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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.
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 allocation group.
The target population is adult patients initiating a first sequence of long term corticosteroid therapy, to the exception of onco-hematological indications, severe chronic renal failure and organ transplant.
Patients in both groups will have baseline and week-52 standardized visits including clinical evaluation, routine biology, dual-energy X-ray absorptiometry and quality of life assessment (SF-36). Corticosteroid consumption will be collected throughout the study using a dedicated notebook. At the week-52 visit, the burden of adverse events related to the use of corticosteroids will be assessed through the glucocorticoid toxicity index (GTI), completed by the blinded physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse-led prevention program | Experimental | Patients will receive a general summary sheet of preventive measures associated with long term corticosteroids therapy (no individual assessment) in addition to the usual care provided by their physician |
|
| Standard of care | Active Comparator | Subjects randomized to the nurse-led prevention program group will be evaluated by the dedicated nurse within 2 weeks following randomization (individual assessment) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nurse-led prevention program | Other | Subjects randomized to the nurse-led prevention program group will be evaluated by the dedicated nurse within 2 weeks following randomization (individual assessment) The nurse-led prevention program will include:
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the ability of a prevention program to reduce the burden of adverse events attributable to corticosteroid therapy | Glucocorticoid Toxicity Index Raw Score | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of at least one clinically significant complication of steroid therapy | binary criterion derived from the glucocorticoid toxicity index. | 12 months |
| Following of the quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Solen NICOL | Contact | +33298145015 | solen.nicol@chu-brest.fr | |
| Dewi GELLEC, PH | Contact | dewi.guellec@chu-brest.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brest | Recruiting | Brest | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41250159 | Derived | Nicol S, Trin K, Simon LA, Nowak E, Duval O, Martin C, Abdelouahad S, Lengagne S, Chinchilla V, Gilet V, Briantais A, Saraux A, Cornec D, De Moreuil C, Tanguy ML, Guellec D. Evaluation of a nurse-led program for the prevention of complications of long-term glucocorticoids (COCORTICO): study protocol for a randomized trial. Trials. 2025 Nov 17;26(1):510. doi: 10.1186/s13063-025-09236-4. |
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All collected data that underlie results in a publication
Data will be available beginning three years and ending fifteen years following the final study report completion
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
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| Current care | Other | Subjects randomized to the standard of care group will receive a general summary sheet of preventive measures associated with long term corticosteroids therapy (no individual assessment) in addition to the usual care provided by their physician |
|
The Short Form 36 (SF36) is used to evaluate the quality of life.
| 12 months |
| The occurrence of different categories of complications of long-term corticosteroid therapy | Complication categories defined by the glucocorticoid toxicity index | 12 months |
| Application of preventive drug measures | Immunization record | 12 months |
| Cumulative glucocorticoid dosage actually received | Cumulative dosage estimated at week 52 using a compliance logbook completed by the patient | 12 months |
| CH La Rochelle | Recruiting | La Rochelle | 17019 | France |
|
| CH Le Mans | Enrolling by invitation | Le Mans | 72000 | France |
| CH Le Puy en Velay | Recruiting | Le Puy-en-Velay | 43000 | France |
|
| CH de Morlaix | Enrolling by invitation | Morlaix | France |