CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 97 enrolled
Drug / intervention
vitalera telemonitoring platformother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05825755
NCT05825755N/ACompleted

Randomized Controlled Multicenter Trial for the Validation of Vitalera Platform

humanITcare·interventional·Posted Apr 24, 2023·Updated Mar 19, 2025

In Brief

A clinical study evaluating vitalera telemonitoring platform for Chronic Patients and Heart Failure. Completed, enrolled 97 participants across 10 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedApr 24, 2023
Enrollment StartMar 20, 2024
Primary CompletionNov 16, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.2 years ago

Interventions

vitalera telemonitoring platformother

Patients will be followed-up with measurements from medical devices and health questionnaires delivered through the app