Clinical trial NCT05287555: Efficacy of Telemetry-assisted Care in Home Home Vented COPD
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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
NIV
Telemonitoring
Lead sponsor: Institut für Pneumologie Hagen Ambrock eV
Sponsor class: INDUSTRY
Collaborators: name: Heinen und Löwenstein GmbH & Co. KG
First posted: 2022-03-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, double-arm, controlled-randomized clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adherence [hours/day]
timeFrame: 12 Months
Secondary outcomes:
measure: QOL [unit]
timeFrame: Survey at 3 dates: 2, 6 und 12 Months
Other outcomes:
measure: Hospitalizations [Nr]
timeFrame: 12 Months
measure: CAT [score]
timeFrame: Survey at 3 dates: 2, 6 und 12 Months
measure: mMRC [score]
timeFrame: Survey at 3 dates: 2, 6 und 12 Months
measure: S3-NIV [score]
timeFrame: Survey at 3 dates: 2, 6 und 12 Months
measure: PCO2 [mmHg]
timeFrame: Survey at 3 dates: 2, 6 und 12 Months
Locations:
city: Essen
country: Germany
facility: Evang. Kliniken Essen-Mitte gGmbH
state: NRW
Study officials:
affiliation: KEM | Evang. Kliniken Essen-Mitte gGmbH
name: Gearg Nilius, MD
role: PRINCIPAL_INVESTIGATOR
References: