RecruitingNAINTERVENTIONAL

Fatigue in Lupus Intervention Programmes (FLIP)

This study, called FLIP, is for people with Systemic Lupus Erythematosus (Lupus) who experience a lot of tiredness. Many people with Lupus find fatigue a big problem, and this study aims to find better ways to manage it. We want to see if online group sessions, either 4 or 7 weeks long, are more helpful than just a fatigue information booklet. These sessions are based on a type of therapy called cognitive behavioural approach, which has helped people with other similar conditions. The goal is to find a simple, affordable way for the NHS to support people with Lupus and their fatigue, making things easier for patients and reducing waiting times.

At a glance

Status

Recruiting

Phase

Sponsor

University of Edinburgh

Enrolment target

Start

08 Apr 2024

Estimated completion

01 Sep 2027

Systemic Lupus Erythematosus

What is this study about?

Imagine you have Lupus and feel constantly exhausted, even when you've rested. This tiredness, called fatigue, can really impact your life, making it hard to do everyday things. Sometimes, this fatigue isn't talked about enough in healthcare, and the support available can be very different from one place to another.

This study, called FLIP (Fatigue in Lupus Intervention Programmes), aims to change that. We want to find the best way to help people with Lupus manage their fatigue. We're looking at two main approaches: one is a simple booklet with information, and the other involves joining online group sessions. These group sessions are designed to teach you ways to understand and cope with your fatigue, similar to programmes that have helped people with tiredness from other conditions.

The study also compares two versions of the online group programme: a shorter 4-week course and a longer 7-week course. The idea is to see if a shorter programme can be just as helpful, which would mean less time commitment for you and potentially allow more people to get support sooner. All participants will answer questionnaires at different times to help us understand how well each approach is working. This pilot study is happening in Edinburgh and hopes to find a practical and affordable solution for the NHS to help everyone in the UK with Lupus who struggles with fatigue.

Key takeaways

This study explores better ways to manage severe tiredness in people with Lupus.
It compares an information booklet with online group fatigue management programmes.
The online programmes are either 4 or 7 weeks long, designed to teach coping strategies.
Participation involves answering online questionnaires and possibly joining online group sessions.
The aim is to find an effective and affordable solution for the NHS to help Lupus patients.
You can take part from home using a computer or smartphone.

Who may be eligible?

To join this study, you need to have a confirmed diagnosis of Systemic Lupus Erythematosus (Lupus). You must be 18 years old or older. It's really important that you've been experiencing significant tiredness for at least the last four weeks, specifically a fatigue impact score of 6 or more on a scale of 1 to 10 (where 10 is the worst).

You'll also need to be able to read and speak English well enough to take part in online group sessions. You should have access to a computer, smartphone, or tablet with internet so you can join video calls. We'll also ask if you're happy to use an NHS-approved online platform and to provide your contact details for the study.

You won't be able to join if you've already participated in a similar group programme for fatigue or pain management in the last five years. Also, if you're taking part in another medical trial that involves a treatment or intervention, you won't be eligible for this 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.

Have I been diagnosed with Systemic Lupus Erythematosus (Lupus)?
Am I 18 years old or older?
Have I felt very tired because of my Lupus for at least the last four weeks (fatigue score of 6 or more out of 10)?
Can I read and chat comfortably in English?
Do I have a computer, smartphone, or tablet with internet access for video calls?
Have I NOT attended a group programme for fatigue or pain management in the past five years?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first be asked to read some information and then give your consent (agreement) online. After that, you'll fill out some questionnaires about your personal details and how your fatigue affects you now. This is called your 'baseline' information.

Then, a computer will randomly assign you to one of three groups: you might only receive the fatigue information booklet (standard care), or you might receive the booklet plus either a 4-week or a 7-week online group programme. These group sessions will be live online. You'll complete the same questionnaires three more times after the first set, at different points during the study, to see how things change over time. All of this can be done from home using your computer or device.

Potential risks and benefits

Taking part in this study may offer you the benefit of learning new ways to manage your fatigue through the online group programmes or by receiving helpful information. This could potentially improve your daily life and how you cope with Lupus. The main 'risk' is the time commitment required to complete the questionnaires and, if assigned to a group, attend the online sessions. While we cannot guarantee an improvement in your fatigue, your participation will help us understand better ways to support people with Lupus in the future. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

NHS Lothian
Verified postcode
Edinburgh, United Kingdom· Recruiting

Common questions

What is Systemic Lupus Erythematosus (Lupus)?

Lupus is a long-term illness where your body's immune system, which normally fights infections, mistakenly attacks healthy parts of your own body.

What is 'fatigue' in this study?

Fatigue here means a deep, persistent tiredness that doesn't go away with rest and significantly affects your daily life due to your Lupus.

What are 'online group sessions'?

These are live video meetings with other people who have Lupus and a healthcare professional, where you'll learn strategies to manage fatigue together.

What does 'randomly assigned' mean?

It means a computer will decide which group you are in, like flipping a coin. You won't get to choose, and neither will the study team. This helps make the study fair.

Do I have to travel for this study?

No, all aspects of this study, including the online sessions and questionnaires, can be completed from your home.

How to find out more

Dervil M Dockrell, BSc Curr Occ

dervil.dockrell@ed.ac.uk 07762929927 Official trial record

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