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Fatigue In Lupus Intervention Programmes FLIP A Randomised Controlled Trial Investigating The Effectiveness Of Fatigue Management In Systemic Lupus Erythematosus
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Actively Recruiting
Phase Not Applicable
Age: 18 Years - 85 Years
All Genders
ID: 06308770
Fatigue in Lupus Intervention Programmes (FLIP)
A Randomised Controlled Trial Investigating the Effectiveness of Fatigue Management in Systemic Lupus Erythematosus
Led by: University of Edinburgh
Updated on: 2026-05-07
90 Participants Needed
1 Research Site
52 weeks Total Duration
On this page
- AI-Summary
- Brief Title
- Who Can Participate
- AI-Screening
- Your Study Journey
- Trial Site Locations
- Research Team
- How is the study designed?
- Similar Trials
- Frequently Asked Questions
- Research Publications
AI-Summary
What This Trial Is About
Researchers are studying Systemic Lupus Erythematosus (SLE), an autoimmune disease where fatigue significantly affects quality of life but is often overlooked in healthcare. This trial aims to find out if a virtual group Fatigue Management Programme (FMP) plus a fatigue booklet is better at reducing fatigue impact in SLE patients than the booklet alone. The study also compares a shorter 4-week program to the standard 7-week program to reduce time commitment and waiting times. Participants are randomly assigned to one of three groups: standard care with fatigue booklets, standard care plus a 4-week virtual FMP with weekly live online sessions for 3 weeks plus a review at week 11, or standard care plus a 7-week virtual FMP with weekly live sessions for 6 weeks plus a review at week 14. The fatigue booklets are from Versus Arthritis and Lupus UK and provide information on managing fatigue, sleep, energy conservation, exercise, and stress. Participants complete questionnaires at baseline, after the intervention, and at 6 and 12 months to measure fatigue impact, quality of life, sleep quality, mental health, self-efficacy, and lupus activity. The main outcome is the Modified Fatigue Impact Score (MFIS) at 12 months. The study also includes economic evaluations and participant satisfaction surveys. The total study duration lasts up to 52 weeks from the last participant's intervention or standard care completion.
Brief Title
Fatigue in Lupus Intervention Programmes (FLIP)
Who Can Participate
Age: 18 Years - 85 Years
All Genders
Eligibility Criteria
You may qualify if you...
- Have a confirmed diagnosis of Systemic Lupus Erythematosus (SLE)
- Be aged 18 years or older at time of consent
- Report fatigue as a chronic problem in the last 4 weeks with a fatigue impact score of 6 or higher on a scale from 1 to 10
- Agree to online consent, complete questionnaires, and be randomized to study groups via a secure server
- Have not participated in a group fatigue or pain management program in the past 5 years
- Be able to read and speak English competently
- Have access to a computer, smartphone, or tablet with internet and audio/video capabilities
- Be able or willing to learn to use an NHS approved online platform
- Be willing to provide telephone, postal address, and email for study communication
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You will not qualify if you...
- Unable to understand English sufficiently to attend live online group sessions
- Unable to provide online informed consent or complete required questionnaires
- Currently participating in another interventional trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
- 1 screening and enrollment visit (online)
Treatment
Duration - 4 to 7 weeks depending on assigned programme
Participants are randomized to either standard care with fatigue booklets, or to a fatigue management programme with live online group sessions lasting 4 or 7 weeks.
- Weekly live online group sessions for 3 or 6 weeks plus a final review session at week 8 or 11
Follow-up
Duration - Up to 12 months after intervention
Participants complete follow-up questionnaires at intervention completion, 6 months, and 12 months to assess fatigue and quality of life.
- 3 questionnaire completion timepoints (post-intervention, 6 months, 12 months)
Trial Site Locations
Total: 1 location
- NHS Lothian
Edinburgh, United Kingdom
Actively Recruiting
Research Team
- D
Dervil M Dockrell, BSc Curr Occ - J
Joanne M Dobson, MSc BSc RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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Research Publications
-
Fatigue in systemic lupus erythematosus.
Grace E Ahn, Rosalind Ramsey-Goldman
https://pubmed.ncbi.nlm.nih.gov/22737181 -
Fatigue in systemic lupus: the role of disease activity and its correlates.
D R Azizoddin, N Gandhi, S Weinberg...
https://pubmed.ncbi.nlm.nih.gov/30580659 -
Predictors of fatigue and severe fatigue in a large international cohort of patients with systemic lupus erythematosus and a systematic review of the literature.
Laurent Arnaud, Pierre Edouard Gavand, Rheinardt Voll...
https://pubmed.ncbi.nlm.nih.gov/30597077 -
Fatigue in lupus is not correlated with disease activity.
B Wang, D D Gladman, M B Urowitz
https://pubmed.ncbi.nlm.nih.gov/9598886 -
2021 EULAR recommendations for the implementation of self-management strategies in patients with inflammatory arthritis.
Elena Nikiphorou, Eduardo José Ferreira Santos, Andrea Marques...
https://pubmed.ncbi.nlm.nih.gov/33962964 -
Group cognitive-behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations.
Sarah Hewlett, Celia Almeida, Nicholas Ambler...
https://pubmed.ncbi.nlm.nih.gov/31601357 -
Reducing arthritis fatigue impact: two-year randomised controlled trial of cognitive behavioural approaches by rheumatology teams (RAFT).
Sarah Hewlett, Celia Almeida, Nicholas Ambler...
https://pubmed.ncbi.nlm.nih.gov/30793700 -
Protocol for a multicentre randomised controlled parallel-group trial to compare the effectiveness of remotely delivered cognitive-behavioural and graded exercise interventions with usual care alone to lessen the impact of fatigue in inflammatory rheumatic diseases (LIFT).
Kathryn R Martin, Eva-Maria Bachmair, Lorna Aucott...
https://pubmed.ncbi.nlm.nih.gov/30705244 -
Remotely delivered cognitive behavioural and personalised exercise interventions for fatigue severity and impact in inflammatory rheumatic diseases (LIFT): a multicentre, randomised, controlled, open-label, parallel-group trial.
Eva-Maria Bachmair, Kathryn Martin, Lorna Aucott...
https://pubmed.ncbi.nlm.nih.gov/36388001 -
Fatigue and Activity Management Education for Individuals with Systemic Lupus Erythematosus.
Ruth O'Riordan, Michele Doran, Deirdre Connolly
https://pubmed.ncbi.nlm.nih.gov/29097965
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