REFUEL-MS: Clinical and Cost-Effectiveness RCT

Treatment tested

• Refuel MS

Other measures (1)

Background and study aims Although 9/10 people living with MS report fatigue as a symptom, fewer than a third have been offered any treatment for fatigue as part of their routine care. Of these people, only 9% were offered behavioural treatments. Our overall research programme aimed to work with people with MS to create a digital intervention to help reduce fatigue and then to test how well this intervention – called REFUEL-MS – works in real life. REFUEL-MS is an app that includes physical activity, balance exercises, and cognitive behavioural therapy (CBT) techniques. These were included because previous research has found that they are all effective at reducing MS fatigue. This current study aims to test how well the REFUEL-MS app is at reducing MS-related fatigue compared to usual care and to make sure it is safe for patients. REFUEL-MS is a patient-led app that people with MS can access on a smartphone or tablet. Patient-led means there are opportunities for patients to choose the content that is most relevant to them (cognitive behavioural therapy, physical activity, or balance exercises), set personal goals, and track progress. The intervention also includes support from a REFUEL-MS healthcare professional through regular virtual appointments and app-based messages. The REFUEL-MS app is not intended to replace the existing MS medical care of participants. Who can participate? People living with MS can take part if they: 1. Are aged 18 years and over 2. Have a confirmed diagnosis of MS 3. Are able to read and communicate in English 4. Are a resident of England, Wales or Scotland 5. Are able to see and use a smartphone or tablet 6. Experience fatigue We are particularly interested in involving participants who are not currently well represented in MS research. This includes those who are older, male, LGBTQ+, from minoritised ethnic backgrounds, live with progressive types of MS, varying levels of disability, lower digital literacy, and lower socioeconomic status. REFUEL-MS is designed to be suitable for individuals with different needs. Participants who do not have a suitable device can be loaned one for the duration of the trial. We will be recruiting 378 people with MS from the UK MS Register, Guy’s and St Thomas’ NHS Foundation Trust, and community groups. What does the study involve? Participants who are eligible and consent will complete an online questionnaire. Participants will then be randomly assigned to one of two groups. One group will get access to the REFUEL-MS programme via the app and the other group will continue their usual care. For both groups, the study will last for 16 weeks. 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. All participants will also receive a monthly phone call from the research team to check how they are doing and if anything unexpected has happened since the last call. Some participants will also be invited to take part in an interview about their experience of using REFUEL-MS. What are the possible benefits and risks of taking part? Taking part in this study could improve treatments for MS-related fatigue and support future research. The risks are small, as REFUEL-MS can be used from home and tailored to suit individual needs. Participant safety is very important to us and the research team will regularly contact participants to check if it is suitable for them to continue in the study. We also understand that MS can come with challenges like anxiety and depression, so along with monthly check-in calls, we will provide information on additional support in the Participant Information Sheet. We know that completing questionnaires can be time-consuming so we are offering participants a £5 voucher when they complete the questionnaires at 6 and 12 months. Where is the study run from? King’s College London (UK) When is the study starting and how long is it expected to run for? March 2025 to March 2027 Who is funding the study? 1. National Institute for Health and Care Research (NIHR) (UK) 2. MS Society (UK) Who is the main contact? Professor Rona Moss-Morris or Harriet Mortimer, refuel-ms@kcl.ac.uk