Efficacy of Telemetry-assisted Care in Home Home Vented COPD (TeleInterVENT)

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]

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Standard Care; Other: Telemonitoring Care

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Essen, North Rhine-Westphalia, Germany, 45276
      • Evang. Kliniken Essen-Mitte gGmbh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Standard Care; NIV, Supplies as needed, especially masks, tubes, humidifiers, and modems
Experimental: 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.	Other: Telemonitoring Care; NIV, Supplies as needed, especially masks, tubes, humidifiers, SpO2 sensor and modems.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalizations [Nr]	Number of hospitalizations/physician visits	12 Months
CAT [score]	COPD Assessment Test, Score 0 to 40, higher units represent worse outcome	Survey at 3 dates: 2, 6 und 12 Months
mMRC [score]	Modified Medical Research Council, Score 0 to 4, higher units represent worse outcome	Survey at 3 dates: 2, 6 und 12 Months
S3-NIV [score]	S3-NIV questionnaire for the assessment of home NIV, Score 0 to10, lower units represent worse outcome	Survey at 3 dates: 2, 6 und 12 Months
PCO2 [mmHg]	Carbon dioxide partial pressure from Blood Gas Analysis	Survey at 3 dates: 2, 6 und 12 Months

Collaborators and Investigators

• Sponsor: Georg Nilius, Prof DR med
• Collaborators: Heinen und Löwenstein GmbH & Co. KG
• Investigators: Principal Investigator: Gearg Nilius, MD, KEM | Evang. Kliniken Essen-Mitte gGmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Actual): April 15, 2025
• Study Completion (Actual): November 24, 2025

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Telemonitoring; NIV
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: TIV2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: Starting 6 months and ending 24 months following article publication,
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review commitee identified for this purpose. Proposals may be submitted upt to 24 months following article publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No