COPDNCT04754308
COPD and Socially Vulnerable Individuals
A study testing Spirometry in people with COPD, run by Hvidovre University Hospital at 10 sites in Denmark.
Trial summary
The trial investigates and describes the prevalence of COPD in patients who are in the social nurses' target group and investigates the effect of opportunistic screening for COPD in these vulnerable patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Spirometry
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 513 participants
- Where
- 10 sitesDenmark
- Study dates
- 19 Apr 2021to 18 Apr 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Able to speak and understand Danish to such an extent that informed consent can be obtained
Who cannot join
- Not having a Danish civil registration number, since foreign patients do not have free access to examinations and medical treatment, and cannot be followed up in the national patient registry
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Denmark10 sites
Århus Universitetshospital
Aarhus
Bispebjerg and Frederiksberg Hospital
Copenhagen
Copenhagen University Hospital Rigshospitalet
Copenhagen
Herlev and Gentofte Hospital
Copenhagen
Regionshospitalet Horsens
Horsens
Hvidovre Hospital
Hvidovre, 2765
Sjællands Universitetshospital Køge og Roskilde
Køge
Nykøbing Falster Sygehus
Nykøbing Falster
Bornholm Hospital
Rønne
Næstved-Slagelse-Ringsted Hospital
Slagelse
About this study
Official title: A Study of the Incidence and Treatment of Impaired Lung Function in Patients Constituting the Target Group of Social Nurses
The trial investigates and describes the prevalence of COPD in patients who are in the social nurses' target group and investigates the effect of opportunistic screening for COPD in these vulnerable patients.
The study population is patients who have been referred to a social nurse at hospitals in the Capital Region, Central Denmark Region and Region Zealand of Denmark during the inclusion period, and monitor them for up to 5 years in order to investigate variables that are significant in terms of the patients' treatment, hospitalisations, and mortality in relation to COPD.
Our hypothesis is that there will be a higher incidence of COPD among those patients with whom the social nurses have contact than in the general population.
Read the detailed description
The study consists of two sub-studies: A a descriptive cross-sectional study "The prevalence of COPD in patients who are in the social nurses' target group" followed by study B a cohort study "The effect of opportunistic screening for COPD in patients who are in the social nurses' target group", based on a closed cohort.
People in the lower social classes are at increased risk of developing COPD due to their lifelong accumulation of risk factors, such as smoking, passive smoking and the influence of lifestyle and the environment.
In the group with the socially vulnerable individuals, 70% are smokers compared to 18% in the general Danish population. The socially vulnerable individuals are defined here as people affected by homelessness, drug abuse, harmful alcohol consumption, mental illness and poverty. Despite the socially vulnerable group having an over-consumption of general practice visits, 25% of the patients in the social nurses' target group state that they do not have contact with or use their own doctor.
Our hypothesis is therefore that there will be a higher incidence of COPD among those patients with whom the social nurses have contact than in the general population.
Purpose: To investigate and describe the prevalence of COPD in patients who are in the social nurses' target group and to investigate the effect of opportunistic screening for COPD in these vulnerable citizens.
Data collection:
Baseline data from the cross-sectional study are derived from lung function measurement and REDCap online-questionnaires completed on inclusion.
The data from the cohort study regarding disease burden and hospital visits originates from the national patient registry (LPR) and mortality data is retrieved from the Danish Register of Causes of Death. Data regarding redeemed prescriptions for COPD medicine originates from the Prescription Database. The patients' connection to the job market and income status are based on extracts from RAS (Registry-based Labour Force Statistics), which is administered by Statistics Denmark. Data regarding the highest acquired education (HFAUDD) is from Statistics Denmark.
Variables:
There will be collected the following variables at inclusion: information on demographics, lung function, selv-reported information on: risk factors, socioeconomic variables and symptoms of lung disease. Moreover register data on socioeconomic status, morbidity, physical health by Charlson score, mortality, hospital visits and prescriptions for COPD Medicine will be retrieved after 5 years follow-up.
Sample size:
To detect a difference between the patient group and the Danish population of minimum 100% a total of 511 participants are needed in the study (power of 80%, p-values=0,05, an estimated COPD prevalence of 4,3% in the Danish population).
The collected data will be kept in accordance to the Data Protection Agency guidelines. The studies are carried out in accordance with the principles of the Helsinki Declaration.
- Conditions
- COPD
- Being tested
- Spirometry
- Keywords
- Screening, Socially vulnerable patients, Social nurses
- 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.
SpirometryDiagnostic test
The method of examination, Spirometry, is non-invasive (i.e. not an intervention that involves penetration into the body by means of incisions or injections.). It is a routine examination and there are no risks, adverse reactions, or discomforts associated with the examination.
| Study group | Role | What they receive |
|---|---|---|
| Patients referred to social nurse | Other | After obtaining informed consent, the social nurse reviews the online-questionnaire with the patient and performs a lung function examination requiring the patient to blow into a plastic tube. If a patient is identified as having obstructive reduction of lung function, they are offered a referral to a local pulmonary medicine department or GP for further investigation - regardless of whether or not they have a diagnosed or undiagnosed lung disease.
In addition, participants are questioned about their motivation for smoking cessation and are informed of the options for this (in hospital and/or referral to the municipality). Receives: Diagnostic Test: Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of obstructive lung function reduction in patients in the social nurses' target group
Measured: Baseline
Distribution of diagnosed and undiagnoses COPD in patients
Measured: Baseline
Numbers of patients diagnosed with obstructive lung function that are subsequently examined at a pulmonary medicine outpatient clinic/GP
Measured: Baseline
Prevalence of patients diagnosed with COPD after screening
Measured: Baseline
Does opportunistic screening by social nurses impact on the number of hospital visits?
The outcome is number of outpatient and acute visits with a-diagnosis related to COPD for 3 groups of patients: The group with undiagnosed COPD at inclusion who were investigated, and the group with undiagnosed COPD at inclusion who did not want investigation compared with the group of patients with already diagnosed COPD at inclusion (control group).
Measured: Follow-up 5 years from inclusion
Does opportunistic screening by social nurses affect medication consumption in connection with the treatment of COPD?
The outcome is redeemed prescriptions for COPD medication among the 2 groups of patients: The group with undiagnosed COPD at inclusion compared with the group of patients with already diagnosed COPD at inclusion (control group).
Measured: Follow-up 5 years from inclusion
Secondary outcomes (3)
Prevalence of patients who smoke and wish to stop smoking
Measured: Baseline
Prevalence of patients with impaired lung function who have a desire to stop smoking
Measured: Baseline
Prevalence of patients who want to quit smoking and accept the smoking cessation offers.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start19 Apr 2021
- Primary completion18 Apr 2024
- Study completion18 Apr 2024
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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
- Responsible party
- Principal investigator, Charlotte Suppli Ulrik, Hvidovre University Hospital
- Investigators
- Nina Brünés, Study chair, Amager and Hvidovre Hospital, PatientforloebCharlotte Ulrik, Principal investigator, Amager and Hvidovre Hospital, Medical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754308
- Sponsor's protocol ID
- H-20031386
- Status last verified
- Apr 2024
- First submitted
- 10 Feb 2021
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brunes N, Lindstroem MB, Ulrik CS, Andersen O, Lisby M, Godtfredsen NS, Hansen TL, Pisinger C, Graven V, Marsaa K, Thomsen LH. Opportunistic screening for COPD among socially marginalized patients. BMC Pulm Med. 2024 Mar 5;24(1):113. doi: 10.1186/s12890-024-02927-9.
PubMed 38443835
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Incidence and Treatment of Impaired Lung Function in Patients Constituting the Target Group of Social Nurses
- ClinicalTrials.gov ID
- NCT04754308
- Acronym / sponsor ID
- H-20031386
- Conditions
- COPD
- Keywords
- Screening, Socially vulnerable patients, Social nurses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 15 Feb 2021 (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.
The trial investigates and describes the prevalence of COPD in patients who are in the social nurses' target group and investigates the effect of opportunistic screening for COPD in these vulnerable patients.
The study population is patients who have been referred to a social nurse at hospitals in the Capital Region, Central Denmark Region and Region Zealand of Denmark during the inclusion period, and monitor them for up to 5 years in order to investigate variables that are significant in terms of the patients' treatment, hospitalisations, and mortality in relation to COPD.
Our hypothesis is that there will be a higher incidence of COPD among those patients with whom the social nurses have contact than in the general population.
Detailed description
The study consists of two sub-studies: A a descriptive cross-sectional study "The prevalence of COPD in patients who are in the social nurses' target group" followed by study B a cohort study "The effect of opportunistic screening for COPD in patients who are in the social nurses' target group", based on a closed cohort.
People in the lower social classes are at increased risk of developing COPD due to their lifelong accumulation of risk factors, such as smoking, passive smoking and the influence of lifestyle and the environment.
In the group with the socially vulnerable individuals, 70% are smokers compared to 18% in the general Danish population. The socially vulnerable individuals are defined here as people affected by homelessness, drug abuse, harmful alcohol consumption, mental illness and poverty. Despite the socially vulnerable group having an over-consumption of general practice visits, 25% of the patients in the social nurses' target group state that they do not have contact with or use their own doctor.
Our hypothesis is therefore that there will be a higher incidence of COPD among those patients with whom the social nurses have contact than in the general population.
Purpose: To investigate and describe the prevalence of COPD in patients who are in the social nurses' target group and to investigate the effect of opportunistic screening for COPD in these vulnerable citizens.
Data collection:
Baseline data from the cross-sectional study are derived from lung function measurement and REDCap online-questionnaires completed on inclusion.
The data from the cohort study regarding disease burden and hospital visits originates from the national patient registry (LPR) and mortality data is retrieved from the Danish Register of Causes of Death. Data regarding redeemed prescriptions for COPD medicine originates from the Prescription Database. The patients' connection to the job market and income status are based on extracts from RAS (Registry-based Labour Force Statistics), which is administered by Statistics Denmark. Data regarding the highest acquired education (HFAUDD) is from Statistics Denmark.
Variables:
There will be collected the following variables at inclusion: information on demographics, lung function, selv-reported information on: risk factors, socioeconomic variables and symptoms of lung disease. Moreover register data on socioeconomic status, morbidity, physical health by Charlson score, mortality, hospital visits and prescriptions for COPD Medicine will be retrieved after 5 years follow-up.
Sample size:
To detect a difference between the patient group and the Danish population of minimum 100% a total of 511 participants are needed in the study (power of 80%, p-values=0,05, an estimated COPD prevalence of 4,3% in the Danish population).
The collected data will be kept in accordance to the Data Protection Agency guidelines. The studies are carried out in accordance with the principles of the Helsinki Declaration.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred to social nurse | Other | Diagnostic Test: SpirometryAfter obtaining informed consent, the social nurse reviews the online-questionnaire with the patient and performs a lung function examination requiring the patient to blow into a plastic tube. If a patient is identified as having obstructive reduction of lung function, they are offered a referral to a local pulmonary medicine department or GP for further investigation - regardless of whether or not they have a diagnosed or undiagnosed lung disease. In addition, participants are questioned about their motivation for smoking cessation and are informed of the options for this (in hospital and/or referral to the municipality). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Able to speak and understand Danish to such an extent that informed consent can be obtained
Key exclusion criteria (1 listed)
- Not having a Danish civil registration number, since foreign patients do not have free access to examinations and medical treatment, and cannot be followed up in the national patient registry
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 |
|---|---|---|
| SpirometryThe method of examination, Spirometry, is non-invasive (i.e. not an intervention that involves penetration into the body by means of incisions or injections.). It is a routine examination and there are no risks, adverse reactions, or discomforts associated with the examination. | Diagnostic test | Patients referred to social nurse |
Primary outcome
Prevalence of obstructive lung function reduction in patients in the social nurses' target group
Time frame: Baseline
Distribution of diagnosed and undiagnoses COPD in patients
Time frame: Baseline
Numbers of patients diagnosed with obstructive lung function that are subsequently examined at a pulmonary medicine outpatient clinic/GP
Time frame: Baseline
Prevalence of patients diagnosed with COPD after screening
Time frame: Baseline
Does opportunistic screening by social nurses impact on the number of hospital visits?
Time frame: Follow-up 5 years from inclusion
The outcome is number of outpatient and acute visits with a-diagnosis related to COPD for 3 groups of patients: The group with undiagnosed COPD at inclusion who were investigated, and the group with undiagnosed COPD at inclusion who did not want investigation compared with the group of patients with already diagnosed COPD at inclusion (control group).
Does opportunistic screening by social nurses affect medication consumption in connection with the treatment of COPD?
Time frame: Follow-up 5 years from inclusion
The outcome is redeemed prescriptions for COPD medication among the 2 groups of patients: The group with undiagnosed COPD at inclusion compared with the group of patients with already diagnosed COPD at inclusion (control group).
3 secondary outcomes
Prevalence of patients who smoke and wish to stop smoking
Time frame: Baseline
Prevalence of patients with impaired lung function who have a desire to stop smoking
Time frame: Baseline
Prevalence of patients who want to quit smoking and accept the smoking cessation offers.
Time frame: Baseline
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 29 Apr 2024.
- Derived from this study: PubMed 38443835Brunes N, Lindstroem MB, Ulrik CS, Andersen O, Lisby M, Godtfredsen NS, Hansen TL, Pisinger C, Graven V, Marsaa K, Thomsen LH. Opportunistic screening for COPD among socially marginalized patients. BMC Pulm Med. 2024 Mar 5;24(1):113. doi: 10.1186/s12890-024-02927-9.
- 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.
Nina Brünés study chair
Amager and Hvidovre Hospital, Patientforloeb
Charlotte Ulrik principal investigator
Amager and Hvidovre Hospital, Medical Department
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirometry in people with COPD, run by Hvidovre University Hospital at 10 sites in Denmark.
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 1 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Denmark. 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 obstructive lung function reduction in patients in the social nurses' target group (time frame: Baseline). The study lists 6 primary outcomes in all. 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 NCT04754308, 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 29 Apr 2024.