NCT05287555

Efficacy of Telemetry-assisted Care in Home Home Vented COPD

Randomisiert-kontrollierte Klinische Studie an häuslich Beatmeten COPD-Patienten Zur Überprüfung Der Wirksamkeit Einer Telemetrisch unterstützten Fernbetreuung Durch Das Beatmungszentrum im Vergleich Zur stationären, halbjährlichen Beatmungskontrolle gemäß Leitlinie [Randomized-controlled Clinical Trial in Home Ventilated COPD Patients to Test the Efficacy of Telemetry-assisted Care Compared to Biannual Inpatient Ventilation Control Visits According to the Guideline]

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Georg Nilius, Prof DR med · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
OTHER	Telemonitoring Care	NIV, Supplies as needed, especially masks, tubes, humidifiers, SpO2 sensor and modems.
OTHER	Standard Care	NIV, Supplies as needed, especially masks, tubes, humidifiers, and modems

Timeline

• Start date: 2022-04-25
• Primary completion: 2025-04-15
• Completion: 2025-11-24
• First posted: 2022-03-18
• Last updated: 2025-12-02

Locations

1 site across 1 country: Germany