Management of severe COPD through a multidisciplinary approach

Longitudinal, Open Label, Clinical Trial Evaluating the Effectiveness of Detailed Phenotyping and Subsequent Multidisciplinary Management of Both COPD and Multimorbidity in Patients With COPD After a Hospitalization Due to Acute Exacerbation of COPD.

This study is testing a team-based approach to care for people with severe COPD who have been hospitalized to see if it helps them feel better and have fewer flare-ups compared to regular treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 40 Years to 100 Years
• Sex: All
• Sponsor: Vastra Gotaland Region (Government)
• Locations: 1 site (Gothenburg, VGR)
• Trial ID: NCT04860375 on ClinicalTrials.gov

What this trial studies

This study focuses on the multidisciplinary management of patients with severe Chronic Obstructive Pulmonary Disease (COPD), particularly those experiencing exacerbations. It aims to provide comprehensive patient care that integrates various healthcare professionals to improve outcomes for individuals suffering from this debilitating condition. The study will involve patients who have been hospitalized due to worsening respiratory symptoms and will assess the effectiveness of this collaborative approach compared to standard care. The goal is to enhance the quality of life and reduce the frequency of exacerbations in COPD patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with a history of smoking and prior hospitalization due to COPD exacerbations.

Not a fit: Patients with alternative diagnoses for their respiratory symptoms or those unable to comply with study procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the management and quality of life for patients with severe COPD.

How similar studies have performed: Other studies have shown promising results with multidisciplinary approaches in managing chronic diseases, suggesting potential success for this method in COPD management.

Eligibility criteria

Inclusion Criteria:

1. Male or female patients, aged ≥40 years.
2. Smokers or ex-smokers (≥10 pack-year).
3. Prior hospitalization because of progressively worsening dyspnea (associated or not with increased cough and sputum, and or sputum purulence), with a clinically suspected diagnosis of exacerbations of COPD that prompt the discharging physician to refer the patient to the COPD Center.
4. Signed informed concent form.

Exclusion Criteria:

1. Presenting to the hospital for similar symptoms, which are not defined by the clinicians as suspected exacerbations of COPD, because of alternative diagnoses not related to patients with COPD (e.g., chest wall trauma, neurological disorders, sepsis, cancer and anemia).
2. Already enrolled in other studies perceived to interfere with this protocol.
3. In whom spirometry test is contraindicated (e.g., hemoptysis, detached retina, active tuberculosis).
4. Unable to comply with study procedures and follow-ups in the opinion of the Investigator (e.g., other severe diseases with short life expectancy or who make it impossible for the patients to participate into the study, evidence of alcohol or drug abuse, dementia, severe psychiatric disorder).
5. Acute myocardial infarction and unstable angina pectoris or arrhythmias requiring specific cardiology ICU.
6. Diagnosed stroke, dementia, degenerative neurological disorders or psychiatry disorders requiring specialized care.
7. At the discretion of the recruiting clinician would not be able to be considered for the study.

Where this trial is running

Gothenburg, VGR

• COPD-Center — Gothenburg, Vgr, Sweden (Recruiting)

Study contacts

• Principal investigator: Lowie Vanfleteren — COPD-center, Sahlgrenska University Hospital
• Study coordinator: Lowie Vanfleteren

Conditions Copd; COPD Exacerbation; COPD; Multidisciplinary management; COPD exacerbation