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Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Care | Study protocol

Nurse-led care versus physician-led care in the management of rheumatoid arthritis and psoriatic arthritis (StaerkeR): study protocol for a multi-center randomized controlled trial

Authors: Anna Mai, Jürgen Braun, Jens-Peter Reese, Benjamin Westerhoff, Ulrike Trampisch, Renate Klaassen-Mielke, Nina Timmesfeld, Hans J. Trampisch, Dietmar Krause

Published in: Trials | Issue 1/2019

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Abstract

Background

In Germany, the care of patients with inflammatory arthritis could be improved. Although specialized rheumatology nurses could take over substantial aspects of patient care, this hardly occurs in Germany. Thus, the aim of the study is to examine structured nursing consultation in rheumatology practices.

Methods/design

In total, 800 patients with a stable course of rheumatoid arthritis or psoriatic arthritis in 20 centers in North Rhine–Westphalia and Lower Saxony will be randomized to either nurse-led care or standard care. Participating nurses will study for a special qualification in rheumatology and trial-specific issues. It is hypothesized that nurse-led care is non-inferior to standard care provided by rheumatologists with regard to a reduction of disease activity (DAS28) while it is hypothesized to be superior regarding changes in health-related quality of life (EQ-5D-5L) after 1 year. Secondary outcomes include functional capacity, patient satisfaction with treatment, and resource consumption.

Discussion

Since there is insufficient care of rheumatology patients in Germany, the study may be able to suggest improvements. Nurse-led care has the potential to provide more efficient and effective patient care. This includes a more stringent implementation of the treat-to-target concept, which may lead to a higher percentage of patients reaching their treatment targets, thereby improving patient-related outcomes, such as quality of life, functional capacity, and participation. Additionally, nurse-led care may be highly cost-effective. Finally, this project may form the basis for a sustainable implementation of nurse-led care in standard rheumatology care in Germany.

Trial registration

German Clinical Trials Register, DRKS00015526. Registered on 11 January 2019.
Appendix
Available only for authorised users
Literature
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Metadata
Title
Nurse-led care versus physician-led care in the management of rheumatoid arthritis and psoriatic arthritis (StaerkeR): study protocol for a multi-center randomized controlled trial
Authors
Anna Mai
Jürgen Braun
Jens-Peter Reese
Benjamin Westerhoff
Ulrike Trampisch
Renate Klaassen-Mielke
Nina Timmesfeld
Hans J. Trampisch
Dietmar Krause
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3808-3

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