TELEMEdizinisches moNiTORing für COPD-Patienten (Telementor COPD): Studienprotokoll einer multizentrischen, randomisierten, kontrollierten Studie

Zusammenfassung

Hintergrund Die chronisch obstruktive Lungenerkrankung (COPD) gehört zu den häufigsten Todesursachen in Europa und geht mit einer hohen Exazerbations- und Hospitalisierungsrate sowie hohen Krankheitskosten einher. Ziel der Studie ist es, durch eine optimierte ambulante Versorgung Exazerbationen frühzeitig zu erkennen, präventiv einzugreifen und Rehospitalisierungen zu vermeiden.

Methoden und Intervention Telementor COPD ist eine prospektive, multizentrische, unverblindete, randomisierte, kontrollierte Studie mit einer Studiendauer von 12 Monaten, umgesetzt an 7 Kliniken und 16 pneumologischen Praxen in Hamburg und Schleswig-Holstein. Sie wird durch den Innovationsfonds gefördert (01NVF20008) und ist im Deutschen Register Klinischer Studien registriert (Studien-ID: DRKS00027961). In die Studie aufgenommen werden COPD-Patienten mit mindestens einer dokumentierten Exazerbation im letzten Jahr. Primärer Endpunkt ist die Anzahl der Exazerbationen. Sekundäre Endpunkte sind die Anzahl COPD-assoziierter Hospitalisierungen, intensivstationärer Aufenthalte sowie der Gesundheitsstatus. In der Interventionsgruppe werden mittels SaniQ-App (Smartphone der Patienten) täglich Symptome erfasst, mittels mobilem Spirometer wird täglich der FEV₁ gemessen. Zudem bekommen die Patienten eine Smartwatch zur kontinuierlichen Messung von Atem- und Herzfrequenz, Sauerstoffsättigung und der Schritte. In der App werden die erhobenen Messwerte dargestellt und motivationsfördernde Komponenten zur Raucherentwöhnung und körperlichen Aktivität sowie Videochats mit den COPD-Nurses und Ärzten angeboten. Sollten die Symptome oder die Lungenfunktion sich verschlechtern, erfolgt die Kontaktaufnahme durch die geschulte COPD-Nurse, welche die Messwerte des Patienten einsieht und den Handlungsbedarf bezüglich eines präventiven Eingreifens einschätzt.

Diskussion Telementor COPD bietet die Möglichkeit, die Wirksamkeitsvorteile des digitalen Monitorings und der Telemedizin zu evaluieren und somit den Weg in die Routineversorgung von COPD-Patienten mit hohem Exazerbationsrisiko zu ebnen.

Abstract

Background COPD is one of the most common causes of death in Europe, and is associated with a high exacerbation and hospitalization rate as well as high medical costs. The aim of the study was early detection of exacerbations, preventative intervention through optimized outpatient care, and thereby to decrease rates of rehospitalizations.

Methods and intervention Telementor COPD is a prospective, multicentre, unblinded, randomized, controlled study with a study duration of 12 months, implemented at seven clinics and 16 pneumology practices in Hamburg and Schleswig-Holstein. It is funded by the Innovation Fund (01NVF20008) and is registered in the German Register of Clinical Studies (study ID: DRKS00027961). COPD patients with at least one documented exacerbation in the last year were included in the study. The primary endpoint was the number of exacerbations. Secondary endpoints were the number of COPD-associated hospitalizations, intensive care unit stays and health status. In the intervention group, symptoms were recorded daily using the SaniQ app (patients’ smartphones), and the FEV₁ was measured daily using a mobile spirometer. Patients were also provided with a smartwatch to continuously measure their respiratory rate, heart rate, oxygen saturation and steps. The app displays the measured values and offers motivational components for smoking cessation and physical activity as well as video chats with the COPD nurses and doctors. If the symptoms or lung function deteriorated, the trained COPD nurse contacted the patient, reviewed the patient’s measurements, and assessed the need for preventive intervention.

Discussion Telementor COPD offers the opportunity to evaluate the efficacy of digital monitoring and telemedicine components and to pave the way for the implementation of telemedicine in the routine care of COPD patients with a high risk of exacerbation.

Schlüsselwörter

COPD - Telemonitoring - Exazerbationsrisiko - Triagierung

Keywords

COPD - telemonitoring - exacerbation risk - triage

Publication History

Received: 09 April 2024

Accepted after revision: 22 July 2024

Article published online:
29 August 2024

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