Clinical trial NCT05825755: Multicenter Trial for the Validation of Vitalera Platform
Official title: Randomized Controlled Multicenter Trial for the Validation of Vitalera Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Patients
Heart Failure
Keywords: Chronic care
Chronic patients
Heart Failure
Telemonitoring
Remote monitoring
Remote care
Healthcare
Home care
Lead sponsor: humanITcare
Sponsor class: NETWORK
First posted: 2023-04-24
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Quality of Life Scale Between Baseline and 3-months Follow-up
timeFrame: 3 months
measure: Change in the Proportion of Treatment Adherent Patients Between Baseline and 3-months Follow-up.
timeFrame: 3 months
measure: Change in Sel-care Behaviour Scale Between Baseline and 3-months Follow-up
timeFrame: 3 months
Secondary outcomes:
measure: Mortality From Any Cause
timeFrame: 3 months
measure: Number of Hospital Readmissions
timeFrame: 3 months
measure: Number of Visits to the Emergency Room Due to HF Decompensation
timeFrame: 3 months
measure: Number of Emergency Visits for CV Causes
timeFrame: 3 months
Other outcomes:
Locations:
city: Denia
country: Spain
facility: Hospital de Dénia
state: Alacant
city: Alcoy
country: Spain
facility: Hospital d'Alcoi
state: Alicante
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Elche
country: Spain
facility: Hospital de Vinalopó
state: Alicante
city: Terrassa
country: Spain
facility: Hospital de Terrassa
state: Barcelona
city: Blanes
country: Spain
facility: Corporació de Salut del Maresme i la Selva (Hospital de Blanes-Hospital de Calella)
state: Girona
city: Torrejón De Ardoz
country: Spain
facility: Hospital de Torrejón
state: Madrid
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus
state: Tarragona
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa de Zaragoza
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Marta MD Farrero
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.
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