NCT06308770

Fatigue in Lupus Intervention Programmes (FLIP)

Fatigue in Lupus Intervention Programmes (FLIP): A Randomised Controlled Trial Investigating the Effectiveness of Fatigue Management in Systemic Lupus Erythematosus
University of Edinburgh·ClinicalTrials.gov·behavioralRecruiting
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
Standard Care
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
University of Edinburgh
Location
Edinburgh, United Kingdom
Timeline & enrollment
Phase
N/A
Start date
Apr 08, 2024
End date
Apr 01, 2027
Enrollment
90 participants
Primary outcome

Modified Fatigue Impact Score (MFIS)

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.

ICD-10 classifications
Systemic lupus erythematosusSystemic lupus erythematosus, unspecifiedLupus erythematosusSystemic lupus erythematosus with organ or system involvementOther forms of systemic lupus erythematosus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06308770
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06308770 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Edinburgh and is currently Recruiting. The study focuses on Systemic Lupus Erythematosus. Target enrollment is 90 participants.

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