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

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.

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Key information

Conditions

Biotherapies Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Rheumatology Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

nursing consultation

Device

nursing consultation

Primary outcomes

Variation of BIOSECURE score between baseline and after nurse consultation

Time frame: one day

Biosecure questionnaire is assessing patient theoretical and practical understanding of biotherapy. Highest score is 100.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: PRECI

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2024
First posted: Mar 9, 2023
Registry last updated: Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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