Heart Failure With Reduced Ejection Fraction
Conditions
Keywords
Heart Failure, Reduced Ejection Fraction, DTx, Caaring, remote patients monitoring, Digital Health
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.
Interventions
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.
Sponsors
Effice Servicios Para la Investigacion S.L.
Persei Vivarium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of re-entries in patients with heart failure | Day 0, Week 12 | Number of re-entries in patients with heart failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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% |
| 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. |
| 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 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. |
| 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 |
| 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% |
| 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. |
Countries
Spain
Contacts
Primary ContactRoberto Bravo
Outcome results
None listed