The REFLECT Study- Flares in axSpA (REFLECT)
Evidence Based, Patient-led Development of a Novel Axial Spondyloarthritis Flare Management Pathway
Axial spondyloarthritis (axSpA) is a long-term inflammatory condition that affects the spine and sacroiliac joints. People living with axSpA often experience periods when their symptoms suddenly worsen, known as disease "flares." These flares can be painful, unpredictable, and significantly affect daily life, work and psychological wellbeing. Their unpredictable nature can leave people feeling helpless and anxious about when symptoms will return.
Research has shown that severe or frequent flares are linked to worse long-term outcomes in axSpA. However, it is difficult for researchers and clinicians to clearly define what a flare is, or to predict when one will happen. There is an unmet, urgent need to improve our understanding and recognition of flares, to enable earlier and more effective intervention, and improve long-term outcomes.
This study will explore people's experiences of flares, through a real-time digital flare and symptom diary. Data will be captured digitally from people living with axSpA over 12 months, including symptoms, diet, and lifestyle, self-management strategies and impact of flare on life, work, psychological wellbeing and relationships. Participants will attend clinic at two time points only (once when in flare, once when not in flare), to collect blood (serum) samples for investigation of inflammatory markers.
Findings will enable us to define and "map" different flare experiences of people living with axSpA and identify windows of opportunity for intervention and effective management. The results will inform the development of a novel, patient-initiated digital pathway for flare identification and management, which will be discussed and refined in a series of workshops with patients and healthcare professionals. This project will take place in two UK NHS hospitals (specialist rheumatology care settings): The Royal National Hospital for Rheumatic Diseases, Bath and King's College Hospital, London. We anticipate future work to pilot test the pathway and inform potential wider NHS implementation
研究概览
地位
研究类型
注册 (估计的)
联系人和位置
学习地点
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Bath、英国、BA1 3NG
- Royal United Hospitals Bath NHS Foundation Trust
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London、英国、SE5 9RS
- King's College Hospital NHS Foundation Trust
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Adult patients (≥18 years) with a diagnosis of axSpA (non-radiographic or radiographic axSpA).
- Access to an email address and electronic device, to participate in data collection.
- Capacity to provide informed consent.
- Sufficient communicative ability to participate in the research study (must be able to communicate in English).
- Patient has experienced at least one (self-reported) flare in the 12-months prior to enrolment.
Exclusion Criteria:
- Patients <18 years of age.
- Patients with another diagnosis of inflammatory arthritis that is not axial spondyloarthritis.
- Living with significant psychiatric morbidity, or if participation may cause distress.
- Patient has participated in Project Nightingale (RUH only, 2018 - 2022).
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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axSpA patients
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Self-reported flares
大体时间:From enrollment to end of 12 months
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To characterise flare manifestations across the heterogeneous spectrum of axSpA disease and treatments and determine how to most effectively self-manage flare to reduce their impact and duration.
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From enrollment to end of 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Flare management pathway development & refinement
大体时间:From the end of the prospective data collection, for 12 months
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To develop a novel, digitally-facilitated patient-initiated flare management pathway for people living with axSpA.
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From the end of the prospective data collection, for 12 months
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合作者和调查者
调查人员
- 首席研究员:Raj Sengupta, Professor、Royal National Hospital for Rheumatic Diseases (RNHRD) at the Royal United Hospitals Bath NHS Foundation Trust (RUH)
出版物和有用的链接
一般刊物
- Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
- O'Cathain A, Croot L, Duncan E, Rousseau N, Sworn K, Turner KM, Yardley L, Hoddinott P. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open. 2019 Aug 15;9(8):e029954. doi: 10.1136/bmjopen-2019-029954.
- Barnett R, Ng S, Sengupta R. Understanding flare in axial spondyloarthritis: novel insights from daily self-reported flare experience. Rheumatol Adv Pract. 2021 Nov 15;5(3):rkab082. doi: 10.1093/rap/rkab082. eCollection 2021.
