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

N/ARecruitingNCT06920160

Persei Vivarium196 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

196

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of re-entries in patients with heart failure

Time frame: Day 0, Week 12

Secondary Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts