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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Brest
RECRUITING
Brest
CH La Rochelle
RECRUITING
La Rochelle
CH Le Mans
ENROLLING_BY_INVITATION
Le Mans
CH Le Puy en Velay
RECRUITING
Le Puy-en-velay
CH de Morlaix
ENROLLING_BY_INVITATION
Morlaix
Contact Information
Primary
Solen NICOL
solen.nicol@chu-brest.fr
+33298145015
Backup
Dewi GELLEC, PH
dewi.guellec@chu-brest.fr
Time Frame
Start Date: 2022-04-26
Estimated Completion Date: 2026-10
Participants
Target number of participants: 191
Treatments
Experimental: 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
Active_comparator: 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)
Authors
Carole DUQUENNE, Marie-Laure TANGUY
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Brest

This content was sourced from clinicaltrials.gov