FAPO-X: Assisted Digital Telemonitoring With Wearables in Patients After Cardiovascular Surgery

Heart; Surgery, Heart, Functional Disturbance as Result Clinical Trial

— FAPO-X  

Official title:

FAPO-X: Assisted Digital Telemonitoring With Wearables in Patients After Cardiovascular Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05966857
• Other study ID #: 66520122.0.0000.0068
• Status: Completed
• Phase: N/A
• Start date: February 17, 2023
• Est. completion date: May 23, 2023

Study information

• Verified date: July 2023
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to develop a digitally assisted telemonitoring platform using the Samsung TM Galaxy Watch5 smartwatch, validating the applicability of the solution in patients with POAF (Postoperative Atrial Fibrillation), along with the accuracy of the smartwatch in detecting vital signs through optical sensors and possibly identifying irregularities in heart rhythm. The validation of its applicability will be carried out through a clinical trial. This is a randomized observational pilot study resulting from the partnership established in the base year of 2022 between InCor and Samsung.

The sample consisted of 108 outpatient patients with cardiac diseases who underwent cardiac surgery and were selected during the preoperative consultation. Subsequently, the patients were randomized (1:1) into the intervention group (teleassisted group) or the control group (standard institution follow-up).

The sample size was proposed by the contracting party as this is a pilot study to assess whether the implementation of a technological solution assists in monitoring and predicting the risk of surgical patients in the postoperative phase, as well as the accuracy of the Samsung TM Galaxy Watch5 smartwatch in a sample with POAF.

Description:

This interventional study was conducted exclusively at the Heart Institute of the Clinics Hospital of the Medical School of the University of São Paulo (InCor - HCFMUSP). It was a single-center study divided into six phases.

The first phase involved outpatient preoperative care, where patients underwent a comprehensive anamnesis during the preoperative consultation and were informed about the study. In the second phase, patients were hospitalized and provided with the Informed Consent Form (ICF) if they met the inclusion criteria. Demographic data were collected during this phase.

During the surgical phase (third phase), intraoperative data were collected after cardiac surgery. The fourth phase focused on postoperative care, where patients were evaluated, and health measures such as blood pressure (BP), heart rate (HR), electrocardiogram (ECG), and peripheral oxygen saturation (SpO2) were collected using the SAMSUNGTM Galaxy Watch5 smartwatch and reference devices.

After discharge, the fifth phase involved a 30-day telemonitoring period, where patients were remotely monitored using the smartwatch. Health data, including BP, HR, ECG, and SpO2, were collected three times a day during this phase. The medical team provided clinical interventions when alerts were received via the "FAPO SI³" platform.

In the final phase, patients returned for an outpatient visit at InCor, where health measures were collected again using the smartwatch and reference devices. Additionally, a World Health Organization Quality of Life (WHOQOL) questionnaire was administered to assess patients' quality of life. ECG reports issued by the smartwatch were also reviewed.

The control group consisted of patients with heart disease who underwent surgical procedures and received standard outpatient and post-surgical follow-up according to institutional routines and protocols.

Overall, the study aimed to develop and validate an assisted digital telemonitoring platform for patients with postoperative atrial fibrillation (POAF). The telemonitored group used the SAMSUNGTM Galaxy Watch5 smartwatch for remote monitoring, while the control group followed standard care protocols.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: May 23, 2023
• Est. primary completion date: May 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Age = 22 years;

• Parameters for surgical indication, in the presence of heart disease (mitral or aortic valve disease, coronary artery disease or aortic disease);

• Agree to adhere to the study's procedures and requirements;

• Be able to consent to their participation in writing;

Exclusion Criteria:

• Not having undergone cardiac surgery;

• Presence of post-surgical complications with prolonged hospital stay for more than 14 days from surgery date;

• Presence of a Peripherally Inserted Central Catheter (PICC) or limb preservation and cardiac pacemaker in case of impediment to acquisition of the ECG (smartwatch);

• Patients with arteriovenous fistula;

• Presence of skin pathology or skin diseases such as vitiligo, lupus and atopic dermatitis, as well as tattoos in the wrist region, which may interfere with the reading by the optical sensor;

