Chronic obstructive pulmonary disease (COPD), GOLD II- IV° J44.9 J44.8
Conditions
Interventions
Group 1: Intervention Group- Telemonitoring, daily measurement of PEF, FEV1, FEV6, COPD Assessment Test (CAT) and self evaluation, weekly: 6-MWT during the first year. Addionally there are planned con
Sponsors
Charité Campus Charité Mitte
CC12, Med. Klinik m. S. Infektiologie und Pneumologie
Arbeitsbereich Pneumologie
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: COPD (GOLD: II-IV°) (FEV1 < 70% pred, FEV1/FVC < 70%), agreement of the patient, min. one exacerbation during the last year (antibiotics and/ or steroids and/or hospitalisation), min. 4 weeks of stable COPD befor inclusion into the study (no change of symptoms or medication)
Exclusion criteria
Exclusion criteria: o2- longterm-therapy (24h), cancer (expectation of life < 6 month), Asthma bronchiale, is not able to understand the studyprotocol and to use the devices because of a cognitive deficiency, diagnosis of left heart decompensation during the last year (chest X-ray or therapy with diuretics), lives not in or close to Berlin, high grade depression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of hospitalisations with a primary diagnosis of COPD exacerbation per year | — |
Secondary
| Measure | Time frame |
|---|---|
| Exacerbations: - Time to first hospitalisation with the primary diagnosis of a COPD exacerbation (time to first event) - Difference in the mean hospitalisation duration by admissions due to exacerbation - overall exacerbations per year - overall hospitalisations per year - Number of exacerbations per patient per year (worsening of symptoms and/or medical treatment) - Observance of changes in FEV1-/ FEV6/ PEF and progression during exacerbations during one year - Influence of heat/cold waves on the number and severety of exacerbations during one year Quality of life: - Number of patients with an improvement in quality of life during one year (improvement in St. George Respiratory Questionaire=SGRQ = 4 points, COPD Assessment Test=CAT improvement =4 points) - Influence of heat/cold waves on patients quality of life during one year (SGRQ/ CAT improvement in 3month/daily measurement Cost effectiveness: - cost for quality adjusted life years (QUALYs) during one year (EuroQol (EQ-5D), duration of hospital admission) Activity: - changes of BODE-Index (body-mass index (B), the degree of airflow obstruction (O) and dyspnea (D), and exercise capacity (E))per year - changes in 6-Minute Walk per year | — |
Countries
Germany
Contacts
Public ContactNora Döhnert
Charité Campus Charité Mitte CC12, Med. Klinik für Infektiologie und Pneumologie Arbeitsbereich Pneumologie
Outcome results
None listed