The study comprised 2 phases:
- Phase A: a feasibility study in 3 pilot centres (Uppsala, Lincoln and Barcelona) to determine the data quality, technical and training issues associated with use of the system in the patient’s home.
- Phase B: a randomized control trial (RCT) in 6 pilot centres (Liverpool, Tallinn, Barcelona, Uppsala, Lincoln, Sezana).
During Phase A (May 2013 – July 2013), a total of 16 out of planned 20 subjects were recruited and their data were used to assess patient’s compliance with the system, identify installation problems, infrastructure issues. Results and feedback from phase A were used as input to improve the CHROMED system and alarms management before phase B starting.
Phase B started on October 2013 till March 2016. Between November 2013 and June 2015, a total of 312 out of planned 300 patients were enrolled in the study, of which 154 were assigned to the monitored group and 158 to the control group. Phase B trial was split in two runs (RUN 1 and RUN 2) of nine monitoring months each.
Patients in the Monitored arm were requested to perform the following daily measurements:
- Lung mechanic using RESMON PRO DIARY device
- Symptomatic questionnaires
- Cardiac parameters using the Medic4all device (only patients with cardiac comorbidities)
Patients in the Control arm were not provided with any device and were requested to complete daily a paper version of the symptomatic questionnaire and to send them to the clinical center at the end of the study period.