We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dervil M Dockrell, BSc Curr Occ
07762929927
dervil.dockrell@ed.ac.uk
Joanne M Dobson, MSc BSc RN
07850256666
joanne.dobson@ed.ac.uk
Lupus Erythematosus, Systemic Fatigue
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
"Ahn GE, Ramsey-Goldman R. Fatigue in systemic lupus erythematosus. Int J Clin Rheumtol. 2012 Apr 1;7(2):217-227. doi: 10.2217/IJR.12.4."; "22737181"; "Azizoddin DR, Gandhi N, Weinberg S, Sengupta M, Nicassio PM, Jolly M. Fatigue in systemic lupus: the role of disease activity and its correlates. Lupus. 2019 Feb;28(2):163-173. doi: 10.1177/0961203318817826. Epub 2018 Dec 22."; "30580659"; "Arnaud L, Gavand PE, Voll R, Schwarting A, Maurier F, Blaison G, Magy-Bertrand N, Pennaforte JL, Peter HH, Kieffer P, Bonnotte B, Poindron V, Fiehn C, Lorenz H, Amoura Z, Sibilia J, Martin T. Predictors of fatigue and severe fatigue in a large international cohort of patients with systemic lupus erythematosus and a systematic review of the literature. Rheumatology (Oxford). 2019 Jun 1;58(6):987-996. doi: 10.1093/rheumatology/key398."; "30597077"; "Wang B, Gladman DD, Urowitz MB. Fatigue in lupus is not correlated with disease activity. J Rheumatol. 1998 May;25(5):892-5."; "9598886"; "Nikiphorou E, Santos EJF, Marques A, Bohm P, Bijlsma JW, Daien CI, Esbensen BA, Ferreira RJO, Fragoulis GE, Holmes P, McBain H, Metsios GS, Moe RH, Stamm TA, de Thurah A, Zabalan C, Carmona L, Bosworth A. 2021 EULAR recommendations for the implementation of self-management strategies in patients with inflammatory arthritis. Ann Rheum Dis. 2021 Oct;80(10):1278-1285. doi: 10.1136/annrheumdis-2021-220249. Epub 2021 May 7."; "33962964"; "Hewlett S, Almeida C, Ambler N, Blair PS, Choy E, Dures E, Hammond A, Hollingworth W, Kadir B, Kirwan J, Plummer Z, Rooke C, Thorn J, Turner N, Pollock J. Group cognitive-behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations. Health Technol Assess. 2019 Oct;23(57):1-130. doi: 10.3310/hta23570."; "31601357"; "Hewlett S, Almeida C, Ambler N, Blair PS, Choy EH, Dures E, Hammond A, Hollingworth W, Kadir B, Kirwan JR, Plummer Z, Rooke C, Thorn J, Turner N, Pollock J; RAFT Study Group. Reducing arthritis fatigue impact: two-year randomised controlled trial of cognitive behavioural approaches by rheumatology teams (RAFT). Ann Rheum Dis. 2019 Apr;78(4):465-472. doi: 10.1136/annrheumdis-2018-214469. Epub 2019 Feb 6."; "30793700"; "Martin KR, Bachmair EM, Aucott L, Dures E, Emsley R, Gray SR, Hewlett S, Kumar V, Lovell K, Macfarlane GJ, MacLennan G, McNamee P, Norrie J, Paul L, Ralston S, Siebert S, Wearden A, White PD, Basu N. 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). BMJ Open. 2019 Jan 30;9(1):e026793. doi: 10.1136/bmjopen-2018-026793."; "30705244"; "Bachmair EM, Martin K, Aucott L, Dhaun N, Dures E, Emsley R, Gray SR, Kidd E, Kumar V, Lovell K, MacLennan G, McNamee P, Norrie J, Paul L, Packham J, Ralston SH, Siebert S, Wearden A, Macfarlane G, Basu N; LIFT study group. 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. Lancet Rheumatol. 2022 Jun 27;4(8):e534-e545. doi: 10.1016/S2665-9913(22)00156-4. eCollection 2022 Aug."; "36388001"; "O'Riordan R, Doran M, Connolly D. Fatigue and Activity Management Education for Individuals with Systemic Lupus Erythematosus. Occup Ther Int. 2017 Jan 11;2017:4530104. doi: 10.1155/2017/4530104. eCollection 2017."; "29097965"; "Carandang K, Poole J, Connolly D. Fatigue and activity management education for individuals with systemic sclerosis: Adaptation and feasibility study of an intervention for a rare disease. Musculoskeletal Care. 2022 Sep;20(3):593-604. doi: 10.1002/msc.1617. Epub 2022 Feb 6."; "35124888"; "Fangtham M, Kasturi S, Bannuru RR, Nash JL, Wang C. Non-pharmacologic therapies for systemic lupus erythematosus. Lupus. 2019 May;28(6):703-712. doi: 10.1177/0961203319841435. Epub 2019 Apr 8."; "30961418"; "Overman CL, Kool MB, Da Silva JA, Geenen R. The prevalence of severe fatigue in rheumatic diseases: an international study. Clin Rheumatol. 