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

July 20, 2023 updated by: Fabio Biscegli Jatene, University of Sao Paulo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403-900
        • Instituto do Coracao (Heart Institute), Faculdade de Medicina, Hospital das Clinicas, Universidade de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group (CTL)
Patients who underwent standard treatment at the institution without any wearable monitoring.
Experimental: Telemonitored Group (TLM)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rehospitalization rate
Time Frame: 30-day
Frequency (n, %)
30-day
Scheduled consultations
Time Frame: 30-day
Frequency (n, %)
30-day
Extra occurences
Time Frame: 30-day
Frequency (n, %)
30-day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technological adherence
Time Frame: 30-day
Frequency (n, %)
30-day
Treatment adherence
Time Frame: 30-day
Frequency (n, %)
30-day
Use of the mobile application by patients
Time Frame: 30-day
Frequency (n, %)
30-day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Samsung Electronics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2023

Primary Completion (Actual)

May 23, 2023

Study Completion (Actual)

May 23, 2023

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 66520122.0.0000.0068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart; Surgery, Heart, Functional Disturbance as Result

Clinical Trials on Wearable: Smartwatch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe