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ClinicalTrials.gov Identifier NCT01878630.

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This paper describes the development, deployment and trial results from 9 volunteers using the eCAALYX system. The eCAALYX system is an ambient assisted living telemonitoring system aimed at older adults suffering with co-morbidity. Described is a raw account of the challenges that exist and results in bringing a Telemedicine system from laboratory to real-world implementation and results for usability, functionality and reliability.

Background The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial showed that, compared with usual care, a structured remote patient management (RPM) intervention done over 12-months reduced the percentage of days lost due to unplanned cardiovascular hospitalisations and all-cause death. The aim of the study was to evaluate whether this clinical benefit seen for the RPM group during the initial 12 month follow-up of the TIM-HF2 trial would be sustained 1 year after stopping the RPM intervention.Methods TIM-HF2 was a prospective, randomised, multicentre trial done in 43 hospitals, 60 cardiology practices, and 87 general practitioners in Germany. Patients with heart failure, New York Heart Association functional class II or III, and who had been hospitalised for heart failure within 12 months before randomisation were randomly assigned to either the RPM intervention or usual care. At the final study visit (main trial), the RPM intervention was stopped and the 1 year extended follow-up period started, which lasted 1 year. The primary outcome was percentage of days lost due to unplanned cardiovascular hospitalisations and all-cause mortality. Analyses were done using the intention-totreat principle. This trial is registered with ClinicalTrials.gov, number NCT01878630.