REFUEL-MS: Clinical and Cost-Effectiveness RCT
Research type
Research Study
Full title
REFUEL-MS: A two-arm parallel group randomised controlled trial of the clinical and cost-effectiveness of a digital CBT, balance and exercise intervention (REFUEL-MS) for treating fatigue in multiple sclerosis (MS)
IRAS ID
350492
Contact name
Rona Moss-Morris
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
1 years, 7 months, 1 days
Research summary
Around 90% of people living with MS (pwMS) experience fatigue, and report it as the most debilitating symptom, yet few have access to effective treatments. The REFUEL-MS programme, co-funded by the National Institute for Health and Care Research (NIHR) and MS Society UK, has developed an app to empower pwMS to manage their fatigue in ways that work for them. The app was developed by MS researchers, collaborators, and pwMS, using up-to-date evidence.
We aim to recruit 378 pwMS, through the UK MS Register, 1 NHS Trust, and community groups, to test the app's clinical and cost-effectiveness in reducing MS-related fatigue, improving physical activity, mood, and quality of life at 4-, 6- and 12-months.
Participants will be randomly assigned to continue their usual care or use the REFUEL-MS app with healthcare professional (HCP) support. They can choose one of three app streams, one of which focuses on changing thoughts, feelings, and responses to fatigue to support engagement in valued activities. Another supports people to increase their physical activity in ways that suit their individual needs, MS symptoms, and lifestyle. The third focuses on improving people’s physical balance to support everyday activities.
Participants will be invited to an interview about the factors impacting their engagement with REFUEL-MS, how effective they found the app, and any changes experienced since using it. HCPs will also be invited to take part in an interview to better create an implementation strategy into MS practice.
Participants must be aged 18+, living in England/Scotland/Wales, diagnosed with MS and experiencing clinical levels of fatigue, fluent in English, and have visual and manual/physical ability to use an app. Participants will also be screened against the exclusion criteria before being invited to take part.
REC name
London - Stanmore Research Ethics Committee
REC reference
25/LO/0256
Date of REC Opinion
28 May 2025
REC opinion
Further Information Favourable Opinion