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Clinical Trial Summary

This study in patients suffering of Chronic Obstructive Pulmonary disease (COPD) aims to investigate whether telemonitoring of their non invasive ventilation (NIV) device together with targeted, tailored intervention in case of increasing symptoms or ventilation abnormalities improves the therapy adherence and effectiveness and can reduce the need for hospitalizations.


Clinical Trial Description

54 NIV naive COPD patients will be randomized to either telemonitoring care with a data-based intervention scheme or standard care according to the guideline of the German Society of Pneumology. Primary objective: Adherence to ventilation in the intervention group versus control group. Secondary objective: Comparisons between the control and intervention groups, over time and against each other, in terms of: - Health-related quality of life assessed by SGRQ - Symptomatology based on blood gas analyses, CAT score, mMRC score and S3-NIV score - Therapy quality according to therapy parameters from device data - Number of hospitalizations and physician visits - Evaluation of the impact of feedback and interventions on therapy adherence, symptomatology and therapy data. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05287555
Study type Interventional
Source Institut für Pneumologie Hagen Ambrock eV
Contact Maik Schroeder
Phone 0049 201 174
Email M.Schroeder@kem-med.com
Status Recruiting
Phase N/A
Start date April 25, 2022
Completion date October 1, 2024

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