NCT06920160

Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction by Using Caaring® Software

Determination of the Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction Using Caaring® Software

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Persei Vivarium · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial investigation with device is to determinate the effectiveness of remote monitoring of patients with heart failure with reduced ejection fraction heart (EFS40%) using Caaring® software. The main question it aims to answer is if the development of a self-management platform (Caaring®) that enhances the role of the patient with heart failure in the course of their disease will reduce the number of re-entries. For this, researchers will compare the assessments between the two groups. This is a randomized study with two arms. Online telemonitoring group: The follow-up of these patients will be carried out prospectively remotely through the Caaring® platform. And Prospective Control group: The data of these patients are collected prospectively for their routine medical visits for 12 weeks after their inclusion. In addition, Control group patients must have clinical data from the 12 weeks after to their inclusion date available in the Medical Record, and/or through the monitoring platforms of the continuous monitoring devices. Participants with heart failure will continue to receive conventional care and must have sufficient technological skills to use a smartphone.

Detailed description

This is a longitudinal, comparative non-inferiority, multicenter, with 2 arms Medical Device Clinical Trial. The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki.

Conditions

• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
DEVICE	software Caaring (remote monitoring app)	Caaring is an electronic data collection notebook that allows patients to confidentially fill out data/ questionnaires on their mobile phone and report them through an application that will be installed on the patient's mobile phone. Besides, This group (G\_CAARING) will receive educational and prevention recommendations relative to Heart Faillure.

Timeline

• Start date: 2025-04-15
• Primary completion: 2025-07-01
• Completion: 2025-08-01
• First posted: 2025-04-09
• Last updated: 2025-06-04

Locations

2 sites across 1 country: Spain