• Show sensitivity or allergic reactions, to any degree, to the component materials of the wearable device;

Related Conditions & MeSH terms

• Heart; Surgery, Heart, Functional Disturbance as Result

Intervention

Device:
• Wearable: Smartwatch
The SAMSUNGTM Galaxy Watch5 Smartwatch, is a new generation of smartwatches, features an innovative 3-in-1 BioActive sensor, which uses a chip to capture optical and read cardiac electrical current, allowing to carry out high-quality real-time single-lead electrocardiogram. Despite the more compact design, there is no decrease in accuracy. These signals are then processed by the device's algorithms and can be sent to a trained professional for evaluation immediately after the measurement, facilitating the monitoring and diagnosis of arrhythmias.

Locations

Country	Name	City	State
Brazil	Instituto do Coracao (Heart Institute), Faculdade de Medicina, Hospital das Clinicas, Universidade de Sao Paulo	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Samsung Electronics

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

Albini A, Malavasi VL, Vitolo M, Imberti JF, Marietta M, Lip GYH, Boriani G. Long-term outcomes of postoperative atrial fibrillation following non cardiac surgery: A systematic review and metanalysis. Eur J Intern Med. 2021 Mar;85:27-33. doi: 10.1016/j.ej — View Citation

Baig MM, GholamHosseini H, Moqeem AA, Mirza F, Linden M. A Systematic Review of Wearable Patient Monitoring Systems - Current Challenges and Opportunities for Clinical Adoption. J Med Syst. 2017 Jul;41(7):115. doi: 10.1007/s10916-017-0760-1. Epub 2017 Jun — View Citation

Chandrasekaran R, Katthula V, Moustakas E. Patterns of Use and Key Predictors for the Use of Wearable Health Care Devices by US Adults: Insights from a National Survey. J Med Internet Res. 2020 Oct 16;22(10):e22443. doi: 10.2196/22443. — View Citation

Goulden CJ, Hagana A, Ulucay E, Zaman S, Ahmed A, Harky A. Optimising risk factors for atrial fibrillation post-cardiac surgery. Perfusion. 2022 Oct;37(7):675-683. doi: 10.1177/02676591211019319. Epub 2021 May 26. — View Citation

Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19. Erratum In: Int J Stroke. 2020 Ja — View Citation

Lopes LA, Agrawal DK. Post-Operative Atrial Fibrillation: Current Treatments and Etiologies for a Persistent Surgical Complication. J Surg Res (Houst). 2022;5(1):159-172. doi: 10.26502/jsr.10020209. Epub 2022 Mar 28. — View Citation

Nachman D, Gilan A, Goldstein N, Constantini K, Littman R, Eisenkraft A, Grossman E, Gepner Y. Twenty-Four-Hour Ambulatory Blood Pressure Measurement Using a Novel Noninvasive, Cuffless, Wireless Device. Am J Hypertens. 2021 Nov 20;34(11):1171-1180. doi: — View Citation

Phan K, Ha HS, Phan S, Medi C, Thomas SP, Yan TD. New-onset atrial fibrillation following coronary bypass surgery predicts long-term mortality: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2015 Dec;48(6):817-24. doi: 10.1093/ejcts/ezu55 — View Citation

Tison GH, Sanchez JM, Ballinger B, Singh A, Olgin JE, Pletcher MJ, Vittinghoff E, Lee ES, Fan SM, Gladstone RA, Mikell C, Sohoni N, Hsieh J, Marcus GM. Passive Detection of Atrial Fibrillation Using a Commercially Available Smartwatch. JAMA Cardiol. 2018 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehospitalization rate	Frequency (n, %)	30-day
Primary	Scheduled consultations	Frequency (n, %)	30-day
Primary	Extra occurences	Frequency (n, %)	30-day
Secondary	Technological adherence	Frequency (n, %)	30-day
Secondary	Treatment adherence	Frequency (n, %)	30-day
Secondary	Use of the mobile application by patients	Frequency (n, %)	30-day