Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction by Using Caaring® Software
(CAARdioRING)
Determination of the Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction Using Caaring® Software
1 other identifier
interventional
196
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2025
CompletedFirst Posted
Study publicly available on registry
April 9, 2025
CompletedStudy Start
First participant enrolled
April 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedJune 4, 2025
June 1, 2025
3 months
March 25, 2025
June 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of re-entries in patients with heart failure
Number of re-entries in patients with heart failure
Day 0, Week 12
Secondary Outcomes (7)
Changes in Health-related quality of life (WHOQOL)
Day 0, Week 12
Adherence treatment equal to or greater than 80%
Day 0 and Weekly up to 12 weeks
Changas in the patient's MEDAS scale: Adherence to Mediterranean Diet
Day 0, Week 12
Changes in the patient's Clinical Data
Day O, every 3 days up to Week 12
Patient satisfaction with the software Caaring
Week 12
- +2 more secondary outcomes
Study Arms (2)
Online telemonitoring group (G_CAARING)
ACTIVE COMPARATORThe 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.
Control Group (G_Control)
NO INTERVENTIONThe data of these patients are collected prospectively from their routine medical visits for 12 weeks after inclusion
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with cognitive ar sensory difficulties or with insufficient command of Spanish who, in the opinion of the investigator, makes it difficult to understand the questions ar the scales, as long as they do not have a legally authorized representative capable of participating in the study.
- Transient patients in whom it may be anticipated that follow-up will not be completed due to a change of residence.
- Patients whose main diagnosis is a poorly controlled mental disorders ar other medical illness.
- Patients with terminal illness and/or in palliative care according to the criteria of the SECPAL (Spanish Society of Palliative Care).
- lnstitutionalized patients
- Patients who are pregnant ar breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Persei Vivariumlead
- Effice Servicios Para la Investigacion S.L.collaborator
Study Sites (2)
Complejo Hospitalario Universitario de Ferrol
Ferrol, A Coruña, 15405, Spain
Hospital Universitario de Son Llatzer
Palma de Mallorca, Balearic Islands, 07198, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2025
First Posted
April 9, 2025
Study Start
April 15, 2025
Primary Completion
July 1, 2025
Study Completion
August 1, 2025
Last Updated
June 4, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share