Clinical trial NCT05966857: FAPO-X: Assisted Digital Telemonitoring With Wearables in Patients After Cardiovascular Surgery
Official title: FAPO-X: Assisted Digital Telemonitoring With Wearables in Patients After Cardiovascular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart; Surgery, Heart, Functional Disturbance as Result
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Samsung Electronics
First posted: 2023-08-01
Enrollment: 108
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Rehospitalization rate
timeFrame: 30-day
measure: Scheduled consultations
timeFrame: 30-day
measure: Extra occurences
timeFrame: 30-day
Secondary outcomes:
measure: Technological adherence
timeFrame: 30-day
measure: Treatment adherence
timeFrame: 30-day
measure: Use of the mobile application by patients
timeFrame: 30-day
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Coracao (Heart Institute), Faculdade de Medicina, Hospital das Clinicas, Universidade de Sao Paulo
state: SP
Study officials:
References:
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