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

NCT06920160 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-06-04

No results posted yet for this study

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.

Conditions

  • Heart Failure With Reduced Ejection Fraction

Interventions

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.

Sponsors & Collaborators

  • Effice Servicios Para la Investigacion S.L.

    collaborator INDUSTRY

  • Persei Vivarium

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2025-07-31
Completion
2025-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06920160 on ClinicalTrials.gov