Multiple sclerosis Nervous System Diseases
Conditions
Interventions
This study will involve randomising participants to one of two groups (1:1), to compare the REFUEL-MS app, a digital, healthcare professional (HCP) supported self-management treatment for MS-related f
TAU) for a period of 16 weeks. Participants in the two groups will complete assessments of fatigue (primary), physical activity, mood, and quality of life at 4, 6, and 12 months. In addition, a qualit
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: People living with MS will be eligible if they: 1. Are 18 years of age and over 2. Able to read and communicate in English 3. Are a resident in England, Wales or Scotland 4. Have a confirmed diagnosis of MS 5. Have sufficient vision and manual abilities to use a smartphone or tablet 6. Experience clinical levels of fatigue, scoring =4 on the Chalder Fatigue Questionnaire (CFQ), when using bimodal scoring
Exclusion criteria
Exclusion criteria: Potential participants will be excluded if they: 1. Currently undertaking another behavioural or exercise/balance fatigue management programme, other behavioural treatments* 2. Have started on a new disease-modifying treatment for their MS within the last 6 months** 3. Have started a new antidepressant or fatigue medication within the past 3 months** 4. Are currently experiencing severe mental health problems, including psychosis, bipolar disorder or active thoughts of self-harm that are not being appropriately managed, assessed by self-report 5. Score of 11 or under out of 15 on the Mini Montreal Cognitive Assessment, which denotes moderate or severe cognitive impairment (MoCA) 6. Are unable to give informed consent (for example, due to reduced mental capacity) *These participants will have the option of being recontacted by the trial team once they have completed their current treatment to be rescreened for entry into the trial. **These participants will have the option of being recontacted by the trial team once they have been on their treatment for sufficient time to be rescreened for entry into the trial. Please note, participants will only be recontacted up until the end of the recruitment period (likely October 2025), as this is the last possible timepoint for enrolment on the trial in order to complete 12-month data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue severity measured by the Chalder Fatigue Questionnaire (CFQ) at 6-months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/08/2025: 1. Fatigue impact measured by the Fatigue Severity Scale (FSS) that captures the impact of fatigue on daily functioning at 4, 6 and 12 months post-randomisation 2. Clinically meaningful improvement in fatigue severity, defined as a reduction of >2.3 points from baseline in the total CFQ score, consistent with estimates of the minimum clinically important difference (binary outcome) at 4 and 12 months post-randomisation 3. Clinically meaningful improvement in fatigue impact, defined as a reduction of =0.45 points from baseline in the mean FSS score (binary outcome) 4. Depression severity using the Patient Health Questionnaire (PHQ-9) at 4, 6 and 12 months post-randomisation 5. Anxiety severity using the Generalised Anxiety Disorder scale (GAD-7) at 4, 6 and 12 months post-randomisation 6. General quality of life captured by the EQ-5D-5L at 4, 6 and 12 months post-randomisation 7. MS-specific quality of life captured by the MSIS v29 at 4, 6 and 12 months post-randomisation 8. Physical Activity using the International Physical Activity Questionnaire short form (IPAQ-SF) at 4, 6 and 12 months post-randomisation 9. Health and social care utilisation using a Modified Adult Service Use Schedule (ADSUS) at 6- and 12-month post-randomisation 10. Safety, assessed through collection of Adverse Events and Serious Adverse Events throughout the trial (monthly until 6 months then again at 12 months post-randomisation) _____ Previous secondary outcome measures: 1. Fatigue impact measured by the Fatigue Severity Scale (FSS) that captures the impact of fatigue on daily functioning at 4, 6 and 12 months post-randomisation 2. Clinically meaningful improvement in fatigue severity, defined as a reduction of >2.3 points from baseline in the total CFQ score, consistent with estimates of the minimum clinically important difference (binary outcome) at 4 and 12 months post-randomisation 3. Clinically meaningful improvement in fatigue i | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactAmber Strang
Outcome results
None listed