NCT06308770Active, not recruiting
Fatigue in Lupus Intervention Programmes (FLIP)
Fatigue in Lupus Intervention Programmes (FLIP): A Randomised Controlled Trial Investigating the Effectiveness of Fatigue Management in Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 261 (actual)
- First submitted
- 23 Feb 2024
- Start date
- 8 Apr 2024
- Primary completion date
- 9 Mar 2026
- Lead sponsor
- University of Edinburgh
- Diseases
- Lupus (SLE)
- NCT number
- NCT06308770
What you commit to
- Study type: Interventional
- Participants enrolled: 261
- From 8 Apr 2024 to the primary completion date, 9 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NHS Lothian Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.