Clinical trial NCT03046199: Detection of COPD in Primary Care
Official title: Detection of COPD in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 3162
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: Chronic obstructive pulmonary disease (COPD) is a common chronic disease with a significant medical and economic impact. Its prevalence is increasing and is estimated at 7.5% of people over 40 in France. COPD is responsible for a significant impairment of quality of life and was the 3rd leading cause of death in the world in 2010 when it was 4th place 20 years ago.

However, about 75% of patients with COPD are not diagnosed. Spirometry is the only examination for the diagnosis of COPD. Patients identified at risk for COPD are insufficiently using spirometry and general practitioners (GPs) underestimate the severity of COPD when they do not practice spirometry in their patients. COPD is often diagnosed too late, the disease being discovered at the stage of complications requiring hospitalization. The underdiagnosis is mainly due to poor knowledge of patients, their difficulty in accessing a specialist performing spirometry, their reluctance to perform spirometry, and the insufficient involvement of general practitioners.

Currently in France, targeted screening for COPD and diagnosis in primary care is a major challenge. The international (GOLD 2014) and French (HAS 2014) recommendations do not indicate a systematic screening in the general population for COPD but advocate targeted screening of patients by five questions to identify risk factors and symptoms of COPD. The presence of at least one of these factors in an adult over the age of 40 requires spirometry.

Recent studies suggest the relevance of finding primary care variables for smoking and respiratory symptoms in order to identify new cases of COPD.

However, the impact of the use of these questionnaires on the prevalence of diagnoses of COPD in general practice has not been demonstrated. Moreover, the heterogeneity of the provision of care according to the territories limits a fast or easy access (distance) to the spirometry.

It is therefore necessary to evaluate in primary care the interest of a targeted screening of COPD and the interest of a coordination of care for the realization of a spirometry, in order to improve the rate of diagnosis of the disease.


Eligibility criteria: Inclusion Criteria:

* Patients with health insurance
* Non-opposition to participation in the study

Exclusion Criteria:

* COPD known and confirmed by spirometry
* Asthma known and confirmed by spirometry
* Patient not having the physical or mental ability to perform spirometry
* Pregnant woman
* Patient under protection
* Patient already included in the study

Primary outcomes:
measure: Prevalence of COPD in each of the study's 4 arms, to assess the relevance of each intervention and the interaction between these interventions.
timeFrame: 6 months
Secondary outcomes:
measure: Distribution of the severity stages of COPD
timeFrame: 6 months
measure: Time to diagnosis of COPD according to the GOLD / HAS score
timeFrame: 6 months
measure: Prevalence of COPD according to the GOLD / HAS score
timeFrame: 6 months
measure: Severity of COPD according to the GOLD / HAS score
timeFrame: 6 months
measure: Time to spirometry
timeFrame: 6 months
measure: Number of spirometries performed in each arm
timeFrame: 6 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes
Study officials:
References:
citation: Chapron A, Pele F, Andres E, Fiquet L, Laforest C, Veislinger A, Fougerou C, Turmel V, Fouchard J, Yourish B, Oumari S, Allory E, Banatre A, Schweyer FX, Pommier J, Brinchault G, Guillot S, Laviolle B, Jouneau S. [Targeted screening of COPD in primary care: Feasibility and effectiveness]. Rev Mal Respir. 2019 Feb;36(2):162-170. doi: 10.1016/j.rmr.2018.08.023. Epub 2019 Jan 24. French.