Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy
NCT ID: NCT04909606
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
191 participants
INTERVENTIONAL
2022-04-26
2026-10-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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
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:
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
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)
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
Interventions
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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:
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Locations
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CHU Brest
Brest, , France
CH La Rochelle
La Rochelle, , France
CH Le Mans
Le Mans, , France
CH Le Puy en Velay
Le Puy-en-Velay, , France
CH de Morlaix
Morlaix, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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29BRC20.0119
Identifier Type: -
Identifier Source: org_study_id
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