Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy
COCORTICO
1 other identifier
interventional
191
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2021
CompletedFirst Posted
Study publicly available on registry
June 2, 2021
CompletedStudy Start
First participant enrolled
April 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 26, 2028
March 20, 2026
March 1, 2026
6.5 years
April 23, 2021
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
occurrence of at least one clinically significant complication of steroid therapy
12 months
Following of the quality of life
12 months
The occurrence of different categories of complications of long-term corticosteroid therapy
12 months
Application of preventive drug measures
12 months
Cumulative glucocorticoid dosage actually received
12 months
Study Arms (2)
Nurse-led prevention program
EXPERIMENTALPatients 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
Standard of care
ACTIVE COMPARATORSubjects randomized to the nurse-led prevention program group will be evaluated by the dedicated nurse within 2 weeks following randomization (individual assessment)
Interventions
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: 1. A video explaining corticosteroids related adverse events and adequate preventive measures 2. An individual interview with the trained nurse 3. A consultation with a dietetician 4. An individual sheet summarizing appropriate non-pharmacological preventive measures for the participant 5. An individual sheet summarizing appropriate pharmacological preventive measures for the referent physician 6. Phone calls at week-12, week-24 and week-36 to ensure the appropriate implementation of preventive measures
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
Eligibility Criteria
You may qualify if:
- Patients aged 18 or older
- Estimated cumulative dosage of corticosteroids ≥ 2000 mg
- Affiliated member of the social security system
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
CHU Brest
Brest, France
CH La Rochelle
La Rochelle, 17019, France
CH Le Mans
Le Mans, 72000, France
CH Le Puy en Velay
Le Puy-en-Velay, 43000, France
CH de Morlaix
Morlaix, France
Related Publications (1)
Nicol S, Trin K, Simon LA, Nowak E, Duval O, Martin C, Abdelouahad S, Lengagne S, Chinchilla V, Gilet V, Briantais A, Saraux A, Cornec D, De Moreuil C, Tanguy ML, Guellec D. Evaluation of a nurse-led program for the prevention of complications of long-term glucocorticoids (COCORTICO): study protocol for a randomized trial. Trials. 2025 Nov 17;26(1):510. doi: 10.1186/s13063-025-09236-4.
PMID: 41250159DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2021
First Posted
June 2, 2021
Study Start
April 26, 2022
Primary Completion (Estimated)
October 26, 2028
Study Completion (Estimated)
October 26, 2028
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available beginning three years and ending fifteen years following the final study report completion
- 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.
All collected data that underlie results in a publication