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CompletedNCT03253549SMArTVIEWUpdated Nov 12, 2024

The SMArTVIEW, CoVeRed

An interventional study of SMArTVIEW in Surgery (Cardiac) and Surgery (Major Vascular), sponsored by McMaster University. Completed at 2 sites in 2 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by McMaster University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
572
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Surgery (Cardiac)
  • Surgery (Major Vascular)

Keywords

  • remote automated monitoring
  • hospital to home virtual care
  • cardiac surgery
  • major vascular surgery
  • self-management
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
572 participants (actual)

Study arms

  • Experimental
    SMArTVIEW

    Device: SMArTVIEW

  • No intervention
    Standard Care

Interventions

  • DeviceSMArTVIEW

    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.

05

What researchers measure

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).

    Time frame: Readmission within 45 days post discharge.

Secondary outcomes

  1. Composite of Major Complications associated with Undetected Hemodynamic Compromise

    Composite death, non-fatal myocardial infarction, non-fatal stroke, non-fatal cardiac arrest, congestive heart failure, clinically important atrial fibrillation, deep vein thrombosis or pulmonary embolism, bleeding, respiratory failure, falls, delirium, reoperation, important hypotension, acute kidney injury w/ dialysis, infection/sepsis and medication error detection and correction.

    Time frame: 45 day and 6 months post discharge

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

    Patient and clinician experience, family/caregiver experience, patient's functional status, patient activation, postoperative pain and satisfaction with care.

    Time frame: 45 days and 6 months post discharge.

  3. Econometrics

    Health service utilization-related costs and patient-level of cost of recovery.

    Time frame: 45 days and 6 months post discharge.

  4. Process & Implementation

    Barriers and facilitators to the intervention

    Time frame: Through study completion. An average of 1 year.

06

Study locations

2 sites
  • Hamilton General Hospital
    Hamilton, Ontario L8L 2X2, Canada
  • Liverpool Heart & Chest Hospital
    Liverpool, England L14 3PE, United Kingdom
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03253549
Lead sponsor
McMaster University
Collaborators
Population Health Research Institute, Canadian Institutes of Health Research (CIHR), Ontario Centres of Excellence
Responsible party
Sponsor
First posted
Aug 18, 2017
Start date
Mar 21, 2018
Primary completion
Nov 15, 2021
Completion
Nov 15, 2021
Last update
Nov 12, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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