Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 18, 2023
Date Accepted: Nov 23, 2023
Follow-up of patients with axial spondyloarthritis in specialist healthcare with Remote Monitoring and self-monitoring compared to regular face-to-face follow-up visits: Protocol for a randomized, controlled open-label non-inferiority trial, the ReMonit study
ABSTRACT
Background:
Patients with chronic inflammatory joint diseases such as axial spondyloarthritis have traditionally received regular follow-up in specialist healthcare in order to maintain low disease activity. The follow-up has been organized as pre-scheduled face-to-face visits, which is time-consuming both for patients and for healthcare professionals (HPs). Technology has enabled remote monitoring of disease activity, giving the possibility for patients to self-monitor their disease and contact the HPs when needed. Remote monitoring or self-monitoring may provide a more personalized follow-up, but there is limited research on how these follow-up strategies perform in maintaining low disease activity, patient satisfaction, safety, and cost-effectiveness.
Objective:
The Remote Monitoring in axial spondyloarthritis (ReMonit) study aims to assess the effectiveness of digital remote monitoring and self-monitoring with regard to maintaining low disease activity in patients with axial spondyloarthritis.
Methods:
The ReMonit study is a three-armed, single-site, randomized, controlled, open-label non-inferiority trial including patients with axial spondyloarthritis in low disease activity (Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1) and on stable treatment with tumor necrosis factor inhibitor. Participants are randomized 1:1:1 to either arm A (Usual care, face-to-face visits every 6th month), arm B (Remote Monitoring, monthly digital registration of patient reported outcomes) or arm C (Patient-initiated Care, self-monitoring, no planned visits during the study-period). The primary endpoint is disease activity measured with ASDAS and evaluated at 6, 12 and 18 months. We aimed to include 240 patients, 80 in each arm. Secondary endpoints include other measures of disease activity, patient satisfaction, safety and cost-effectiveness.
Results:
The project is funded by the South-Eastern Norway Regional Health Authority and Centre for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Norway. The enrolment started in September 2021 and was completed with 242 patients included by June 2022. The data collection will be completed in December 2023.
Conclusions:
To our knowledge, this trial will be among the first to evaluate effectiveness, safety, and cost-effectiveness of remote digital monitoring and self-monitoring of patient with axial spondyloarthritis compared to usual care. Hence, the ReMonit study will contribute with important knowledge on personalized follow-up strategies for patients with axial spondyloarthritis. A. The results may also be relevant for other patient groups with inflammatory joint diseases. Clinical Trial: ClinicalTrials.gov: NCT050317, registered September 2nd, 2021; Study Record | ClinicalTrials.gov
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