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

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654597
• Other study ID #: 2022-A00209-34
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Obstructive Pulmonary Disease
• Respiration Disorders
• Respiratory Tract Diseases

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