Biobeat Digital Home Monitoring Feasibility

Postoperative Digital Care Home Monitoring

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Surgery; Home Monitoring
• Intervention / Treatment: Other: Digital Group

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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deb Lewis; Phone Number: 75685 5196858500; Email: deb.lewis@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • London Health Sciences Centre
      • Contact: Deb Lewis; Phone Number: 75685 5196858500; Email: deb.lewis@lhsc.on.ca
      • Contact: Richard Malthaner; Phone Number: 5196676835; Email: richard.malthaner@lhsc.on.ca
      • Sub-Investigator: Mahesh Nagappa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; The control group will not be monitored with continuity of care.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 </= 20% of patients are lost to follow-up.	365 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of ED Visits	Number of ED visits	30 days from discharge
Readmission Rates	Number of readmissions	30 days from discharge

Collaborators and Investigators

• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Digital Home Monitoring

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No