RecruitingNot ApplicableNCT04860375

Multidisciplinary Management of Severe COPD

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.


Sponsor

Vastra Gotaland Region

Enrollment

110 participants

Start Date

Sep 22, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a multidisciplinary team-based care program for people with severe COPD (chronic obstructive pulmonary disease) who have recently been hospitalized due to a serious flare-up, to help reduce future hospitalizations and improve quality of life. **You may be eligible if...** - You are male or female and at least 40 years old - You are a current or former smoker (at least 10 pack-years) - You were recently hospitalized for worsening shortness of breath that was diagnosed as a COPD exacerbation - You have been referred to a COPD specialist center **You may NOT be eligible if...** - You have previously presented to the hospital with similar symptoms under the study criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMultidisciplinary patient care

A holistic, multidisciplinary, patient-centered care.

OTHERStandard care

Standard care in Sweden


Locations(1)

COPD-Center

Gothenburg, VGR, Sweden

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NCT04860375


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