TeleInterVENT: Efficacy of Telemetry-assisted Care in Home Home Vented COPD

• Sponsor: Georg Nilius, Prof DR med (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05287555
• Collaborator: Heinen und Löwenstein GmbH & Co. KG (Industry)
• Enrollment: 54
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 31
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Other: Telemonitoring Care; Other: Standard Care	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, double-arm, controlled-randomized clinical trialProspective, double-arm, controlled-randomized clinical trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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]
• Anticipated Study Start Date: Mar 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Oct 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Adherence [hours/day] [12 Months]

   Usage of Ventilator in hours per day

Secondary Outcome Measures

1. QOL [unit] [Survey at 3 dates: 2, 6 und 12 Months]

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

Other Outcome Measures

1. Hospitalizations [Nr] [12 Months]

   Number of hospitalizations/physician visits

2. CAT [score] [Survey at 3 dates: 2, 6 und 12 Months]

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

3. mMRC [score] [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] [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] [Survey at 3 dates: 2, 6 und 12 Months]

   Carbon dioxide partial pressure from Blood Gas Analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Evang. Kliniken Essen-Mitte gGmbH	Essen	NRW	Germany	45276

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Gearg Nilius, MD, KEM | Evang. Kliniken Essen-Mitte gGmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Georg Nilius, Prof DR med, Research and Clinic Director, Institut für Pneumologie Hagen Ambrock eV
• ClinicalTrials.gov Identifier: NCT05287555
• Other Study ID Numbers: TIV2022
• First Posted: Mar 18, 2022
• Last Update Posted: Mar 18, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Georg Nilius, Prof DR med, Research and Clinic Director, Institut für Pneumologie Hagen Ambrock eV: COPD; NIV; Telemonitoring
• Additional relevant MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Mar 18, 2022