All studies
CompletedNot ApplicableInterventional

REFUEL-MS: Clinical and Cost-Effectiveness RCT

The REFUEL-MS study is testing a new app designed to help people with Multiple Sclerosis (MS) who experience fatigue. Even though fatigue is common in MS, many don't get treatment for it. The REFUEL-MS app includes physical activities, balance exercises, and techniques to help manage thoughts and feelings related to fatigue (like CBT). It's patient-led, meaning you can choose what areas to focus on and set your goals, with support from a healthcare professional. We want to find out if this app works better than standard care at reducing MS fatigue and if it's safe. We’re especially keen to include people often missed in research, like older adults, men, and those from different ethnic backgrounds.

At a glance

Status
Completed
Phase
Not Applicable
Enrolment target
378
Start
21 Aug 2025
Estimated completion
05 Mar 2026

What is this study about?

Many people living with Multiple Sclerosis (MS) find that tiredness, or fatigue, is a big problem for them. However, not everyone gets help for it as part of their routine care. This study is about testing a new app called REFUEL-MS, which was created with input from people with MS themselves. The app is designed to help reduce that feeling of extreme tiredness. It offers different tools like physical activities, balance exercises, and ways to manage thoughts and feelings (similar to a technique called Cognitive Behavioural Therapy, or CBT). Past research suggests these types of approaches can be helpful for MS fatigue.

The main goal of this study is to see how well the REFUEL-MS app works to reduce MS-related fatigue compared to the usual care you might receive. We also want to make sure it's safe to use. The app is a bit special because it's 'patient-led'. This means you can choose what parts of the app are most helpful for you, like focusing on physical exercise or coping strategies. You can also set your own goals and keep track of your progress. Plus, a healthcare professional will be there to support you through virtual appointments and messages in the app. It's important to remember that the REFUEL-MS app is meant to be an extra tool and won't replace any medical care you’re already getting for your MS.

We are looking for 378 people with MS from across the UK to take part. We're particularly interested in including people who might not usually get involved in MS research, such as older people, men, those from LGBTQ+ communities, different ethnic backgrounds, or those with varying levels of disability or digital experience. If you don't have a suitable smartphone or tablet, we can lend you one for the study. By taking part, you could help us find new ways to improve treatment for MS fatigue and contribute to future research.

Key takeaways

  • The study tests an app (REFUEL-MS) to help manage MS fatigue.
  • It involves physical activity, balance, and coping strategies.
  • Participation lasts 16 weeks, with follow-up questionnaires for 12 months.
  • You'll get support from a healthcare professional via the app.
  • If you don't have a device, one can be loaned to you.
  • Taking part could help improve future treatments for MS fatigue.

Who may be eligible?

You might be able to join this study if you are 18 years old or older and have been officially diagnosed with Multiple Sclerosis. You also need to be able to read and communicate in English and live in England, Wales, or Scotland. Importantly, you should be experiencing fatigue (tiredness) and be able to see and use a smartphone or tablet.

However, there are some reasons why you might not be able to take part. For example, if you are already involved in another programme for managing fatigue through exercise or therapy. Also, if you’ve recently started a new MS treatment (within the last 6 months) or a new antidepressant or fatigue medicine (within the last 3 months), you’d need to wait a bit before joining.

We also can't include you if you're experiencing severe mental health problems that aren't being managed, or if tests show you have moderate to severe memory or thinking difficulties, or if you're unable to give informed consent for any reason.

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 18 years old or over?
  2. Do you have a diagnosis of Multiple Sclerosis?
  3. Do you experience fatigue/tiredness?
  4. Can you read and communicate in English?
  5. Do you live in England, Wales, or Scotland?
  6. Can you see and use a smartphone or tablet?
Answer every question to see your result.

What does participation involve?

If you decide to take part and are eligible, you'll first fill out an online questionnaire. Then, you'll be randomly placed into one of two groups. One group will get access to the REFUEL-MS app, and the other will continue with their usual medical care. The study will last for 16 weeks for everyone, regardless of what group you're in.

To help us understand the effects of the app, all participants will be asked to complete online questionnaires about their fatigue, physical activity, mood, and quality of life at 4, 6, and 12 months after starting the study. The research team will also give you a monthly phone call to check in and see how you're doing. Some participants might also be invited for an interview to share their experiences using the REFUEL-MS app. You will receive a £5 voucher for completing the questionnaires at 6 and 12 months.

Potential risks and benefits

Taking part in this study could help us learn more about treating MS-related fatigue, which might improve care for people with MS in the future. The risks of taking part are considered very small because the REFUEL-MS app can be used from your home and is designed to fit your individual needs. Your safety is very important, and the research team will regularly check in with you to make sure it's still suitable for you to continue. We understand that living with MS can sometimes bring challenges like anxiety or low mood, so we will provide information on extra support in the study details you'll receive. You are free to withdraw from the study at any time without giving a reason, and it will not affect your medical care.

Locations (2)

  • Guy's and St Thomas NHS Foundation Trust
    City only
    London, England
  • King's College London
    Approximate
    London, England

Common questions

What is the REFUEL-MS app?

It's an app for smartphones or tablets that offers exercises, balance routines, and coping strategies to help people with MS manage fatigue (tiredness).

Will I still get my usual MS treatment if I join?

Yes, the REFUEL-MS app is designed to be an extra tool and won't replace any medical care you’re already getting for your MS.

How long will I be in the study?

The study itself lasts for 16 weeks, and we'll ask you to complete questionnaires for up to 12 months after you've started.

What if I don't have a smartphone or tablet?

If you don't have a suitable device, the study team can lend you one for the duration of the trial.

Who is running this study?

This study is being run by King's College London and is funded by the National Institute for Health and Care Research (NIHR) and the MS Society.

How to find out more

Amber Strang

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

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