Multicenter Trial for the Validation of Vitalera Platform

NCT05825755 | Completed Results DMC

• 1 other identifier: FOLLOWHEALTH-2023-02
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 10

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).

Conditions

Chronic Patients; Heart Failure

Keywords

Chronic care; Chronic patients; Heart Failure; Telemonitoring; Remote monitoring; Remote care; Healthcare; Home care

Outcome Measures

Primary Outcomes (3)

• Change in Quality of Life Scale Between Baseline and 3-months Follow-up

  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.

  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

  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 Outcomes (4)

• Mortality From Any Cause

  3 months

• Number of Hospital Readmissions

  3 months

• Number of Visits to the Emergency Room Due to HF Decompensation

  3 months

• Number of Emergency Visits for CV Causes

  3 months

Study Arms (2)

Usual care (UC)

NO INTERVENTION

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.

Telemonitoring (TM)

EXPERIMENTAL

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

Interventions

vitalera telemonitoring platform OTHER

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

Telemonitoring (TM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• humanITcare: lead

Study Sites (10)

Hospital de Dénia

Denia, Alacant, 03700, Spain

Location

Hospital d'Alcoi

Alcoy, Alicante, 03801, Spain

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital de Vinalopó

Elche, Alicante, 03292, Spain

Location

Hospital de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Corporació de Salut del Maresme i la Selva (Hospital de Blanes-Hospital de Calella)

Blanes, Girona, 17300, Spain

Location

Hospital de Torrejón

Torrejón de Ardoz, Madrid, 28850, Spain

Location

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, 43204, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Clínico Lozano Blesa de Zaragoza

Zaragoza, 50009, Spain

Location

Related Publications (12)

• Tripoliti EE, Papadopoulos TG, Karanasiou GS, Naka KK, Fotiadis DI. Heart Failure: Diagnosis, Severity Estimation and Prediction of Adverse Events Through Machine Learning Techniques. Comput Struct Biotechnol J. 2016 Nov 17;15:26-47. doi: 10.1016/j.csbj.2016.11.001. eCollection 2017.

  PMID: 27942354 BACKGROUND

• 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.

  PMID: 35083827 BACKGROUND

• Schiff GD, Fung S, Speroff T, McNutt RA. Decompensated heart failure: symptoms, patterns of onset, and contributing factors. Am J Med. 2003 Jun 1;114(8):625-30. doi: 10.1016/s0002-9343(03)00132-3.

  PMID: 12798449 BACKGROUND

• Brahmbhatt DH, Cowie MR. Remote Management of Heart Failure: An Overview of Telemonitoring Technologies. Card Fail Rev. 2019 May 24;5(2):86-92. doi: 10.15420/cfr.2019.5.3. eCollection 2019 May.

  PMID: 31179018 BACKGROUND

• Scherr D, Kastner P, Kollmann A, Hallas A, Auer J, Krappinger H, Schuchlenz H, Stark G, Grander W, Jakl G, Schreier G, Fruhwald FM; MOBITEL Investigators. Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial. J Med Internet Res. 2009 Aug 17;11(3):e34. doi: 10.2196/jmir.1252.

  PMID: 19687005 BACKGROUND

• Koulaouzidis G, Iakovidis DK, Clark AL. Telemonitoring predicts in advance heart failure admissions. Int J Cardiol. 2016 Aug 1;216:78-84. doi: 10.1016/j.ijcard.2016.04.149. Epub 2016 Apr 21.

  PMID: 27140340 BACKGROUND

• Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, Boll H, Baumann G, Honold M, Koehler K, Gelbrich G, Kirwan BA, Anker SD; Telemedical Interventional Monitoring in Heart Failure Investigators. Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation. 2011 May 3;123(17):1873-80. doi: 10.1161/CIRCULATIONAHA.111.018473. Epub 2011 Mar 28.

  PMID: 21444883 BACKGROUND

• Lee S, Chu Y, Ryu J, Park YJ, Yang S, Koh SB. Artificial Intelligence for Detection of Cardiovascular-Related Diseases from Wearable Devices: A Systematic Review and Meta-Analysis. Yonsei Med J. 2022 Jan;63(Suppl):S93-S107. doi: 10.3349/ymj.2022.63.S93.

  PMID: 35040610 BACKGROUND

• Guidi G, Pollonini L, Dacso CC, Iadanza E. A multi-layer monitoring system for clinical management of Congestive Heart Failure. BMC Med Inform Decis Mak. 2015;15 Suppl 3(Suppl 3):S5. doi: 10.1186/1472-6947-15-S3-S5. Epub 2015 Sep 4.

  PMID: 26391638 BACKGROUND

• Jaarsma T, Arestedt KF, Martensson J, Dracup K, Stromberg A. The European Heart Failure Self-care Behaviour scale revised into a nine-item scale (EHFScB-9): a reliable and valid international instrument. Eur J Heart Fail. 2009 Jan;11(1):99-105. doi: 10.1093/eurjhf/hfn007.

  PMID: 19147463 BACKGROUND

• Roque NA, Boot WR. A New Tool for Assessing Mobile Device Proficiency in Older Adults: The Mobile Device Proficiency Questionnaire. J Appl Gerontol. 2018 Feb;37(2):131-156. doi: 10.1177/0733464816642582. Epub 2016 Apr 11.

  PMID: 27255686 BACKGROUND

• Bilbao A, Escobar A, Garcia-Perez L, Navarro G, Quiros R. The Minnesota living with heart failure questionnaire: comparison of different factor structures. Health Qual Life Outcomes. 2016 Feb 17;14:23. doi: 10.1186/s12955-016-0425-7.

  PMID: 26887590 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Data Scientist of vitalera
• Organization: vitalera (FollowHealth SL)

val-hic@humanitcare.com

+34644499760

Study Officials

• Marta MD Farrero

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 24, 2023
• Study Start: March 20, 2024
• Primary Completion: November 16, 2024
• Study Completion: November 16, 2024
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)