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

NCT ID: NCT05762185

Last Updated: 2023-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-04

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Biotherapies Rheumatology Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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nursing consultation

Group Type EXPERIMENTAL

nursing consultation

Intervention Type DEVICE

nursing consultation

Interventions

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nursing consultation

nursing consultation

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens Picardie

Amiens, Picardie, France

Site Status

Countries

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France

Other Identifiers

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PI2019_843_0045

Identifier Type: -

Identifier Source: org_study_id

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