COPDUNANIMENCT03104348
Screening for COPD in Primary Care: a Synergistic Approach - Dentists - Pharmacists -Physiotherapists - Nurses - Physicians
A study testing COPD screening in people with COPD, run by University Hospital, Brest at 2 sites in France.
Trial summary
A recent French study conducted in the general population in the north, using more than 12,000 people randomly drawn from the electoral lists, shows a prevalence of nearly 15% of an obstructive spirometric function disorder; The diagnosis was ignored in 70% of cases. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- COPD screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Apr 2017to 9 Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 40 years,
- Smoking greater than 10 packs / year, active.
- No previous diagnosis of COPD
- Signature of informed consent
Who cannot join
- Patients under 40 years of age
- Previous of COPD diagnosis
- Refusing to participate
Trial locations and contacts
2 sites in 1 country.
About this study
A recent French study conducted in the general population in the north, using more than 12,000 people randomly drawn from the electoral lists, shows a prevalence of nearly 15% of an obstructive spirometric function disorder; The diagnosis was ignored in 70% of cases. If we consider the Finistère situation, the mortality data are unfavorable, with an excess of COPD mortality compared to the French average.
Compared to other frequent chronic conditions, such as high blood pressure or diabetes, the management of COPD may appear complex for at least two reasons:
Read more
- Screening is difficult because of the banality of symptoms and the need for spirometry to confirm the diagnosis;
- Comorbidities are masking the respiratory pathology; It is on this first point concerning the difficulty of screening that this project focuses.
It is true that the development of screening strategies for COPD has been the subject of numerous studies, the results of which are controversial. The target population of smokers over the age of 40, who are readily selected, is difficult to achieve as a whole because the use of care is far from homogeneous. Many people do not have a general practitioner.
Recent reviews of COPD screening do not recommend systematic screening for COPD in adults. However, they emphasize the feasibility of screening by questionnaire and / or portable spirometry. A selection of patients suspected of exacerbations (patients with at least one episode labeled "bronchitis") could increase the cost-effectiveness of screening by focusing on the most severe cases.
In France, the High Authority for Health (HAS), inspired by the work of the WHO (GOLD programs), offers a simple five-question questionnaire available online for all healthcare professionals in order to facilitate an indication of screening spirometry, where the proposed approach combines symptom identification with active smoking. General practitioners are in this first line of approach for the diagnosis: in fact, the HAS, in its guide of the "pathway of care of the patient COPD", recommends that the general practitioner can carry out the spirometric screening. The corresponding pulmonologist intervenes in this course by completing the explorations and optimizing the management, especially in patients with frequent exacerbations. This ideal scheme is hampered by the present practical organization, a minority of general practitioners (10%) practicing in multidisciplinary health centers, places where the organization of a functional respiratory measurement can be easier.
The current recommendations for smoking cessation allow the coding of this management. It is global, applicable in primary care. It proposes as a starting point the minimal advice, then associates medicines of assistance with the stop, cognitive-behavioral therapies and a prolonged follow-up of the patients after weaning. However, although these comprehensive management techniques are effective for smoking cessation, it is shown that they are underutilized in routine practice by health professionals with low patient participation rates. This is noticed, whereas the application of the minimum board alone would allow about 200 000 people to have access to weaning every year.
In a complementary way, the performance of a functional respiratory test in the active smoking patient has been proposed as a full-fledged tool for the weaning assistance process. Analysis of the literature, however, yields discordant results. Two recent studies have revived the debate: they highlight the potential of spirometry as a communication medium in the context of smoking cessation (using pulmonary age) by confronting patients with the discovery and understanding of their ventilatory disorder obstructive.
Finally, if other health care providers are invited to participate actively in screening, including pharmacists, their place in this screening strategy has been less valued. In particular, pharmacists and dentists are required to provide care to patients with little or no use of the general practitioner: screening for COPD among these patients deserves consideration. Similarly, nurses occupy a special place, being called in particular to carry out regular care of patients, both in their office and at home. The administration of injectable antibiotics in a context of exacerbation of unlikely COPD is a frequent care opportunity, which may include this more comprehensive approach. Finally, physiotherapists, who are increasingly trained in the concept of respiratory rehabilitation, are taking charge of other potentially COPD smokers for other pathologies.
