COPDNCT05660460
COPD at a Street Level
A study testing Spirometry in people with COPD, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The trial investigates and describes the prevalence of COPD among socially vulnerable individuals who come in contact with a mobile clinic and investigates the effect of opportunistic screening for COPD in these vulnerable persons. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- 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
- 511 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2023to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Able to speak and understand Danish or English 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Brugernes Akademi
Copenhagen, 1660
Jannet van der Veen, +45 21157392, jannet@brugernesakademi.dk
About this study
Official title: A Study of the Incidence and Treatment of Impaired Lung Function Among Socially Vulnerable Individuals at a Street Level
The trial investigates and describes the prevalence of COPD among socially vulnerable individuals who come in contact with a mobile clinic and investigates the effect of opportunistic screening for COPD in these vulnerable persons. The study population is individuals who come in contact with a mobile clinic, that visits home shelters, open drugs scenes etc. in the Capital Region of Denmark during the inclusion period, and monitor them for up to 1 year in order to investigate variables that are significant in terms of the patients' treatment, hospitalizations, and mortality in relation to COPD. Our hypothesis is that there will be a higher incidence of COPD among socially vulnerable individuals who come in contact with the mobile clinic than in the general population.
Read the detailed description
The study consists of three sub-studies: A. a descriptive cross-sectional study "The prevalence of COPD among socially vulnerable individuals who come in contact with a mobile clinic" followed by study B a cohort study "The effect of opportunistic screening for COPD among socially vulnerable individuals who come in contact with a mobile clinic", based on a closed cohort, and study C "A qualitative study of patient experiences with screening and treatment of COPD.
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 socially vulnerable individuals 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 socially vulnerable persons who come in contact with the mobile clinic. Purpose: To investigate and describe the prevalence of COPD among socially vulnerable individuals who come in contact with a mobile clinic and to investigate the effect of opportunistic screening for COPD in these vulnerable citizens, followed by a qualitative study of patient experiences with COPD treatment.
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 a 1 year 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, mobile clinic
- 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 noninvasive (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 |
|---|---|---|
| Socially vulnerable individuals in contact with a mobile clinic | Other | After obtaining informed consent, a project nurse in the mobile clinic reviews the online-questionnaire with the participant and performs a lung function examination requiring the individual to blow into a plastic tube. If the participant is identified as having obstructive reduction of lung function, they are offered a referral and patient support 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 COPD
- Prevalence of obstructive lung function reduction among socially vulnerable
Measured: Baseline
Undiagnosed COPD
- Prevalence of previously undetected COPD
Measured: Baseline
Adherence to first appointment
- Numbers of socially vulnerable individuals diagnosed with obstructive lung function that are subsequently examined at a pulmonary medicine outpatient clinic/GP
Measured: Baseline
Subscription at first appointment
- Number of socially vulnerable individuals who after COPD diagnosis are subscribed medical treatment
Measured: Baseline
Secondary outcomes (5)
Smoking status
- Prevalence of socially vulnerable individuals who smoke and wish to stop smoking
Measured: Baseline
COPD and smoking cessation
- Prevalence of socially vulnerable individuals with impaired lung function who have a desire to stop smoking
Measured: Baseline
smoking cessation invitation
- Prevalence of socially vulnerable individuals who want to quit smoking and accept the smoking cessation offers
Measured: Baseline
Adherence to treatment
- Prevalence of socially vulnerable individuals who claim their prescription for COPD medication
Measured: Baseline
Health service barriers
- Patient-perceived barriers with COPD treatment through outpatient clinic/GP
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start15 Mar 2023
- Primary completion15 Mar 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 511 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brugernes Akademi
- Responsible party
- Principal investigator, Charlotte Suppli Ulrik, Hvidovre University Hospital
- Investigators
- Jannet van der Veen, Study chair, Brugernes AkademiCharlotte S Ulrik, Principal investigator, Amager and Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660460
- Sponsor's protocol ID
- H-22046465
- Status last verified
- Apr 2024
- First submitted
- 13 Dec 2022
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 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 Among Socially Vulnerable Individuals at a Street Level
- ClinicalTrials.gov ID
- NCT05660460
- Acronym / sponsor ID
- H-22046465
- Conditions
- COPD
- Keywords
- screening, socially vulnerable patients, mobile clinic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 511 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Brugernes Akademi
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 21 Dec 2022 (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 among socially vulnerable individuals who come in contact with a mobile clinic and investigates the effect of opportunistic screening for COPD in these vulnerable persons. The study population is individuals who come in contact with a mobile clinic, that visits home shelters, open drugs scenes etc. in the Capital Region of Denmark during the inclusion period, and monitor them for up to 1 year in order to investigate variables that are significant in terms of the patients' treatment, hospitalizations, and mortality in relation to COPD. Our hypothesis is that there will be a higher incidence of COPD among socially vulnerable individuals who come in contact with the mobile clinic than in the general population.
Detailed description
The study consists of three sub-studies: A. a descriptive cross-sectional study "The prevalence of COPD among socially vulnerable individuals who come in contact with a mobile clinic" followed by study B a cohort study "The effect of opportunistic screening for COPD among socially vulnerable individuals who come in contact with a mobile clinic", based on a closed cohort, and study C "A qualitative study of patient experiences with screening and treatment of COPD.
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 socially vulnerable individuals 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 socially vulnerable persons who come in contact with the mobile clinic. Purpose: To investigate and describe the prevalence of COPD among socially vulnerable individuals who come in contact with a mobile clinic and to investigate the effect of opportunistic screening for COPD in these vulnerable citizens, followed by a qualitative study of patient experiences with COPD treatment.
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 a 1 year 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 |
|---|---|---|
| Socially vulnerable individuals in contact with a mobile clinic | Other | Diagnostic Test: SpirometryAfter obtaining informed consent, a project nurse in the mobile clinic reviews the online-questionnaire with the participant and performs a lung function examination requiring the individual to blow into a plastic tube. If the participant is identified as having obstructive reduction of lung function, they are offered a referral and patient support 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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Able to speak and understand Danish or English 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 noninvasive (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 | Socially vulnerable individuals in contact with a mobile clinic |
Primary outcome
Prevalence of COPD
Time frame: Baseline
1. Prevalence of obstructive lung function reduction among socially vulnerable
Undiagnosed COPD
Time frame: Baseline
2. Prevalence of previously undetected COPD
Adherence to first appointment
Time frame: Baseline
3. Numbers of socially vulnerable individuals diagnosed with obstructive lung function that are subsequently examined at a pulmonary medicine outpatient clinic/GP
Subscription at first appointment
Time frame: Baseline
4. Number of socially vulnerable individuals who after COPD diagnosis are subscribed medical treatment
5 secondary outcomes
Smoking status
Time frame: Baseline
COPD and smoking cessation
Time frame: Baseline
smoking cessation invitation
Time frame: Baseline
Adherence to treatment
Time frame: Baseline
Health service barriers
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- 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.
Jannet van der Veen study chair
Brugernes Akademi
Charlotte S Ulrik principal investigator
Amager and Hvidovre Hospital
1 site 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 1 site 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: looking for participants now, as of the sponsor's last update on 9 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jannet van der Veen (+45 21157392, jannet@brugernesakademi.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of COPD (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2024.