NCT02855320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

January 27, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2018

Completed
Last Updated

January 28, 2019

Status Verified

December 1, 2018

Enrollment Period

1.8 years

First QC Date

July 1, 2016

Last Update Submit

January 25, 2019

Conditions

Rheumatoid Arthritis (RA)Spondyloarthritis (SpA)

Keywords

Biologics safetyRheumatoid arthritisSpondyloarthritispatient educationself-management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Quality of life

    6 months

  • Severe infections rate

    6 months

  • Coping and psychological well-being (RAID Rheumatoid arthritis Impact of disease score)

    6 months

  • Coping and psychological well-being (AHI Arthritis helplessness index)

    6 months

  • Disease activity (DAS 28)

    6 months

  • +3 more secondary outcomes

Study Arms (2)

PE (patient education)

EXPERIMENTAL

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

Standard

NO INTERVENTION

The control group will be followed up by their rheumatologist in hospital or private care according to usual management of biologics treatment.

Interventions

Nurse-led self-management education interventionOTHER

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.

Also known as: Nurse-led patient education, Nurse-led patient safety education
PE (patient education)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Rhumatologie Hôpital Saint Antoine

Paris, 75012, France

Location

Related Publications (1)

  • 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.

    PMID: 35296528DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidSpondylarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylitisSpinal DiseasesBone Diseases

Study Officials

  • Catherine BEAUVAIS, Dr

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2016

First Posted

August 4, 2016

Study Start

January 27, 2017

Primary Completion

November 26, 2018

Study Completion

November 26, 2018

Last Updated

January 28, 2019

Record last verified: 2018-12

Locations

FR(1)