[TELEMEdical moNiTORing for COPD patients (Telementor COPD): Study protocol of a multicentre, randomised, controlled study].

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.