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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
NIV, Supplies as needed, especially masks, tubes, humidifiers, SpO2 sensor and modems.
NIV, Supplies as needed, especially masks, tubes, humidifiers, and modems
Evang. Kliniken Essen-Mitte gGmbH
Essen, North Rhine-Westphalia, Germany
Adherence [hours/day]
Usage of Ventilator in hours per day
Time frame: 12 Months
QOL [unit]
Health related Quality of Life by SGRQ-Score \[higher units represent worse outcome\]
Time frame: Survey at 3 dates: 2, 6 und 12 Months
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