Multicenter Trial for the Validation of Vitalera Platform (VAL-HIC)

February 27, 2025 updated by: humanITcare

Randomized Controlled Multicenter Trial for the Validation of Vitalera Platform

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Zaragoza, Spain, 50009
        • Hospital Clínico Lozano Blesa de Zaragoza
    • Alacant
      • Denia, Alacant, Spain, 03700
        • Hospital de Denia
    • Alicante
      • Alcoy, Alicante, Spain, 03801
        • Hospital d'Alcoi
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
      • Elche, Alicante, Spain, 03292
        • Hospital de Vinalopó
    • Barcelona
      • Terrassa, Barcelona, Spain, 08227
        • Hospital de Terrassa
    • Girona
      • Blanes, Girona, Spain, 17300
        • Corporació de Salut del Maresme i la Selva (Hospital de Blanes-Hospital de Calella)
    • Madrid
      • Torrejón De Ardoz, Madrid, Spain, 28850
        • Hospital de Torrejón
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Hospital Universitari Sant Joan de Reus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care (UC)

The follow-up of the patients in the UC arm will be carried out in accordance with the usual clinical practice of each recruitment center. All recruiting centers have active and mature HF programs in place and therefore each center will decide how to follow up the patient. However, medical professionals will be required to register each patient on the platform, enter their baseline data (sociodemographics and risk factors) and enter all possible clinical events (death, non-fatal HF event, hospitalization or emergency room visit). that the patient could suffer during the entire follow-up period.

The number of pre-planned contacts will be defined according to the particular clinical practice of each recruitment center.
Experimental: Telemonitoring (TM)
Patients in the TM arm will be followed up with the vitalera platform and app. Physiological parameters (measured periodically), socio-demographic data, risk factors, medication tracking, symptomatology questionnaire for patients, NYHA-class, clinical interventions, health questionnaire answers, classified alarms with their respective timestamp and annotation by the MD, and measurement ranges for each personalized alarm and their changes.
Other: vitalera telemonitoring platform
Patients will be followed-up with measurements from medical devices and health questionnaires delivered through the app

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life Scale Between Baseline and 3-months Follow-up
Time Frame: 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.
3 months
Change in the Proportion of Treatment Adherent Patients Between Baseline and 3-months Follow-up.
Time Frame: 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.
3 months
Change in Sel-care Behaviour Scale Between Baseline and 3-months Follow-up
Time Frame: 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.
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

humanITcare

Investigators

  • Principal Investigator: Marta MD Farrero, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2024

Primary Completion (Actual)

November 16, 2024

Study Completion (Actual)

November 16, 2024

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOLLOWHEALTH-2023-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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