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

NCT05966857 | Completed

• 1 other identifier: 66520122.0.0000.0068
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result

Outcome Measures

Primary Outcomes (3)

• Rehospitalization rate

  Frequency (n, %)

  30-day

• Scheduled consultations

  Frequency (n, %)

  30-day

• Extra occurences

  Frequency (n, %)

  30-day

Secondary Outcomes (3)

• Technological adherence

  30-day

• Treatment adherence

  30-day

• Use of the mobile application by patients

  30-day

Study Arms (2)

Control Group (CTL)

NO INTERVENTION

Patients who underwent standard treatment at the institution without any wearable monitoring.

Telemonitored Group (TLM)

EXPERIMENTAL

Patients who received telemonitoring with a Samsung Galaxy smartwatch and FAPO SI³ platform, which is integrated with the hospital's electronic medical record system.

Device: Wearable: Smartwatch

Interventions

Wearable: Smartwatch DEVICE

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.

Telemonitored Group (TLM)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Sao Paulo: lead
• Samsung Electronics: collaborator

Study Sites (1)

Instituto do Coracao (Heart Institute), Faculdade de Medicina, Hospital das Clinicas, Universidade de Sao Paulo

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (9)

• 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.

  PMID: 31955707 RESULT

• 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.ejim.2020.12.018. Epub 2021 Jan 2.

  PMID: 33402281 RESULT

• 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.

  PMID: 35445200 RESULT

• 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.

  PMID: 34034586 RESULT

• 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/ezu551. Epub 2015 Jan 18.

  PMID: 25602053 RESULT

• 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 19.

  PMID: 28631139 RESULT

• 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 May 1;3(5):409-416. doi: 10.1001/jamacardio.2018.0136.

  PMID: 29562087 RESULT

• 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.

  PMID: 33064083 RESULT

• 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: 10.1093/ajh/hpab095.

  PMID: 34143867 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: During the 30-day telemonitoring period in the TLM (Telemonitoring) group, the ECG report evaluator was blinded to the patient's clinical condition and the presence of underlying atrial fibrillation (AF). This masking approach was adopted to ensure that the evaluator was not influenced by prior clinical information or knowledge of the presence of AF before analyzing the ECG results provided by the smartwatch. The objective is to ensure impartiality and objectivity in the evaluation of the data obtained during the telemonitoring period. By keeping this information hidden from the evaluator, a more unbiased and accurate analysis of the results can be achieved, without the influence of prior knowledge about the patient's clinical condition or the presence of AF. This contributes to ensuring the validity and reliability of the results obtained through smartwatch telemonitoring in the TLM group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: This interventional study utilized a parallel assignment model to develop and validate an assisted digital telemonitoring platform for patients with POAF. The telemonitored group received interventions and telemonitoring through the platform, while the control group followed the standard institutional patient journey without any intervention or telemonitoring.

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 1, 2023
• Study Start: February 17, 2023
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

BR (1)