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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis (RA); Spondyloarthritis (SpA)
• Intervention / Treatment: Other: Nurse-led self-management education intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Service de Rhumatologie Hôpital Saint Antoine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety knowledge and skills towards biologic treatment	score of the BIOSECURE Questionnaire, a 54 item questionnaire including competences to deal with fever, infections, vaccination, and other daily life situations	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	SF12	6 months
Severe infections rate	Severe infections will be defined as infections requiring Intravenous antibiotics or hospitalization.	6 months
Coping and psychological well-being (RAID Rheumatoid arthritis Impact of disease score)	VASs coping and psychological well-being from the RAID Rheumatoid arthritis Impact of disease score	6 months
Coping and psychological well-being (AHI Arthritis helplessness index)	VASs coping and psychological well-being from AHI Arthritis helplessness index	6 months
Disease activity (DAS 28)	DAS 28 (Disease Activity index) for the patients with RA	6 months
Disease activity (ASDAS)	ASDAS (Ankylosing spondylarthritis Disease activity score) for the patients with SpA	6 months
Disease activity (BASDAI)	BASDAI (Bath Ankylosing spondylarthritis Disease activity Index) for the patients with SpA	6 months
Beliefs about biologics	BMQ Beliefs about medicine questionnaire (specific)	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Catherine BEAUVAIS, Dr, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Beauvais C, Fayet F, Rousseau A, Sordet C, Pouplin S, Maugars Y, Poilverd RM, Savel C, Segard V, Godon B, L'amour C, Perdriger A, Brin F, Peyrard P, Chalier F, Pallot-Prades B, Tuffet S, Griffoul I, Gossec L. Efficacy of a nurse-led patient education intervention in promoting safety skills of patients with inflammatory arthritis treated with biologics: a multicentre randomised clinical trial. RMD Open. 2022 Mar;8(1):e001828. doi: 10.1136/rmdopen-2021-001828.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2017
• Primary Completion (Actual): November 26, 2018
• Study Completion (Actual): November 26, 2018

Study Registration Dates

• First Submitted: July 1, 2016
• First Submitted That Met QC Criteria: July 31, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): January 28, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: self-management; patient education; Rheumatoid arthritis; Spondyloarthritis; Biologics safety
• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Arthritis; Arthritis, Rheumatoid; Spondylitis; Spondylarthritis
• Other Study ID Numbers: K151201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No