Biobeat Digital Home Monitoring Feasibility

NCT06417996 | Recruiting

• 1 other identifier: Digital Home Monitoring
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgery; Home Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of ED Visits

  30 days from discharge

• Readmission Rates

  30 days from discharge

Study Arms (2)

Control Group

NO INTERVENTION

The control group will not be monitored with continuity of care.

Digital Group

EXPERIMENTAL

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

Interventions

Digital Group OTHER

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.

Digital Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Central Study Contacts

Deb Lewis

CONTACT

5196858500; deb.lewis@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair/Head, Thoracic Surgery

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: May 16, 2024
• Study Start: February 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)