Actively Recruiting
Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction by Using Caaring® Software
Led by Persei Vivarium · Updated on 2025-06-04
196
Participants Needed
2
Research Sites
15 weeks
Total Duration
On this page
Sponsors
P
Persei Vivarium
Lead Sponsor
E
Effice Servicios Para la Investigacion S.L.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction by Using Caaring® Software
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Informed consent is obtained from the patient
You will not qualify if you...
- Patients with cognitive or sensory difficulties or insufficient command of Spanish that hinder understanding questions or scales without a legally authorized representative
- Transient patients unlikely to complete follow-up due to change of residence
- Patients currently participating in another clinical trial (observational studies allowed)
- Patients with poorly controlled mental disorders or other medical illnesses as main diagnosis
- Patients with terminal illness and/or receiving palliative care as per SECPAL criteria
- Institutionalized patients
- Patients who are pregnant or breastfeeding
- Patients under specific follow-up in other hospital units requiring mandatory hospital attendance less frequently than once every two months, if inclusion is not advisable by investigator's assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Complejo Hospitalario Universitario de Ferrol
Ferrol, A Coruña, Spain, 15405
Not Yet Recruiting
2
Hospital Universitario de Son Llatzer
Palma de Mallorca, Balearic Islands, Spain, 07198
Actively Recruiting
Research Team
R
Roberto Bravo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here