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

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Long Term Corticosteroid Therapy

Treatments: Other: nurse-led prevention program; Other: Current care

Study type: Interventional

Funder types: Other

Identifiers

NCT04909606

29BRC20.0119

Details and patient eligibility

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.

Full 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.

Enrollment: 191 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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191 participants in 2 patient groups

Nurse-led prevention program

Experimental group

Description:

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

Treatment:

Other: nurse-led prevention program

Standard of care

Active Comparator group

Description:

Subjects randomized to the nurse-led prevention program group will be evaluated by the dedicated nurse within 2 weeks following randomization (individual assessment)

Treatment:

Other: Current care