Rheumatoid Arthritis (RA) Clinical Trial
Official title:
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. 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.
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.
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