TELERA-Asynchronous TELEmedicine for Patients With Rheumatoid Arthritis: Study Protocol for a Prospective, Multi-Center, Randomized Controlled Trial

Johanna Mucke; Johannes Knitza; Felix Muehlensiepen; Manuel Grahammer; Ramona Stenzel; David Simon; Arnd Kleyer; Gerhard Krönke; Charlotte Sharp; Gerlinde Bendzuck; Marianne Korinth; Corinna Elling-Audersch; Nicolas Vuillerme; Georg Schett; Ann-Christin Pecher; Martin Krusche

doi:10.3389/fmed.2021.791715

TELERA-Asynchronous TELEmedicine for Patients With Rheumatoid Arthritis: Study Protocol for a Prospective, Multi-Center, Randomized Controlled Trial

Front Med (Lausanne). 2021 Dec 13:8:791715. doi: 10.3389/fmed.2021.791715. eCollection 2021.

Authors

Johanna Mucke¹, Johannes Knitza^{2

3

4}, Felix Muehlensiepen^{5

6}, Manuel Grahammer⁷, Ramona Stenzel², David Simon^{2

3}, Arnd Kleyer^{2

3}, Gerhard Krönke^{2

3}, Charlotte Sharp⁸, Gerlinde Bendzuck⁹, Marianne Korinth⁹, Corinna Elling-Audersch⁹, Nicolas Vuillerme^{4

10

11}, Georg Schett^{2

3}, Ann-Christin Pecher¹², Martin Krusche¹³

Affiliations

¹ Policlinic and Hiller Research Unit for Rheumatology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
² Department of Internal Medicine Rheumatology and Immunology, Friedrich-Alexander- University Erlangen-Nürnberg (FAU), Universitätsklinikum Erlangen, Erlangen, Germany.
³ Deutsches Zentrum fuer Immuntherapie (DZI), FAU Erlangen-Nuremberg and Universitätsklinikum, Erlangen, Germany.
⁴ Université Grenoble Alpes, AGEIS, Grenoble, France.
⁵ Center for Health Services Research, Brandenburg Medical School Theodor Fontane, Ruedersdorf, Germany.
⁶ Faculty of Health Sciences Brandenburg, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany.
⁷ Abaton GmbH, Berlin, Germany.
⁸ Centre for Epidemiology Versus Arthritis, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, The University of Manchester, Manchester, United Kingdom.
⁹ Deutsche Rheuma-Liga Bundesverband e.V., Bonn, Germany.
¹⁰ LabCom Telecom4Health, Orange Labs and Univ. Grenoble Alpes, CNRS, Inria, Grenoble INP-UGA, Grenoble, France.
¹¹ Institut Universitaire de France, Paris, France.
¹² Centre for Interdisciplinary Clinical Immunology, Rheumatology and Autoinflammatory Diseases, University Hospital Tuebingen, Tübingen, Germany.
¹³ Division of Rheumatology and Inflammatory Rheumatic Diseases, University Hospital Hamburg Eppendorf, Hamburg, Germany.

Abstract

Innovative strategies are needed to adequately assess and monitor disease activity of patients with rheumatoid arthritis (RA) in times of scarce appointments. The aim of the TELERA study is to evaluate the feasibility and performance of asynchronous telemedicine visits based on patient-generated data and patient's drug history. RA patients use a medical app, ABATON, that captures the results of a self-performed quick CRP-test, joint-count, and electronic patient-reported outcomes in between visits. This is a prospective, multi-center, randomized controlled trial performed in four German university centers. The estimated sample size is 120 patients. The main outcome is the agreement of rheumatologists' treatment decisions based on asynchronous telemedicine patient-generated data with traditional in-person rheumatology clinic-based decisions and with patient suggestions. The TELERA trial will provide evidence regarding the implementation of remote care in rheumatology. Clinical Trial Registration: This clinical trial was registered at German Registry for Clinical Trials (DRKS). http://www.drks.de/DRKS00016350, identifier: DRKS00024928.

Keywords: digital health applications; ePRO; mHealth; mobile medical apps; remote care; rheumatoid arthritis; telemedicine.