The SMArTVIEW, CoVeRed

NCT03253549 | Completed DMC

• 1 other identifier: SMArTVIEW v1.0
• Study Type: interventional
• Target: 572
• Locations: 2 countries
• Sites: 2

Brief Summary

The SMArTVIEW program evaluates the use of remote, automated monitoring in hospital and at home, on patients undergoing cardiac and major vascular surgery, to determine the effect on the 45-day risk of a composite of hospital readmission and emergency department/urgent care centre visits (not requiring hospital admission). Half of participants will receive the SMArTVIEW intervention of increased monitoring, while the other half will receive standard care after surgery.

Conditions

Surgery (Cardiac); Surgery (Major Vascular)

Keywords

remote automated monitoring; hospital to home virtual care; cardiac surgery; major vascular surgery; self-management

Outcome Measures

Primary Outcomes (1)

• Hospital Readmission Rate

  45-day risk of a composite of hospital readmission and emergency department/urgent care centre visits (not requiring hospital admission).

  Readmission within 45 days post discharge.

Secondary Outcomes (4)

• Composite of Major Complications associated with Undetected Hemodynamic Compromise

  45 day and 6 months post discharge

• User Experience while on the SMArTVIEW Intervention compared to standard of care

  45 days and 6 months post discharge.

• Econometrics

  45 days and 6 months post discharge.

• Process & Implementation

  Through study completion. An average of 1 year.

Study Arms (2)

SMArTVIEW

EXPERIMENTAL

Device: SMArTVIEW

Standard Care

NO INTERVENTION

Interventions

SMArTVIEW DEVICE

Remote automated, continuous monitoring in hospital after cardiac or vascular surgery, followed by 30-day at home monitoring, daily nurse video visits and a self-management training program.

SMArTVIEW

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60 years;
• Patient has undergone major cardiac or vascular surgery and has been admitted post-op to the surgical floor;
• Anticipated length of stay (LOS) on the surgical floor is ≥ 48 hours;
• Patient has a negative Confusion Assessment Method (CAM) test result preceding, or within 12 hours of arriving on the surgical floor and is randomized within the first 24 hours after arriving on the ward;
• Patient is able to provide consent autonomously.

You may not qualify if:

• Patient is unable to communicate with research staff, complete surveys and questionnaires, or a telephone interview;
• Patient has an intolerance/allergy to adhesive;
• Patient unable to complete 30 days of at-home follow up due to current or planned relocation to nursing home or rehab facility; and
• Patients with radial graft sites

Sponsors & Collaborators

• McMaster University: lead
• Population Health Research Institute: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Ontario Centres of Excellence: collaborator

Study Sites (2)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Liverpool Heart & Chest Hospital

Liverpool, England, L14 3PE, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized to SMArTVIEW or Standard Care.

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 18, 2017
• Study Start: March 21, 2018
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

GB (1); CA (1)