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EOSS-ATTR Study (eHealth Based Operative Support System in ATTR-CM)
Sponsor: Hospital Universitari de Bellvitge
Summary
Unicenter, proof-of-concept, prospective, randomised, controlled, open-label and blinded end-point adjudication trial to assess the effect on patient-reported outcomes measures (PROMs), patient-reported experience measures (PREMs) and clinical events of a mHealth-based comprehensive management program for patients with chronic heart failure (HF) due to transthyretin-associated amyloidosis (ATTR)-cardiomyopathy (CM) by means of remote daily telemonitoring of signs and symptoms and remote structured follow-up using videoconference.
Official title: Information and Communications Technology (ICT)-based Modeling of Transthyretin-associated Amyloidosis Cardiomyopathies (ATTR-CM) Care: EOSS-ATTR Study (eHealth Based Operative Support System in ATTR-CM)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-12-01
Completion Date
2026-03-15
Last Updated
2024-10-23
Healthy Volunteers
No
Interventions
mHealth
Follow-up and treatment of patients in the mHealth arm will be based on a comprehensive solution for the care and monitoring of chronic patients, modelled and tested in chronic HF patients. This is the PIRENe platform, previously described and evaluated in HF patients. It is a digital solution, external to the centre's information systems (external platform). However, it has some special features in its design in terms of remote monitoring, educational tools, among others, expressly conceived and designed for patients with ATTR-CM. This platform allows the provision of multichannel service and monitoring of patients through: 1. Patient monitoring of: Biometric data and symptom report. 2. Generation and management of warning alarms notified to the professionals assigned to each patient in case one of the following situations occurs. 3. Follow-up via videoconference.