Informations générales (source: ClinicalTrials.gov)
Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy (COCORTICO)
Interventional
N/A
University Hospital, Brest (Voir sur ClinicalTrials)
avril 2022
octobre 2026
27 mars 2025
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Brest - Brest - France | Solen NICOL | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH de Morlaix - Morlaix - France | Contact (sur clinicalTrials) | ||||
| CH La Rochelle - 17019 - La Rochelle - France | Ophélie DUVAL | Contact (sur clinicalTrials) | |||
| CH Le Mans - 72000 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| CH Le Puy en Velay - 43000 - Le Puy-en-Velay - France | Sophie LENGAGNE, IDE | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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