Preparing to deliver a stepped wedge cluster-randomised trial to test the effectiveness of daily symptom tracking integrated into electronic health records for managing rheumatoid arthritis: a mixed-methods feasibility trial.

Abstract

Background: We sought to assess the feasibility of a stepped-wedge cluster-randomised trial testing the effectiveness of a complex mHealth intervention called REMORA: a co-designed smartphone app enabling daily, weekly and monthly symptom tracking integrated into electronic health records for people with rheumatoid arthritis (RA).

Methods: We conducted a mixed-methods feasibility trial using a convergent approach with some explanatory sequential elements. Patients were eligible to take part if they were older than ≥18 years of age, had (suspected) RA or undifferentiated inflammatory arthritis, and consented to take part from two outpatient departments. We analysed quantitative app and electronic health record data descriptively. We analysed qualitative data from interviews and clinic observations thematically. We assessed four feasibility domains: recruitment and consent (target: 15 patients per site), intervention uptake (≥70% of recruited participants completed on-boarding, i.e., registered with the app and submitted at least one symptom report), intervention adherence (>50% daily symptom reports provided), and measuring disease activity as the primary outcome (scores available for ≥80% of people with a follow-up clinic visit). Due to time constraints, we only recruited patients to the intervention group, leaving us unable to test the logistics of randomising sites in accordance with the trial's cluster stepped wedge design.

Results: Of 130 people screened, 52 consented. Of those, 32 (62%) completed on-boarding. On-boarded participants provided symptom data on 2384/3771 (63%) of possible days. Among the 48 people who had ≥1 follow-up appointment, at least one disease activity scored was obtained for 46 (96%) of them. Factors related to intervention uptake formed the biggest threat to trial feasibility, including lack of clarity of communication and guidance, access to technology, and personal challenges (e.g., being busy or unwell).

Conclusion: We found that delivering a trial to test the effectiveness of integrated symptom tracking in rheumatology outpatient settings was feasible. The future REMORA trial will contribute to the much-needed evidence base for the impact of integrated symptom tracking on care delivery and patient outcomes, including decision-making, patient experience, disease activity, and symptom burden.

Trial registration: This feasibility trial was registered at https://www.isrctn.com/ on 23-Jan-2023 (ISRCTN21226438).