COPD at a Street Level

NCT05660460 | Recruiting DMC

• 1 other identifier: H-22046465
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

screening; socially vulnerable patients; mobile clinic

Outcome Measures

Primary Outcomes (4)

• Prevalence of COPD

  1\. Prevalence of obstructive lung function reduction among socially vulnerable

  Baseline

• Undiagnosed COPD

  2\. Prevalence of previously undetected COPD

  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

Secondary Outcomes (5)

• Smoking status

  Baseline

• COPD and smoking cessation

  Baseline

• smoking cessation invitation

  Baseline

• Adherence to treatment

  Baseline

• Health service barriers

  Baseline

Study Arms (1)

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).

Diagnostic Test: Spirometry

Interventions

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.

Socially vulnerable individuals in contact with a mobile clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Brugernes Akademi: collaborator

Study Sites (1)

Brugernes Akademi

Copenhagen, 1660, Denmark

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jannet van der Veen

  Brugernes Akademi

  STUDY CHAIR

• Charlotte S Ulrik

  Amager and Hvidovre Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jannet van der Veen

CONTACT

+45 21157392; jannet@brugernesakademi.dk

Mette Lindstroem, MPH

CONTACT

+45 38623308; mette.bendtz.lindstroem@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, consultant

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: March 15, 2023
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)