J44
Conditions
Interventions
Group 1: CDSS (clinical decision support system) supported standard of care treatment
The aim of this study is to investigate the additional benefit of a clinical decision support system based on clin
Sponsors
Koordinierungszentrum für klinische Studien Marburg
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: • Signed written informed consent • Patients with a diagnosis of COPD • Ability of study participation • Knowledge of the German language
Exclusion criteria
Exclusion criteria: • Moderate or severe exacerbation in the 4 weeks prior to baseline • A malignant lung neoplasm in active tumour therapy, not curatively treated • Physical or cognitive impairment resulting in an inability to understand the intention of the study, according to the estimation of the investigator • Pregnant or breastfeeding women • Participation in other interventional studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome will be health-related quality of life as measured with the St. George’s Respira-tory Questionnaire (SGRQ). The SGRQ sum-scores range from 0 to 100, with higher scores indicating more limitations in daily living. The hypothesis is that a personalized approach to diagnostic procedures and treatment will improve the quality of life of patients with COPD compared to standard of care treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| • COPD-Assessment Test (CAT) • Minimal Clinically important deterioration (MCID) of patient reported outcomes (PRO) • General quality of life (EQ-5D-5L) • Fear and depression PHQ-D • TDI focal score • mMRC scale • MEP questionnaire • 6-minute walking distance • Number of Participants with Adverse Events (AE) and Serious Adverse Events (SAE) • Fitting of molecular marker panels of clusters from COSYCONET | — |
Countries
Germany
Contacts
Public ContactSandra Söhler
Koordinierungszentrum für klinische Studien Marburg
Outcome results
None listed