A Tele-health Follow-up Strategy for Tight Control of Disease Activity in Rheumatoid Arthritis: Results of the Non-inferiority Randomised Controlled Trail (the TeRA study)

Annette Thurah, Kristian Stengaard-Pedersen, Mette Gubi Axelsen, Ulrich Fredberg, Liv M V Schougaard, Niels H I Hjollund, Mogens Pfeiffer-Jensen, Trine B Laurberg, Ulrik Tarp, Kirsten Lomborg, Thomas Maribo

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OBJECTIVE: To test the effect of patient-reported outcome (PRO) based tele-health follow-up for tight control of disease activity in patients with rheumatoid arthritis (RA), and the differences between tele-health follow-up performed by rheumatologists or rheumatology nurses.

METHODS: A total of 294 patients were randomized (1:1:1) to either PRO-based tele-health follow-up carried out by a nurse (PRO-TN) or a rheumatologist (PRO-TR), or conventional out-patient follow-up by physicians. The primary outcome was change in DAS28 after week 52. Secondary outcomes were: physical function, quality of life and self-efficacy. The non-inferiority margin was a DAS28 change of 0.6. Mean differences were estimated following per-protocol (PP), intention to treat (ITT) and mulitivariate imputation (IMP) analysis.

RESULTS: Overall patients had low disease activity at baseline and end follow-up. Demographics and baseline characteristics were similar between groups. Non-inferiority was established for DAS28. In the ITT analysis mean difference (MD) in DAS28 between PRO-TR vs. control were -0.10 (90% CI -0.30; 0.13) and -0.19 (-0.41; 0.02) between PRO-TN vs.

CONTROL: When including one yearly visit to the outpatient clinic, patients i PRO-TN had a total of 1.72 (SD 1.03) visit/year, PRO-TR 1.75 (SD 1.03) vist/year and controls 4.15 (SD 1.0) visits/year. This included extra visits due to inflammatory flare.

CONCLUSION: Among RA patients with low disease activity or remission a PRO-based tele-health follow-up for tight control of disease activity in RA can achieve similar disease control as conventional outpatient follow-up. The degree of disease control did not differ between patients seen by rheumatologists or rheumatology nurses. This article is protected by copyright. All rights reserved.

TidsskriftArthritis Care & Research
Udgave nummer3
Sider (fra-til)353-360
Antal sider7
StatusUdgivet - mar. 2018
Udgivet eksterntJa


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