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:
University Hospital, Brest
Organization:
Study Overview
Official Title:
Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COCORTICO
Brief 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.
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.
Detailed Description:
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: