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

Sponsor
Hospices Civils de Lyon
Study ID
NCT06599892
Status
Recruiting
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Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Sep 19, 2024
Start date
Sep 1, 2023
Status verified
Sep 2024
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
5,000 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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

Primary Outcome Measure

Obtaining a national consensus on a proposal for a new organisation of the cystic fibrosis care pathway, including the CRCMs and the liberal network [ Time Frame: The outcome measure will be measured at the twelfth month of the survey. ]

Central Contacts

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