COPD at a Street Level

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.

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Diagnostic test: Spirometry

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 Type: Interventional
• Enrollment (Estimated): 511
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jannet van der Veen; Phone Number: +45 21157392; Email: jannet@brugernesakademi.dk
• Study Contact Backup: Name: Mette Lindstroem, MPH; Phone Number: +45 38623308; Email: mette.bendtz.lindstroem@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 1660
    • Recruiting
    • Brugernes Akademi
    • Contact: Jannet van der Veen; Phone Number: +45 21157392; Email: jannet@brugernesakademi.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Socially vulnerable individuals in contact with a mobile clinic; 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).

Diagnostic test: Spirometry; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of COPD	1. Prevalence of obstructive lung function reduction among socially vulnerable	Baseline
Adherence to first appointment	3. Numbers of socially vulnerable individuals diagnosed with obstructive lung function that are subsequently examined at a pulmonary medicine outpatient clinic/GP	Baseline
Subscription at first appointment	4. Number of socially vulnerable individuals who after COPD diagnosis are subscribed medical treatment	Baseline
Undiagnosed COPD	2. Prevalence of previously undetected COPD	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking status	5. Prevalence of socially vulnerable individuals who smoke and wish to stop smoking	Baseline
COPD and smoking cessation	6. Prevalence of socially vulnerable individuals with impaired lung function who have a desire to stop smoking	Baseline
smoking cessation invitation	7. Prevalence of socially vulnerable individuals who want to quit smoking and accept the smoking cessation offers	Baseline
Adherence to treatment	8. Prevalence of socially vulnerable individuals who claim their prescription for COPD medication	Baseline
Health service barriers	9. Patient-perceived barriers with COPD treatment through outpatient clinic/GP	Baseline

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: Brugernes Akademi
• Investigators: Study Chair: Jannet van der Veen, Brugernes Akademi; Principal Investigator: Charlotte S Ulrik, Amager and Hvidovre Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: screening; socially vulnerable patients; mobile clinic
• Other Study ID Numbers: H-22046465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No