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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Telemonitoring Care
Standard Care
Sponsored by
Georg Nilius, Prof DR med
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, NIV, Telemonitoring

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Evang. Kliniken Essen-Mitte gGmbHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Telemonitoring

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adherence [hours/day]
Usage of Ventilator in hours per day

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2022
Last Updated
May 19, 2023
Sponsor
Georg Nilius, Prof DR med
Collaborators
Heinen und Löwenstein GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT05287555
Brief Title
Efficacy of Telemetry-assisted Care in Home Home Vented COPD
Acronym
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]
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Georg Nilius, Prof DR med
Collaborators
Heinen und Löwenstein GmbH & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, NIV, Telemonitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, double-arm, controlled-randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Telemonitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telemonitoring Care
Intervention Description
NIV, Supplies as needed, especially masks, tubes, humidifiers, SpO2 sensor and modems.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
NIV, Supplies as needed, especially masks, tubes, humidifiers, and modems
Primary Outcome Measure Information:
Title
Adherence [hours/day]
Description
Usage of Ventilator in hours per day
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
QOL [unit]
Description
Health related Quality of Life by SGRQ-Score [higher units represent worse outcome]
Time Frame
Survey at 3 dates: 2, 6 und 12 Months
Other Pre-specified Outcome Measures:
Title
Hospitalizations [Nr]
Description
Number of hospitalizations/physician visits
Time Frame
12 Months
Title
CAT [score]
Description
COPD Assessment Test, Score 0 to 40, higher units represent worse outcome
Time Frame
Survey at 3 dates: 2, 6 und 12 Months
Title
mMRC [score]
Description
Modified Medical Research Council, Score 0 to 4, higher units represent worse outcome
Time Frame
Survey at 3 dates: 2, 6 und 12 Months
Title
S3-NIV [score]
Description
S3-NIV questionnaire for the assessment of home NIV, Score 0 to10, lower units represent worse outcome
Time Frame
Survey at 3 dates: 2, 6 und 12 Months
Title
PCO2 [mmHg]
Description
Carbon dioxide partial pressure from Blood Gas Analysis
Time Frame
Survey at 3 dates: 2, 6 und 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maik Schroeder
Phone
0049 201 174
Ext
22057
Email
M.Schroeder@kem-med.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gearg Nilius, MD
Organizational Affiliation
KEM | Evang. Kliniken Essen-Mitte gGmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evang. Kliniken Essen-Mitte gGmbH
City
Essen
State/Province
NRW
ZIP/Postal Code
45276
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Nilius, Professor
Phone
+49201174
Ext
22001
Email
g.nilius@kem-med.com
First Name & Middle Initial & Last Name & Degree
Maik Schroeder
Phone
+49201174
Ext
22057
Email
m.schroeder@kem-med.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://kem-med.com/kompetenz-in-kliniken/fachkliniken/lungenheilkunde/forschung/

Learn more about this trial

Efficacy of Telemetry-assisted Care in Home Home Vented COPD

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