- Aouad K, Gossec L. Defining and managing flares in axial spondyloarthritis. Curr Opin Rheumatol. 2022 Jul 1;34(4):195-202. doi: 10.1097/BOR.0000000000000883. Epub 2022 Jun 9.
- Vasileiou K, Barnett J, Thorpe S, Young T. Characterising and justifying sample size sufficiency in interview-based studies: systematic analysis of qualitative health research over a 15-year period. BMC Med Res Methodol. 2018 Nov 21;18(1):148. doi: 10.1186/s12874-018-0594-7.
- Ondrejcakova L, Gregova M, Bubova K, Senolt L, Pavelka K. Serum biomarkers and their relationship to axial spondyloarthritis associated with inflammatory bowel diseases. Autoimmun Rev. 2024 Mar;23(3):103512. doi: 10.1016/j.autrev.2023.103512. Epub 2023 Dec 31.
- Hellman U, Lejon K, Do L, Geijer M, Baraliakos X, Witte T, Forsblad-d'Elia H. Immunological biomarkers in patients with radiographic axial spondyloarthritis, an exploratory longitudinal Swedish study. Mod Rheumatol. 2024 Dec 25;35(1):134-143. doi: 10.1093/mr/roae039.
- Liu D, Xie Y, Tu L, Wen X, Lv Q, Liu B, Yang M, Wu X, Zheng X, Luo X, Zhou L, Wu J, Liu B, Wang K, Jin O, Wang X, Qin J, Wu L, Zhao D, He D, He S, Huang W, Ye S, Zhou H, Wu J, Wang Y, Liu S, Li Z, Tan Z, Xu C, Wang Y, Zheng D, Zhan F, Lin C, Wen Y, Wu J, Wen S, Liao Z, Shen Y, Yang K, Gu J. A guideline on biomarkers in the diagnosis and evaluation in axial spondyloarthritis. Front Immunol. 2024 Oct 30;15:1394148. doi: 10.3389/fimmu.2024.1394148. eCollection 2024.
- Reilly E, Fisher C, Sengupta R. FRI0193 Prognostic markers in axial spondyloarthritis (PROMISE) - cross sectional evaluation of serum biomarkers in axspa, mechanical back pain and healthy controls. Annals of the Rheumatic Diseases. 2018;77(Suppl 2):637-.
- Carter SM, Shih P, Williams J, Degeling C, Mooney-Somers J. Conducting Qualitative Research Online: Challenges and Solutions. Patient. 2021 Nov;14(6):711-718. doi: 10.1007/s40271-021-00528-w. Epub 2021 Jun 11.
- Gandrup J, Selby DA, Dixon WG. Classifying Self-Reported Rheumatoid Arthritis Flares Using Daily Patient-Generated Data From a Smartphone App: Exploratory Analysis Applying Machine Learning Approaches. JMIR Form Res. 2024 May 14;8:e50679. doi: 10.2196/50679.
- Molto A, Gossec L, Meghnathi B, Landewe RBM, van der Heijde D, Atagunduz P, Elzorkany BK, Akkoc N, Kiltz U, Gu J, Wei JCC, Dougados M; ASAS-FLARE study group. An Assessment in SpondyloArthritis International Society (ASAS)-endorsed definition of clinically important worsening in axial spondyloarthritis based on ASDAS. Ann Rheum Dis. 2018 Jan;77(1):124-127. doi: 10.1136/annrheumdis-2017-212178. Epub 2017 Oct 16.
- van Gaalen FA, Navarro-Compan V, Baraliakos X, van den Bosch F, Gensler LS, Hmamouchi I, Landewe R, Machado PM, Marzo-Ortega H, Rodriguez VR, Poddubnyy D, Ramiro S, van der Heijde D. ASAS recommendations on reporting axial spondyloarthritis clinical trials. Ann Rheum Dis. 2025 Nov;84(11):1770-1778. doi: 10.1016/j.ard.2025.07.017. Epub 2025 Sep 6.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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关键字
其他研究编号
- 364763
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