Fatigue in Lupus Intervention Programmes (FLIP)

Systemic Lupus Erythematosus Clinical Trial

— FLIP  

Official title:

Fatigue in Lupus Intervention Programmes (FLIP): A Randomised Controlled Trial Investigating the Effectiveness of Fatigue Management in Systemic Lupus Erythematosus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06308770
• Other study ID #: AC21137
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: April 2027

Study information

• Verified date: April 2024
• Source: University of Edinburgh
• Contact: Dervil M Dockrell, BSc Curr Occ
• Phone: 07762929927
• Email: dervil.dockrell[@]ed.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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:

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Fatigue
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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.
• 4 week FMP
Participants attend 3 once weekly live online group interventions with a final intervention 8 weeks later.
• 7 week FMP
Participants attend 6 once weekly live online group interventions with a final intervention 8 weeks later.

Locations

Country	Name	City	State
United Kingdom	NHS Lothian	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

References & Publications (30)

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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. — View Citation

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. — View Citation

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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. — View Citation

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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. — View Citation

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 Months
Secondary	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.	12 months
Secondary	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.	12 months

External Links

•   Lupus UK fatigue booklet
•   NICE guidelines for insomnia
•   prevalence of severe fatigue in Lupus
•   Versus Arthritis booklet on fatigue