Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04909606

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

Led by University Hospital, Brest · Updated on 2026-03-20

191

Participants Needed

5

Research Sites

339 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 or older
  • Initiation of corticosteroids within 30 days prior to inclusion
  • Estimated cumulative corticosteroid dosage of 2000 mg or more
  • Affiliated with the social security system
Not Eligible

You will not qualify if you...

  • Unable to give consent or understand the study protocol
  • Unable to communicate remotely by telephone
  • Under legal guardianship
  • Previous long-term corticosteroid treatment
  • Corticosteroid use for malignant cancer management
  • Severe chronic kidney failure with creatinine clearance below 30 ml/min
  • History of organ transplantation
  • Pregnant or breastfeeding women

AI-Screening

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Trial Site Locations

Total: 5 locations

1

CHU Brest

Brest, France

Actively Recruiting

2

CH La Rochelle

La Rochelle, France, 17019

Actively Recruiting

3

CH Le Mans

Le Mans, France, 72000

Enrolling by Invitation

4

CH Le Puy en Velay

Le Puy-en-Velay, France, 43000

Actively Recruiting

5

CH de Morlaix

Morlaix, France

Enrolling by Invitation

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Research Team

S

Solen NICOL

CONTACT

D

Dewi GELLEC, PH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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