Fatigue in Lupus Intervention Programmes (FLIP)

NCT06308770 | Recruiting

• 1 other identifier: AC21137
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

Fatigue management

Outcome Measures

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.

  12 months

Secondary Outcomes (7)

• Lupus quality of life questionnaire (LupusQoL)

  12 months

• Pittsburgh Sleep quality Inventory ( PSQI)

  12 months

• Visual Analog scale of fatigue impact (FI-VAS)

  12 months

• Participant Health Questionnaire (PHQ4)

  12 months

• Self-Efficacy for Managing Chronic Diseases 6-item Scale

  12 Months

Study Arms (3)

Standard care

ACTIVE COMPARATOR

Participants will be provided with access to Versus Arthritis and Lupus UK fatigue booklets.

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.

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.

Behavioral: Standard Care; Behavioral: 7 week FMP

Interventions

Standard Care BEHAVIORAL

Participants receive fatigue booklets from two charitable organisations providing information on fatigue, sleep, energy conservation, exercise and stress to help manage fatigue.

Standard care; Standard care and 4 week Fatigue Management Programme (FMP); Standard care and 7 week Fatigue Management Programme (FMP)

4 week FMP BEHAVIORAL

Participants attend 3 once weekly live online group interventions with a final intervention 8 weeks later.

Standard care and 4 week Fatigue Management Programme (FMP)

7 week FMP BEHAVIORAL

Participants attend 6 once weekly live online group interventions with a final intervention 8 weeks later.

Standard care and 7 week Fatigue Management Programme (FMP)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

RECRUITING

Related Publications (30)

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• O'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.

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• 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.

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  BACKGROUND

• Lee, D.R., Teaching the World to Sleep. 2018.

  BACKGROUND

• Dobson, J., et al., POS1496-HPR HARD TIMES: ADAPTING A FATIGUE MANAGEMENT PROGRAMME IN A PANDEMIC. Annals of the Rheumatic Diseases, 2022. 81(Suppl 1): p. 1093-1093.

  RESULT

Related Links

• prevalence of severe fatigue in Lupus
• prevalence of SLE in the UK

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Standard of Care; N-formylmethionylphenylalanine

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Helen Harris, BA MB BCh BAO

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dervil M Dockrell, BSc Curr Occ

CONTACT

07762929927; dervil.dockrell@ed.ac.uk

Joanne M Dobson, MSc BSc RN

CONTACT

07850256666; joanne.dobson@ed.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician who analyses the results will be blind to the intervention to which the participant was randomised.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 13, 2024
• Study Start: April 8, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)