protocolSection identificationModule nctId: NCT06308770, orgStudyIdInfo id: AC21137, briefTitle: Fatigue in Lupus Intervention Programmes (FLIP), acronym: FLIP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: University of Edinburgh, class: OTHER, collaborators name: Accord Clinical Research, descriptionModule briefSummary: 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., conditionsModule conditions: Systemic Lupus Erythematosus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The pilot study for the FLIP trial is a single centre three arm, randomised controlled trial (RCT) comparing the effectiveness of a virtual group fatigue management intervention with standard care in SLE participants. Participants will self-enrol via a secure database and then be randomised electronically to one of the three interventions;1. Standard care (SC) - Lupus UK and Versus Arthritis Booklets2. SC and 4 week Fatigue management Programme (FMP)3. SC and 7 week FMP Results will be measured by comparing Patient Reported Outcome measures (PROMs) submitted before and after the intervention and, at 6 and 12 months., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The statistician who analyses the results will be blind to the intervention to which the participant was randomised., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Standard Care, interventions name: 4 week FMP, interventions name: 7 week FMP, outcomesModule primaryOutcomes measure: Modified Fatigue Impact Score (MFIS), secondaryOutcomes measure: Lupus quality of life questionnaire (LupusQoL), secondaryOutcomes measure: Pittsburgh Sleep quality Inventory ( PSQI), secondaryOutcomes measure: Visual Analog scale of fatigue impact (FI-VAS), secondaryOutcomes measure: Participant Health Questionnaire (PHQ4), secondaryOutcomes measure: Self-Efficacy for Managing Chronic Diseases 6-item Scale, secondaryOutcomes measure: Quick Systemic Lupus Erythematosus Activity Questionnaire (Q-SLAQ), secondaryOutcomes measure: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False