Detection of COPD in Primary Care

NCT03046199 | Completed

• 1 other identifier: 35RC16_9770_DISCO
• Study Type: interventional
• Target: 3,162
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Prevalence of COPD in each of the study's 4 arms, to assess the relevance of each intervention and the interaction between these interventions.

  Prevalence is defined as the number of patients with positive spirometry (i.e FEV1 / post-bronchodilator CVF \<0.70) in relation to the number of patients included.

  6 months

Secondary Outcomes (6)

• Distribution of the severity stages of COPD

  6 months

• Time to diagnosis of COPD according to the GOLD / HAS score

  6 months

• Prevalence of COPD according to the GOLD / HAS score

  6 months

• Severity of COPD according to the GOLD / HAS score

  6 months

• Time to spirometry

  6 months

Study Arms (4)

Control

NO INTERVENTION

Questionnaire

EXPERIMENTAL

Other: Questionnaire

Coordination

EXPERIMENTAL

Other: Coordination

Questionnaire + coordination

EXPERIMENTAL

Other: Questionnaire; Other: Coordination

Interventions

Questionnaire OTHER

Targeted screening of COPD by GPs via the GOLD / HAS questionnaire. The questionnaire includes 4 questions for patients over 40. At least one positive response is an indication to perform a spirometry.

Questionnaire; Questionnaire + coordination

Coordination OTHER

Information of the GPs of the existence of a coordination of the care of proximity to facilitate the access to the spirometry (identification of a referent specialist, making appointments).

Coordination; Questionnaire + coordination

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes

Rennes, France

Location

Related Publications (1)

• 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.

  PMID: 30686560 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 8, 2017
• Study Start: February 27, 2017
• Primary Completion: October 4, 2019
• Study Completion: October 4, 2019
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)