Multidisciplinary Management of Severe COPD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-100
SponsorVastra Gotaland Region

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Male or female patients, aged ≥40 years.

Smokers or ex-smokers (≥10 pack-year).

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.

Signed informed concent form.

Disqualifiers

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).

Already enrolled in other studies perceived to interfere with this protocol.

In whom spirometry test is contraindicated (e.g., hemoptysis, detached retina, active tuberculosis).

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multidisciplinary patient care

    Procedure/Surgery

    A holistic, multidisciplinary, patient-centered care.

  • Standard care

    Other intervention

    Standard care in Sweden

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Multidisciplinary, holistic and patient-centered careExperimental treatment 1 intervention
Group B: Standard careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total number of hospitalizations

The aim is to investigate whether comprehensive care according to an individual plan (accurate diagnosis, assessment of severity, and multidisciplinary management of COPD patients referred to the COPD center after hospitalization caused by hospitalization due to acute exacerbation of COPD) will be associated with a decreased number of hospitalizations from all causes compared to a standard care. Change in number of hospitalizations will be calculated by total number of hospitalizations from all causes per year.

Time frame
Baseline and 3 years after baseline

Secondary outcomes

1

Number of hospitalizations for COPD diagnosis

Change will be calculated by number of hospitalizations for COPD and compared to a total number of hospitalizations from other causes.

Time frame
Baseline and 3 years after baseline
2

Length of hospitalization

Change in mean hospitalization time will be calculated by number of hospitalization days per year and in total study period.

Time frame
Baseline and 3 years after baseline
3

Mortality

Change in all cause mortality will be measured by time to death (days, months or years).

Time frame
Baseline and up to 3 years after baseline
4

Impact of COPD on patient's health

Change in disease-specific impact on health will be assessed by using a COPD Assessment Test (CAT) questionnaire. CAT measures COPD symptoms with scores from 0 to 5 points (0 indicating no impact or symptoms, 5- worst possible impact or symptoms) summing up to a total CAT score range of 0-40 points.

Time frame
Baseline and 3 years after baseline

Other outcomes

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