An interventional study of PPG and PROM in Telemedicine, sponsored by Technical University of Munich. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Technical University of Munich · Not applicable, Interventional, and Supportive care
We designed a monocenter prospective cohort study using PROM via app and remote monitoring via pho-toplethysmography (PPG). The application of these technologies enables an early detection of infections and therefore initiation of medical interventions. The study is conducted as feasibility analysis; primary endpoints are adherence (according to wearing time) and technical robustness.
Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Telemonitoring via PPG (photoplethysmography) and PROM (patient reported outcome monitoring) via app
Device: PPG and PROM
description will follow
Compliance
Compliance is defined as wearing time of the in-ear-sensor.
Time frame: 3 months
robustness of the ppg-signal
number and duration of the ppg-signal transmitted
Time frame: 3 months
number of correct- and false-positive alerts
definition via comparison of alerts with clinical data
Time frame: 3 months
number of contacts and hospitalization rates
definition via comparison of alerts and resulting contacts and hospitalization rates with clinical data
Time frame: 3 months
infections
detection of infesctions via suspected ppg-signal transmitted or PRO-data. This results in blood test zu verify acute infections.
Time frame: 3 months
therapy modifications
dose-reductions (%), postponing of therapy cycles (time in days between actual and plannend date), therapy discontinuation
Time frame: 3 months
effect on quality of life
change in minimum 9 points in the EORTC QLQ-C30-questionnaire is evaluated as significant change. In questions 1-28: 28-112 points can be achieved: higher scores are associated with a worse outcome. In questions 29-30:2-14 points can be achieved: higher scores are associated with a better outcome.
Time frame: 3 months
OS; PFS
time between study inclusion and death; time between study inclusion and proven increasing tumor mass (number of days)
Time frame: 3 months
health-related costs
cost-effectiveness analysis
Time frame: 3 months
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Technical University of Munich