Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in the Management of His Subcutaneous Biotherapy

Rheumatoid Arthritis Clinical Trial

— PRECI  

Official title:

Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in the Management of His Subcutaneous Biotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05762185
• Other study ID #: PI2019_843_0045
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: November 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Biotherapy present specifics risks that patients must know and learn to manage. A national survey has been carried in this study to evaluate patients safety skills. (wording: " cross study of safety skills of 677 patients treat by biopharmaceuticals for an inflammatory rheumatism). This survey has allowed showcasing patients difficulties in managing their treatment, including for those under subcutaneous biotherapy. More than 60% patients interviewed doesn't know symptoms to bring them to consult and mainly postpone to their injection. The aim of this study is to prove that nursing consultation can allow the patient to become independent in treatment management and thus avoid occurrence of adverse event.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 138
• Est. completion date: November 2023
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient suffering from rheumatoid arthritis followed by Rheumatology consultation of Amiens-Picardie University Hospital
• Patient treated by Subcutaneous Biotherapy for at least 6 months at the time of inclusion
• Major patient
• Patient having signed an informed consent

Exclusion Criteria:

• Minor patient
• Patient with cognitive impairment diagnosed by a physician
• Patient under tutorship or curatorship
• Patient deaf or hard of hearing
• Patient not fluent in the French language (at the decision of the investigator)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Rheumatology

Intervention

Device:
• nursing consultation
nursing consultation

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of BIOSECURE score between baseline and after nurse consultation	Biosecure questionnaire is assessing patient theoretical and practical understanding of biotherapy. Highest score is 100.	one day