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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

研究类型

观察性的

注册 (估计的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Bath、英国、BA1 3NG
        • Royal United Hospitals Bath NHS Foundation Trust
      • London、英国、SE5 9RS
        • King's College Hospital NHS Foundation Trust

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients with axSpA will be recruited from two study sites (RUH and KCH), whilst the RUH (Bath) patient population has limited ethnic and sociodemographic diversity. However, KCH (London) serves a more diverse population of patients.

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
axSpA patients

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
Self-reported flares
大体时间:From enrollment to end of 12 months
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.
From enrollment to end of 12 months

次要结果测量

结果测量
措施说明
大体时间
Flare management pathway development & refinement
大体时间:From the end of the prospective data collection, for 12 months
To develop a novel, digitally-facilitated patient-initiated flare management pathway for people living with axSpA.
From the end of the prospective data collection, for 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (实际的)

2026年6月1日

研究完成 (估计的)

2026年8月31日

研究注册日期

首次提交

2026年6月30日

首先提交符合 QC 标准的

2026年6月30日

首次发布 (实际的)

2026年7月7日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年6月30日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Anonymised data may be shared with researchers in the future to carry out other research into axSpA. This is documented in the participant information sheets and consent forms and specific consent for future use is an option.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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