The SMArTVIEW, CoVeRed

NCT ID: NCT03253549

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 572 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-21
• Study Completion Date: 2021-11-15

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.

Detailed Description

SMArTVIEW is an eHealth-enabled service delivery program that combines remote automated monitoring, education, and self-management training. SMArTVIEW is a two-stage intervention program. Stage 1 supports seniors after cardiac or major vascular surgery in hospital on the surgical unit (post-ICU). Participants are assigned automated, cableless, vital sign monitoring devices that are worn during their entire stay on the surgical unit (blood pressure cuff, respiration pod, and oxygen saturation probe). Any signs of deterioration are sent via handheld device to the primary care nurse for early intervention.

With a view to seamless transition home, Stage 2 supports these individuals at home during the first 30 days of recovery. Participants are sent home with Bluetooth enabled monitoring equipment including a tablet, blood pressure cuff, thermometer, pulse oximeter and weight scale. From home, the tablet uploads patients' vital signs and measurements automatically and sends them, via secure cloud infrastructure, to the SMArTVIEW Nurse on the surgical ward back at the hospital. The tablet interface also prompts patients to respond to brief, easy to read, daily surveys in order to inform the nurse about their status. The tablet also supports secure daily video visits and daily interaction with the nurse for postoperative assessment and support, surgical wound photographs, as well as patient access to customized educational materials.

Conditions

Surgery (Cardiac); Surgery (Major Vascular)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

SMArTVIEW

Group Type: EXPERIMENTAL

SMArTVIEW

Intervention Type: 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.

Standard Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SMArTVIEW

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 60 years;

2. Patient has undergone major cardiac or vascular surgery and has been admitted post-op to the surgical floor;

3. Anticipated length of stay (LOS) on the surgical floor is ≥ 48 hours;

4. 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;

5. Patient is able to provide consent autonomously.

Exclusion Criteria

1. Patient is unable to communicate with research staff, complete surveys and questionnaires, or a telephone interview;

2. Patient has an intolerance/allergy to adhesive;

3. Patient unable to complete 30 days of at-home follow up due to current or planned relocation to nursing home or rehab facility; and

4. Patients with radial graft sites

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ontario Centres of Excellence

INDUSTRY

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hamilton General Hospital

Hamilton, Ontario, Canada

Liverpool Heart & Chest Hospital

Liverpool, England, United Kingdom

Countries

Canada; United Kingdom

Other Identifiers

SMArTVIEW v1.0

Identifier Type: -

Identifier Source: org_study_id