Organizing care for cystic fibrosis patients using new treatments
Rethinking CF Organization of Care in the Era of Highly Effective Modulator: a Nationwide Research Program HORIZON.
This study looks at how new cystic fibrosis treatments are changing the way care is organized and delivered to patients in France.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT06599892 on ClinicalTrials.gov |
What this trial studies
This observational study examines how the introduction of highly effective CFTR modulators has transformed the management of cystic fibrosis in France. It focuses on the organization of care provided by cystic fibrosis resource and competence centers (CRCMs), which offer multidisciplinary support to patients. The study aims to redefine the roles of healthcare professionals and the patient-professional relationship in light of these new treatment options. By analyzing the experiences of patients and healthcare providers, the study seeks to improve care pathways and outcomes for cystic fibrosis patients.
Who should consider this trial
Good fit: Ideal candidates include patients aged 6 and over with cystic fibrosis who have been treated with CFTR modulators for at least 12 months, as well as those not eligible for such treatment.
Not a fit: Patients who refuse to participate or those under legal protection or psychiatric care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved care coordination and better health outcomes for cystic fibrosis patients.
How similar studies have performed: Other studies have shown positive outcomes with similar approaches in managing cystic fibrosis care, particularly with the introduction of new therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 6 and over with cystic fibrosis treated with CFTRmHE for at least 12 months * Patients aged over 6 years with cystic fibrosis not eligible for CFTRmHE treatment * Families of patients under 18 years of age * Professionals working in a CRCM for more than 12 months, physiotherapists and community nurses involved in the management of cystic fibrosis. Exclusion Criteria \* : * Refusal to participate * Persons deprived of their liberty by judicial or administrative decision * Persons under psychiatric care * Adults under legal protection (guardianship, curatorship) * Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Where this trial is running
Lyon
- Groupement Hospitalier Est Pediatric CFcenter — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Philippe REIX, Professor — Hospices Civils de Lyon
- Study coordinator: Philippe REIX, Professor
- Email: philippe.reix@chu-lyon.fr
- Phone: 04 27 85 50 42
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.