Long Term Corticosteroid TherapyCOCORTICONCT04909606
Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy
A study testing nurse-led prevention program and Current care in people with Long Term Corticosteroid Therapy, run by University Hospital, Brest at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Term Corticosteroid Therapy
- What is being tested?
- nurse-led prevention program and Current care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 5 sitesFrance
- Study dates
- 26 Apr 2022to 26 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dewi GELLEC, PH contact
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU Brest
Brest
Solen NICOL, +3302 98 14 50 15, solen.nicol@chu-brest.fr
Dewi GUELLEC, PH, dewi.guellec@chu-brest.fr
- Recruiting
CH La Rochelle
La Rochelle, 17019
Ophélie DUVAL, 05 16 49 41 65, ophelie.duval@ght-atrlantique17.fr
- Enrolling by invitation
CH Le Mans
Le Mans, 72000
- Recruiting
CH Le Puy en Velay
Le Puy-en-Velay, 43000
Sophie LENGAGNE, IDE, 04 71 04 35 26, sophie.lengagne@ch-lepuy.fr
Benjamin CASTAGNE, Dr, 04 71 04 14 03, benjamin.castagne@ch-lepuy.fr
- Enrolling by invitation
CH de Morlaix
Morlaix
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Long Term Corticosteroid Therapy
- Being tested
- nurse-led prevention program, Current care
- Keywords
- Nurse-led program, Prevention, Corticosteroids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse-led prevention programOther
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
Current careOther
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
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led prevention program | Experimental | 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 Receives: Other: nurse-led prevention program |
| Standard of care | Active comparator | Subjects randomized to the nurse-led prevention program group will be evaluated by the dedicated nurse within 2 weeks following randomization (individual assessment) Receives: Other: Current care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the ability of a prevention program to reduce the burden of adverse events attributable to corticosteroid therapy
Glucocorticoid Toxicity Index Raw Score
Measured: 12 months
Secondary outcomes (5)
occurrence of at least one clinically significant complication of steroid therapy
binary criterion derived from the glucocorticoid toxicity index.
Measured: 12 months
Following of the quality of life
The Short Form 36 (SF36) is used to evaluate the quality of life.
Measured: 12 months
The occurrence of different categories of complications of long-term corticosteroid therapy
Complication categories defined by the glucocorticoid toxicity index
Measured: 12 months
Application of preventive drug measures
Immunization record
Measured: 12 months
Cumulative glucocorticoid dosage actually received
Cumulative dosage estimated at week 52 using a compliance logbook completed by the patient
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start26 Apr 2022
- Primary completion26 Oct 2028 (estimated)
- Study completion26 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long Term Corticosteroid TherapyStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 191 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909606
- Sponsor's protocol ID
- 29BRC20.0119
- Acronym
- COCORTICO
- Status last verified
- Mar 2026
- First submitted
- 23 Apr 2021
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
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.
PubMed 41250159
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy
- ClinicalTrials.gov ID
- NCT04909606
- Acronym / sponsor ID
- COCORTICO / 29BRC20.0119
- Conditions
- Long Term Corticosteroid Therapy
- Keywords
- Nurse-led program, Prevention, Corticosteroids
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 191 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 26 Oct 2028 (estimated)
- Study completion
- 26 Oct 2028 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led prevention program | Experimental | Other: nurse-led prevention programPatients 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 comparator | Other: Current careSubjects randomized to the nurse-led prevention program group will be evaluated by the dedicated nurse within 2 weeks following randomization (individual assessment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nurse-led prevention programSubjects 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 | Other | Nurse-led prevention program |
| Current careSubjects 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 | Other | Standard of care |
Primary outcome
Determine the ability of a prevention program to reduce the burden of adverse events attributable to corticosteroid therapy
Time frame: 12 months
Glucocorticoid Toxicity Index Raw Score
5 secondary outcomes
occurrence of at least one clinically significant complication of steroid therapy
Time frame: 12 months
Following of the quality of life
Time frame: 12 months
The occurrence of different categories of complications of long-term corticosteroid therapy
Time frame: 12 months
Application of preventive drug measures
Time frame: 12 months
Cumulative glucocorticoid dosage actually received
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Derived from this study: PubMed 41250159Nicol 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.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dewi GELLEC, PH contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurse-led prevention program and Current care in people with Long Term Corticosteroid Therapy, run by University Hospital, Brest at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Solen NICOL (+33298145015, solen.nicol@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the ability of a prevention program to reduce the burden of adverse events attributable to corticosteroid therapy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04909606, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.