Biobeat Digital Home Monitoring Feasibility

Thoracic Surgery Clinical Trial

Official title:

Postoperative Digital Care Home Monitoring

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06417996
• Other study ID #: Digital Home Monitoring
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Lawson Health Research Institute
• Contact: Deb Lewis
• Phone: 5196858500
• Email: deb.lewis[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the feasibility of evaluating postoperative home monitoring with Biobeat digital monitoring. The investigators hypothesize that the Biobeat digital home monitoring platform will lead to a decrease in unplanned visits to the ED (Emergency Department). In addition, patients' quality of life is postulated to be improved compared to patients receiving the current standard of care without home monitoring.

Description:

This trial will be a single centre, parallel arm, randomized controlled feasibility trial. The investigators will evaluate postoperative home monitoring with the Biobeat digital monitoring and two-way communication through the digital portal for 4 weeks post-operatively to the standard of care (no digital monitoring) in thoracic surgery patients undergoing elective thoracic surgical procedures. The investigators will assess whether conducting a larger randomized trial of digital home monitoring vs. standard of care is feasible in terms of recruitment, data collection and logistics.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: May 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient willing to provide informed consent

• Wi-fi or cellular connectivity at the patient's home

• Patient undergoing elective lung cancer surgery

• Patient familiar/comfortable with the use of technology such as online banking.

Exclusion Criteria:

• Patients who are not comfortable with the use of technology.

Related Conditions & MeSH terms

• Home Monitoring
• Thoracic Surgery

Intervention

Other:
• Digital Group
Once patients are ready for discharge, patients in the digital group will be sent home with the Biobeat digital monitoring kit with written & oral instructions on how it will be used in maintaining continuity of care which will track ECG (electrocardiogram), HR, NIBP, SPO2, and pain scores. A continuous recording and two-lead ECG patch will be applied and activated at the time of discharge to identify any paroxysmal atrial fibrillation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess whether conducting a larger randomized trial of digital home monitoring vs. standard of care is feasible in terms of recruitment, data collection and logistics.	The trial will be deemed feasible if >/= 60% of eligible patients are recruited, >/= 80% of data is collected, and	365 days
Secondary	Number of ED Visits	Number of ED visits	30 days from discharge
Secondary	Readmission Rates	Number of readmissions	30 days from discharge