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

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05762185
Collaborator
(none)
138
1
1
47.9
2.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: nursing consultation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
138 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Interest of a Nursing Consultation in the Empowerment of the Patient With Rheumatoid Arthritis in the Management of His Subcutaneous Biotherapy
Actual Study Start Date :
Nov 4, 2019
Actual Primary Completion Date :
Nov 4, 2021
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: nursing consultation

Device: nursing consultation
nursing consultation

Outcome Measures

Primary Outcome Measures

  1. Variation of BIOSECURE score between baseline and after nurse consultation [one day]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Picardie Amiens Picardie France 80054

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT05762185
Other Study ID Numbers:
  • PI2019_843_0045
First Posted:
Mar 9, 2023
Last Update Posted:
Mar 9, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2023