Evaluation of a nurse-led program for the prevention of complications of long-term glucocorticoids (COCORTICO): study protocol for a randomized trial.

BACKGROUND

Long-term glucocorticoids are widely prescribed for autoimmune and inflammatory diseases, but their use is associated with a wide range of adverse events, some of which can be severe. Patient education on toxicity and preventive strategies is essential, yet many patients do not receive sufficient information. In some areas, nurse-led therapeutic programs have been developed to optimize care. However, no standardized, institutionally supported education program exists to prevent the adverse events of long-term glucocorticoid therapy.

METHODS

We are conducting a superiority, open-label, parallel-group, randomized trial, comparing a nurse-led interdisciplinary program with standard of care, across five French hospitals. Eligible participants are adult patients initiating a first sequence of long-term glucocorticoids for a medical condition, excluding onco-hematological diseases, severe chronic renal failure and organ transplantation. The nurse-led prevention program consists of the following: (1) a video explaining glucocorticoids-related adverseevents and appropriate preventive measures, (2) a personal meeting with a trained nurse, (3) a consultation with a dietitian, (4) a personalized individual paper sheet summarizing appropriate non-drug preventive measures for the patient, (5) an information paper sheet summarizing appropriate drug preventive measures for the treating physician, and (6) phone calls at week 12, week 24, and week 36 to ensure that the preventive measures are adequately implemented and understood. Patients in both groups receive an information paper sheet summarizing preventive measures related to glucocorticoid therapy. Patients randomized to the control group receive the standard care provided by their physician. The primary endpoint is the burden of glucocorticoid toxicity, evaluated by a blinded investigator using the cumulative worsening score of the Glucocorticoid Toxicity Index (GTI) at 52 weeks. The secondary endpoints are the occurrence of specific glucocorticoid-related adverse events, quality of life, implementation of preventive measures and cumulative glucocorticoid dosage at 52 weeks.

DISCUSSION

We hypothesize that this therapeutic education program will reduce the burden of long-term glucocorticoid toxicity and improve patients' quality of life. If so, this program could be implemented in routine care for patients receiving long-term glucocorticoid therapy.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04909606. Registered on 2 June 2021, https://clinicaltrials.gov/study/NCT04909606.

© 2025. The Author(s).