Efficiency of a Nurse-led Self-management Education Intervention in Promoting Safety Knowledge and Skills of Patients With Arthritis Treated Par Biologics (BIOSAFE)
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|ClinicalTrials.gov Identifier: NCT02855320|
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : January 28, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis (RA) Spondyloarthritis (SpA)||Other: Nurse-led self-management education intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Efficiency of a Nurse-led Self-management Education Intervention in Promoting Safety Knowledge and Skills of Patients With Arthritis Treated Par Biologics|
|Actual Study Start Date :||January 27, 2017|
|Actual Primary Completion Date :||November 26, 2018|
|Actual Study Completion Date :||November 26, 2018|
Experimental: PE (patient education)
Nurse-led self-management education intervention : 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.
Other: Nurse-led self-management education intervention
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.
No Intervention: Standard
The control group will be followed up by their rheumatologist in hospital or private care according to usual management of biologics treatment.
- Safety knowledge and skills towards biologic treatment [ Time Frame: 6 months ]score of the BIOSECURE Questionnaire, a 54 item questionnaire including competences to deal with fever, infections, vaccination, and other daily life situations
- Quality of life [ Time Frame: 6 months ]SF12
- Severe infections rate [ Time Frame: 6 months ]Severe infections will be defined as infections requiring Intravenous antibiotics or hospitalization.
- Coping and psychological well-being (RAID Rheumatoid arthritis Impact of disease score) [ Time Frame: 6 months ]VASs coping and psychological well-being from the RAID Rheumatoid arthritis Impact of disease score
- Coping and psychological well-being (AHI Arthritis helplessness index) [ Time Frame: 6 months ]VASs coping and psychological well-being from AHI Arthritis helplessness index
- Disease activity (DAS 28) [ Time Frame: 6 months ]DAS 28 (Disease Activity index) for the patients with RA
- Disease activity (ASDAS) [ Time Frame: 6 months ]ASDAS (Ankylosing spondylarthritis Disease activity score) for the patients with SpA
- Disease activity (BASDAI) [ Time Frame: 6 months ]BASDAI (Bath Ankylosing spondylarthritis Disease activity Index) for the patients with SpA
- Beliefs about biologics [ Time Frame: 6 months ]BMQ Beliefs about medicine questionnaire (specific)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855320
|Service de Rhumatologie Hôpital Saint Antoine|
|Paris, France, 75012|
|Principal Investigator:||Catherine BEAUVAIS, Dr||Assistance Publique - Hôpitaux de Paris|