Impact of systemic manifestations/comorbidities on clinical state, prognosis and utilisation of health care resources in patients with COPD

Conditions: J44.8
J44.9
Other specified chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease, unspecified

Registration Number: DRKS00000284

Lead Sponsor: Philipps-Universität Marburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 2741

Inclusion Criteria

Diagnosis COPD (GOLD criteria) or chronic cough
written informed consent
cognitive and physical ability to meet the demands of the study protocol
Available for repeated study visits over 18 months

Exclusion Criteria

Having undergone lung surgery (e.g. lung volumen reduction, lung transplant)
Patients with lung cancer under treatment
Moderate or severe exacerbation within the last 4 weeks
Unable to walk or to understand the intention of the project

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main outcome will be the multidimensional BODE-Score: based on the Body-Mass-Index, FEV1, Dyspnoe (modified MRC-Scale),and the physical capacity (measured ny 6-minute-walk-test).<br>The Bode-Score will be assessed at baseline, 6, 18, 36, 572, 90and 108 months after first visit in the study centres.<br>Progression is defined as a change in BODE-Score by >=1 point over the observation period

Secondary Outcome Measures

Name	Time	Method
umber of hospitalization during the observation period:<br>patients will be ask how often they were hospitalised in the last year (at baseline) or since the last visit (after 6, 18, 36, 54, 72, 90 and 108 months). All cause mortality rate:<br>assessed by the study centres 6, 18, 36, 54, 72, 90 and 108 months after inlcusion. \|\| Comorbidities:<br>will be asked by the studycentres based on a list of diseases.<br>The following examinations will be performed at each visite:<br>Nutritional status: Bioimpedance, waist circumstance<br>Labaratory tests: Lipid status, Haemoglobin, haematocrit, glucose, Markers of systemic inflammation and aging: IL-6, IL-8, TNF-alpha, firinogen, NT-NT-pro BNP, telomere lenght<br>Cardiovascular diseases: ECG at rest, Echocardiographie at rest, Ankle-Arm-Index, Carotid artery intima-media thickness<br>Quality of life: EQ-5D (Questionnaire)<br>Depression: PHQ-D (Questionnaire)<br>Cognitive impairement: (DemTec) <br>physical activity: IPAQ (Questionnaire)