J45 J44
Conditions
Interventions
Group 1: Patients aged 18 years and over with an at least one year old diagnosis of bronchial asthma or COPD which are participating in a disease management program bronchial asthma or COPD for at lea
Sponsors
Mundipharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -Patients who have given their written consent for participation in the study including the privacy statement after being informed -Patients with an at least one year old diagnosis of bronchial asthma (ICD-10-GM 2014 J45.-) or COPD (ICD-10-GM 2014 J44.-) -Only for DMP+ patients: Participation in the DMP bronchial asthma or COPD for at least 1 year -Only for DMP- patients: No participation in the DMP bronchial asthma or COPD so far
Exclusion criteria
Exclusion criteria: -Patients suffering from acute exacerbation -Patients suffering from acute infection of the respiratory tract or lungs -Patients suffering additionally to bronchial asthma or COPD to another lung disease -Patients suffering from bronchial asthma and COPD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma: disease control, as measured by the asthma control test (Nathan et al., 2004; Thomas et al., 2009) COPD: impairments by COPD, as measured by the COPD assessment test (CAT; Jones et al., 2009) | — |
Secondary
| Measure | Time frame |
|---|---|
| Bronchial asthma: -Patients with well-controlled bronchial asthma (ACT = 20), partially controlled asthma (ACT 16-19) and poorly controlled asthma (ACT = 15) (Nathan et al, 2004; Thomas et al., 2009) -Quality of life as measured by the Mini Asthma Quality of Life Questionnaire (AQLQ Mini-J; Juniper et al, 1999a) -Avoidance of anxiety measured with the Fear-Avoidance Beliefs Questionnaire (FABQ) adapted for chronic obstructive pulmonary diseases (Stenzel et al, 2013) -Social support as measured by the scales of social support in case of illness (SSUK; Ramm and Hasenbring 2003; Revenson and Schiaffino 1990) -The extent to anxiety and depression as measured by the Health Anxiety and Depression Scale (HADS-D; Zigmond and Snaith, 1983) -Proportion of patients with guideline-compliant or non-compliant medication according to national asthma care guidelines (German Medical Association et al, 2013) -Analysis of a potential difference in disease-specific symptoms during recruitment period using the ACT score and the secondary variables, eg SSUK COPD: -Proportion of patients with very severe impairment (CAT score> 30), severe impairment (CAT score 21 - 30), moderate impairment (CAT score 10 - 20) and mild impairment (CAT score <10) -Quality of life as measured by the self-reported Chronic Respiratory Questionnaire (CRQ-SR; Williams et al., 2001) -Prevention of anxiety measured with the Fear-Avoidance Beliefs Questionnaire (FABQ) adapted for chronic obstructive pulmonary diseases (Stenzel et al, 2013) -Social support as measured by the scale of social support in case of illness (SSUK; Ramm and Hasenbring 2003; Revenson and Schiaffino 1990) -The extent to anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS-D; Zigmond and Snaith, 1983) -Proportion of patients with guideline-compliant or non-compliant medication according to the GOLD guidelines (Global Initiative for Chronic Obstructive Lung Disease, 2014) -Analysi | — |
Countries
Germany
Contacts
Public ContactArne Schreiber
Zentrum für klinische Studien an der Universität zu Lübeck
Outcome results
None listed