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

Recruiting

• Conditions: Lung Diseases; Obstructive Pulmonary Disease; Lung Diseases, Obstructive
• Interventions: Other: CAPTURE tool; Other: Spirometry

• Registration Number: NCT05654597
• Lead Sponsor: Groupe Hospitalier du Havre

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.

Study Timeline

• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-16
• Study Start: 2023-04-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-28
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1881

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants aged 40 or more, without diagnosis of COPD or asthma	Spirometry	Men and women attending aged 40 or more, without previous diagnosis of chronic obstructive pulmonary disease or asthma.
Participants aged 40 or more, without diagnosis of COPD or asthma	CAPTURE tool	Men and women attending aged 40 or more, without previous diagnosis of chronic obstructive pulmonary disease or asthma.

Primary Outcome Measures

Name	Time	Method
Sensitivity, specificity and area under the ROC curve of the CAPTURE tool	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients who have taken steps to enter a healthcare pathway 6 months after the referral to a doctor	6 months after	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.
Primary care investigators' opinion of the CAPTURE tool used in this study	Baseline to 2 years	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.

Trial Locations

Locations (1)

Groupe Hospitalier du Havre; 🇫🇷 Le Havre, Normandie, France