Monocentric, randomized study to investigate the impact of telemonitoring on the frequency of hospital admissions due to exacerbations in patients with chronic obstructive lung disease under the observance of atmospheric conditions

Authors
Category Primary study
Registry of TrialsGerman Clinical Trials Register
Year 2011
INTERVENTION: Intervention 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 control‐ visits every three month during the intervention phase and also during the one year follow up. Extreme weather conditions in the intervention phase will lead to max. 2 extra‐ visits in the clinic. Intervention 2: Control Group‐ standard Care with control visits every three month for one year and one year follow‐ up. CONDITION: Chronic obstructive pulmonary disease (COPD), GOLD II‐ IV° J44.8 ‐ Other specified chronic obstructive pulmonary disease J44.9 ‐ Chronic obstructive pulmonary disease, unspecified PRIMARY OUTCOME: Frequency of hospitalisations with a primary diagnosis of COPD exacerbation per year SECONDARY OUTCOME: 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 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)
Epistemonikos ID: 0e0d962b6aa73ac4dda5737ea2b960a015d8c7d1
First added on: Aug 22, 2024