Fatigue in Lupus Intervention Programmes (FLIP): A Randomised Controlled Trial Investigating the Effectiveness of Fatigue Management in Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Modified Fatigue Impact Score (MFIS)
研究概览
简要总结
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.
详细描述
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:
- 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 .
- Participants can be identified through the Scottish Lupus Registry Database as they will have already consented to being contacted about research.
- 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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistician who analyses the results will be blind to the intervention to which the participant was randomised.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Modified Fatigue Impact Score (MFIS)
时间窗: 12 months
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.
次要结局
- Visual Analog scale of fatigue impact (FI-VAS)(12 months)
- Self-Efficacy for Managing Chronic Diseases 6-item Scale(12 Months)
- Quick Systemic Lupus Erythematosus Activity Questionnaire (Q-SLAQ)(12 months)
- Pittsburgh Sleep quality Inventory ( PSQI)(12 months)
- Participant Health Questionnaire (PHQ4)(12 months)
- Lupus quality of life questionnaire (LupusQoL)(12 months)
- Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)(12 months)