RecruitingNot ApplicableNCT04909606

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


Sponsor

University Hospital, Brest

Enrollment

191 participants

Start Date

Apr 26, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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

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Interventions

OTHERnurse-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

OTHERCurrent 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


Locations(5)

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

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NCT04909606