Actively Recruiting
Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy
Led by University Hospital, Brest · Updated on 2026-03-20
191
Participants Needed
5
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 central problematic of prolonged corticosteroid therapy is the burden of adverse events associated with its long term use, including bone, metabolic and infectious complications. The management of patients for whom the prescription of long term corticosteroid therapy is indicated should include an evaluation of the individual risk and implementation of the appropriate preventive measures. Such an approach should particularly include cortisonic osteoporosis prevention, infectious prevention including vaccination, prevention of adrenal insufficiency, promotion of physical activity, as well as dietary management. In France, nurse-led prevention programs are highly developed for patients initiating immunosuppressive targeted therapies. Conversely, there are no dedicated nurse-led programs for patients starting prolonged corticosteroid therapy, for several historical and economical reasons. The implementation of such programs is likely to be beneficial at different levels, including the reduction of the number of adverse events and improvement of health-related quality of life. The main objective of the study is to determine the long-term benefit of a nurse-led prevention program among patients starting long-term corticosteroids therapy, compared to routine care.
CONDITIONS
Official Title
Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 or older
- Initiation of corticosteroids within 30 days prior to inclusion
- Estimated cumulative corticosteroid dosage of 2000 mg or more
- Affiliated with the social security system
You will not qualify if you...
- Unable to give consent or understand the study protocol
- Unable to communicate remotely by telephone
- Under legal guardianship
- Previous long-term corticosteroid treatment
- Corticosteroid use for malignant cancer management
- Severe chronic kidney failure with creatinine clearance below 30 ml/min
- History of organ transplantation
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 5 locations
1
CHU Brest
Brest, France
Actively Recruiting
2
CH La Rochelle
La Rochelle, France, 17019
Actively Recruiting
3
CH Le Mans
Le Mans, France, 72000
Enrolling by Invitation
4
CH Le Puy en Velay
Le Puy-en-Velay, France, 43000
Actively Recruiting
5
CH de Morlaix
Morlaix, France
Enrolling by Invitation
Research Team
S
Solen NICOL
CONTACT
D
Dewi GELLEC, PH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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