Effectiveness and cost-effectiveness of combined asynchronous telemonitoring and patient-initiated care for spondyloarthritis: protocol for a pragmatic multicentre randomised controlled trial (TeleSpA Study)

INTRODUCTION: During the COVID-19 pandemic, an accelerated uptake of remote monitoring strategies, replacing traditional face-to-face care, has been observed. However, data on the effects of remote care interventions for patients with rheumatic and musculoskeletal diseases remain scarce and interpretation is hampered by study heterogeneity and research quality concerns. High-quality evidence is required to guide future implementation in clinical practice, with health economic analyses identified as an important knowledge gap. Randomised controlled trials (RCTs) comparing telemonitoring with conventional care for patients with spondyloarthritis (SpA) are currently lacking. METHODS AND ANALYSIS: TeleSpA is a pragmatic, multicentre RCT investigating the effectiveness and cost-effectiveness of combined asynchronous telemonitoring and patient-initiated follow-up for patients with SpA, compared with conventional care. Two-hundred patients will be recruited at two hospitals and randomised (1:1) to the study intervention or standard care. The primary endpoint is a reduction in the number of follow-up visits by ≥25% in the intervention compared with standard care group, during a 1-year period. Secondary endpoints are (a) non-inferiority of the study intervention with regard to health outcomes, quality of care and patient-reported experience with care; and (b) cost-effectiveness of the intervention, evaluated through a prospective trial-based cost-utility analysis. In addition, experiences with the study intervention will be assessed among patients and healthcare providers, and factors associated with primary and secondary endpoints will be identified. ETHICS AND DISSEMINATION: This study was approved by the Medical Research Ethics Committee of the Academic Hospital Maastricht/Maastricht University (NL71041.068.19/METC 19-059). Results will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: NCT04673825.