Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction by Using Caaring® Software
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: software Caaring (remote monitoring app).
- Who it may be relevant to
- Registry conditions: Heart Failure With Reduced Ejection Fraction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Determination of the Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction Using Caaring® Software
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.
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.
Interventions
- 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.
Primary outcome measures
- Number of re-entries in patients with heart failure [Time frame: Day 0, Week 12]
Secondary outcome measures (7)
- Changes in Health-related quality of life (WHOQOL) [Time frame: Day 0, Week 12]
- Adherence treatment 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 [Time frame: Day 0, Week 12]
- Changes in the patient's Clinical Data [Time frame: Day O, every 3 days up to Week 12]
- Patient satisfaction with the software Caaring [Time frame: Week 12]
- Changes in the patient's in Liquid Consumption [Time frame: Day 0, Week 12]
- Adherence treatment equal to 100% [Time frame: Day 0 and Weekly up to 12 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Spain · 2 centers
- Complejo Hospitalario Universitario de Ferrol — Ferrol
- Hospital Universitario de Son Llatzer — Palma de Mallorca
Identifiers
NCT: NCT06920160 · CAARdioRING