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French Validation of the CAPTURE Case Finding Tool for Obstructive Respiratory Disease

French Validation of the CAPTURE Case Finding Tool for Obstructive Respiratory Disease

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05654597
Enrollment
1002
Registered
2022-12-16
Start date
2023-04-01
Completion date
2025-01-01
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases, Lung Diseases, Obstructive, Obstructive Pulmonary Disease

Keywords

COPD, Asthma, Case finding

Brief 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.

Detailed 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.

Interventions

CAPTURE 5-item questionnaire and a selected use of peak expiratory flow measurement.

OTHERSpirometry

Spirometry performed with a portable device, used for comparison with the CAPTURE tool.

Sponsors

Groupe Hospitalier du Havre
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity, specificity and area under the ROC curve of the CAPTURE toolBaselineSensitivity, 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.

Secondary

MeasureTime frameDescription
Number of patients who have taken steps to enter a healthcare pathway 6 months after the referral to a doctor6 months afterNumber 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.
Primary care investigators' opinion of the CAPTURE tool used in this studyBaseline to 2 yearsResponses 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026