Chronic Obstructive Pulmonary DiseaseDISCONCT03046199
Detection of COPD in Primary Care
A study testing Questionnaire and Coordination in people with Chronic Obstructive Pulmonary Disease, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Questionnaire and Coordination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,162 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2017to 4 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with health insurance
- Non-opposition to participation in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Questionnaire, Coordination
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
CoordinationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Questionnaire | Experimental | Not described Receives: Other: Questionnaire |
| Coordination | Experimental | Not described Receives: Other: Coordination |
| Questionnaire + coordination | Experimental | Not described Receives: Other: Questionnaire; Other: Coordination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
Distribution of the severity stages of COPD
Severity stage will be evaluated with FEV1 in each arm
Measured: 6 months
Time to diagnosis of COPD according to the GOLD / HAS score
Measured: 6 months
Prevalence of COPD according to the GOLD / HAS score
Measured: 6 months
Severity of COPD according to the GOLD / HAS score
Measured: 6 months
Time to spirometry
Delay between consultation with GP and realization of a spirometry when applicable in each arm
Measured: 6 months
Number of spirometries performed in each arm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start27 Feb 2017
- Primary completion4 Oct 2019
- Study completion4 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 3,162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046199
- Sponsor's protocol ID
- 35RC16_9770_DISCO
- Acronym
- DISCO
- Status last verified
- May 2023
- First submitted
- 1 Feb 2017
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30686560
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of COPD in Primary Care
- ClinicalTrials.gov ID
- NCT03046199
- Acronym / sponsor ID
- DISCO / 35RC16_9770_DISCO
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,162 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Questionnaire | Experimental | Other: Questionnaire |
| Coordination | Experimental | Other: Coordination |
| Questionnaire + coordination | Experimental | Other: Questionnaire, Other: Coordination |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with health insurance
- Non-opposition to participation in the study
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireTargeted 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. | Other | Questionnaire, Questionnaire + coordination |
| CoordinationInformation 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). | Other | Coordination, Questionnaire + coordination |
Primary outcome
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.
6 secondary outcomes
Distribution of the severity stages of COPD
Time frame: 6 months
Time to diagnosis of COPD according to the GOLD / HAS score
Time frame: 6 months
Prevalence of COPD according to the GOLD / HAS score
Time frame: 6 months
Severity of COPD according to the GOLD / HAS score
Time frame: 6 months
Time to spirometry
Time frame: 6 months
Number of spirometries performed in each arm
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Results publication: PubMed 30686560Chapron 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire and Coordination in people with Chronic Obstructive Pulmonary Disease, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03046199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.