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Detection of COPD in Primary Care (DISCO)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaire
Coordination
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rennes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

Questionnaire

Coordination

Questionnaire + coordination

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Distribution of the severity stages of COPD
Severity stage will be evaluated with FEV1 in each arm
Time to diagnosis of COPD according to the GOLD / HAS score
Prevalence of COPD according to the GOLD / HAS score
Severity of COPD according to the GOLD / HAS score
Time to spirometry
Delay between consultation with GP and realization of a spirometry when applicable in each arm
Number of spirometries performed in each arm

Full Information

First Posted
February 1, 2017
Last Updated
May 22, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03046199
Brief Title
Detection of COPD in Primary Care
Acronym
DISCO
Official Title
Detection of COPD in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
October 4, 2019 (Actual)
Study Completion Date
October 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Questionnaire
Arm Type
Experimental
Arm Title
Coordination
Arm Type
Experimental
Arm Title
Questionnaire + coordination
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Coordination
Intervention Description
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 Outcome Measure Information:
Title
Prevalence of COPD in each of the study's 4 arms, to assess the relevance of each intervention and the interaction between these interventions.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Distribution of the severity stages of COPD
Description
Severity stage will be evaluated with FEV1 in each arm
Time Frame
6 months
Title
Time to diagnosis of COPD according to the GOLD / HAS score
Time Frame
6 months
Title
Prevalence of COPD according to the GOLD / HAS score
Time Frame
6 months
Title
Severity of COPD according to the GOLD / HAS score
Time Frame
6 months
Title
Time to spirometry
Description
Delay between consultation with GP and realization of a spirometry when applicable in each arm
Time Frame
6 months
Title
Number of spirometries performed in each arm
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Rennes
City
Rennes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30686560
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.
Results Reference
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Detection of COPD in Primary Care

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