Systemic Lupus ErythematosusFLIPNCT06308770
Fatigue in Lupus Intervention Programmes (FLIP)
A study testing 4 week FMP and 7 week FMP in people with Systemic Lupus Erythematosus, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- 4 week FMP and 7 week FMP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Apr 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fatigue in Lupus Intervention Programmes (FLIP): A Randomised Controlled Trial Investigating the Effectiveness of Fatigue Management in Systemic Lupus Erythematosus
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.
Read the detailed description
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:
- 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 .
- Participants can be identified through the Scottish Lupus Registry Database as they will have already consented to being contacted about research.
- 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
- Modified Fatigue Impact Score (MFIS)
- SLE quality of life questionnaire (LupusQoL)
- Pittsburgh Sleep quality Inventory ( PSQI)
- Visual Analog scale of fatigue impact ( FI-VAS)
- Participant health questionnaire -4 item (PHQ4)
- Self -Efficacy for managing chronic disease 6 item scale (SEMCD-6)
- 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
- Systemic Lupus Erythematosus
- Being tested
- Standard Care, 4 week FMP, 7 week FMP
- Keywords
- Fatigue management
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareBehavioural
Participants receive fatigue booklets from two charitable organisations providing information on fatigue, sleep, energy conservation, exercise and stress to help manage fatigue.
4 week FMPBehavioural
Participants attend 3 once weekly live online group interventions with a final intervention 8 weeks later.
7 week FMPBehavioural
Participants attend 6 once weekly live online group interventions with a final intervention 8 weeks later.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Participants will be provided with access to Versus Arthritis and Lupus UK fatigue booklets. Receives: Behavioral: Standard Care |
| Standard care and 4 week Fatigue Management Programme (FMP) | Active comparator | 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. Receives: Behavioral: Standard Care; Behavioral: 4 week FMP |
| Standard care and 7 week Fatigue Management Programme (FMP) | Active comparator | 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. Receives: Behavioral: Standard Care; Behavioral: 7 week FMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Fatigue Impact Score (MFIS)
A tool to measure the impact of fatigue including physical, cognitive, and psychosocial subscales. Scoring is 0-84, the higher the score the greater the impact of fatigue.
Measured: 12 months
Secondary outcomes (7)
Lupus quality of life questionnaire (LupusQoL)
A self-reported disease-specific health related quality of life questionnaire in adult Lupus. It consists of 34 items covering eight areas which include physical health, emotional health, body image, pain, planning, fatigue, intimate relationships, and burden to others. The questionnaire also has a 5-point Likert response format ranging from 0=all the time, 1=most of the time, 2=a good bit of the time, 3=occasionally, and 4=never. The higher the score the higher the reported quality of life.
Measured: 12 months
Pittsburgh Sleep quality Inventory ( PSQI)
A self-rated questionnaire which measures sleep quality and sleep disturbances over a 1-month time period. There are 19 items which produce 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The calculation of scores for these seven components produces one global score. If this score is greater than 5 it indicates poor sleep quality.
Measured: 12 months
Visual Analog scale of fatigue impact (FI-VAS)
Designed by the researchers for this study, it is a 100mm horizontal line fastened by two statements representing extremes of a single range. The two statements in this VAS are Fatigue does /does not impact my life. A score of 100 mm indicates maximum impact of fatigue.
Measured: 12 months
Participant Health Questionnaire (PHQ4)
A 4-item Likert response questionnaire using the first two items from the PHQ9 and GAD7 to briefly measure depression and anxiety. The brevity of the questionnaire was designed for clinical practice as a screening tool and is easier for participants who have fatigue and poor concentration. The maximum score is 12, a score of >8 indicates severe levels of distress.
Measured: 12 months
Self-Efficacy for Managing Chronic Diseases 6-item Scale
A 6 item scale on a visual analogue scale, ranging from 1 (not at all confident) to 10 (totally confident). The maximum score s 60.
Measured: 12 Months
Quick Systemic Lupus Erythematosus Activity Questionnaire (Q-SLAQ)
A shortened version of the Systemic Lupus Erythematosus Activity Questionnaire, a patient reported questionnaire of their Lupus related symptoms and disease activity. Maximum score is 37, the higher the score the higher the patient reported lupus activity.
Measured: 12 months
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
A measure of disease activity in Lupus participants, calculated by a healthcare professional, based on symptoms experienced in the previous 10 days. The maximum score is 105, a score of 10 or above indicates high disease activity.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start8 Apr 2024
- Primary completion9 Mar 2026
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen Harris, BA MB BCh BAO, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308770
- Sponsor's protocol ID
- AC21137
- Acronym
- FLIP
- Status last verified
- Oct 2026
- First submitted
- 23 Feb 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22737181Azizoddin 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.
PubMed 30580659Arnaud 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.
PubMed 30597077Wang B, Gladman DD, Urowitz MB. Fatigue in lupus is not correlated with disease activity. J Rheumatol. 1998 May;25(5):892-5.
PubMed 9598886Nikiphorou 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.
PubMed 33962964Hewlett 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.
PubMed 31601357Hewlett 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.
PubMed 30793700Martin 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.
PubMed 30705244Bachmair 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.
PubMed 36388001O'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.
PubMed 29097965Carandang 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.
PubMed 35124888Fangtham 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.
PubMed 30961418Overman 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.
PubMed 26272057Meacock 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.
PubMed 25510215Harris 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.
PubMed 18929686
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in Lupus Intervention Programmes (FLIP): A Randomised Controlled Trial Investigating the Effectiveness of Fatigue Management in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06308770
- Acronym / sponsor ID
- FLIP / AC21137
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Fatigue management
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 261 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 9 Mar 2026 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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 .
- Participants can be identified through the Scottish Lupus Registry Database as they will have already consented to being contacted about research.
- 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
- Modified Fatigue Impact Score (MFIS)
- SLE quality of life questionnaire (LupusQoL)
- Pittsburgh Sleep quality Inventory ( PSQI)
- Visual Analog scale of fatigue impact ( FI-VAS)
- Participant health questionnaire -4 item (PHQ4)
- Self -Efficacy for managing chronic disease 6 item scale (SEMCD-6)
- 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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Behavioral: Standard CareParticipants will be provided with access to Versus Arthritis and Lupus UK fatigue booklets. |
| Standard care and 4 week Fatigue Management Programme (FMP) | Active comparator | Behavioral: Standard Care, Behavioral: 4 week FMPParticipants 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. |
| Standard care and 7 week Fatigue Management Programme (FMP) | Active comparator | Behavioral: Standard Care, Behavioral: 7 week FMPParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard CareParticipants receive fatigue booklets from two charitable organisations providing information on fatigue, sleep, energy conservation, exercise and stress to help manage fatigue. | Behavioural | Standard care, Standard care and 4 week Fatigue Management Programme (FMP), Standard care and 7 week Fatigue Management Programme (FMP) |
| 4 week FMPParticipants attend 3 once weekly live online group interventions with a final intervention 8 weeks later. | Behavioural | Standard care and 4 week Fatigue Management Programme (FMP) |
| 7 week FMPParticipants attend 6 once weekly live online group interventions with a final intervention 8 weeks later. | Behavioural | Standard care and 7 week Fatigue Management Programme (FMP) |
Primary outcome
Modified Fatigue Impact Score (MFIS)
Time frame: 12 months
A tool to measure the impact of fatigue including physical, cognitive, and psychosocial subscales. Scoring is 0-84, the higher the score the greater the impact of fatigue.
7 secondary outcomes
Lupus quality of life questionnaire (LupusQoL)
Time frame: 12 months
Pittsburgh Sleep quality Inventory ( PSQI)
Time frame: 12 months
Visual Analog scale of fatigue impact (FI-VAS)
Time frame: 12 months
Participant Health Questionnaire (PHQ4)
Time frame: 12 months
Self-Efficacy for Managing Chronic Diseases 6-item Scale
Time frame: 12 Months
Quick Systemic Lupus Erythematosus Activity Questionnaire (Q-SLAQ)
Time frame: 12 months
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 22737181Ahn 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.
- Background: PubMed 30580659Azizoddin 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.
- Background: PubMed 30597077Arnaud 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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- prevalence of severe fatigue in LupusLink provided by the sponsor.
- prevalence of SLE in the UKLink provided by the sponsor.
- Versus Arthritis booklet on fatigueLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Harris, BA MB BCh BAO principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 week FMP and 7 week FMP in people with Systemic Lupus Erythematosus, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Fatigue Impact Score (MFIS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06308770, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.