Active not recruitingOBSERVATIONAL

FIT Study (Functional Outcomes In Trauma Study)

The FIT Study is looking at how people recover after major injuries, often called 'trauma'. These are serious injuries that can affect many parts of the body. We don't know much in the UK about how people truly get on after these types of injuries. This study aims to fill that gap by asking people about their physical and mental health, and how well they can do daily activities, work, and hobbies. By gathering this information through online questionnaires and interviews, researchers hope to understand what helps people recover and what challenges they face. This will help doctors and healthcare professionals improve the care and support they offer to future patients with similar injuries, leading to better long-term outcomes and a better quality of life for everyone.

At a glance

Status

Active not recruiting

Sponsor

The Leeds Teaching Hospitals NHS Trust

Enrolment target

440

Start

10 Aug 2020

Estimated completion

01 Sep 2032

Patient Reported Outcome Measures Recovery of Function Rehabilitation Disability Evaluation Trauma Centers Trauma Severity Indices Advanced Trauma Life Support Care Multiple Trauma/Injuries Wounds and Injuries Orthopedic Disorder Surgery

What is this study about?

Imagine you've had a very serious accident – a 'major trauma' – which means you have significant injuries, possibly affecting several parts of your body. When you leave the hospital, what happens next? How well do you recover, not just physically, but emotionally and socially too? Do you get back to your job, your hobbies, and your daily life activities as you did before? This is what the FIT Study wants to find out.

In the UK, we don't have a lot of detailed information about how people truly recover and live their lives months or even years after serious injuries. This study aims to change that. By understanding the real-life experiences of people who have been through major trauma, including what helps them get better and what challenges they face, doctors and healthcare teams can learn how to provide even better care in the future. The ultimate goal is to help future patients recover more fully and have a better quality of life.

The study will look at two groups of people: those who have recently had serious injuries and those who had them some years ago. Researchers will ask them about their experiences using online questionnaires and some will also be invited for a chat. This will help them understand how recovery changes over time and what matters most to patients. This research is important because it's driven by what patients say they need, which can directly lead to improvements in how we care for people after major injuries.

Key takeaways

The study helps understand recovery after serious injuries.
Participation involves filling out online questionnaires about your health and daily life.
You might be asked to continue for up to 10 years to track long-term recovery.
Your input directly contributes to improving care for future patients.
All participation is online, no hospital visits required.
You can stop participating at any time without affecting your care.

Who may be eligible?

To join this study, you need to be between 18 and 65 years old. You must also have had a serious injury – a 'major trauma' – that doctors have identified as significant. This usually means injuries that affected several parts of your body.

There are a few reasons why someone might not be able to join. For example, if you have a memory condition like dementia, or if you're not in a physical or mental state to understand and agree to take part. Also, if your injuries only affected your head, or if you're already in another research study that might conflict with this one, you wouldn't be able to join.

It's also important that you have access to a device (like a computer or smartphone) that can connect to the internet to complete online questionnaires, and you need to have a good understanding of English to take part.

Quick self-check

Are you between 18 and 65 years old?
Have you had a serious injury (major trauma) as assessed by doctors?
Are you able to use a computer or smartphone to access the internet?
Do you understand English well enough to read and answer questionnaires?
Are you able to understand what the study involves and give your permission to take part?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in the FIT Study involves filling out online questionnaires. These questionnaires will ask you about your physical health, your feelings, and how well you're managing daily activities, work, and your social life after your injury. You’ll complete these using a special online service. Some questions will be multiple choice, and others will let you write in your own words how you’re doing and what’s affecting your recovery.

A selection of participants will also be invited for a more in-depth interview. This interview will be a chance to talk more about your experiences, how your trauma has affected you, and how you found being part of the study. Initially, the study will last for at least 12 months for those who recently had injuries. For those who had injuries a few years ago, data will be collected at the same time.

After the initial phase, you might be invited to continue completing questionnaires once a year for up to 10 years after your injury. This helps the researchers understand long-term recovery. There are no visits to a clinic involved or taking any medication as part of this study.

Potential risks and benefits

Participating in this study offers several potential benefits. By sharing your experience, you'll be directly contributing to valuable research that aims to improve care for future patients with serious injuries. Your feedback will help healthcare professionals better understand long-term recovery and develop more effective support. The main 'risk' is that some questions about your recovery might bring up difficult memories or feelings, but you can choose to skip any question you don't wish to answer. Your information will be kept confidential, and you are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Leeds teaching Hospitals
Leeds, United Kingdom

Common questions

What is 'major trauma'?

'Major trauma' means you've had very serious injuries, often affecting several parts of your body, like after a bad accident. It's not just a single, less serious injury.

How long will I be involved in the study?

Initially, you'll be involved for about 12 months by filling out questionnaires. You might then be asked if you'd like to continue doing them once a year for up to 10 years after your injury.

Do I have to go to the hospital for this study?

No, all your participation, including questionnaires and potential interviews, will be done online from your own home. There are no hospital visits for the study.

Will my answers be kept private?

Yes, all your information is kept confidential. Your individual answers will not be shared in a way that identifies you.

What happens with the study results?

The researchers will share what they learn from the study with you, and they also plan to publish the findings in medical journals to help other doctors and researchers.