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

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.

Study Overview

• Status: Recruiting
• Conditions: Long Term Corticosteroid Therapy
• Intervention / Treatment: Other: nurse-led prevention program; Other: Current 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.

• Study Type: Interventional
• Enrollment (Anticipated): 191
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Solen NICOL; Phone Number: +33298145015; Email: solen.nicol@chu-brest.fr
• Study Contact Backup: Name: Dewi GELLEC, PH; Email: dewi.guellec@chu-brest.fr

Study Locations

• France
  • Brest, France
    • Recruiting
    • CHU Brest
    • Contact: Solen NICOL; Phone Number: +3302 98 14 50 15; Email: solen.nicol@chu-brest.fr
    • Contact: Dewi GUELLEC, PH; Email: dewi.guellec@chu-brest.fr
    • Principal Investigator: Solen NICOL
  • Morlaix, France
    • Not yet recruiting
    • CH de Morlaix
    • Contact: Catherine LE HENAFF, PH
    • Principal Investigator: Catherine LE HENAFF, PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse-led prevention program; 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; 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
Active Comparator: Standard of care; 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; 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

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Prevention; Corticosteroids; Nurse-led program
• Other Study ID Numbers: 29BRC20.0119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No