Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Dec 27:12:e52872.
doi: 10.2196/52872.

Follow-Up of Patients With Axial Spondyloarthritis in Specialist Health Care With Remote Monitoring and Self-Monitoring Compared With Regular Face-to-Face Follow-Up Visits (the ReMonit Study): Protocol for a Randomized, Controlled Open-Label Noninferiority Trial

Inger Jorid Berg  1 , Anne Therese Tveter  1   2 , Gunnstein Bakland  3   4 , Sarah Hakim  1 , Eirik K Kristianslund  1 , Siri Lillegraven  1 , Gary J Macfarlane  5 , Ellen Moholt  1 , Sella A Provan  1   6 , Joseph Sexton  1 , Emil Ek Thomassen  1 , Annette De Thurah  7   8 , Laure Gossec  9   10 , Espen A Haavardsholm  1 , Nina Østerås  1
Affiliations

Follow-Up of Patients With Axial Spondyloarthritis in Specialist Health Care With Remote Monitoring and Self-Monitoring Compared With Regular Face-to-Face Follow-Up Visits (the ReMonit Study): Protocol for a Randomized, Controlled Open-Label Noninferiority Trial

Inger Jorid Berg et al. JMIR Res Protoc. .

Abstract

Background: Patients with chronic inflammatory joint diseases such as axial spondyloarthritis have traditionally received regular follow-up in specialist health care to maintain low disease activity. The follow-up has been organized as prescheduled face-to-face visits, which are time-consuming for both patients and health care professionals. Technology has enabled the remote monitoring of disease activity, allowing patients to self-monitor their disease and contact health care professionals 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 aimed to assess the effectiveness of digital remote monitoring and self-monitoring in maintaining low disease activity in patients with axial spondyloarthritis.

Methods: The ReMonit study is a 3-armed, single-site, randomized, controlled, open-label noninferiority trial including patients with axial spondyloarthritis with low disease activity (Ankylosing Spondylitis Disease Activity Score <2.1) and on stable treatment with a tumor necrosis factor inhibitor. Participants were randomized 1:1:1 to arm A (usual care, face-to-face visits every sixth 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 end point was disease activity measured with the Ankylosing Spondylitis Disease Activity Score, evaluated at 6, 12, and 18 months. We aimed to include 240 patients, 80 in each arm. Secondary end points included 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 the treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Norway. Enrollment started in September 2021 and was completed with 242 patients 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 the effectiveness, safety, and cost-effectiveness of remote digital monitoring and self-monitoring of patients with axial spondyloarthritis compared with usual care. Hence, the ReMonit study will contribute important knowledge to personalized follow-up strategies for patients with axial spondyloarthritis. These results may also be relevant for other patient groups with inflammatory joint diseases.

Trial registration: ClinicalTrials.gov NCT05031767; hpps://www.clinicaltrials.gov/study/NCT05031767.

International registered report identifier (irrid): DERR1-10.2196/52872.

Keywords: cost-effectiveness; inflammatory joint disease; randomized controlled trial; remote care; remote monitoring; self-management; spondyloarthritis; telemedicine.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: IJB has received consultation fees from Novartis outside the submitted work. GB has received consultation fees from UCB outside the submitted work. SAP has received consultation fees from Boehringer Ingelheim and Pfizer and a research grant from Boehringer Ingelheim outside the submitted work. LG has received grants from AbbVie, Biogen, Lilly, Novartis, and UCB; personal fees from AbbVie, Amgen, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, and UCB; and nonfinancial support from AbbVie, Janssen, MSD, Novartis, Pfizer, UCB, and Viatris outside the submitted work. EAH has received grants from the Research Council of Norway during the conduct of the study and for the last 36 months outside of the submitted work, as well as speaker or consultant fees from Pfizer, AbbVie, Gilead, UCB Pharma, Galapagos, Eli Lilly, Novartis, and Boehringer Ingelheim. ATT, SH, EKK, SL, GJM, EM, JS, EEKT, ADT, and NØ have no conflicts of interests.

Figures

Figure 1
Figure 1
Logo of the Remote Monitoring in Axial Spondyloarthritis (ReMonit) study.
Figure 2
Figure 2
Illustration of the Remote Monitoring in Axial Spondyloarthritis (ReMonit) study design. CRP: c-reactive protein; HP: health care professional; PRO: patient-reported outcome.
See this image and copyright information in PMC

References

    1. McBain H, Newman S, Shipley M, Olaleye A, Moore S. Experiences of a patient‐initiated self‐monitoring service in inflammatory arthritis: A qualitative exploration. Musculoskeletal Care. 2018 Jan 30;16(2):278–286. doi: 10.1002/msc.1232. - DOI - PubMed
    1. Taurog JD, Chhabra A, Colbert RA. Ankylosing spondylitis and axial spondyloarthritis. N Engl J Med. 2016 Jun 30;374(26):2563–74. doi: 10.1056/NEJMra1406182. - DOI - PubMed
    1. Sieper J, Poddubnyy D. Axial spondyloarthritis. Lancet. 2017 Jul 01;390(10089):73–84. doi: 10.1016/S0140-6736(16)31591-4.S0140-6736(16)31591-4 - DOI - PubMed
    1. Sieper J, Braun J, Dougados M, Baeten D. Axial spondyloarthritis. Nat Rev Dis Primers. 2015 Jul 09;1(1):15013. doi: 10.1038/nrdp.2015.13.nrdp201513 - DOI - PubMed
    1. Ramiro S, Nikiphorou E, Sepriano A, Ortolan A, Webers C, Baraliakos X, Landewé RB, Van den Bosch FE, Boteva B, Bremander A, Carron P, Ciurea A, van Gaalen FA, Géher P, Gensler L, Hermann J, de Hooge M, Husakova M, Kiltz U, López-Medina C, Machado PM, Marzo-Ortega H, Molto A, Navarro-Compán V, Nissen MJ, Pimentel-Santos FM, Poddubnyy D, Proft F, Rudwaleit M, Telkman M, Zhao SS, Ziade N, van der Heijde D. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023 Jan;82(1):19–34. doi: 10.5167/uzh-222189. doi: 10.1136/ard-2022-223296.ard-2022-223296 - DOI - PubMed

Associated data