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

Study Overview
=================
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 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.

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 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.

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

Conditions
-----------------
Long Term Corticosteroid Therapy

Intervention / Treatment
-----------------
* Other: nurse-led prevention program
* Other: Current care


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Exclusion Criteria: Patients unable to give consent or unable to understand the protocol 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse-led prevention program<br>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 | Other: nurse-led prevention program<br>* 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: A video explaining corticosteroids related adverse events and adequate preventive measures An individual interview with the trained nurse A consultation with a dietetician An individual sheet summarizing appropriate non-pharmacological preventive measures for the participant An individual sheet summarizing appropriate pharmacological preventive measures for the referent physician Phone calls at week-12, week-24 and week-36 to ensure the appropriate implementation of preventive measures<br>|
| Active Comparator: Standard of care<br>Subjects randomized to the nurse-led prevention program group will be evaluated by the dedicated nurse within 2 weeks following randomization (individual assessment) | Other: Current care<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nurse-led program, Prevention, Corticosteroids