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Axial Spondylarthritis (axSpA)NCT07782541

Presenting Patient-generated Data in axSpA Care

An observational study of Axial Spondylarthritis (axSpA), run by Royal United Hospitals Bath NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Chronic health conditions are often managed in secondary care services that are facing long waiting lists, limited appointment times, and financial pressures. With the increasing availability of mobile devices including smartphones and wearables, patients can collect vast amounts of patient-generated health data… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Axial Spondylarthritis (axSpA)
How many people
17 participants
Where
1 siteUnited Kingdom
Study dates
10 Feb 2026to 31 Jul 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients treated for axSpA at RUH

Who may be able to join

  • Adults over 18 with a diagnosis of axSpA
  • Treated at the Royal National Hospital for Rheumatic Diseases, at the Royal United Hospitals Bath NHS Foundation Trust
  • Due to have a planned consultation during the study period
  • If participating in the interview via Teams, access to an electronic device (computer, laptop, tablet, or smartphone) and email address is required. If participating over the phone or via Teams, a quiet, private space is required to conduct the interview.

Who cannot join

  • The person believes that participation may cause them to feel distress, discomfort or embarrassment.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Royal National Hospital for Rheumatic Diseases, at the Royal United Hospitals Bath NHS Foundation Trust

    Bath

Other trials in United Kingdom

About this study

Official title: Evaluating and Co-designing a Secondary Care Clinical Dashboard for Presenting Patient-generated Health Data in Axial Spondyloarthritis (axSpA) Care.

Chronic health conditions are often managed in secondary care services that are facing long waiting lists, limited appointment times, and financial pressures. With the increasing availability of mobile devices including smartphones and wearables, patients can collect vast amounts of patient-generated health data (PGHD) outside of the clinic. This includes symptoms, biometrics and treatment adherence, providing clinicians with a more complete picture of patients' health. This data has the potential to support more insightful patient-clinician collaboration based on lived experiences; to enable remote clinical review; and ultimately, to improve the efficiency and quality of care. Clinicians and patients have expressed significant interest in using PGHD to manage their health, yet most attempts to review this data in clinic are unsuccessful. This project will investigate this problem with a case study in axial spondyloarthritis (axSpA) care. Firstly, a model will be created of how the axSpA care pathway works, including activities, data, and outcomes. Following this a newly implemented PGHD platform for axSpA care at the Royal United Hospitals (RUH) Bath will be evaluated. This evaluation will take place at the RUH, and will involve consultation observations and follow-up interviews with patients and clinicians. It will also involve a series of co-design workshops with patients and clinicians to explore their views on how the current platform may be optimised and improved, including their views on the potential value of predictive analytics. This research will provide insights how the platform is used during consultations, the barriers surrounding its uptake and impact across all parts of the axSpA model, and users' requirements for future versions.

Read the detailed description

Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic disease primarily affecting the spine and sacroiliac joints. AxSpA usually develops in the second or third decade of a patient's life and impacts quality of life, mobility, function and work ability . Cornerstones of treatment are non-steroidal anti-inflammatory drugs, disease-modifying antirheumatic drugs and physical activity/rehabilitation . However, across the UK, there is huge variation in care provided for axSpA, and a significant residual burden on healthcare services post-pandemic . Capacity to deliver specialist rheumatology care is being exceeded by demand; the 2021 British Society for Rheumatology report highlighting a dangerous lack of consultants, specialist nurses and poor access to allied health professionals . The lack of healthcare capacity to meet demand is resulting in serious consequences for people living with rheumatic diseases in the UK, such as progressively worse health and debilitating pain . The 2022 NICE Impact Arthritis report suggested that support for education and non-pharmacological treatment is particularly lacking, making good long-term self-management more difficult for patients . Development of novel digital interventions to support patients in their self-management could revolutionise axSpA care in the UK by reducing pressure on healthcare services and ensuring that every patient has access to specialist treatment, thereby likely improving patient experience and clinical outcomes. The European Alliance of Associations for Rheumatology (EULAR, formerly European League Against Rheumatism) indeed suggest that digital healthcare is essential for supporting and optimising patient education and self-management in rheumatology.

As axSpA is highly variable across patients, personalised treatment plans are an important part of ensuring that patients receive effective care. However, as per current standard care in the UK, many people living with axSpA will see their rheumatologist or specialist physiotherapist once a year, or less - leaving them with 8,758 hours in a year where they must manage their condition somewhat independently . This results in limited time spent with patients in which to discuss treatment and management plans tailored to their individual needs. Additionally, previous work by Hue et al. with consultant rheumatologists and axSpA patients at the Royal National Hospital for Rheumatic Diseases (RNHRD), showed that clinicians were "acutely aware of time constraints placed on their interactions with the patient", and that these constraints limited opportunities for patients to lead conversations. It is therefore crucial that any activities that take place during consultations are as efficient as possible to maximize the time available for patients and clinicians to discuss topics that are important to them, and to collaboratively make decisions.

The increasing maturity and availability of digital health applications and wearable technologies are allowing patients to collect large amounts of health and lifestyle data outside of the clinic. This data can support patients in tracking their symptoms and disease progression, and has the potential to support existing patient-reported evidence that is often subject to recall bias, and is limited in its collection by appointment attendance. While a systematic review by Demiris et al. highlights several studies investigating the use of patient-gathered data in clinical practice, attempts to collaboratively use patient-gathered data in the clinic have been met with many challenges. These include a lack of mutual expectations between patients and clinicians when reviewing this data , clinical time constraints , and difficulties interpreting non-standard data formats . These challenges, among many others, highlight the importance of systems and visualisations that can support the efficient and meaningful use of patient-gathered data in clinical contexts.

At the Royal National Hospital for Rheumatic Diseases (RNHRD), Royal Untied Hospitals (RUH) Bath, a new digital health platform has been implemented for axSpA care. This platform helps patients to track their symptoms, share health data with their clinicians, review this data in clinic, and access educational resources. As this platform has not yet been evaluated in clinical practice, and given the historic barriers to utilising PGHD in clinic, it is important to understand how the platform is being used across the axSpA care pathway, and the experiences of clinicians and people living with axSpA in using the platform.

The study consists of three methodological approaches for data collection:

  1. Observational study The first part of the study will involve observations and recordings of scheduled routine axSpA consultations. An observational approach was chosen to ensure that the role that the platform plays naturally in consultations is captured and understood. This method of data collection also aims to minimise intrusions or interruptions for participants, allowing them to focus on their consultation without needing to stop to fill in questionnaires or other forms of data collection.
  2. Semi structured interviews The second part of the study will involve semi-structured interviews with patients and clinicians to gather their perspectives on the platform and how it was used during their consultation. A semi-structured interview format was chosen to allow participants to speak more freely about any points they feel are important, while retaining a focus on the topics relevant to the research questions.
  3. Co-design workshops The final part of the study will involve optional co-design workshops with patients and clinicians. These will run as group sessions, in which participants will be asked to reflect on their experiences with the platform, and to co-design potential new platform features and use cases, aided by creative tools such as paper and pens to draw any ideas.

The objectives of this research are to understand: (1) how this platform is used during consultations to interact with PGHD; (2) the barriers surrounding its uptake and impact within axSpA care; (3) the perspectives of patients and clinicians on the platform and how it is used, and (4) the requirements of patients and clinicians for future versions or features of the platform. To guide and structure the process evaluation, a logic model will be created of the axSpA care pathway, with input from axSpA clinicians, academic researchers, and patients. This logic model will form the basis of the evaluation, which will allow for a better understanding of how the platform is (or is not) supporting the outputs and impacts of the logic model.

The outcomes of this research will be (1) qualitative analyses of consultation recordings to investigate how the platform was used to interact with PGHD; (2) thematic analyses of patient and clinician perspectives on the use of the platform during consultations; (3) outputs from co-design workshops exploring patient and clinician requirements for future versions and features of the platform. Ultimately, this research will provide a greater understanding of how the platform is used, the next steps to ensuring its future success, and the success of similar platforms. The findings from this research will be shared with the developer of the platform (Inhealthcare) to guide the development of subsequent versions of the platform, which will have a local impact at the RNHRD. The results will also be shared across the wider axSpA and rheumatology network to ensure that the findings are useful and generalisable beyond this project.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quotes and resulting themes from semi-structured interviews and workshops with patients and clinicians relating to self-management and patient-generated health data

    Thematic analysis of interviews and co-design workshops with patients and clinicians to identify themes relating to patient self-management and the use of patient-generated health data in the treatment and management of axSpA

    Measured: From enrolment until end of interview or optional co-design workshop (up to 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2026
  2. Study start10 Feb 2026
  3. Primary completion31 Jul 2026
  4. Study completion31 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07782541
Sponsor's protocol ID
354037
Status last verified
Aug 2025
First submitted
18 Feb 2026
Last updated
24 Aug 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Axial Spondylarthritis (axSpA), run by Royal United Hospitals Bath NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quotes and resulting themes from semi-structured interviews and workshops with patients and clinicians relating to self-management and patient-generated health data (time frame: From enrolment until end of interview or optional co-design workshop (up to 6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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