P050 Determining the feasibility of a multi-centre randomised clinical trial to test the effectiveness of integrated symptom tracking for managing rheumatoid arthritis
Authors: Druce Katie L , Parkes Matthew , Bravo Ramiro , Griffiths-Jones Deb , van der Veer Sabine N , Dixon William , McBeth John ,   on behalf of the REMORA team
Published: April 2024

Background/Aims

In a series of studies, we co-developed and piloted the remote monitoring of rheumatoid arthritis (REMORA) system. REMORA enables patients to daily track symptoms via their smartphone and integrates this data into their electronic health record for discussion during routine clinic visits. This offers the opportunity to make better, and shared, treatment decisions and improve disease management. The effectiveness of integrated daily symptom tracking on clinical and patient-reported outcomes will be tested in a multi-centre stepped wedge randomised clinical trial (RCT). Here, we present the results of the REMORA feasibility study to test trial procedures and intervention delivery.

Methods

Across two NHS sites in the Northwest of England we aimed to recruit 60 patients, aged ≥18 years with rheumatoid arthritis (RA) or inflammatory arthritis (IA), and access to an Android/iOS smartphone with daily internet access. Participants were asked to complete a baseline web-survey and use the REMORA app to collect daily symptom reports for up to six months. Clinical care teams extracted data from participants’ medical records for all baseline and follow-up appointments, including disease activity scores. To assess feasibility, we reported recruitment rates, participants’ uptake of and adherence to daily symptom tracking, and outcome data completeness. We also compared characteristics of a) those who consented vs. trackers (defined as submitting ≥1 symptom report, i.e., successful intervention uptake), and b) high adherers (symptoms reported on &gt; 60% days) vs. low adherers (symptoms reported on &lt; 25% days).

Results

A total of 130 patients were screened across study sites, and 52 were eligible and provided consent to take part (40.0%). Of those, 32 (61.5%) initiated symptom tracking; their demographic characteristics were broadly similar to those who consented, though more people of white ethnicity appeared higher in the tracker group (93.8% (95% CI 79.2-99.2) vs 86.5% (74.2-94.4), respectively). Participants completed at least one symptom report on 63.2% of study days (2384/3771 days). We observed few differences between low vs high adherers, though low adherers (n = 6) were younger (median (IQR) years: 41.5 (34.5-55.3)) than the high engagers (n = 20; 61.0 (50.5-65.3)) and had a shorter disease duration (years: 1.0 (0-5.8) vs 3.0 (0.8-10.8)). In total, 48 consented participants had at least one follow-up appointment during the study window; 46 (95.8%) had complete primary outcome data.

Conclusion

Across two clinical sites, we determined that the procedures and intervention delivery designed for use within a future multi-centre stepped wedge RCT of the REMORA system were feasible for recruitment, adherence to the intervention and completion of the primary outcome. However, uptake of the intervention was lower than we hoped. To enhance intervention uptake in the main trial, we clarified inclusion criteria, improved patient information on what is required to initiate symptom tracking and modified our supporting materials.

Disclosure

K.L. Druce: None. M. Parkes: None. R. Bravo: None. D. Griffiths-Jones: None. S.N. van der Veer: None. W. Dixon: Consultancies; consultancy fees from Google unrelated to this work. J. McBeth: None.