Efficacy of Telemetry-assisted Care in Home Home Vented COPD

NCT05287555 | Completed

• 1 other identifier: TIV2022
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; NIV; Telemonitoring

Outcome Measures

Primary Outcomes (1)

• Adherence [hours/day]

  Usage of Ventilator in hours per day

  12 Months

Secondary Outcomes (1)

• QOL [unit]

  Survey at 3 dates: 2, 6 und 12 Months

Other Outcomes (5)

• Hospitalizations [Nr]

  12 Months

• CAT [score]

  Survey at 3 dates: 2, 6 und 12 Months

• mMRC [score]

  Survey at 3 dates: 2, 6 und 12 Months

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Telemonitoring

EXPERIMENTAL

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

Interventions

Telemonitoring Care OTHER

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

Telemonitoring

Standard Care OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georg Nilius, Prof DR med: lead
• Heinen und Löwenstein GmbH & Co. KG: collaborator

Study Sites (1)

Evang. Kliniken Essen-Mitte gGmbH

Essen, North Rhine-Westphalia, 45276, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gearg Nilius, MD

  KEM | Evang. Kliniken Essen-Mitte gGmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research and Clinic Director

Model Details: Prospective, double-arm, controlled-randomized clinical trial

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 18, 2022
• Study Start: April 25, 2022
• Primary Completion: April 15, 2025
• Study Completion: November 24, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 6 months and ending 24 months following article publication,
• 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.

Locations

DE (1)