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Recruiting NCT06417996

Biobeat Digital Home Monitoring Feasibility

No phase Interventional Thoracic Surgery Home Monitoring

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital Group.
Who it may be relevant to
Registry conditions: Thoracic Surgery, Home Monitoring. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Postoperative Digital Care Home Monitoring

Overview

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

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • Number of ED Visits [Time frame: 30 days from discharge]
  • Readmission Rates [Time frame: 30 days from discharge]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Canada · 1 center
  • London Health Sciences Centre — London

Identifiers

NCT: NCT06417996 · Digital Home Monitoring

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