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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Device: software Caaring (remote monitoring app)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberto Bravo; Phone Number: +34 915004013; Email: roberto.bravo@perseivivarium.com

Study Locations

• Spain
  • A Coruña
    • Ferrol, A Coruña, Spain, 15405
      • Not yet recruiting
      • Complejo Hospitalario Universitario de Ferrol
      • Contact: Raquel Marzoa Rivas, PhD; Phone Number: +34 981334000; Email: raquel.marzoa.rivas@sergas.es
      • Principal Investigator: Raquel Marzoa Rivas, PhD
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07198
      • Recruiting
      • Hospital Universitario de Son Llatzer
      • Contact: José María Gámez Martínez, PhD; Phone Number: +34 871202000; Email: jmgamez3@gmail.com
      • Principal Investigator: José María Gámez Martínez, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Who are participating at the time of recruitment in any other clinical trial. Participation in observational studies will not be an exclusion criteria.
• 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.
• Patients whose inclusion is not considered advisable by the investigator's assessment due to they are under specific follow-up in other hospital units (hemodialysis, transplants, etc.) that require mandatory hospital attendance less frequently than once every two months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
No Intervention: Control Group (G_Control); The data of these patients are collected prospectively from their routine medical visits for 12 weeks after inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of re-entries in patients with heart failure	Number of re-entries in patients with heart failure	Day 0, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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%	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.	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.	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.	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	Day 0, Week 12
Adherence treatment equal to 100%	Percentage of patients with treatment for heart failure adherence equal to 100%	Day 0 and Weekly up to 12 weeks

Collaborators and Investigators

• Sponsor: Persei Vivarium
• Collaborators: Effice Servicios Para la Investigacion S.L.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Heart Failure; Digital Health; Reduced Ejection Fraction; DTx; Caaring; remote patients monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: CAARdioRING

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No