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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 : Recruiting
First Posted : August 4, 2016
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis (RA) Spondyloarthritis (SpA) Other: Nurse-led self-management education intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
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
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arm Intervention/treatment
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.
Other Names:
  • Nurse-led patient education
  • Nurse-led patient safety education

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Adherence to the biologic treatment [ Time Frame: 6 months ]
    MMAS4 Modified Morisky adherence scale

  2. Quality of life [ Time Frame: 6 months ]
    SF12

  3. Severe infections rate [ Time Frame: 6 months ]
    Severe infections will be defined as infections requiring Intravenous antibiotics or hospitalization.

  4. 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

  5. Coping and psychological well-being (AHI Arthritis helplessness index) [ Time Frame: 6 months ]
    VASs coping and psychological well-being from AHI Arthritis helplessness index

  6. Disease activity (DAS 28) [ Time Frame: 6 months ]
    DAS 28 (Disease Activity index) for the patients with RA

  7. Disease activity (ASDAS) [ Time Frame: 6 months ]
    ASDAS (Ankylosing spondylarthritis Disease activity score) for the patients with SpA

  8. Disease activity (BASDAI) [ Time Frame: 6 months ]
    BASDAI (Bath Ankylosing spondylarthritis Disease activity Index) for the patients with SpA

  9. Beliefs about biologics [ Time Frame: 6 months ]
    BMQ Beliefs about medicine questionnaire (specific)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-75 years
  • Patients with RA ( ACR/EULAR criteria), axial or peripheral Spondyloarthritis (ASAS criteria), patients who are eligible for a Sub cutaneous biologic treatment according to the French recommendations of care
  • patients naïve from biologics.
  • Patients benefiting from French Social Security insurance.

Exclusion Criteria:

  • Patients unable to speak or read French language,
  • Patients unable to complete a questionnaire or meet with the trial obligations
  • Patients suffering from severe cognitive or psychiatric dysfunction

Information from the National Library of Medicine

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


Contacts
Contact: Catherine BEAUVAIS, Dr 0149282520 ext -33 catherine.beauvais@aphp.fr
Contact: Laure GOSSEC, Pr 0142160000 ext +33 laure.gossec@aphp.fr

Locations
France
Service de Rhumatologie Hôpital Saint Antoine Recruiting
Paris, France, 75012
Contact: Catherine BEAUVAIS, Dr    0149282520 ext +33    catherine.beauvais@aphp.fr   
Contact: Laure GOSSEC, Pr    0142160000 ext +33    laure.gossec@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Catherine BEAUVAIS, Dr Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02855320     History of Changes
Other Study ID Numbers: K151201
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Biologics safety
Rheumatoid arthritis
Spondyloarthritis
patient education
self-management

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Spondylarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylitis
Spinal Diseases
Bone Diseases