Lung Diseases Clinical Trial
Official title:
French Validation of the CAPTURE Case Finding Tool for Obstructive Respiratory Disease
NCT number | NCT05654597 |
Other study ID # | 2022-A00209-34 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2023 |
Est. completion date | June 30, 2026 |
The objective of this multicentre prospective study is to validate CAPTURE as a French case finding tool for undiagnosed patients suffering from obstructive pulmonary disease.
Status | Recruiting |
Enrollment | 1881 |
Est. completion date | June 30, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - People aged 40 or more, - Provision of dated and signed informed consent form, - Currently being treated by a healthcare professional, - Patients affiliated to the french social security system. Exclusion Criteria: - Patients previously diagnosed with COPD or asthma, - Patients with any condition making them unable to perform spirometry or answer a short questionnaire, - Patients unable to give free and informed consent. |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier du Havre | Le Havre | Normandie |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier du Havre |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity, specificity and area under the ROC curve of the CAPTURE tool | Sensitivity, specificity and area under the ROC curve of the CAPTURE tool; i.e. its ability to identify undiagnosed patients with an obstructive ventilatory disorder assessed with a portable spirometry. | Baseline | |
Secondary | Number of patients who have taken steps to enter a healthcare pathway 6 months after the referral to a doctor | Number of patients screened by the CAPTURE tool who have taken steps to enter a healthcare pathway 6 months after the referral to a doctor, i.e. the impact of the screening process at 6 months on patient diagnosis, management and follow-up. | 6 months after | |
Secondary | Primary care investigators' opinion of the CAPTURE tool used in this study | Responses on a Likert scale from all investigators to a questionnaire on the easiness of use of spirometry and CAPTURE tool and its implementation in clinical practice once each center's inclusions had been completed. | Baseline to 2 years |
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