NCT05825755

Multicenter Trial for the Validation of Vitalera Platform

Randomized Controlled Multicenter Trial for the Validation of Vitalera Platform

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: humanITcare · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Patients
• Heart Failure

Interventions

Type	Name	Description
OTHER	vitalera telemonitoring platform	Patients will be followed-up with measurements from medical devices and health questionnaires delivered through the app

Timeline

• Start date: 2024-03-20
• Primary completion: 2024-11-16
• Completion: 2024-11-16
• First posted: 2023-04-24
• Last updated: 2025-03-19
• Results posted: 2025-03-19

Locations

10 sites across 1 country: Spain