## Protocol Section
### Identification Module
**NCT ID:** NCT06417996

**Brief Title:** Biobeat Digital Home Monitoring Feasibility

**Official Title:** Postoperative Digital Care Home Monitoring

#### Organization Study ID Info
**ID:** Digital Home Monitoring
#### Organization
**Class:** OTHER
**Full Name:** Lawson Health Research Institute
### Status Module
#### Completion Date
**Date:** 2025-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-02-21
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Lawson Health Research Institute

#### Responsible Party

**Investigator Affiliation:** Lawson Health Research Institute

**Investigator Full Name:** Richard Malthaner

**Investigator Title:** Chair Chief Thoracic Surgery

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Thoracic Surgery

- Home Monitoring

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 48

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Label:** Control Group

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Other: Digital Group

**Label:** Digital Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Digital Group

**Description:** 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.

**Name:** Digital Group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** 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 Outcomes

**Description:** Number of ED visits

**Measure:** Number of ED Visits

**Time Frame:** 30 days from discharge

**Description:** Number of readmissions

**Measure:** Readmission Rates

**Time Frame:** 30 days from discharge

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** deb.lewis@lhsc.on.ca

**Name:** Deb Lewis

**Phone:** 5196858500

**Phone Ext:** 75685

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