2016 Feb;35(2):409-15. doi: 10.1007/s10067-015-3035-6. Epub 2015 Aug 15."; "26272057"; "Meacock R, Harrison M, McElhone K, Abbott J, Haque S, Bruce I, Teh LS. Mapping the disease-specific LupusQoL to the SF-6D. Qual Life Res. 2015 Jul;24(7):1749-58. doi: 10.1007/s11136-014-0892-4. Epub 2014 Dec 16."; "25510215"; "Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30."; "18929686"; "Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9."; "31078660"; "Larson RD. Psychometric properties of the modified fatigue impact scale. Int J MS Care. 2013 Spring;15(1):15-20. doi: 10.7224/1537-2073.2012-019."; "24453758"; "Yazdany J. Health-related quality of life measurement in adult systemic lupus erythematosus: Lupus Quality of Life (LupusQoL), Systemic Lupus Erythematosus-Specific Quality of Life Questionnaire (SLEQOL), and Systemic Lupus Erythematosus Quality of Life Questionnaire (L-QoL). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S413-9. doi: 10.1002/acr.20636. No abstract available."; "22588761"; "Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4."; "2748771"; "Hewlett S, Dures E, Almeida C. Measures of fatigue: Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF MDQ), Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales (BRAF NRS) for severity, effect, and coping, Chalder Fatigue Questionnaire (CFQ), Checklist Individual Strength (CIS20R and CIS8R), Fatigue Severity Scale (FSS), Functional Assessment Chronic Illness Therapy (Fatigue) (FACIT-F), Multi-Dimensional Assessment of Fatigue (MAF), Multi-Dimensional Fatigue Inventory (MFI), Pediatric Quality Of Life (PedsQL) Multi-Dimensional Fatigue Scale, Profile of Fatigue (ProF), Short Form 36 Vitality Subscale (SF-36 VT), and Visual Analog Scales (VAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S263-86. doi: 10.1002/acr.20579. No abstract available."; "22588750"; "Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613."; "19996233"; "Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62."; "11769298"; "Svenungsson E, Gunnarsson I, Illescas-Backelin V, Trysberg E, Jonsen A, Leonard D, Sjowall C, Pettersson S. Quick Systemic Lupus Activity Questionnaire (Q-SLAQ): a simplified version of SLAQ for patient-reported disease activity. Lupus Sci Med. 2021 May;8(1):e000471. doi: 10.1136/lupus-2020-000471."; "33972457"; "Cleanthous S, Tyagi M, Isenberg DA, Newman SP. What do we know about self-reported fatigue in systemic lupus erythematosus? Lupus. 2012 Apr;21(5):465-76. doi: 10.1177/0961203312436863. Epub 2012 Feb 16."; "22345120"; "Hewlett S, Ambler N, Almeida C, Blair PS, Choy E, Dures E, Hammond A, Hollingworth W, Kirwan J, Plummer Z, Rooke C, Thorn J, Tomkinson K, Pollock J; RAFT Study Team. Protocol for a randomised controlled trial for Reducing Arthritis Fatigue by clinical Teams (RAFT) using cognitive-behavioural approaches. BMJ Open. 2015 Aug 6;5(8):e009061. doi: 10.1136/bmjopen-2015-009061."; "26251413"; "Cervilla O, Miro E, Martinez MP, Sanchez AI, Sabio JM, Prados G. Sleep quality and clinical and psychological manifestations in women with mild systemic lupus erythematosus activity compared to women with fibromyalgia: A preliminary study. Mod Rheumatol. 2020 Nov;30(6):1016-1024. doi: 10.1080/14397595.2019.1679973. Epub 2019 Nov 14."; "31599659"; "Xerfan EMS, Andersen ML, Tomimori J, Tufik S, Facina AS. The role of sleep in the activity of lupus erythematosus: an overview of this possible relationship. Rheumatology (Oxford). 2021 Feb 1;60(2):483-486. doi: 10.1093/rheumatology/keaa744. No abstract available."; "33241379"; "Fenn, K. and M. Byrne, The key principles of cognitive behavioural therapy. InnovAiT: Education and inspiration for general practice, 2013. 6(9): p. 579-585."; null; "Lee, D.R., Teaching the World to Sleep. 2018."; null; "Dobson, J., et al., POS1496-HPR HARD TIMES: ADAPTING A FATIGUE MANAGEMENT PROGRAMME IN A PANDEMIC. Annals of the Rheumatic Diseases, 2022. 81(Suppl 1): p. 1093-1093."; null
You can take part if:
You may not be able to take part if:
This is in the inclusion criteria above
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Joanne M Dobson, MSc BSc RN
07850256666
joanne.dobson@ed.ac.uk
Dervil M Dockrell, BSc Curr Occ
07762929927
dervil.dockrell@ed.ac.uk
The study is sponsored by University of Edinburgh
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