Based on the willingness of Finnish actors to work on a COPD pathway with the help of the regional health agency, the investigators propose to question the respective place of health care professionals involved in primary care among potentially COPD patients: Dentists, nurses, general practitioners, physiotherapists and pharmacists
- Conditions
- COPD
- Being tested
- COPD screening
- Keywords
- COPD, Primary care
- 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.
COPD screeningDiagnostic test
Self-questionnaire with 5 questions Fagerström's test Spirometry
| Study group | Role | What they receive |
|---|---|---|
| COPD screening | Other | Not described Receives: Diagnostic Test: COPD screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of a COPD screening procedure on primary care with a questionnaire and a measure with a micro-spirometer
Evaluate the effectiveness of a COPD screening procedure in primary care with a questionnaire and an estimate of the FEV1 / FVC ratio by a micro-spirometer, in primary gare
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start7 Apr 2017
- Primary completion9 Nov 2018
- Study completion9 Nov 2018
Why it stopped: Very important delay in the pace of inclusions. Likely overestimation of the potential for inclusion. Lack of involvement of some health professionals.
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 COPDStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104348
- Sponsor's protocol ID
- 29BRC17.0022 UNANIME
- Acronym
- UNANIME
- Status last verified
- Nov 2018
- First submitted
- 23 Mar 2017
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hourmant B, Gobert CG, Plumet R, Lott MC, Zabbe C, Tromeur C, Leroyer C, Couturaud F. Screening for COPD in primary care, involving dentists, pharmacists, physiotherapists, nurses and general practitioners (the UNANIME pilot study). Respir Med Res. 2021 Nov;80:100853. doi: 10.1016/j.resmer.2021.100853. Epub 2021 Aug 2.
PubMed 34385099
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for COPD in Primary Care: a Synergistic Approach - Dentists - Pharmacists -Physiotherapists - Nurses - Physicians
- ClinicalTrials.gov ID
- NCT03104348
- Acronym / sponsor ID
- UNANIME / 29BRC17.0022 UNANIME
- Conditions
- COPD
- Keywords
- COPD, Primary care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very important delay in the pace of inclusions. Likely overestimation of the potential for inclusion. Lack of involvement of some health professionals.
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 9 Nov 2018 (actual)
- First posted
- 7 Apr 2017 (actual)
- 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.
A recent French study conducted in the general population in the north, using more than 12,000 people randomly drawn from the electoral lists, shows a prevalence of nearly 15% of an obstructive spirometric function disorder; The diagnosis was ignored in 70% of cases. If we consider the Finistère situation, the mortality data are unfavorable, with an excess of COPD mortality compared to the French average.
Compared to other frequent chronic conditions, such as high blood pressure or diabetes, the management of COPD may appear complex for at least two reasons:
- Screening is difficult because of the banality of symptoms and the need for spirometry to confirm the diagnosis;
- Comorbidities are masking the respiratory pathology; It is on this first point concerning the difficulty of screening that this project focuses.
It is true that the development of screening strategies for COPD has been the subject of numerous studies, the results of which are controversial. The target population of smokers over the age of 40, who are readily selected, is difficult to achieve as a whole because the use of care is far from homogeneous. Many people do not have a general practitioner.
Recent reviews of COPD screening do not recommend systematic screening for COPD in adults. However, they emphasize the feasibility of screening by questionnaire and / or portable spirometry. A selection of patients suspected of exacerbations (patients with at least one episode labeled "bronchitis") could increase the cost-effectiveness of screening by focusing on the most severe cases.
