Multidisciplinary Management of Severe COPD

NCT ID: NCT04860375

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-22
• Study Completion Date: 2027-03-31

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) is a common chronic disease that is characterized by persistent airflow limitation, that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases, particularly cigarette smoking. Latest updates of the Global Burden of Disease emphasize the dramatic size of the problem. In 2015, 3,2 million people died from COPD worldwide, an increase of 11,6% compared with 1990. The overall prevalence of COPD increased by 44,2% and was associated with a significant increase of disability-adjusted life years. In Sweden the prevalence of COPD is approximately 8% bringing the annual total estimated cost for society of 9.1 billion SEK. About 1/3 of patients with COPD undergo periods of acute worsening of respiratory symptoms, particularly dyspnea. Acute worsening of respiratory symptoms is associated with increased in-hospital mortality (up to 20%), short term- (up to 60% at 1 year) and long-term mortality (> 50% at 5 years) and high risk of re-hospitalization. Because patients with COPD often suffer concomitant disorders that significantly worsen their health status and vital prognosis, the management of the patients is not only the management of COPD but must include identification and treatment of other concomitant chronic diseases.

Accurate diagnosis, assessment of severity, and long-term interdisciplinary management of both COPD and concomitant chronic diseases in patients with COPD could be associated with a decreased number of hospitalizations and deaths, improved quality of life and decreased health care utilization in the following 3 years. This longitudinal study will evaluate the effectiveness of detailed phenotyping and comprehensive multidisciplinary management of COPD and multimorbidity in patients.

This is a prospective, open label, cohort study using design of intervention and registries data. The anticipated study time is 5 years, with 3 years of intervention (including 2 years of recruitment period) and 1-year data collection from the National Registries. The study will compare number of rehospitalizations from all causes of patient recruited after a hospitalization due to acute exacerbations of COPD to control patients included from the Swedish Airway Register (SAR). The selection of the control population within the SAR is based on risk score matching. At the first visit a thorough individual's assessment will be performed. The assessment includes information about demographics, COPD and exacerbations, medical history, comorbidities, vital parameters, blood and sputum tests and assessment of quality of life. Based on the outcome from the assessment and disease phenotype, personalized care plans will be prepared and given to the patients, including dietary program, adjusted exercise program, psychological counselling, treatment of comorbidities etc. Patients will come for planned follow-up visits, according to the protocol. The last visit will take place at 5th year after the study start. The "end of study" is defined as last visit of the last subject or if the effectiveness of the intervention is shown before. Data collected at eCRFs will be combined with the data from SAR and complemented with data from Swedish National Registries.

Conditions

Copd; COPD Exacerbation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Multidisciplinary, holistic and patient-centered care

Based on the outcome from the assessment and disease phenotype, personalized care plans will be prepared and given to the patients, including dietary program, adjusted exercise program, psychological counselling, treatment of comorbidities etc. Patients will come for planned follow-up visits, according to the protocol (total 5 visits).

Group Type: EXPERIMENTAL

Multidisciplinary patient care

Intervention Type: PROCEDURE

A holistic, multidisciplinary, patient-centered care.

Standard care

The control group will be recruited from the Swedish Airway Register at the end of the study. Selection will be based on propensity score matching to the intervention group.

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

Standard care in Sweden

Interventions

Multidisciplinary patient care

A holistic, multidisciplinary, patient-centered care.

Intervention Type: PROCEDURE

Standard care

Standard care in Sweden

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Lowie Vanfleteren

Principal Investigator, Head of COPD-center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lowie Vanfleteren

Role: PRINCIPAL_INVESTIGATOR

COPD-center, Sahlgrenska University Hospital

Locations

COPD-Center

Gothenburg, VGR, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Lowie Vanfleteren

Role: CONTACT

lowie.vanfleteren@vgregion.se

0046736601730

Facility Contacts

Lowie Vanfleteren

Role: primary

Anna Lundborg

Role: backup

Other Identifiers

Care4COPD

Identifier Type: -

Identifier Source: org_study_id