An interventional study of software Caaring (remote monitoring app) in Heart Failure With Reduced Ejection Fraction, sponsored by Persei Vivarium. Recruiting at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by Persei Vivarium · Not applicable, Interventional, and Other
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 196 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Persei Vivarium is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: software Caaring (remote monitoring app)
The data of these patients are collected prospectively from their routine medical visits for 12 weeks after inclusion
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.
Number of re-entries in patients with heart failure
Number of re-entries in patients with heart failure
Time frame: Day 0, Week 12
Changes in Health-related quality of life (WHOQOL)
Change in the patient's quality of life scale the study comparad to baseline: WHOQOL questionnaire (Value 0- 100). A higher score reflects a higher health-related quality of life.
Time frame: Day 0, Week 12
Adherence treatment equal to or greater than 80%
Percentage of patients with treatment adherence for heart failure equal to or greater than 80%
Time frame: Day 0 and Weekly up to 12 weeks
Changas in the patient's MEDAS scale: Adherence to Mediterranean Diet
Changes in patient's scale MEDAS (Mediterranean Diet Adherence Screener) scores at week 4 and at the end of the study compared to baseline. Values: 0-14, a higher score reflects a better adherence to the Mediterranean Diet.
Time frame: Day 0, Week 12
Changes in the patient's Clinical Data
Changes in patient's Clinical data (symptoms related to heart failure) measured through a specific form created for this purpose.
Time frame: Day O, every 3 days up to Week 12
Patient satisfaction with the software Caaring
The patient satisfaction will be measured through a specific satisfaction questionnaire created for this purpose. (Value 3-15). A higher score reflects greater satisfaction with software care.
Time frame: Week 12
Changes in the patient's in Liquid Consumption
Changes in patient's Liquid Consumption Questionnaire. The changes will be measured through a specific form created for this purpose
Time frame: Day 0, Week 12
Adherence treatment equal to 100%
Percentage of patients with treatment for heart failure adherence equal to 100%
Time frame: Day 0 and Weekly up to 12 weeks
Plan to share: No
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