NCT07782541

Brief 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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
Last Updated

August 24, 2026

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

February 18, 2026

Last Update Submit

August 19, 2026

Conditions

Outcome Measures

Primary Outcomes (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

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated for axSpA at RUH

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bath, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2026

First Posted

August 24, 2026

Study Start

February 10, 2026

Primary Completion

July 31, 2026

Study Completion

July 31, 2026

Last Updated

August 24, 2026

Record last verified: 2025-08

Locations