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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients aged 18 years or older

• Patients diagnosed with heart failure with reduced ejection fraction (EFS40%)

• Patients discharged after an episode of acute heart failure and/or patients who are being followed up after being admitted for heart failure.

• Patients who extensively use a smartphone.

• lnformed Consent is obtained from the patient

Locations
Other Locations
Spain
Complejo Hospitalario Universitario de Ferrol
NOT_YET_RECRUITING
Ferrol
Hospital Universitario de Son Llatzer
RECRUITING
Palma De Mallorca
Contact Information
Primary
Roberto Bravo
roberto.bravo@perseivivarium.com
+34 915004013
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2025-08
Participants
Target number of participants: 196
Treatments
Active_comparator: Online telemonitoring group (G_CAARING)
The monitoring and control of these patients will be carried out remotely through the Caaring® platform. Patients will connect to an APP on a mobile phone. They will have to complete the data and questionnaires related to the study variables.
No_intervention: Control Group (G_Control)
The data of these patients are collected prospectively from their routine medical visits for 12 weeks after inclusion
Related Therapeutic Areas
Sponsors
Leads: Persei Vivarium
Collaborators: Effice Servicios Para la Investigacion S.L.

This content was sourced from clinicaltrials.gov