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

digital health applications ePRO mHealth mobile medical apps remote care rheumatoid arthritis telemedicine

Journal

Frontiers in medicine
ISSN: 2296-858X
Titre abrégé: Front Med (Lausanne)
Pays: Switzerland
ID NLM: 101648047

Informations de publication

Date de publication:
2021
Historique:
received: 08 10 2021
accepted: 22 11 2021
entrez: 30 12 2021
pubmed: 31 12 2021
medline: 31 12 2021
Statut: epublish

Résumé

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.

Identifiants

pubmed: 34966765
doi: 10.3389/fmed.2021.791715
pmc: PMC8710736
doi:

Types de publication

Journal Article

Langues

eng

Pagination

791715

Informations de copyright

Copyright © 2021 Mucke, Knitza, Muehlensiepen, Grahammer, Stenzel, Simon, Kleyer, Krönke, Sharp, Bendzuck, Korinth, Elling-Audersch, Vuillerme, Schett, Pecher and Krusche.

Déclaration de conflit d'intérêts

JK, JM, A-CP, and MK have received research support from Sanofi. JK reports personal fees from ABATON GmbH. MG is founder and shareholder of ABATON GmbH. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Références

Int J Rheumatol. 2015;2015:834070
pubmed: 26633974
Rheumatol Int. 2021 Jun;41(6):1187-1188
pubmed: 33839886
Rheumatology (Oxford). 2020 Feb 1;59(2):367-378
pubmed: 31335942
JMIR Mhealth Uhealth. 2020 Nov 5;8(11):e19260
pubmed: 33151161
Joint Bone Spine. 2020 Dec;87(6):525-527
pubmed: 32278812
Arthritis Res Ther. 2005;7(4):R796-806
pubmed: 15987481
Arthritis Care Res (Hoboken). 2018 Mar;70(3):353-360
pubmed: 28511288
Semin Arthritis Rheum. 2016 Dec;46(3):380-385
pubmed: 27395561
RMD Open. 2021 Feb;7(1):
pubmed: 33622673
Z Rheumatol. 2019 Oct;78(8):692-697
pubmed: 31468164
Arthritis Care Res (Hoboken). 2018 Apr;70(4):617-626
pubmed: 29400009
Curr Opin Rheumatol. 2020 Mar;32(2):119-125
pubmed: 31913162
BMC Musculoskelet Disord. 2016 Apr 02;17:146
pubmed: 27038788
JMIR Mhealth Uhealth. 2018 Oct 29;6(10):e12221
pubmed: 30373732
J Telemed Telecare. 2008;14(2):62-6
pubmed: 18348749
JMIR Mhealth Uhealth. 2020 Aug 12;8(8):e19661
pubmed: 32678796
Semin Arthritis Rheum. 2020 Aug;50(4):791-796
pubmed: 32540672
Int J Environ Res Public Health. 2021 Mar 05;18(5):
pubmed: 33807952
Ann Rheum Dis. 2011 Oct;70(10):1822-5
pubmed: 21821867
Eur J Rheumatol. 2019 May 20;6(3):136-141
pubmed: 31329541
Ann Rheum Dis. 2021 Oct;80(10):1278-1285
pubmed: 33962964
Lancet. 2017 Sep 2;390(10098):959-968
pubmed: 28716313
Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30
pubmed: 16336556
BMC Med Inform Decis Mak. 2015 Dec 23;15:109
pubmed: 26699852
Arthritis Rheum. 1995 Jan;38(1):44-8
pubmed: 7818570
J Rheumatol. 2008 Nov;35(11):2136-47
pubmed: 18793006
Ann Rheum Dis. 2020 Jun;79(6):685-699
pubmed: 31969328
Z Rheumatol. 2020 Aug;79(6):562-569
pubmed: 32651681
JMIR Mhealth Uhealth. 2020 Jul 20;8(7):e18117
pubmed: 32390592

Auteurs

Johanna Mucke (J)

Policlinic and Hiller Research Unit for Rheumatology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.

Johannes Knitza (J)

Department of Internal Medicine Rheumatology and Immunology, Friedrich-Alexander- University Erlangen-Nürnberg (FAU), Universitätsklinikum Erlangen, Erlangen, Germany.
Deutsches Zentrum fuer Immuntherapie (DZI), FAU Erlangen-Nuremberg and Universitätsklinikum, Erlangen, Germany.
Université Grenoble Alpes, AGEIS, Grenoble, France.

Felix Muehlensiepen (F)

Center for Health Services Research, Brandenburg Medical School Theodor Fontane, Ruedersdorf, Germany.
Faculty of Health Sciences Brandenburg, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany.

Manuel Grahammer (M)

Abaton GmbH, Berlin, Germany.

Ramona Stenzel (R)

Department of Internal Medicine Rheumatology and Immunology, Friedrich-Alexander- University Erlangen-Nürnberg (FAU), Universitätsklinikum Erlangen, Erlangen, Germany.

David Simon (D)

Department of Internal Medicine Rheumatology and Immunology, Friedrich-Alexander- University Erlangen-Nürnberg (FAU), Universitätsklinikum Erlangen, Erlangen, Germany.
Deutsches Zentrum fuer Immuntherapie (DZI), FAU Erlangen-Nuremberg and Universitätsklinikum, Erlangen, Germany.

Arnd Kleyer (A)

Department of Internal Medicine Rheumatology and Immunology, Friedrich-Alexander- University Erlangen-Nürnberg (FAU), Universitätsklinikum Erlangen, Erlangen, Germany.
Deutsches Zentrum fuer Immuntherapie (DZI), FAU Erlangen-Nuremberg and Universitätsklinikum, Erlangen, Germany.

Gerhard Krönke (G)

Department of Internal Medicine Rheumatology and Immunology, Friedrich-Alexander- University Erlangen-Nürnberg (FAU), Universitätsklinikum Erlangen, Erlangen, Germany.
Deutsches Zentrum fuer Immuntherapie (DZI), FAU Erlangen-Nuremberg and Universitätsklinikum, Erlangen, Germany.

Charlotte Sharp (C)

Centre for Epidemiology Versus Arthritis, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, The University of Manchester, Manchester, United Kingdom.

Gerlinde Bendzuck (G)

Deutsche Rheuma-Liga Bundesverband e.V., Bonn, Germany.

Marianne Korinth (M)

Deutsche Rheuma-Liga Bundesverband e.V., Bonn, Germany.

Corinna Elling-Audersch (C)

Deutsche Rheuma-Liga Bundesverband e.V., Bonn, Germany.

Nicolas Vuillerme (N)

Université Grenoble Alpes, AGEIS, Grenoble, France.
LabCom Telecom4Health, Orange Labs and Univ. Grenoble Alpes, CNRS, Inria, Grenoble INP-UGA, Grenoble, France.
Institut Universitaire de France, Paris, France.

Georg Schett (G)

Department of Internal Medicine Rheumatology and Immunology, Friedrich-Alexander- University Erlangen-Nürnberg (FAU), Universitätsklinikum Erlangen, Erlangen, Germany.
Deutsches Zentrum fuer Immuntherapie (DZI), FAU Erlangen-Nuremberg and Universitätsklinikum, Erlangen, Germany.

Ann-Christin Pecher (AC)

Centre for Interdisciplinary Clinical Immunology, Rheumatology and Autoinflammatory Diseases, University Hospital Tuebingen, Tübingen, Germany.

Martin Krusche (M)

Division of Rheumatology and Inflammatory Rheumatic Diseases, University Hospital Hamburg Eppendorf, Hamburg, Germany.

Classifications MeSH