Efficacy of Telemetry-assisted Care in Home Home Vented COPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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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]

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Telemonitoring Care
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, double-arm, controlled-randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Home non-invasive mask ventilation with prisma VENT device. Modem for the daily transmission of specific therapy parameters. Standard care according to clinical standard (technical support by the provider and three hospital follow-up appointments after 2, 6 and after 12 months) with assessment of health status and NIV therapy settings. Study specific: During visits, recording of HRQOL by SGRQ and S3NIV questionnaires, hospitalizaion and physician visits. Therapy data from NIV device. | Other: Standard Care<br>* NIV, Supplies as needed, especially masks, tubes, humidifiers, and modems<br>|
| Experimental: Telemonitoring<br>Home non-invasive mask ventilation with prisma VENT device. Modem for the daily transmission of specific therapy parameters. An electronic feedback system provides patients with feedback and recommendations on their therapy based on the data submitted. The study center regularly reviews and reacts to all therapy data and other information according to the remote care scheme of intervention. Telemonitoring care patients also receive an SpO2 sensor for monitoring of oxygen saturation. Ambulantory implementation of three blood gas analyses to check the health status after 2, 6 and 12 months. There are no regular routine inpatient stays. Study specific: During visits, recording of HRQOL by SGRQ and S3NIV questionnaires, hospitalizaion and physician visits. | Other: Telemonitoring Care<br>* NIV, Supplies as needed, especially masks, tubes, humidifiers, SpO2 sensor and modems.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence [hours/day] | Usage of Ventilator in hours per day | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL [unit] | Health related Quality of Life by SGRQ-Score [higher units represent worse outcome] | Survey at 3 dates: 2, 6 und 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, NIV, Telemonitoring