Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
90 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-04-08
Study Completion Date
2027-04-30
Brief Summary
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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.
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.
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Detailed Description
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The FLIP study will recruit SLE patients to a single centre, three arm randomised controlled trial which will compare standard care ( fatigue booklets available in all Rheumatology departments in the UK or online ) with live online fatigue management groups for effectiveness at managing fatigue.
Lupus UK will advertise the study through their website, newsletter and social media. Participants can be identified and enrolled to the study in three ways:
1. The participant can be identified by any member of the Rheumatology department in NHS Lothian through participant routine Rheumatology appointment or local database. No patient records will be screened .
2. Participants can be identified through the Scottish Lupus Registry Database as they will have already consented to being contacted about research.
3. Participants can also self-enrol to the study through the link to the FLIP website from Lupus UK .
Posters, leaflets and LUPUS UK communications will have a link and QR code which will take interested participants to the patient information sheet to read about the study.They can contact the study team with any questions before proceeding to accessing the enrolment process in the REDCap secure server. The central study team or the participant themselves can confirm their eligibility by completing short screening questions.The study team can also help the patient with any questions regarding the online consent form if necessary. If the participant is eligible and wishes to proceed they will be asked to complete an online consent and be assigned a unique identification code number (UICN).
After the participant has consented online in REDCap and completed personal details/demographics and baseline PROMs questionnaires they will be randomised to either standard care, standard care plus 4 week programme or standard care plus 7 week programme. The ratio of randomisation will be 1.1.1 .
Participants will complete the same PROMS three more times after the baseline: on completion of the intervention, at 6 months and at 12 months.
The PROMs will be
1. Modified Fatigue Impact Score (MFIS)
2. SLE quality of life questionnaire (LupusQoL)
3. Pittsburgh Sleep quality Inventory ( PSQI)
4. Visual Analog scale of fatigue impact ( FI-VAS)
5. Participant health questionnaire -4 item (PHQ4)
6. Self -Efficacy for managing chronic disease 6 item scale (SEMCD-6)
7. Quick Systemic Lupus Activity Questionnaire (Q-SLAQ)
If a participant has access to a Systemic Lupus Erythematosus Disease Activity Index ( SLEDAI) score this may be included .
Participants will also be asked to complete a satisfaction questionnaire after the intervention completion.
The end of study is defined as the last data collection at 52 weeks from the last participant after group intervention or standard care whichever comes last.
The trial team will analyse the qualitative data from participants. A health economist will calculate the NHS utilisation / economic evaluation by mapping the LUPUSQoL to the Short Form 6 dimension (SF6D) to obtain quality adjusted life years (QALYs) .
A statistician will analyse the data from the PROMs with standard statistical software in R and report descriptive statistics such as means, medians, standard deviations and standard errors of the variables measured. Statistical significance will be measured for the aims of the study using unmatched and paired T- tests.
The primary outcome of our study, MFIS measurements, will be assessed using linear regression models including a random effect to account for grouping by centre. The investigators will assess whether the treatment outcome is maintained by analysing longitudinal data collected over 1 year using linear mixed-effect models with a suitable covariance structure. The secondary outcomes will be analysed in an analogous way. The investigators will also analyse how the secondary outcomes covary with the MFIS scores. The investigators will handle non-compliance by analysing the data according to intention-to-treat principles. In the unlikely event of unused data arising, the investigators will include these in suitable subgroup analyses. Spurious data will be followed up with patients and will only be excluded from the study as a measure of last resort. The investigators are not planning to carry out interim analyses nor to terminate the study early.
The results will be published in peer reviewed journals and by Lupus UK .
Lupus UK will advertise the study through their website, newsletter and social media. Participants can be identified and enrolled to the study in three ways:
1. The participant can be identified by any member of the Rheumatology department in NHS Lothian through participant routine Rheumatology appointment or local database. No patient records will be screened .
2. Participants can be identified through the Scottish Lupus Registry Database as they will have already consented to being contacted about research.
3. Participants can also self-enrol to the study through the link to the FLIP website from Lupus UK .
Posters, leaflets and LUPUS UK communications will have a link and QR code which will take interested participants to the patient information sheet to read about the study.They can contact the study team with any questions before proceeding to accessing the enrolment process in the REDCap secure server. The central study team or the participant themselves can confirm their eligibility by completing short screening questions.The study team can also help the patient with any questions regarding the online consent form if necessary. If the participant is eligible and wishes to proceed they will be asked to complete an online consent and be assigned a unique identification code number (UICN).
After the participant has consented online in REDCap and completed personal details/demographics and baseline PROMs questionnaires they will be randomised to either standard care, standard care plus 4 week programme or standard care plus 7 week programme. The ratio of randomisation will be 1.1.1 .
Participants will complete the same PROMS three more times after the baseline: on completion of the intervention, at 6 months and at 12 months.
The PROMs will be
1. Modified Fatigue Impact Score (MFIS)
2. SLE quality of life questionnaire (LupusQoL)
3. Pittsburgh Sleep quality Inventory ( PSQI)
4. Visual Analog scale of fatigue impact ( FI-VAS)
5. Participant health questionnaire -4 item (PHQ4)
6. Self -Efficacy for managing chronic disease 6 item scale (SEMCD-6)
7. Quick Systemic Lupus Activity Questionnaire (Q-SLAQ)
If a participant has access to a Systemic Lupus Erythematosus Disease Activity Index ( SLEDAI) score this may be included .
Participants will also be asked to complete a satisfaction questionnaire after the intervention completion.
The end of study is defined as the last data collection at 52 weeks from the last participant after group intervention or standard care whichever comes last.
The trial team will analyse the qualitative data from participants. A health economist will calculate the NHS utilisation / economic evaluation by mapping the LUPUSQoL to the Short Form 6 dimension (SF6D) to obtain quality adjusted life years (QALYs) .
A statistician will analyse the data from the PROMs with standard statistical software in R and report descriptive statistics such as means, medians, standard deviations and standard errors of the variables measured. Statistical significance will be measured for the aims of the study using unmatched and paired T- tests.
The primary outcome of our study, MFIS measurements, will be assessed using linear regression models including a random effect to account for grouping by centre. The investigators will assess whether the treatment outcome is maintained by analysing longitudinal data collected over 1 year using linear mixed-effect models with a suitable covariance structure. The secondary outcomes will be analysed in an analogous way. The investigators will also analyse how the secondary outcomes covary with the MFIS scores. The investigators will handle non-compliance by analysing the data according to intention-to-treat principles. In the unlikely event of unused data arising, the investigators will include these in suitable subgroup analyses. Spurious data will be followed up with patients and will only be excluded from the study as a measure of last resort. The investigators are not planning to carry out interim analyses nor to terminate the study early.
The results will be published in peer reviewed journals and by Lupus UK .
Conditions
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Systemic Lupus Erythematosus
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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 Booklets
2. 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.
1. Standard care (SC) - Lupus UK and Versus Arthritis Booklets
2. 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.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
The statistician who analyses the results will be blind to the intervention to which the participant was randomised.
Study Groups
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Standard care
Participants will be provided with access to Versus Arthritis and Lupus UK fatigue booklets.
Group Type
ACTIVE_COMPARATOR
Standard Care
Intervention Type
BEHAVIORAL
Participants receive fatigue booklets from two charitable organisations providing information on fatigue, sleep, energy conservation, exercise and stress to help manage fatigue.
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.
Group Type
ACTIVE_COMPARATOR
Standard Care
Intervention Type
BEHAVIORAL
Participants receive fatigue booklets from two charitable organisations providing information on fatigue, sleep, energy conservation, exercise and stress to help manage fatigue.
4 week FMP
Intervention Type
BEHAVIORAL
Participants attend 3 once weekly live online group interventions with a final intervention 8 weeks later.
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.
Group Type
ACTIVE_COMPARATOR
Standard Care
Intervention Type
BEHAVIORAL
Participants receive fatigue booklets from two charitable organisations providing information on fatigue, sleep, energy conservation, exercise and stress to help manage fatigue.
7 week FMP
Intervention Type
BEHAVIORAL
Participants attend 6 once weekly live online group interventions with a final intervention 8 weeks later.
Interventions
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Standard Care
Participants receive fatigue booklets from two charitable organisations providing information on fatigue, sleep, energy conservation, exercise and stress to help manage fatigue.
Intervention Type
BEHAVIORAL
4 week FMP
Participants attend 3 once weekly live online group interventions with a final intervention 8 weeks later.
Intervention Type
BEHAVIORAL
7 week FMP
Participants attend 6 once weekly live online group interventions with a final intervention 8 weeks later.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
1. Have a confirmed SLE Diagnosis
2. Be over 18 at time of consent
3. 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).\[20\]
4. Agree to online consent, complete questionnaires and be randomised to standard care or group intervention programme via secure server (REDCap).
5. Not have taken part in a group fatigue or pain management programme in the past 5 years.
6. Have the ability to read and converse in English competently
7. Have access to a computer/Smartphone/Tablet for internet and audio/video access.
8. Be able to or willing to learn to use an NHS approved platform.
9. Be willing to provide a telephone, postal address and email address for communication related to the FLIP trial.
2. Be over 18 at time of consent
3. 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).\[20\]
4. Agree to online consent, complete questionnaires and be randomised to standard care or group intervention programme via secure server (REDCap).
5. Not have taken part in a group fatigue or pain management programme in the past 5 years.
6. Have the ability to read and converse in English competently
7. Have access to a computer/Smartphone/Tablet for internet and audio/video access.
8. Be able to or willing to learn to use an NHS approved platform.
9. Be willing to provide a telephone, postal address and email address for communication related to the FLIP trial.
Exclusion Criteria
1. 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.
2. They are unable to provide confirmation of eligibility, complete online informed consent or questionnaires
3. They are currently participating in an interventional trial
2. They are unable to provide confirmation of eligibility, complete online informed consent or questionnaires
3. They are currently participating in an interventional trial
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Edinburgh
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Helen Harris, BA MB BCh BAO
Role: PRINCIPAL_INVESTIGATOR
University of Edinburgh
Locations
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NHS Lothian
Edinburgh, , United Kingdom
Site Status
RECRUITING
Countries
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United Kingdom
Central Contacts
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Facility Contacts
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Joanne Dobson
Role: primary
References
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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.
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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.
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BACKGROUND
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.
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BACKGROUND
Wang B, Gladman DD, Urowitz MB. Fatigue in lupus is not correlated with disease activity. J Rheumatol. 1998 May;25(5):892-5.
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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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Lee, D.R., Teaching the World to Sleep. 2018.
Reference Type
BACKGROUND
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.
Reference Type
RESULT
Related Links
Access external resources that provide additional context or updates about the study.
http://www.webmd.com/lupus/lupus-fatigue
prevalence of severe fatigue in Lupus
http://www.versusarthritis.org/media/23151/fatigue-and-arthritis-information-booklet.pdf
Versus Arthritis booklet on fatigue
Other Identifiers
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AC21137
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
NA
Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region
NCT03138941
RECRUITING
Photoprovocation Testing in Subjects With Cutaneous Lupus
NCT01516788
COMPLETED
NA
Biomarkers of Lupus Disease: Serial Biomarker Sampling in Patients With Active Systemic Lupus Erythematosus (SLE)
NCT00987831
COMPLETED
PHASE1/PHASE2
Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients
NCT06287125
NOT_YET_RECRUITING
A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus
NCT02725515
COMPLETED
PHASE2
Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone
NCT00119678
COMPLETED
PHASE2
Can Targeted Elimination of B-cell Depletion Therapy and/or Combination Therapy on Systemic Lupus Erythematosus
NCT00556192
COMPLETED
PHASE2
Cardiology Prevention in Systemic Lupus Erythematosus (SLE)
NCT00610805
WITHDRAWN
NA
Exploratory Study of Changes in Disease Activity and Biomarkers With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE)
NCT00997100
COMPLETED
PHASE2