Efficacy of Telemetry-assisted Care in Home Home Vented COPD

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT05287555
• Lead Sponsor: Georg Nilius, Prof DR med

Brief 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.

Study Timeline

• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-18
• Study Start: 2022-04-25
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-22
• Primary Completion: 2023-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• NIV-naive / Continuation after 3 Months Interruption
• Indication for initiation of NIV according to S2k guideline of the German Society of Pneumology
• Presence of the signed informed consent

Exclusion Criteria

• Absence of signed written informed consent for data protection and study participation.
• contraindication to PAP therapy
• Participation in another study that influences the setting of NIV therapy through specifications regarding device settings or titration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adherence [hours/day]	12 Months	Usage of Ventilator in hours per day

Secondary Outcome Measures

Name	Time	Method
QOL [unit]	Survey at 3 dates: 2, 6 und 12 Months	Health related Quality of Life by SGRQ-Score \[higher units represent worse outcome\]

Trial Locations

Locations (1)

Evang. Kliniken Essen-Mitte gGmbH; 🇩🇪 Essen, NRW, Germany