COPD at a Street Level

NCT ID: NCT05660460

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 511 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-15
• Study Completion Date: 2029-01-31

Brief 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. 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.

Conditions

COPD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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).

Group Type: OTHER

Spirometry

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brugernes Akademi

UNKNOWN

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Charlotte Suppli Ulrik

Professor, consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jannet van der Veen

Role: STUDY_CHAIR

Brugernes Akademi

Charlotte S Ulrik

Role: PRINCIPAL_INVESTIGATOR

Amager and Hvidovre Hospital

Locations

Brugernes Akademi

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Jannet van der Veen

Role: CONTACT

jannet@brugernesakademi.dk

+45 21157392

Mette Lindstroem, MPH

Role: CONTACT

mette.bendtz.lindstroem@regionh.dk

+45 38623308

Facility Contacts

Jannet van der Veen

Role: primary

jannet@brugernesakademi.dk

+45 21157392

Other Identifiers

H-22046465

Identifier Type: -

Identifier Source: org_study_id