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

Not Applicable

Not yet recruiting

• Conditions: Heart Failure With Reduced Ejection Fraction

• Registration Number: NCT06920160
• Lead Sponsor: Persei Vivarium

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.

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 Timeline

• Study First Submitted: 2025-03-25
• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 196

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of re-entries in patients with heart failure	Day 0, Week 12	Number of re-entries in patients with heart failure

Secondary Outcome Measures

Name	Time	Method
Changas in the patient's MEDAS scale: Adherence to Mediterranean Diet	Day 0, Week 12	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.
Patient satisfaction with the software Caaring	Week 12	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.
Adherence treatment equal to 100%	Day 0 and Weekly up to 12 weeks	Percentage of patients with treatment for heart failure adherence equal to 100%
Changes in Health-related quality of life (WHOQOL)	Day 0, Week 12	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.
Adherence treatment equal to or greater than 80%	Day 0 and Weekly up to 12 weeks	Percentage of patients with treatment adherence for heart failure equal to or greater than 80%
Changes in the patient's Clinical Data	Day O, every 3 days up to Week 12	Changes in patient's Clinical data (symptoms related to heart failure) measured through a specific form created for this purpose.
Changes in the patient's in Liquid Consumption	Day 0, Week 12	Changes in patient's Liquid Consumption Questionnaire. The changes will be measured through a specific form created for this purpose

Trial Locations

Locations (2)

Complejo Hospitalario Universitario de Ferrol; 🇪🇸 Ferrol, A Coruña, Spain

Hospital Universitario de Son Llatzer; 🇪🇸 Palma de Mallorca, Islas Baleares, Spain