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

Institute for Pneumology Hagen Ambrock

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Telemonitoring Care; Other: Standard Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT05287555

TIV2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Control

Active Comparator group

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.

Treatment:

Other: Standard Care

Telemonitoring

Experimental group

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.

Treatment:

Other: Telemonitoring Care