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Biobeat Digital Home Monitoring Feasibility

Postoperative Digital Care Home Monitoring

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06417996
Enrollment
48
Registered
2024-05-16
Start date
2025-02-01
Completion date
2025-12-31
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Home Monitoring, Thoracic Surgery

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.

Interventions

OTHERDigital 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.

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 daysThe 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

MeasureTime frameDescription
Number of ED Visits30 days from dischargeNumber of ED visits
Readmission Rates30 days from dischargeNumber of readmissions

Countries

Canada

Contacts

Primary ContactDeb Lewis
deb.lewis@lhsc.on.ca5196858500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026