Biobeat Digital Home Monitoring Feasibility

Not Applicable

Recruiting

• Conditions: Home Monitoring; Thoracic Surgery
• Interventions: Other: Digital Group

• Registration Number: NCT06417996
• Lead Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-16
• Study Start: 2025-02-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Group	Digital Group	At the time of hospital discharge, the control group will be discharged without receipt of home monitoring, and the intervention group will receive a home monitoring kit with (NIBP (non-invasive blood pressure) and SPO2 (pulse oximetry) with instructions on how to use these devices. Patients in the intervention groups will receive digital communication for four weeks and have their NIBP, HR (heart rate), SPO2 and pain scores evaluated twice a day for two weeks.

Primary Outcome Measures

Name	Time	Method
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.	365 days	The trial will be deemed feasible if \>/= 60% of eligible patients are recruited, \>/= 80% of data is collected, and \</= 20% of patients are lost to follow-up.

Secondary Outcome Measures

Name	Time	Method
Number of ED Visits	30 days from discharge	Number of ED visits
Readmission Rates	30 days from discharge	Number of readmissions

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada