REMORA2 - SWT (Version 1.0)
Research type
Research Study
Full title
Transforming outpatient consultations by integrating regular symptom tracking into clinical care: a Stepped wedge randomised control trial (RCT) of remote monitoring of rheumatoid arthritis, compared to usual care.
IRAS ID
322792
Contact name
Mohammed Zubair
Contact email
Sponsor organisation
Research Governance and Integrity, University of Manchester
Duration of Study in the UK
1 years, 11 months, 0 days
Research summary
Rheumatoid Arthritis (RA) is a common chronic inflammatory disease which exemplifies challenges in the management of long-term conditions. Current best practice can lead to gaps in knowledge which prevent effective disease management. Symptom tracking using an app has previously been demonstrated to improve shared decision-making and provide a clearer picture of fluctuations in a patient’s condition. REMORA2 is a mixed-methods stepped wedge randomised controlled trial to provide evidence on comparative effectiveness of integrated symptom tracking (IST) compared with standard of care (SoC), knowledge of the cost-effectiveness, and insight into the impact on shared decision-making and factors that influence successful implementation.
The trial involves 16 NHS sites over a period of approximately 22 months, recruiting 736 patients. Patients will be randomly allocated to IST or SoC and followed for 12-15 months. Those allocated to IST will complete daily, weekly and monthly questionnaires about their symptoms using the REMORA app. This data will then be viewed with the clinician at the next clinic consultation. All participants will be asked to complete web surveys at baseline, 3, 6, 9 and 12 months and to allow data from their medical record to be provided to the study team.
A number of clinician and patient participants will be invited to take part in interviews about their experience in the trial. Clinic consultations will also be observed.
Interviews will be conducted with a range of stakeholders to provide qualitative data on barriers to IST and ways they can be addressed.
The results of the proposed research are anticipated to:
1. Improve care and outcomes of people living with long-term conditions, using RA as an exemplar, by integrating regular patient-reported symptom tracking into existing care pathways
2. Generate and disseminate knowledge on how to successfully implement patient-generated data into the NHS, including necessary change of behaviours and workflows.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0266
Date of REC Opinion
15 Aug 2023
REC opinion
Favourable Opinion