RecruitingNot ApplicableNCT06920160

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


Sponsor

Persei Vivarium

Enrollment

196 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a smartphone app called Caaring® that remotely monitors patients with heart failure after they leave the hospital. The goal is to see if digital monitoring of symptoms and vitals helps reduce readmissions and improve quality of life. **You may be eligible if...** - You are 18 or older - You have heart failure with reduced ejection fraction (your heart pumps out less than 40% of its blood with each beat) - You were recently hospitalized for heart failure or are being monitored after such a hospitalization - You regularly use a smartphone **You may NOT be eligible if...** - You have cognitive or sensory difficulties that prevent you from understanding the app's questions, unless you have a representative who can help - You are likely to move away before follow-up is complete - You do not speak enough Spanish to use the app (the app appears to be in Spanish) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEsoftware 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.


Locations(2)

Complejo Hospitalario Universitario de Ferrol

Ferrol, A Coruña, Spain

Hospital Universitario de Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

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NCT06920160


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