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 symptom tracking integrated into electronic health records (EHR) for people with rheumatoid arthritis (RA). Methods: We recruited patients aged ≥ 18 years with RA or inflammatory arthritis who consented to track their symptoms for up to six months using REMORA, from two outpatient departments. We analysed quantitative app and EHR data descriptively. Qualitative data from interviews and clinic observations was analysed thematically. We assessed four feasibility domains: recruitment and consent (target: 15 patients per site), intervention uptake (≥ 70% of recruited participants completed on-boarding), 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). Results: Of 52 people consented, 32 (62%) completed on-boarding. Participants provided symptom data on 62% of study days. Among 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 stepped-wedge cluster-randomised trial to test the effectiveness of REMORA would be feasible. This 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).