Chronius

News & Events

5th General Meeting

3rd – 4th June, 2010 9:00 – 18:00 / 9:00 – 15:00
Meeting Venue: ISCHIA, Hotel Miramare e Castello

2nd Review Meeting

1st – 2nd July, 2010 9:00 – 18:00 / 10:00 – 13:00
Meeting Venue: Brussels, European Commission

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  • Chronic Diseases
  • COPD
  • CKD and Renal Insufficiency
  • Clinical Validation
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Clinical Validation

The pilot site will be setup and the clinical validation phase will commence. A clinical validation protocol will be used in real environment but with “dummy” patients. Measurable indicators will be identified in order to understand and assess system performance.

The system will be extensively tested both from the technical point of view as well as from the user point of view and the final system will be produced. Finally, the system will be validated, in two phases (A and B), by the healthcare professionals according to pre-defined validation protocol.

• In the Phase A, 50 “dummy patients” (25 COPD and 25 KD) will be used in order to test and validate the system’s components and services and. These dummy patients will be defined by a set of real sensors signals characterising typical phenotypes of the disease (for example trend of saturation, patterns of physical activity, drugs and food intake). 20 physicians will be involved in this study and asked to fill a questionnaire prepared in order to provide clear results on the ease of use, the efficacy and the usability of the system:
  • 5 in Barcelona
  • 5 in Feltre ULSS
  • 10 in Careggi.
• In the Phase B and in the optic of a validation process with real volunteer patients a series of extensive trials will take place. During this task the final version of the medical validation plan of the platform will be drawn. All appropriate material (consent forms, relevant information sheets etc) will be prepared and distributed to people involved in Clinical Validation Phase B.

Possible clinical scenarios that have to be tested with respect to normal and abnormal medical values (diagnostic and screening tests). User associations will be contacted in order to ensure best possible user involvement in the CHRONIOUS project. 6 such associations are already contacted and their intentions of actively participating in the project are investigated:

• ASSOCIAZIONE ITALIANA PAZIENTI DI BPC
• EPOC – Asociaciòn de pacientes
• ANED – Associazione Nazionale Emodializzati
• ALCER – Asociación para la Lucha Contra las Enfermedades Renales
• A.N.T.R. – Associazione Nazionale Trapiantati di Rene Sede
• Associazione malati di reni