Clinical trial NCT06920160: Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction by Using Caaring® Software
Official title: Determination of the Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction Using Caaring® Software
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: Heart Failure
Reduced Ejection Fraction
DTx
Caaring
remote patients monitoring
Digital Health
Lead sponsor: Persei Vivarium
Sponsor class: OTHER
Collaborators: name: Effice Servicios Para la Investigacion S.L.
First posted: 2025-04-09
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of re-entries in patients with heart failure
timeFrame: Day 0, Week 12
Secondary outcomes:
measure: Changes in Health-related quality of life (WHOQOL)
timeFrame: Day 0, Week 12
measure: Adherence treatment equal to or greater than 80%
timeFrame: Day 0 and Weekly up to 12 weeks
measure: Changas in the patient's MEDAS scale: Adherence to Mediterranean Diet
timeFrame: Day 0, Week 12
measure: Changes in the patient's Clinical Data
timeFrame: Day O, every 3 days up to Week 12
measure: Patient satisfaction with the software Caaring
timeFrame: Week 12
measure: Changes in the patient's in Liquid Consumption
timeFrame: Day 0, Week 12
measure: Adherence treatment equal to 100%
timeFrame: Day 0 and Weekly up to 12 weeks
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol
state: A Coruña
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario de Son Llatzer
state: Islas Baleares
Study officials:
References: