Virtual group program for managing fatigue in lupus patients
Fatigue in Lupus Intervention Programmes (FLIP): A Randomised Controlled Trial Investigating the Effectiveness of Fatigue Management in Systemic Lupus Erythematosus
This study is testing whether a virtual group program can help people with lupus manage their fatigue better than just using standard care booklets.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 1 site (Edinburgh) |
| Trial ID | NCT06308770 on ClinicalTrials.gov |
What this trial studies
The FLIP study aims to evaluate the effectiveness of a virtual group Fatigue Management Programme compared to standard care using fatigue booklets for patients with Systemic Lupus Erythematosus (SLE). This single-center, three-arm randomized controlled trial will recruit participants from NHS Lothian and the Scottish Lupus Registry. Participants will be randomly assigned to receive either standard care or the virtual group intervention over a specified period. The study seeks to address the significant impact of fatigue on the quality of life of SLE patients, which is often overlooked in clinical settings.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a confirmed diagnosis of SLE who report chronic fatigue as a significant issue.
Not a fit: Patients who do not have access to the internet or are unable to understand English may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve fatigue management and overall quality of life for patients with lupus.
How similar studies have performed: Previous studies in other rheumatic diseases have shown that group cognitive behavioral approaches can effectively manage fatigue, suggesting potential success for this approach in lupus.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Edinburgh
- NHS Lothian — Edinburgh, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Helen Harris, BA MB BCh BAO — University of Edinburgh
- Study coordinator: Dervil M Dockrell, BSc Curr Occ
- Email: dervil.dockrell@ed.ac.uk
- Phone: 07762929927
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.