Not yet recruitingOBSERVATIONAL

Symptoms of Anxiety and/or Depression and SDM in Older Patients With CLTI

This study is about how symptoms of anxiety and depression impact older people who have a severe leg condition called Critical Limb Threatening Ischaemia (CLTI). When older patients with mental health issues have surgery, they can sometimes stay in hospital longer or need to be readmitted more often. Life-changing operations, like amputations, can also affect mental health. This research aims to understand how patients feel and how doctors and patients can make important healthcare decisions together, using a process called 'shared decision-making'. It hopes to improve how patients are supported and reduce any regrets they might have about their treatment choices.

At a glance

Status

Not yet recruiting

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

Start

01 Jun 2026

Estimated completion

01 Dec 2026

Critical Limb Threatening Ischaemia Depression Disorder Anxiety

What is this study about?

This research is looking into how anxiety and depression affect older people who have a serious condition called Critical Limb Threatening Ischaemia (CLTI). This is where blood flow to the legs is severely restricted.

We know that mental health issues are common in older people and are not always spotted. Studies have shown that older patients with anxiety or depression who have surgery, especially for conditions like CLTI, sometimes have a tougher time recovering. This can mean longer stays in hospital, or needing to be readmitted more often. Operations for CLTI can sometimes be life-changing, such as needing an amputation, which can also understandably affect a person's mental health and overall quality of life.

This study wants to understand this situation better by talking to older patients with CLTI about their experiences. It's also exploring 'shared decision-making', which is a way for patients and their doctors to work together. This means making healthcare choices based on the best evidence, while also considering what matters most to the patient and their personal preferences. By hearing directly from patients, researchers hope to improve how decisions are made, so that patients feel more involved, confident, and have fewer regrets about their treatment.

Key takeaways

This study focuses on older people (65+) with a serious leg condition and symptoms of anxiety or depression.
It aims to understand how mental health impacts surgical outcomes for CLTI.
The research explores how patients and doctors can make healthcare decisions together (shared decision-making).
It involves interviews to hear directly about patients' experiences.
The goal is to improve patient support and reduce regret about treatment choices.
Participation will not involve new medications or changes to your care.

Who may be eligible?

You might be able to take part in this study if you are 65 years old or older and have a serious leg condition called Critical Limb Threatening Ischaemia (CLTI), along with symptoms of anxiety or depression that a doctor has noticed.

This study also includes carers who look after someone meeting these criteria, and healthcare staff (like surgeons, nurses, or therapists) who provide care for older people with CLTI.

However, you cannot take part if your doctor feels you are nearing the end of your life (within about a month), or if the research team believes you aren't able to understand and make decisions about taking part in the study. Similarly, carers cannot take part if they are unable to understand the study, and staff need to be actively caring for older patients with CLTI.

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 65 years old or older?
Do you have Critical Limb Threatening Ischaemia (CLTI)?
Have you been told you have symptoms of anxiety or depression?
Are you able to understand information about taking part in a study?
(If a carer) Do you care for someone who meets the above? This person must be 65 or older and have CLTI and anxiety/depression symptoms.
(If staff) Do you provide care for older people with CLTI?

Answer every question to see your result.

What does participation involve?

This study is a qualitative study, which means it focuses on understanding experiences and perspectives rather than testing treatments. If you take part, you will be invited for an interview. These interviews are 'semi-structured', meaning there will be some planned questions, but also flexibility to discuss what is important to you. The interviews will explore topics related to your experiences with CLTI, mental health, and making decisions about your care. Some participants might also be invited to a workshop where different people can share ideas. The research team will do their best to make sure the interview questions are sensitive and appropriate for your background, and they can provide interpreters if needed. The total duration of your participation would involve the interview time and any follow-up discussions, but it won't involve taking any new medications or having additional medical assessments beyond your usual care.

Potential risks and benefits

Taking part in this study may offer you the benefit of sharing your experiences, which could help improve how older people with CLTI and mental health concerns are supported in the future. It could also help develop better ways for patients and doctors to make decisions together. There are no direct medical risks as this study doesn't involve new treatments, but you might find discussing your health and experiences emotionally challenging. You are always free to stop the interview at any time or withdraw from the study without giving a reason, and this will not affect your usual medical care.

Locations (1)

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

Guy's and St Thomas' NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is CLTI?

CLTI stands for Critical Limb Threatening Ischaemia. It's a serious condition where the blood flow to your legs is severely reduced, which can cause pain, sores, and sometimes lead to amputation.

What does 'shared decision-making' mean?

It's a way for doctors and patients to work together to make healthcare decisions. Your doctor gives you clear information about your options, and you share what matters most to you, so you can decide together.

Will I have to take any new medicines?

No, this study is about understanding experiences and talking about them. It does not involve taking any new medications or changing your current treatment plan.

How long will I need to be involved?

Your involvement will mainly be for an interview, which usually takes one to two hours. Some people might also be invited to a workshop.

Who is running this study?

This study is being carried out by researchers from Guy's and St Thomas' NHS Foundation Trust and University Hospitals of Leicester.

How to find out more

Bridget C Strasser, MBBS (Hons) MPHTM BSc

b.strasser@nhs.net +44 20 7188 7188 Official trial record

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