to give extra support to people who have been in ICU and have other health conditions, helping them get back on their feet after leaving the hospital. We want to find out if this program can be successfully used in local communities, and most importantly, if it's something that patients and their families find helpful and easy to use.

By taking part, you would help us understand if HARMONISE could be a valuable new way to support people like you. The information we gather will help us decide if we should do an even bigger study to see if the HARMONISE program can truly improve people's health and happiness, reduce how often they need to go back to hospital, and generally make life better for intensive care survivors across the UK.

Key takeaways

Researchers are testing a new support program (HARMONISE) for people after intensive care.
The study focuses on survivors with two or more long-term health conditions.
It aims to make the move from hospital to home easier and improve recovery.
Participation involves questionnaires and a simple fitness test over 6 months.
You'll be randomly assigned to either usual care or usual care plus HARMONISE.
The goal is to see if HARMONISE is practical and helpful for patients and families.

Who may be eligible?

This study is looking for adults aged 18 or over. You would need to have recently been in the Intensive Care Unit (ICU) for at least two days. Importantly, you should also have two or more ongoing health conditions, like diabetes or heart disease.

There are a few reasons why someone might not be able to join. For example, if you can't understand or agree to take part, or if your doctors think you have less than six months to live. Also, if you're going to a special rehabilitation centre or a nursing home directly after leaving the hospital, this study might not be suitable for you.

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 recently been in Intensive Care (ICU) for at least 2 days?
Do you have two or more ongoing health conditions?
Are you able to understand and agree to take part in the study?
Are you NOT going directly to a rehabilitation unit or nursing home after discharge?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll first be asked to sign a consent form, which means you agree to take part. We'll also ask you to complete some questionnaires about your physical and mental health and how you feel about your life after ICU – this usually takes about 30 minutes. You'll also do a simple standing and sitting test to check your fitness. These questionnaires and tests will be done at the start, then again at 6 weeks and 6 months.

After these initial checks, you'll be randomly placed into one of two groups. One group will receive the usual care you would get from your GP and hospital. The other group will receive usual care plus the HARMONISE support program for up to 6 weeks after leaving hospital. With your permission, we might also ask your family or carers, and your healthcare providers, to share their thoughts through questionnaires or interviews. Some meetings with the HARMONISE team might be recorded to help us understand what worked well. The study is expected to run from February 2024 to August 2028, and your individual participation will involve assessments over several months.

Potential risks and benefits

We can't promise that you will personally feel better by taking part in this study. However, the information we learn will be very helpful for planning bigger studies that could improve care for many other patients in the future. The main benefit is helping to shape a potentially new and better way to support people after critical illness, which could include reducing hospital readmissions and improving quality of life, strength, and emotional wellbeing. We don't expect any serious risks. You might find completing the questionnaires a bit inconvenient, and occasionally, talking about your experiences could be upsetting. Our trained staff are there to provide support if this happens. Remember, you are free to stop participating at any time without explaining why.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Belfast Health and Social Care Trust
City only
Belfast, United Kingdom

Common questions

What is 'critical illness'?

Critical illness means you were very poorly and needed intensive care in hospital, often needing special equipment or monitoring to help you recover.

What does 'multimorbidity' mean?

Multimorbidity means having two or more long-term health conditions at the same time, like diabetes and heart disease.

What is 'randomised'?

Being 'randomised' means you are put into one of the study groups by chance, like flipping a coin. Neither you nor the researchers choose which group you're in.

Will I have to travel for this study?

Participants will be recruited from hospitals in Northern Ireland. The study activities, including the HARMONISE program, will take place in people's homes after they leave the hospital.

What if I feel uncomfortable during the study?

Our specialist staff are fully trained to provide support and help if you find any part of the study, like questionnaires or discussions, upsetting.

How to find out more

Jonathan Stewart

jstewart52@qub.ac.uk +44 (0)7845043006 Official trial record

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