Nurse-led program to prevent complications from long-term corticosteroid use
Evaluation of a Nurse-led Program for the Prevention of Complications of Long-term Corticosteroid Therapy
NA · University Hospital, Brest · NCT04909606
This study tests a nurse-led program to help adults using long-term corticosteroids avoid complications like osteoporosis and infections.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 191 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Brest (other) |
| Locations | 5 sites (Brest and 4 other locations) |
| Trial ID | NCT04909606 on ClinicalTrials.gov |
What this trial studies
This study evaluates a nurse-led prevention program aimed at reducing complications associated with long-term corticosteroid therapy in adult patients. It employs a Prospective Randomized Open trial with a Blind Evaluation (PROBE) design, where participants will be assessed at baseline and after 52 weeks. The program focuses on preventing adverse effects such as osteoporosis, infections, and adrenal insufficiency through tailored interventions including vaccinations, physical activity promotion, and dietary management. The effectiveness of the program will be measured using clinical evaluations, routine biology tests, and quality of life assessments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older who are initiating corticosteroid therapy within 30 days and have a cumulative dosage of at least 2000 mg.
Not a fit: Patients who have previously been exposed to long-term corticosteroids or those with severe chronic renal failure or organ transplant history may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the adverse effects of long-term corticosteroid therapy, improving patient quality of life.
How similar studies have performed: While nurse-led prevention programs for other therapies have shown success, this specific approach for long-term corticosteroid therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Brest and 4 other locations
- CHU Brest — Brest, France (RECRUITING)
- CH La Rochelle — La Rochelle, France (RECRUITING)
- CH Le Mans — Le Mans, France (ENROLLING_BY_INVITATION)
- CH Le Puy en Velay — Le Puy-en-Velay, France (RECRUITING)
- CH de Morlaix — Morlaix, France (ENROLLING_BY_INVITATION)
Study contacts
- Study coordinator: Solen NICOL
- Email: solen.nicol@chu-brest.fr
- Phone: +33298145015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Long Term Corticosteroid Therapy, Nurse-led program, Prevention, Corticosteroids