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NCT Number: NCT05660460

COPD 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brugernes Akademi

Copenhagen, 1660, Denmark

Location status: Recruiting

Location contact

Jannet van der Veen

CONTACT

[email protected]

+45 21157392

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Able to speak and understand Danish or English to such an extent that informed consent can be obtained

Exclusion criteria

  • 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

Treatment and study plan

Spirometry

Diagnostic 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.

Primary outcomes

  1. Prevalence of COPD

    Time frame: Baseline

    • Prevalence of obstructive lung function reduction among socially vulnerable
  2. Undiagnosed COPD

    Time frame: Baseline

    • Prevalence of previously undetected COPD
  3. Adherence to first appointment

    Time frame: Baseline

    • Numbers of socially vulnerable individuals diagnosed with obstructive lung function that are subsequently examined at a pulmonary medicine outpatient clinic/GP
  4. Subscription at first appointment

    Time frame: Baseline

    • Number of socially vulnerable individuals who after COPD diagnosis are subscribed medical treatment

Secondary outcomes

  1. Smoking status

    Time frame: Baseline

    • Prevalence of socially vulnerable individuals who smoke and wish to stop smoking
  2. COPD and smoking cessation

    Time frame: Baseline

    • Prevalence of socially vulnerable individuals with impaired lung function who have a desire to stop smoking
  3. smoking cessation invitation

    Time frame: Baseline

    • Prevalence of socially vulnerable individuals who want to quit smoking and accept the smoking cessation offers
  4. Adherence to treatment

    Time frame: Baseline

    • Prevalence of socially vulnerable individuals who claim their prescription for COPD medication
  5. Health service barriers

    Time frame: Baseline

    • Patient-perceived barriers with COPD treatment through outpatient clinic/GP

Study contacts

Contact information is provided by the study sponsor or research team.

Jannet van der Veen

CONTACT

[email protected]

+45 21157392

Mette Lindstroem, MPH

CONTACT

[email protected]

+45 38623308

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Brugernes Akademi

Registry information

Official study title

A Study of the Incidence and Treatment of Impaired Lung Function Among Socially Vulnerable Individuals at a Street Level

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Dec 21, 2022
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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