Clinical trial NCT04860375: Multidisciplinary Management of Severe COPD
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Copd
COPD Exacerbation
Keywords: COPD
Multidisciplinary management
COPD exacerbation
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2021-04-26
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, open label, cohort study using design of intervention and registries data. Eligible patients for intervention group will be recruited consecutively from patients referred to the COPD-Center at the Sahlgrenska University Hospital, after a hospital admission because of acute or progressive worsening dyspnea. The control group will be recruited from the Swedish Airway Register and selection will be based on propensity score matching. A total of 110 patients will be included in the intervention group and 220 in the control group.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Total number of hospitalizations
timeFrame: Baseline and 3 years after baseline
Secondary outcomes:
measure: Number of hospitalizations for COPD diagnosis
timeFrame: Baseline and 3 years after baseline
measure: Length of hospitalization
timeFrame: Baseline and 3 years after baseline
measure: Mortality
timeFrame: Baseline and up to 3 years after baseline
measure: Impact of COPD on patient's health
timeFrame: Baseline and 3 years after baseline
measure: Dyspnea
timeFrame: Baseline and 3 years after baseline
measure: Anxiety and depression
timeFrame: Baseline and 3 years after baseline
measure: Sleepiness
timeFrame: Baseline and 3 years after baseline
measure: Physical activity
timeFrame: Baseline and 3 years after baseline
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: COPD-Center
state: VGR
Study officials:
affiliation: COPD-center, Sahlgrenska University Hospital
name: Lowie Vanfleteren
role: PRINCIPAL_INVESTIGATOR
References: