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

Sponsor

Groupe Hospitalier du Havre (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05654597

Collaborator

(none)

1,881

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases Lung Diseases, Obstructive Obstructive Pulmonary Disease	Other: CAPTURE tool

Detailed Description

A large number of physiotherapist across the country will screen participants. Participants 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1881 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Participants aged 40 or more, without diagnosis of COPD or asthma Men and women attending aged 40 or more, without previous diagnosis of chronic obstructive pulmonary disease or asthma.	Other: CAPTURE tool CAPTURE 5-item questionnaire and a selected use of peak expiratory flow measurement.

Arm

Intervention/Treatment

Participants aged 40 or more, without diagnosis of COPD or asthma

Men and women attending aged 40 or more, without previous diagnosis of chronic obstructive pulmonary disease or asthma.

Other: CAPTURE tool

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

People aged 40 or more,
Provision of dated and signed informed consent form,
Currently being treated by a physiotherapist,
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.