NCT05762185

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

March 9, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

February 28, 2023

Last Update Submit

February 28, 2023

Conditions

BiotherapiesRheumatologyRheumatoid Arthritis

Keywords

nurse consultationbiotherapiesRheumatologyRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

nursing consultation

EXPERIMENTAL
Device: nursing consultation

Interventions

nursing consultationDEVICE

nursing consultation

nursing consultation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient suffering from rheumatoid arthritis followed by Rheumatology consultation of Amiens-Picardie University Hospital
  • Major patient
  • Patient having signed an informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 9, 2023

Study Start

November 4, 2019

Primary Completion

November 4, 2021

Study Completion

November 1, 2023

Last Updated

March 9, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)