Multicenter Trial for the Validation of HumanITcare Platform

Heart Failure Clinical Trial

— VAL-HIC  

Official title:

Randomized Controlled Multicenter Trial for the Validation of HumanITcare Platform

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05825755
• Other study ID #: FOLLOWHEALTH-2023-02
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: March 2024
• Source: humanITcare
• Contact: Ricard Sanjosé Alemany
• Phone: 0034644499760
• Email: val-hic[@]humanitcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

HumanITcare 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).

Description:

This is a randomized controlled trial involving a Spanish network of hospitals. The study consists of continuous remote patient monitoring using HumanITcare'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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• HumanITcare telemonitoring platform
Patients will be followed-up with measurements from medical devices and health questionnaires delivered through the app

Locations

Country	Name	City	State
Spain	Hospital d'Alcoi	Alcoy	Alicante
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Corporació de Salut del Maresme i la Selva (Hospital de Blanes-Hospital de Calella)	Blanes	Girona
Spain	Hospital de Dénia	Denia	Alacant
Spain	Hospital de Vinalopó	Elche	Alicante
Spain	Hospital General Universitario de Elche	Elche	Alicante
Spain	Hospital Universitari Sant Joan de Reus	Reus	Tarragona
Spain	Hospital de Terrassa	Terrassa	Barcelona
Spain	Hospital de Torrejón	Torrejón De Ardoz	Madrid
Spain	Hospital Clínico Lozano Blesa de Zaragoza	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
humanITcare

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the combination of the normalized and weighted quality of life, self-care and adherence to treatment scales by the patient	Composite of change in the value of the combined value of the normalized and weighted scales of each questionnaire: the Minnesota Living with Heart Failure scale, The European Heart Failure Self-care behaviour scale and the Simplified Medication Adherence Questionnaire.	3 months
Secondary	Mortality from cardiovascular (CV) causes	Number of deaths	3 months
Secondary	Mortality from any cause	Number of deaths	3 months
Secondary	Acute decompensation of HF (first and recurrent) during the follow-up period	Number of total decompensations	3 months
Secondary	Hospital readmission due to HF decompensation	Total number of hospitalizations	3 months
Secondary	Hospital readmission for CV causes	Total number of hospitalizations	3 months
Secondary	Visits to the emergency room due to HF decompensation	Total number of visits	3 months
Secondary	Emergency visits for CV causes	Total number of visits	3 months
Secondary	Quality of life scale	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
Secondary	Treatment adherence	Adherence to treatment measured with SMAQ. Scale from 0 to 5. The higher the score the better outcome.	3 months
Secondary	Self-care	Patient's self-care measured with The European Heart Failure Self-Care Behavior Scale scale. Scale from 0 to 100. The higher the score the better outcome.	3 months