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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date August 2023
Source Groupe Hospitalier du Havre
Contact Clément MEDRINAL
Phone +33630039745
Email clement.medrinal@ch-havre.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

A large number of healthcare professional across the country will screen participants. Participants willing to participate will have a short interview, and then will have to answer the 5-item CAPTURE questionnaire. They will be assisted to perform a peak expiratory flow measurement with a portable device. The comparison will be made between the CAPTURE decision and a portable spirometry assessing the presence or not of an obstructive disorder. Patient screened either by the tool or the spirometry will be addressed to a doctor. Follow-up at 6 months will be set up in order to assess the entry or not of those patients to an approved health care pathway. At the end of each center's participation, a questionnaire will be sent to all healthcare professionals working on the study, to assess the ease of use of spirometry and the CAPTURE tool and its possible implementation in clinical practice.


Recruitment information / eligibility

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.

Study Design


Intervention

Other:
CAPTURE tool
CAPTURE 5-item questionnaire and a selected use of peak expiratory flow measurement.
Spirometry
Spirometry performed with a portable device, used for comparison with the CAPTURE tool.

Locations

Country Name City State
France Groupe Hospitalier du Havre Le Havre Normandie

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier du Havre

Country where clinical trial is conducted

France, 

Outcome

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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