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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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