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Completed

NCT Number: NCT03046199

Detection of COPD in Primary Care

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rennes

Rennes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

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.

    Time frame: 6 months

    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.

Secondary outcomes

  1. Distribution of the severity stages of COPD

    Time frame: 6 months

    Severity stage will be evaluated with FEV1 in each arm

  2. Time to diagnosis of COPD according to the GOLD / HAS score

    Time frame: 6 months

  3. Prevalence of COPD according to the GOLD / HAS score

    Time frame: 6 months

  4. Severity of COPD according to the GOLD / HAS score

    Time frame: 6 months

  5. Time to spirometry

    Time frame: 6 months

    Delay between consultation with GP and realization of a spirometry when applicable in each arm

  6. Number of spirometries performed in each arm

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: DISCO

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2017
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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