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

Abstract

IntroductionDuring 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 analysisTeleSpA 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 disseminationThis 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 numberNCT04673825.

Evaluation of a hybrid telehealth care pathway for patients with axial spondyloarthritis including self-sampling at home: results of a longitudinal proof-of-concept mixed-methods study (TeleSpactive)

“…Results of other randomized controlled hybrid care model studies are still pending. The ongoing large randomized controlled trial TeleSpA [ 18 ] is solely based on questionnaires. The ongoing Remonit study [ 19 ] included point-of-care (POC) CRP tests for a subgroup of 12 patients additional to questionnaire-based ePROs.…”

Knowledge, perceptions, and practices of axial spondyloarthritis diagnosis and management among healthcare professionals: an online cross-sectional survey

“…This indicates the potential for extending telemedicine services in the management of axSpA. Telemedicine has an opportunity for remote monitoring, prompt intervention, and improved healthcare accessibility, particularly for patients residing in rural regions or with restricted mobility [ 21 , 22 ].…”

Digitale Erfassung der Krankheitsaktivität – Einblicke in ein Versorgungsforschungsprojekt.

“…Hier ist einschränkend zu erwähnen, dass sich diese Aussage nur auf ePRO bezieht, die rein auf Patientenselbstauskunft beruhen (Beispiel FFbH und BASDAI) und nicht als Composite Score konzipiert sind (Beispiel DAS-28 und ASDAS). Kollegen aus Maastricht analysieren in einer aktuellen Studie derzeit die Wirksamkeit und Kosteneffektivität eines asynchronen Telemonitorings bei SpA Patienten, wobei die Patienten in diesem Projekt auch die Möglichkeit haben werden, Visiten beim Arzt aufgrund einer erhöhten Krankheitsaktivität selber zu initiieren [22]. Ein weiterer Vorteil ist es, dass bei regelmäßigem Export von ePRO an den behandelnden Arzt zwischen den einzelnen Präsenzvisiten eine Rückmeldung zur Krankheitsaktivität eingeholt werden kann.…”