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NCT Number: NCT06417996

Biobeat Digital Home Monitoring Feasibility

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.

Recruiting

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Key information

Conditions

Thoracic Surgery Home Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

    Time frame: 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 outcomes

  1. Number of ED Visits

    Time frame: 30 days from discharge

    Number of ED visits

  2. Readmission Rates

    Time frame: 30 days from discharge

    Number of readmissions

Study contacts

Contact information is provided by the study sponsor or research team.

Deb Lewis

CONTACT

[email protected]

5196858500 ext. 75685

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Postoperative Digital Care Home Monitoring

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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