Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-31 @ 2:19 PM
Study NCT ID:
NCT04909606
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2021-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 191}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2021-04-23', 'studyFirstSubmitQcDate': '2021-05-26', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the ability of a prevention program to reduce the burden of adverse events attributable to corticosteroid therapy', 'timeFrame': '12 months', 'description': 'Glucocorticoid Toxicity Index Raw Score'}], 'secondaryOutcomes': [{'measure': 'occurrence of at least one clinically significant complication of steroid therapy', 'timeFrame': '12 months', 'description': 'binary criterion derived from the glucocorticoid toxicity index.'}, {'measure': 'Following of the quality of life', 'timeFrame': '12 months', 'description': 'The Short Form 36 (SF36) is used to evaluate the quality of life.'}, {'measure': 'The occurrence of different categories of complications of long-term corticosteroid therapy', 'timeFrame': '12 months', 'description': 'Complication categories defined by the glucocorticoid toxicity index'}, {'measure': 'Application of preventive drug measures', 'timeFrame': '12 months', 'description': 'Immunization record'}, {'measure': 'Cumulative glucocorticoid dosage actually received', 'timeFrame': '12 months', 'description': 'Cumulative dosage estimated at week 52 using a compliance logbook completed by the patient'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nurse-led program', 'Prevention', 'Corticosteroids'], 'conditions': ['Long Term Corticosteroid Therapy']}, 'referencesModule': {'references': [{'pmid': '41250159', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nIn 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.\n\nThe 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.\n\nThe 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.', 'detailedDescription': "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.\n\nThe 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.\n\nPatients 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 18 or older\n* Initiation of corticosteroids within 30 days prior to inclusion\n* Estimated cumulative dosage of corticosteroids ≥ 2000 mg\n* Affiliated member of the social security system\n\nExclusion Criteria:\n\n* Patients unable to give consent or unable to understand the protocol\n* 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.\n* Patients under guardianship\n* Previous exposure to long-term corticosteroids\n* Prescription of corticosteroids for the management of malignant neoplasms\n* Severe chronic renal failure with clearance of creatinine \\< 30 ml/min.\n* History of organ transplantation\n* Pregnant or breastfeeding women"}, 'identificationModule': {'nctId': 'NCT04909606', 'acronym': 'COCORTICO', 'briefTitle': 'Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy', 'orgStudyIdInfo': {'id': '29BRC20.0119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nurse-led prevention program', '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', 'interventionNames': ['Other: nurse-led prevention program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'description': 'Subjects randomized to the nurse-led prevention program group will be evaluated by the dedicated nurse within 2 weeks following randomization (individual assessment)', 'interventionNames': ['Other: Current care']}], 'interventions': [{'name': 'nurse-led prevention program', 'type': 'OTHER', 'description': 'Subjects randomized to the nurse-led prevention program group will be evaluated by the dedicated nurse within 2 weeks following randomization (individual assessment)\n\nThe nurse-led prevention program will include:\n\n1. A video explaining corticosteroids related adverse events and adequate preventive measures\n2. An individual interview with the trained nurse\n3. A consultation with a dietetician\n4. An individual sheet summarizing appropriate non-pharmacological preventive measures for the participant\n5. An individual sheet summarizing appropriate pharmacological preventive measures for the referent physician\n6. Phone calls at week-12, week-24 and week-36 to ensure the appropriate implementation of preventive measures', 'armGroupLabels': ['Nurse-led prevention program']}, {'name': 'Current care', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Solen NICOL', 'role': 'CONTACT', 'email': 'solen.nicol@chu-brest.fr', 'phone': '+3302 98 14 50 15'}, {'name': 'Dewi GUELLEC, PH', 'role': 'CONTACT', 'email': 'dewi.guellec@chu-brest.fr'}, {'name': 'Solen NICOL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '17019', 'city': 'La Rochelle', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ophélie DUVAL', 'role': 'CONTACT', 'email': 'ophelie.duval@ght-atrlantique17.fr', 'phone': '05 16 49 41 65'}], 'facility': 'CH La Rochelle', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'zip': '72000', 'city': 'Le Mans', 'status': 'ENROLLING_BY_INVITATION', 'country': 'France', 'facility': 'CH Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '43000', 'city': 'Le Puy-en-Velay', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie LENGAGNE, IDE', 'role': 'CONTACT', 'email': 'sophie.lengagne@ch-lepuy.fr', 'phone': '04 71 04 35 26'}, {'name': 'Benjamin CASTAGNE, Dr', 'role': 'CONTACT', 'email': 'benjamin.castagne@ch-lepuy.fr', 'phone': '04 71 04 14 03'}], 'facility': 'CH Le Puy en Velay', 'geoPoint': {'lat': 45.04366, 'lon': 3.88523}}, {'city': 'Morlaix', 'status': 'ENROLLING_BY_INVITATION', 'country': 'France', 'facility': 'CH de Morlaix', 'geoPoint': {'lat': 48.57784, 'lon': -3.82792}}], 'centralContacts': [{'name': 'Solen NICOL', 'role': 'CONTACT', 'email': 'solen.nicol@chu-brest.fr', 'phone': '+33298145015'}, {'name': 'Dewi GELLEC, PH', 'role': 'CONTACT', 'email': 'dewi.guellec@chu-brest.fr'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning three years and ending fifteen years following the final study report completion', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}