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Multicenter Trial for the Validation of Vitalera Platform

NCT05825755 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-03-19

Study results available
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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).

Conditions

Interventions

OTHER

vitalera telemonitoring platform

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

Sponsors & Collaborators

  • humanITcare

    lead NETWORK

Principal Investigators

  • Marta MD Farrero · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2024-11-16
Completion
2024-11-16

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05825755 on ClinicalTrials.gov