CF Organization of Care in the Era of Highly Effective Modulator.

NCT06599892 | Recruiting

• 1 other identifier: 69HCL23_0749
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, triple therapy has made it possible to extend access to these modulators to a large proportion of the patient population, with spectacular clinical benefits, provided the patient carries at least one F508del mutation. The hypothesis is that the arrival of CFTRmHEs has considerably altered the way cystic fibrosis is managed, requiring a rethink of how the CRCMs are organised, and a redefinition of the practices and missions of professionals, as well as the patient-professional relationship.

Conditions

Cystic Fibrosis

Keywords

Cystic; organisation; relationship; intervention; healthcare; mapping; fibrosis

Outcome Measures

Primary Outcomes (1)

• Obtaining a national consensus on a proposal for a new organisation of the cystic fibrosis care pathway, including the CRCMs and the liberal network

  It will be measured by a mixed approach based on the intervention mapping model combining patient and professional questionnaires and a qualitative survey using individual interviews with patients and focus groups with professionals to identify the obstacles and levers to change at the level of patients, professionals and organisations. The main outcome measure is to establish a new organization of care for pwCF and HCPs in the era of HEMT by the develop an evaluation plan using a community-based participatory approach to promote external validity.

  The outcome measure will be measured at the twelfth month of the survey.

Study Arms (2)

Patients from the 47 CF French center

National registry indicator study = 7513 patients in total, including 5000 eligible for highly effective CFTRm, for the study of pathways at national level, for which clinical and healthcare consumption data are available in the national registry linked to the SNDS

Other: Intervention mapping

Healthcare professionels

Case study: 8 to 10 CRCMs, 7 to 8 professionals and 7 to 8 patients per CRCM, i.e. 56 to 80 professionals, 200 to 400 patients DELPHI: panel of 80 professionals and patients/parents

Other: Intervention mapping

Interventions

Intervention mapping OTHER

Intervention mapping is a model combining patient and professional questionnaires and a qualitative survey using individual interviews with patients and focus groups with professionals to identify the obstacles and levers to change at the level of patients, professionals and organisations.

Healthcare professionels; Patients from the 47 CF French center

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In each phase we will use the sample size recommendations for each methodological approach * National surveys by CRCM questionnaire: all national CRCM centres will be contacted by the network. * National registry indicator study = 7513 patients in total, including 5000 eligible for highly effective CFTRm, for the study of pathways at national level, for which clinical and healthcare consumption data are available in the national registry linked to the SNDS. * Case study: 8 to 10 CRCMs, 7 to 8 professionals and 7 to 8 patients per CRCM, i.e. 56 to 80 professionals, 56 to 80 patients.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Groupement Hospitalier Est Pediatric CFcenter

Lyon, France

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis; Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe REIX, Professor

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe REIX, Professor

CONTACT

04 27 85 50 42; philippe.reix@chu-lyon.fr

Julie HAESEBAERT, Professor

CONTACT

04 72 11 57 05; julie.haesebaert@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)