Clinical trial NCT04909606: Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy
Official title: Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long Term Corticosteroid Therapy
Keywords: Nurse-led program
Prevention
Corticosteroids
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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
* 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

Primary outcomes:
measure: Determine the ability of a prevention program to reduce the burden of adverse events attributable to corticosteroid therapy
timeFrame: 12 months
Secondary outcomes:
measure: occurrence of at least one clinically significant complication of steroid therapy
timeFrame: 12 months
measure: Following of the quality of life
timeFrame: 12 months
measure: The occurrence of different categories of complications of long-term corticosteroid therapy
timeFrame: 12 months
measure: Application of preventive drug measures
timeFrame: 12 months
measure: Cumulative glucocorticoid dosage actually received
timeFrame: 12 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
city: La Rochelle
country: France
facility: CH La Rochelle
city: Le Mans
country: France
facility: CH Le Mans
city: Le Puy-en-Velay
country: France
facility: CH Le Puy en Velay
city: Morlaix
country: France
facility: CH de Morlaix
Study officials:
References: