Efficiency of a Nurse-led Self-management Education Intervention in Promoting Safety Knowledge and Skills of Patients With Arthritis Treated Par Biologics
Condition: Rheumatoid Arthritis (RA); Spondyloarthritis (SpA)
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Spondylarthritis
Study type: Interventional

Summary: 
      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. 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. 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].

      Aims and Hypothesis: this trial aims to investigate 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.

      Methods : multicentric randomized controlled open trial with blinded assessment of the
      primary outcome. The intervention group will have a nurse education consultation at M 0 and
      M3 in addition to the usual care by the rheumatologist. The nurse will assess the patients'
      health beliefs and educational needs, focusing on safety skills, self-injections and
      motivation. The control group will have usual care by the rheumatologist.
    

Detailed description: 
      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.

      The pre selection visit will take place during the medical consultation. The rheumatologist
      will check the eligibility criteria. Eligible patients will receive written information and
      will be invited to participate in the RCT. The pre selection visit and the selection visit
      will possibly be done during the same medical consultation. At the selection visit a M0, the
      patients will sign the non-opposition form, will be assessed for baseline characteristics and
      complete the questionnaires. The randomization schedule will be prepared by the
      biostatistician using a computer-generated random numbers. The randomization will take place
      after the medical consultation and completion of the baseline assessment, in order to
      preserve the blinding. After randomization, the participants will be either in the
      intervention group (IG) or the control group (CG). Patients of the intervention group will be
      referred to the nurse, the same day or within 2 weeks ( maximum 4 weeks) after inclusion.

      Intervention group. The intervention group will benefit from the nurse intervention in
      addition to usual care : follow up by their rheumatologist in hospital or private care
      according to usual management of biologics treatment.

      Nurse intervention At M0, the nurse face to face intervention will include 1/ assessment of
      the patients' health beliefs and educational needs towards arthritis and treatment through a
      semi directive questionnaire to enhance communication 2/ Information about biologics 3/
      specific education on safety skills and self-injections 4/ Motivational communication on
      biologics treatment. At M3, the nurse will communicate on the patient's experience and
      motivation and will reinforce the safety messages.

      The MO and M3 intervention will last approximately 1 hour 30. The actual duration of the
      consultation will be left to the nurse's appreciation depending on the patient's needs and
      will be collected.

      The nurse intervention has been standardized through physical meeting among the centers
      leading to the development of a dedicated educational booklet including : the components of
      the educational diagnosis, assessment of the patients of educational needs, safety messages
      and motivational messages. The elaboration of the booklet is derived from previous work on
      the BIOSECURE study, recommendations for PE and previous work on educational needs of
      arthritis patients.

      All the nurses have been trained for patient education and self-management (University 1 year
      curriculum or minimum 40 hours training) and specifically for safety issues of biologics.

      Control group. The control group will be followed up by their rheumatologist in hospital or
      private care according to usual management of biologics treatment.

      Baseline characteristics

      Baseline assessment will include demographics features, age, gender, education level, disease
      duration, type of arthritis ( RA versus SpA), disease activity measured by the DAS 28
      (Disease Activity index) for the patients with RA and the BASDAI ( Bath ankylosing
      spondylitis disease activity index) for the patients with SpA, comorbidities, patients
      previous self-reported knowledge, quality of life (SF12), coping and psychological well-being
      (VASs from the RAID score, AHI Arthritis helplessness index), Disease activity (DAS, ASDAS,
      BASDAI), beliefs about medication ( BMQ)

      Final assessment

      Patients of both groups (IG and CG) will be assessed at M6 for primary and secondary
      outcomes. The administration of the questionnaires will be done by a member of the
      multidisciplinary team blinded for the treatment group. An additional nurse consultation will
      be proposed independently to the trial to the patients especially those whose safety
      knowledge will be proved to be inadequate at M6 assessment.
    

Intervention name(s): Nurse-led self-management education intervention
Intervention type(s): Other
Intervention description(s): A nurse education consultation at M 0 and M3 in addition to the usual care by the rheumatologist. The nurse will assess the patients' health beliefs and educational needs, focusing on safety skills, self-injections and motivation. The control group will have usual care by the rheumatologist.
Other intervention name(s): Nurse-led patient education; Nurse-led patient safety education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Biologics safety; Rheumatoid arthritis; Spondyloarthritis; patient education; self-management