Abstract
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)
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Background: Despite the increased prevalence of rheumatoid arthritis (RA) in recent years, no studies have yet investigated the effect of monitoring disease activity through a standardized tele-health strategy in patients with RA (1).
Objectives: To test the effect of patient-reported outcome (PRO) based tele-health follow-up for tight control of disease activity in patients with 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 Flare-RA (2) was used as decision aid for assessing disease activity.
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, intention to treat (ITT) and imputation (IMP).
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 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 in PRO-TN had a total of 1.72 (SD 1.03) visit/year, PRO-TR 1.75 (SD 1.03) vist/year and control 4.15 (SD 1.0) visits/year. This included extra visits due to inflammatory flare.
Overall more than 80% of the patients in all three groups answered that they were “very satisfied” with the consultation form they received and no differences were found between the three groups.
Conclusions: 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.
References:
References.
Ward IM, Schmidt TW, Lappan C, Battafarano DF. How critical is tele-medicine to the rheumatology workforce? Arthritis Care Res (Hoboken). 2016 Feb 11.
Berthelot JM, De Bandt M, Morel J, Benatig F, Constantin A, Gaudin P, et al. A tool to identify recent or present rheumatoid arthritis flare from both patient and physician perspectives: The 'FLARE' instrument. Ann Rheum Dis. 2012 Jul;71(7):1110–6.
ClinicalTrails.gov identifier: NCT02155894.
Disclosure of Interest: None declared
DOI: 10.1136/annrheumdis-2017-eular.2995Citation: Annals of the Rheumatic Diseases, volume 76, supplement 2, year 2017, page 454Session: Public health, health services research and health economics
(Poster Presentations )
9 organizations
Organization
Clinical Medicine, Aarhus University, AarhusOrganization
WestChronic, Department of Occupational Medicine, University Clinic, Health, Aarhus University, HerningOrganization
Clinical Epidemiology, Aarhus UniversityOrganization
Defactum, Central Denmark Region