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Completed

NCT Number: NCT05287555

Efficacy of Telemetry-assisted Care in Home Home Vented COPD

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evang. Kliniken Essen-Mitte gGmbH

Essen, North Rhine-Westphalia, 45276, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemonitoring Care

Other

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

Standard care

Other

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

Primary outcomes

  1. Adherence [hours/day]

    Time frame: 12 Months

    Usage of Ventilator in hours per day

Secondary outcomes

  1. QOL [unit]

    Time frame: Survey at 3 dates: 2, 6 und 12 Months

    Health related Quality of Life by SGRQ-Score [higher units represent worse outcome]

Other outcomes

  1. Hospitalizations [Nr]

    Time frame: 12 Months

    Number of hospitalizations/physician visits

  2. CAT [score]

    Time frame: Survey at 3 dates: 2, 6 und 12 Months

    COPD Assessment Test, Score 0 to 40, higher units represent worse outcome

  3. mMRC [score]

    Time frame: Survey at 3 dates: 2, 6 und 12 Months

    Modified Medical Research Council, Score 0 to 4, higher units represent worse outcome

  4. S3-NIV [score]

    Time frame: Survey at 3 dates: 2, 6 und 12 Months

    S3-NIV questionnaire for the assessment of home NIV, Score 0 to10, lower units represent worse outcome

  5. PCO2 [mmHg]

    Time frame: Survey at 3 dates: 2, 6 und 12 Months

    Carbon dioxide partial pressure from Blood Gas Analysis

Sponsors and collaborators

Lead sponsor

Georg Nilius, Prof DR med

Industry

Collaborators

  • Heinen und Löwenstein GmbH & Co. KG

Registry information

Official study title

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]

Acronym: TeleInterVENT

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2022
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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