Efficacy of Telemetry-assisted Care in Home Home Vented COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

— TeleInterVENT  

Official 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]

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05287555
• Other study ID #: TIV2022
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2023
• Source: Institut für Pneumologie Hagen Ambrock eV
• Contact: Maik Schroeder
• Phone: 0049 201 174
• Email: M.Schroeder[@]kem-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Telemonitoring Care
NIV, Supplies as needed, especially masks, tubes, humidifiers, SpO2 sensor and modems.
• Standard Care
NIV, Supplies as needed, especially masks, tubes, humidifiers, and modems

Locations

Country	Name	City	State
Germany	Evang. Kliniken Essen-Mitte gGmbH	Essen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Georg Nilius, Prof DR med	Heinen und Löwenstein GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospitalizations [Nr]	Number of hospitalizations/physician visits	12 Months
Other	CAT [score]	COPD Assessment Test, Score 0 to 40, higher units represent worse outcome	Survey at 3 dates: 2, 6 und 12 Months
Other	mMRC [score]	Modified Medical Research Council, Score 0 to 4, higher units represent worse outcome	Survey at 3 dates: 2, 6 und 12 Months
Other	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
Other	PCO2 [mmHg]	Carbon dioxide partial pressure from Blood Gas Analysis	Survey at 3 dates: 2, 6 und 12 Months
Primary	Adherence [hours/day]	Usage of Ventilator in hours per day	12 Months
Secondary	QOL [unit]	Health related Quality of Life by SGRQ-Score [higher units represent worse outcome]	Survey at 3 dates: 2, 6 und 12 Months