In France, the High Authority for Health (HAS), inspired by the work of the WHO (GOLD programs), offers a simple five-question questionnaire available online for all healthcare professionals in order to facilitate an indication of screening spirometry, where the proposed approach combines symptom identification with active smoking. General practitioners are in this first line of approach for the diagnosis: in fact, the HAS, in its guide of the "pathway of care of the patient COPD", recommends that the general practitioner can carry out the spirometric screening. The corresponding pulmonologist intervenes in this course by completing the explorations and optimizing the management, especially in patients with frequent exacerbations. This ideal scheme is hampered by the present practical organization, a minority of general practitioners (10%) practicing in multidisciplinary health centers, places where the organization of a functional respiratory measurement can be easier.
The current recommendations for smoking cessation allow the coding of this management. It is global, applicable in primary care. It proposes as a starting point the minimal advice, then associates medicines of assistance with the stop, cognitive-behavioral therapies and a prolonged follow-up of the patients after weaning. However, although these comprehensive management techniques are effective for smoking cessation, it is shown that they are underutilized in routine practice by health professionals with low patient participation rates. This is noticed, whereas the application of the minimum board alone would allow about 200 000 people to have access to weaning every year.
In a complementary way, the performance of a functional respiratory test in the active smoking patient has been proposed as a full-fledged tool for the weaning assistance process. Analysis of the literature, however, yields discordant results. Two recent studies have revived the debate: they highlight the potential of spirometry as a communication medium in the context of smoking cessation (using pulmonary age) by confronting patients with the discovery and understanding of their ventilatory disorder obstructive.
Finally, if other health care providers are invited to participate actively in screening, including pharmacists, their place in this screening strategy has been less valued. In particular, pharmacists and dentists are required to provide care to patients with little or no use of the general practitioner: screening for COPD among these patients deserves consideration. Similarly, nurses occupy a special place, being called in particular to carry out regular care of patients, both in their office and at home. The administration of injectable antibiotics in a context of exacerbation of unlikely COPD is a frequent care opportunity, which may include this more comprehensive approach. Finally, physiotherapists, who are increasingly trained in the concept of respiratory rehabilitation, are taking charge of other potentially COPD smokers for other pathologies.
Based on the willingness of Finnish actors to work on a COPD pathway with the help of the regional health agency, the investigators propose to question the respective place of health care professionals involved in primary care among potentially COPD patients: Dentists, nurses, general practitioners, physiotherapists and pharmacists
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD screening | Other | Diagnostic Test: COPD screening |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 40 years,
- Smoking greater than 10 packs / year, active.
- No previous diagnosis of COPD
- Signature of informed consent
Key exclusion criteria (3 listed)
- Patients under 40 years of age
- Previous of COPD diagnosis
- Refusing to participate
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 |
|---|---|---|
| COPD screeningSelf-questionnaire with 5 questions Fagerström's test Spirometry | Diagnostic test | COPD screening |
Primary outcome
Effectiveness of a COPD screening procedure on primary care with a questionnaire and a measure with a micro-spirometer
Time frame: 2 months
Evaluate the effectiveness of a COPD screening procedure in primary care with a questionnaire and an estimate of the FEV1 / FVC ratio by a micro-spirometer, in primary gare
Results and safety
The study was stopped early (reason given: Very important delay in the pace of inclusions. Likely overestimation of the potential for inclusion. Lack of involvement of some health professionals.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Derived from this study: PubMed 34385099Hourmant B, Gobert CG, Plumet R, Lott MC, Zabbe C, Tromeur C, Leroyer C, Couturaud F. Screening for COPD in primary care, involving dentists, pharmacists, physiotherapists, nurses and general practitioners (the UNANIME pilot study). Respir Med Res. 2021 Nov;80:100853. doi: 10.1016/j.resmer.2021.100853. Epub 2021 Aug 2.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COPD screening in people with COPD, run by University Hospital, Brest at 2 sites 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Very important delay in the pace of inclusions. Likely overestimation of the potential for inclusion. Lack of involvement of some health professionals.). Results are not available in the source record.
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?
Effectiveness of a COPD screening procedure on primary care with a questionnaire and a measure with a micro-spirometer (time frame: 2 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 NCT03104348, 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 20 Nov 2018.