Efficacy of Telemetry-assisted Care in Home Home Vented COPD

NCT ID: NCT05287555

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-25
• Study Completion Date: 2025-11-24

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

NIV, Supplies as needed, especially masks, tubes, humidifiers, and modems

Telemonitoring

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.

Group Type: EXPERIMENTAL

Telemonitoring Care

Intervention Type: OTHER

NIV, Supplies as needed, especially masks, tubes, humidifiers, SpO2 sensor and modems.

Interventions

Telemonitoring Care

NIV, Supplies as needed, especially masks, tubes, humidifiers, SpO2 sensor and modems.

Intervention Type: OTHER

Standard Care

NIV, Supplies as needed, especially masks, tubes, humidifiers, and modems

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinen und Löwenstein GmbH & Co. KG

INDUSTRY

Sponsor Role: collaborator

Georg Nilius, Prof DR med

INDUSTRY

Sponsor Role: lead

Responsible Party

Georg Nilius, Prof DR med

Research and Clinic Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gearg Nilius, MD

Role: PRINCIPAL_INVESTIGATOR

KEM | Evang. Kliniken Essen-Mitte gGmbH

Locations

Evang. Kliniken Essen-Mitte gGmbH

Essen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

TIV2022

Identifier Type: -

Identifier Source: org_study_id