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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
97
Patients will be followed-up with measurements from medical devices and health questionnaires delivered through the app
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
Change in Quality of Life Scale Between Baseline and 3-months Follow-up
Quality of life measured with the Minnesota Living with Heart Failure scale. Scale from 0 to 105. The lower the score the better outcome.
Time frame: 3 months
Change in the Proportion of Treatment Adherent Patients Between Baseline and 3-months Follow-up.
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.
Time frame: 3 months
Change in Sel-care Behaviour Scale Between Baseline and 3-months Follow-up
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.
Time frame: 3 months
Mortality From Any Cause
Number of deaths during the study period
Time frame: 3 months
Number of Hospital Readmissions
Total number of hospitalizations
Time frame: 3 months
Number of Visits to the Emergency Room Due to HF Decompensation
Total number of visits with intravenous decongestive therapy
Time frame: 3 months
Number of Emergency Visits for CV Causes
Total number of visits due to cardiovascular causes
Time frame: 3 months
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