You are here

  • Home
  • Archive
  • Volume 7, Issue 1
  • Effect of nurse-led care on outcomes in patients with ACPA/RF-positive rheumatoid arthritis with active disease undergoing treat-to-target: a multicentre randomised controlled trial

Article Text

Article menu

Download PDFPDF

Rheumatoid arthritis
Original research
Effect of nurse-led care on outcomes in patients with ACPA/RF-positive rheumatoid arthritis with active disease undergoing treat-to-target: a multicentre randomised controlled trial
  1. Juliana Rachel Hoeper1,2,
  2. Jan Zeidler1,
  3. Sara Eileen Meyer2,
  4. Georg Gauler3,
  5. Patricia Steffens-Korbanka3,
  6. Martin Welcker4,
  7. Jörg Wendler5,
  8. Florian Schuch5,
  9. Ulrich von Hinüber6,
  10. Andreas Schwarting7,8,
  11. Torsten Witte2,
  12. Dirk Meyer-Olson2,9 and
  13. Kirsten Hoeper2
  1. 1Center for Health Economics Research Hannover (CHERH), Leibniz Universität Hannover, Hannover, Germany
  2. 2Rheumatologie and Immunologie, Medizinische Hochschule Hannover, Hannover, Germany
  3. 3Rheumapraxis an der Hase, Osnabrück, Germany
  4. 4MVZ für Rheumatologie, Planegg, Germany
  5. 5Internistische Praxisgemeinschaft, Rheumatologie, Erlangen, Germany
  6. 6Praxis für Rheumatologie und Osteologie, Hildesheim, Germany
  7. 7Division of Rheumatology and Clinical Immunology, University Hospital Mainz, Mainz, Germany
  8. 8ACURA Rheumatology Center Rhineland-Palatinate, Bad Kreuznach, Germany
  9. 9Rheumatologie, m&i Fachklinik Bad Pyrmont, Bad Pyrmont, Germany
  1. Correspondence to Dr Kirsten Hoeper; hoeper.kirsten{at}mh-hannover.de

Abstract

Objective To determine the non-inferiority of nurse-led care (NLC) in patients with anticitrullinated protein antibody (ACPA)-positive and/or rheumatoid factor (RF)-positive rheumatoid arthritis (RA) with active disease who are starting disease-modifying antirheumatic drug therapy, following treat-to-target (T2T) recommendations.

Methods A multicentre, pragmatic randomised controlled trial was conducted to assess clinical effectiveness, anxiety, depression and patient satisfaction following a non-inferiority design. The participants were 224 adults with ACPA/RF-positive RA who were randomly assigned to either NLC or rheumatologist-led care (RLC). The primary outcome was the Disease Activity Score in 28 Joints measured with C reactive protein (DAS28-CRP) assessed at baseline and after 3, 6, 9 and 12 months. A DAS28-CRP difference of 0.6 was set as the non-inferiority margin. Mean differences between the groups were assessed following per-protocol and intention-to-treat strategies.

Results Demographic data and baseline characteristics of patients in the NLC group (n=111) were comparable to those of patients in the RLC group (n=113). The improvement in disease activity (change in DAS28-CRP, primary outcome) over the course of 12 months was significant in both groups (p<0.001). No significant differences were observed between the NLC and RLC groups (p=0.317). Non-inferiority of NLC was shown for the primary outcome and all secondary outcomes.

Conclusion This study supported the non-inferiority of NLC in managing T2T and follow-up care of patients with RA with moderate to high disease activity and poor prognostic factors in addition to RLC.

Trial registration number DRKS00013055.

  • nursing
  • health services research
  • outcomes research
  • rheumatoid arthritis

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/rmdopen-2021-001627

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

    View Full Text

    Footnotes

    • Presented at The study was introduced and discussed at the EULAR 2020 International Virtual Press Conference and has been presented at the EULAR 2020 Conference. Hoeper JR, Gauler G, Meyer-Olson D et al. OP0154. Effect of nurse-led-care on patient outcomes in rheumatoid arthritis in Germany: a multicentre randomised controlled trial. Annals of the Rheumatic Diseases 2020; 79:97–98

    • Contributors JRH, GG, PS-K, MW, JW, FS, UvH and KH conceptualised and designed the study. AS was the main grant holder. KH and JRH were responsible for the study protocol development. KH was responsible for study set-up, recruiting sites and ethics application, and oversaw the study conduct. SEM conducted the data management. JRH and JZ conducted the statistical analyses. GG, PS-K, MW, JW, FS and DM-O recruited patients and collected data. JRH, KH, DM-O, TW, SEM, AS and JZ participated in the analysis and drafting or revision of the manuscript. All coauthors edited and reviewed the final version of the manuscript.

    • Funding The study was conducted as a subproject of the 'Rheuma-VOR' project and received funding from the Federal Joint Committee (G-BA). Funding number: 01NVF16029.

    • Competing interests JH, JZ, SEM, TW and UvH: none declared; GG has undertaken consultancies and speakers’ bureau for Abbvie, Lilly, Gilead, Celgene and Novartis; PSK has undertaken consultancies and speakers’ bureau for Abbvie, Chugai, Novartis, Sanofi, Mylan and Lilly. MW has undertaken consultancies and speakers’ bureau for Abbvie, Actelion, Aescu, Amgen, Biogen, BMS, Berlin Chemie, Celgene, Gilead, GSK, Hexal, Janssen, Medac, MSD, Mundipharma, Mylan, Novartis, Pfizer, Riemser, Roche, Sanofi, SOBI and UCB. JW has undertaken consultancies and speakers’ bureau for Janssen, Abbvie, Roche, Chugai and Novartis. FS has undertaken consultancies and speakers’ bureau for Novartis, Abbvie and Gilead. AS has received grants from Pfizer, GSK and Novartis, and has undertaken consultancies and speakers’ bureau for GSK and Roche. DMO has received grants from Novartis and Sandoz Hexal and has undertaken consultancies and speakers’ bureau for Abbvie, Amgen, BMS, Chugai, Lilly, Mylan, Novartis, Pfizer, Sandoz Hexal and Sanofi. KH has undertaken consultancies and speakers’ bureau for Abbvie, Chugai, Novartis, Lilly, Celgene, UCB, Sandoz Hexal, Sanofi and Gilead.

    • Provenance and peer review Not commissioned; externally peer reviewed.