[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539817":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":43,"locations":53,"responsibleParty":69,"collaborators":30,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":30,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":56,"whyStopped":30,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University of Edinburgh","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard care","ACTIVE_COMPARATOR","Participants will be provided with access to Versus Arthritis and Lupus UK fatigue booklets.",[13],"Behavioral: Standard Care",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard care and 4 week Fatigue Management Programme (FMP)","Participants will be provided with access to Versus Arthritis and Lupus UK fatigue booklets and be randomised to a 4 week virtual FMP. They will attend live online group weekly sessions for 3 consecutive weeks followed by a review session at week 11.",[13,18],"Behavioral: 4 week FMP",{"label":20,"type":10,"description":21,"interventionNames":22},"Standard care and 7 week Fatigue Management Programme (FMP)","Participants will be provided with access to Versus Arthritis and Lupus UK fatigue booklets and be randomised to a 7 week virtual FMP. They will attend live online group weekly sessions for 6 consecutive weeks followed by a review session at week 14.",[13,23],"Behavioral: 7 week FMP",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","Standard Care","Participants receive fatigue booklets from two charitable organisations providing information on fatigue, sleep, energy conservation, exercise and stress to help manage fatigue.",[9,15,20],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"4 week FMP","Participants attend 3 once weekly live online group interventions with a final intervention 8 weeks later.",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"7 week FMP","Participants attend 6 once weekly live online group interventions with a final intervention 8 weeks later.",[20],[40],{"name":41,"affiliation":5,"role":42},"Helen Harris, BA MB BCh BAO","PRINCIPAL_INVESTIGATOR",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":48},"Dervil M Dockrell, BSc Curr Occ","CONTACT","07762929927","dervil.dockrell@ed.ac.uk",{"name":50,"role":46,"phone":51,"phoneExt":30,"email":52},"Joanne M Dobson, MSc BSc RN","07850256666","joanne.dobson@ed.ac.uk",[54],{"facility":55,"status":56,"city":57,"state":30,"zip":30,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"NHS Lothian","RECRUITING","Edinburgh","United Kingdom","UK",{"type":61,"coordinates":62},"Point",[63,64],-3.19648,55.95206,{"lat":64,"lon":63},[67],{"name":68,"role":46,"phone":30,"phoneExt":30,"email":30},"Joanne Dobson",{"type":70,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100539817","fatigue-in-lupus-intervention-programmes-flip-100539817",false,"NCT06308770","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","FLIP","Inclusion Criteria:\n\n1. Have a confirmed SLE Diagnosis\n2. Be over 18 at time of consent\n3. 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\\]\n4. Agree to online consent, complete questionnaires and be randomised to standard care or group intervention programme via secure server (REDCap).\n5. Not have taken part in a group fatigue or pain management programme in the past 5 years.\n6. Have the ability to read and converse in English competently\n7. Have access to a computer\u002FSmartphone\u002FTablet for internet and audio\u002Fvideo access.\n8. Be able to or willing to learn to use an NHS approved platform.\n9. Be willing to provide a telephone, postal address and email address for communication related to the FLIP trial.\n\nExclusion Criteria:\n\n1. 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.\n2. They are unable to provide confirmation of eligibility, complete online informed consent or questionnaires\n3. They are currently participating in an interventional trial","ALL","18 Years","85 Years",{"count":83,"type":84},90,"ESTIMATED","INTERVENTIONAL",[87],"NA","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.\n\nOur 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.\n\nThe 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.",[90],"Systemic Lupus Erythematosus",[92],"Fatigue management","2026-05-01",{"date":95,"type":96},"2026-05-07","ACTUAL",{"date":98,"type":96},"2024-04-08",{"date":100,"type":84},"2027-09",{"name":5,"class":6},1]