Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in the Management of His Subcutaneous Biotherapy (PRECI)
Primary Purpose
Biotherapies, Rheumatology, Rheumatoid Arthritis
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
nursing consultation
Sponsored by
About this trial
This is an interventional prevention trial for Biotherapies focused on measuring nurse consultation, biotherapies, Rheumatology, Rheumatoid Arthritis
Eligibility Criteria
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)
Sites / Locations
- CHU Amiens Picardie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nursing consultation
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05762185
First Posted
February 28, 2023
Last Updated
February 28, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05762185
Brief Title
Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in the Management of His Subcutaneous Biotherapy
Acronym
PRECI
Official Title
Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in the Management of His Subcutaneous Biotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
November 4, 2021 (Actual)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biotherapies, Rheumatology, Rheumatoid Arthritis
Keywords
nurse consultation, biotherapies, Rheumatology, Rheumatoid Arthritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nursing consultation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
nursing consultation
Intervention Description
nursing consultation
Primary Outcome Measure Information:
Title
Variation of BIOSECURE score between baseline and after nurse consultation
Description
Biosecure questionnaire is assessing patient theoretical and practical understanding of biotherapy. Highest score is 100.
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in the Management of His Subcutaneous Biotherapy
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