Efficiency of a Nurse-led Self-management Education Intervention in Promoting Safety Knowledge and Skills of Patients With Arthritis Treated Par Biologics

Background Inflammatory arthritis (rheumatoid arthritis (RA) or spondyloarthritis (SpA) are painful chronic diseases which impair quality of life and work capacity. Biologics are very effective and widely used therapies. However, they are known to entail risks, particularly of infections, such as pulmonary infections, tuberculosis, and a few cases of opportunist infections.. The risk of severe infections is of 5%/patient-year with a maximum during the first six month after the initiation of the first biologic therapy.

Patient education (PE) is recommended for the management of chronic diseases. In the case of biologics, PE aims to help patients to learn specific skills particularly on safety issues, e.g stopping the biologic treatment in case of fever or surgery. Safety skills are assessed by the validated BIOSECURE questionnaire, a 54 item questionnaire assessing patients competences to deal with fever, infections, vaccination, and other daily life situations ie travelling, surgery, pregnancy. PE seems efficient for safety skills in a few non-randomized studies. In 2010 a national cross sectional survey on 677 patients showed that the risk of incorrect answers in the BIOSECURE questionnaire was 4 times lower among patients who had benefited from an education by a nurse or other kind of educational process (OR =3,8 IC95% :[1,68-8,8]. Although PE is recommended, a small rate of patients are proposed PE : in the national survey only 30% patients had had a face to face nurse consultation and for 11% patients the nurse consultation was part of a self-management program.

When a biotherapy is initiated, the initiation period is known to be critical for the patients motivation, particularly for patients treated by sub cutaneous biotherapy.

Aims and Hypothesis: this trial aims to investigate, as a primary outcome, the effects of a nurse-led self-management education face to face intervention on safety skills of patients with arthritis treated par sub cutaneous biologics. Our hypothesis is that the intervention group will report better skills at the 6 months follow up compared to usual care i.e information by the rheumatologist in current consultation. As the treatment initiation period is of importance, this trial will also include, as secondary outcomes, disease activity coping, patient's quality of life, self-efficacy. Our hypothesis is that the nurse intervention will increase motivation with positive effects on disease activity, patient's quality of life and coping, as well as self-efficacy.

Methods : multicentric randomized controlled open trial with blinded assessment of the primary outcome.