Biobeat Digital Home Monitoring Feasibility

NCT ID: NCT06417996

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Thoracic Surgery Home Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Digital Group

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Richard Malthaner

Chair/Head, Thoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Deb Lewis

Role: CONTACT

5196858500 ext. 75685

Facility Contacts

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Deb Lewis

Role: primary

5196858500 ext. 75685

Richard Malthaner

Role: backup

5196676835

Other Identifiers

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Digital Home Monitoring

Identifier Type: -

Identifier Source: org_study_id

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