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| Name | Class |
|---|---|
| Effice Servicios Para la Investigacion S.L. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online telemonitoring group (G_CAARING) | Active Comparator | The monitoring and control of these patients will be carried out remotely through the Caaring® platform. Patients will connect to an APP on a mobile phone. They will have to complete the data and questionnaires related to the study variables. |
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| Control Group (G_Control) | No Intervention | The data of these patients are collected prospectively from their routine medical visits for 12 weeks after inclusion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| software Caaring (remote monitoring app) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of re-entries in patients with heart failure | Number of re-entries in patients with heart failure | Day 0, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0, Week 12 |
| Adherence treatment equal to or greater than 80% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Bravo | Contact | +34 915004013 | roberto.bravo@perseivivarium.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de Ferrol | Not yet recruiting | Ferrol | A Coruña | 15405 | Spain |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Percentage of patients with treatment adherence for heart failure equal to or greater than 80% |
| 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. | 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. | 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. | 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 | Day 0, Week 12 |
| Adherence treatment equal to 100% | Percentage of patients with treatment for heart failure adherence equal to 100% | Day 0 and Weekly up to 12 weeks |
| Hospital Universitario de Son Llatzer | Recruiting | Palma de Mallorca | Balearic Islands | 07198 | Spain |
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