Status:

RECRUITING

Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy

Lead Sponsor:

University Hospital, Brest

Conditions:

Long Term Corticosteroid Therapy

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Long term corticosteroid therapy concerns 0.5 to 1% of the population and about 2.5% of elderly subjects. It is currently used as a cornerstone therapy in a wide variety of clinical contexts. The cent...

Detailed Description

It is a PROBE (Prospective Randomized Open trial with a Blind Evaluation) study, in which the primary endpoint will be assessed at week-52 by an independent physician blinded to the participant's allo...

Eligibility Criteria

Inclusion

  • Patients aged 18 or older
  • Initiation of corticosteroids within 30 days prior to inclusion
  • Estimated cumulative dosage of corticosteroids ≥ 2000 mg
  • Affiliated member of the social security system

Exclusion

  • Patients unable to give consent or unable to understand the protocol
  • A patient who is not 'or is no longer' able to communicate remotely by telephone could not 'or no longer' be included in the study.
  • Patients under guardianship
  • Previous exposure to long-term corticosteroids
  • Prescription of corticosteroids for the management of malignant neoplasms
  • Severe chronic renal failure with clearance of creatinine \< 30 ml/min.
  • History of organ transplantation
  • Pregnant or breastfeeding women

Key Trial Info

Start Date :

April 26 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2026

Estimated Enrollment :

191 Patients enrolled

Trial Details

Trial ID

NCT04909606

Start Date

April 26 2022

End Date

October 1 2026

Last Update

March 26 2025

Active Locations (5)

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Page 1 of 2 (5 locations)

1

CHU Brest

Brest, France

2

CH La Rochelle

La Rochelle, France, 17019

3

CH Le Mans

Le Mans, France, 72000

4

CH Le Puy en Velay

Le Puy-en-Velay, France, 43000