Multicenter Trial for the Validation of Vitalera Platform

Not Applicable

Completed

Brief Summary: Vitalera has implemented a cloud platform for the telemonitoring of chronic patients through portable medical devices and an alarm-based system that issues health alerts when a patient's biomedical measurement is outside a predefined clinical range. The platform frees doctors and caregivers from reviewing individual patient data for abnormalities, speeding up the decision-making process and reducing hospital visits. With this study we intend to validate the efficacy of the app for patients and digital platform for medical professionals, evaluating the increase in the quality of life of patients and measuring the reduction in the incidence of the main critical events of HF. In addition, the study will validate the new API interoperability standards and platform architecture and will assess the usability of the platform by delivering satisfaction questionnaires to patients and professionals at the end of the study.

This study is being carried out within the framework of a European project promoted by the European Innovation Council (EIC).

Detailed Description: This is a randomized controlled trial involving a Spanish network of hospitals. The study consists of continuous remote patient monitoring using vitalera's digital platform and the supplied devices (blood pressure monitor, wearable, scale and oximeter). For 3 months, a total of 250 patients suffering from HF will have their physiological constants monitored.

Patients will be included in the study based on the eligibility criteria and must complete the informed consent provided. Each hospital will decide when to include their patients according to their particular clinical practice. The recruitment period is defined as 3 months. That means patients will be incorporated into the study from its start until the third month. The last subject included in the study will then finish the study after six months from the first day of the study. Medical professionals from each hospital will be in charge of recruiting the participants. The recruitment rate is specific for each hospital, and it may vary depending on the month.

Recruitment & Eligibility

Inclusion Criteria

Heart failure (HF) patients with NYHA Functional Class >= II (according to 2021 EU guidelines).
Patients older than 18 years old.
Patients who have suffered an acute decompensation of HF (first and recurrent) in the 30 days prior to enrollment in the study.
NT-pro BNP ≥300 pg/ml at the moment of hospitalization for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter, NT-pro BNP must be ≥600 pg/mL
Patients must have had an echocardiogram during their HF hospitalization or in the previous 12 months.
Prior to initiating any procedures, the hospital will ensure that the patient obtains an informed consent document, if applicable.
All patients will be eligible regardless of the level of LVEF: HFrEF, HFmrEF, and HFpEF.

Exclusion Criteria

Oncology patients with metastasis or with chemotherapy treatment ongoing
Patients participating in other studies or trials.
Patients not willing to participate.
Patients over 150 kg
Patients who do not use Catalan, Spanish, English, Portuguese, Italian, Dutch, German, Swedish, Hungarian, Romanian or French.
Patients without a mobile phone
Patients without internet connexion
Patients with moderate or severe cognitive impairment without a competent caregiver
Patients with serious psychiatric illness
Patients with planned cardiac surgery
Patients with planned heart transplantation or LVAD implant

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life Scale Between Baseline and 3-months Follow-up	3 months	Quality of life measured with the Minnesota Living with Heart Failure scale. Scale from 0 to 105. The lower the score the better outcome.
Change in the Proportion of Treatment Adherent Patients Between Baseline and 3-months Follow-up.	3 months	Change in the proportion of patients adherent to treatment measured with SMAQ between start and end of the study. This questionnaire consists of six questions that evaluate different aspects of patient compliance with treatment: forgetfulness, routine, adverse effects, and a quantification of omissions. A patient is classified as non-compliant (non-adherent) if he/she responds to any of the questions with a non-adherence answer, and in terms of quantification, if the patient has lost more than two doses during the last week or has not taken medication during more than two complete days during the last three months. Then we compute the proportion of adherent patients at baseline and 3-months follow-up and compute the change in proportion.
Change in Sel-care Behaviour Scale Between Baseline and 3-months Follow-up	3 months	Patient's self-care behavior measured with The European Heart Failure Self-Care Behavior Scale. Scale from 9 to 45. The higher the score the poorer self-care.

Secondary Outcome Measures

Name	Time	Method
Number of Emergency Visits for CV Causes	3 months	Total number of visits due to cardiovascular causes
Mortality From Any Cause	3 months	Number of deaths during the study period
Number of Hospital Readmissions	3 months	Total number of hospitalizations
Number of Visits to the Emergency Room Due to HF Decompensation	3 months	Total number of visits with intravenous decongestive therapy

Locations (10): Hospital de Dénia
🇪🇸
Denia, Alacant, Spain
Hospital d'Alcoi
🇪🇸
Alcoy, Alicante, Spain
Hospital General Universitario de Elche
🇪🇸
Elche, Alicante, Spain
Hospital de Vinalopó
🇪🇸
Elche, Alicante, Spain
Hospital de Terrassa
🇪🇸
Terrassa, Barcelona, Spain
Corporació de Salut del Maresme i la Selva (Hospital de Blanes-Hospital de Calella)
🇪🇸
Blanes, Girona, Spain
Hospital de Torrejón
🇪🇸
Torrejón De Ardoz, Madrid, Spain
Hospital Universitari Sant Joan de Reus
🇪🇸
Reus, Tarragona, Spain
Hospital Clínic de Barcelona
🇪🇸
Barcelona, Spain
Hospital Clínico Lozano Blesa de Zaragoza
🇪🇸
Zaragoza, Spain
Hospital de Dénia
🇪🇸Denia, Alacant, Spain