Fatigue in Lupus Intervention Programmes (FLIP)
ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Edinburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Standard Care
BehavioralParticipants receive fatigue booklets from two charitable organisations providing information on fatigue, sleep, energy conservation, exercise and stress to help manage fatigue.
4 week FMP
BehavioralParticipants attend 3 once weekly live online group interventions with a final intervention 8 weeks later.
7 week FMP
BehavioralParticipants attend 6 once weekly live online group interventions with a final intervention 8 weeks later.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Standard careActive comparator 1 intervention
Group B: Standard care and 4 week Fatigue Management Programme (FMP)Active comparator 2 interventions
Group C: Standard care and 7 week Fatigue Management Programme (FMP)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
12 monthsSecondary outcomes
1
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.
Time frame
12 months2
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.
Time frame
12 months3
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.
Time frame
12 months4
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.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov