Fatigue in Lupus Intervention Programmes (FLIP)
Recruiting · NCT06308770 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Edinburgh
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Systemic Lupus Erythematosus (SLE) is an autoimmune rheumatic disease. Patients report that fatigue has a significant impact on their quality of life but is often not discussed in healthcare settings. Fatigue is more prevalent in SLE than other Rheumatic diseases. Management across the NHS is very variable ranging from a booklet to one to one appointments or, less often, a group intervention. Previous studies in other Rheumatic diseases have shown that a group cognitive behavioural approach can be effective in helping patients manage their fatigue. The COVID-19 pandemic changed the way healthcare is delivered in the NHS . Healthcare professionals had to find alternate solutions e.g. Virtual appointments. Our study aims to establish whether a virtual group Fatigue Management Programme and a fatigue booklet (Versus Arthritis and Lupus UK) is more effective at reducing the impact of fatigue in SLE participants than the fatigue booklet alone. The investigators will also compare a shortened 4-week to the standard 7-week programme to lessen the time commitment for participants and potentially reduce waiting times.The investigators will measure the effectiveness of the interventions through the use of Patient Reported Outcome Measures (PROMs) at several intervals whilst the participant is enrolled in the study.The pilot study will run in a single site in Edinburgh. The investigators aim to find a manageable, cost effective solution for the NHS and patients to address this frequently unmet need.
Who can take part
Inclusion criteria
- Have a confirmed SLE Diagnosis
- Be over 18 at time of consent
- Report fatigue to be a chronic problem in the last 4 weeks with a VAS fatigue impact ≥ 6, based on a scale of 1 ( no fatigue impact on quality of life ) to 10 (severe impact of fatigue on quality of life).\[20\]
- Agree to online consent, complete questionnaires and be randomised to standard care or group intervention programme via secure server (REDCap).
- Not have taken part in a group fatigue or pain management programme in the past 5 years.
- Have the ability to read and converse in English competently
- Have access to a computer/Smartphone/Tablet for internet and audio/video access.
- Be able to or willing to learn to use an NHS approved platform.
- Be willing to provide a telephone, postal address and email address for communication related to the FLIP trial.
Exclusion criteria
- They are unable to understand English sufficiently to attend a live online group programme. Facilitators and other group members will most likely only speak English.
- They are unable to provide confirmation of eligibility, complete online informed consent or questionnaires
- They are currently participating in an interventional trial
Where it is running
1 location listed.
- NHS Lothian - Edinburgh, United Kingdom