Surgery (Cardiac)SMArTVIEWNCT03253549
The SMArTVIEW, CoVeRed
A study testing SMArTVIEW in people with Surgery (Cardiac) and Surgery (Major Vascular), run by McMaster University at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Surgery (Cardiac), Surgery (Major Vascular)
- What is being tested?
- SMArTVIEW
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Mar 2018to 15 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Liverpool Heart & Chest Hospital
Liverpool, England, L14 3PE
About this study
Official title: TecHnology Enabled Self-MAnagemenT - VIsion for Remote Automated Patient Monitoring and EmpoWerment Following Cardiac and VasculaR Surgery
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.
- Conditions
- Surgery (Cardiac), Surgery (Major Vascular)
- Being tested
- SMArTVIEW
- Keywords
- remote automated monitoring, hospital to home virtual care, cardiac surgery, major vascular surgery, self-management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMArTVIEWDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SMArTVIEW | Experimental | Not described Receives: Device: SMArTVIEW |
| Standard Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Readmission Rate
45-day risk of a composite of hospital readmission and emergency department/urgent care centre visits (not requiring hospital admission).
Measured: Readmission within 45 days post discharge.
Secondary outcomes (4)
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.
Measured: 45 day and 6 months post discharge
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.
Measured: 45 days and 6 months post discharge.
Econometrics
Health service utilization-related costs and patient-level of cost of recovery.
Measured: 45 days and 6 months post discharge.
Process & Implementation
Barriers and facilitators to the intervention
Measured: Through study completion. An average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start21 Mar 2018
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery (Cardiac)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to SMArTVIEW or Standard Care.
- Masking
- None (open label)
- Enrolment
- 572 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute, Canadian Institutes of Health Research (CIHR), Ontario Centres of Excellence
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253549
- Sponsor's protocol ID
- SMArTVIEW v1.0
- Acronym
- SMArTVIEW
- Status last verified
- Nov 2024
- First submitted
- 10 Aug 2017
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TecHnology Enabled Self-MAnagemenT - VIsion for Remote Automated Patient Monitoring and EmpoWerment Following Cardiac and VasculaR Surgery
- ClinicalTrials.gov ID
- NCT03253549
- Acronym / sponsor ID
- SMArTVIEW / SMArTVIEW v1.0
- Conditions
- Surgery (Cardiac), Surgery (Major Vascular)
- Keywords
- remote automated monitoring, hospital to home virtual care, cardiac surgery, major vascular surgery, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Population Health Research Institute, Canadian Institutes of Health Research (CIHR), Ontario Centres of Excellence
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to SMArTVIEW or Standard Care.
| Arm | Type | Receives |
|---|---|---|
| SMArTVIEW | Experimental | Device: SMArTVIEW |
| Standard Care | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMArTVIEWRemote 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. | Device | SMArTVIEW |
Primary outcome
Hospital Readmission Rate
Time frame: Readmission within 45 days post discharge.
45-day risk of a composite of hospital readmission and emergency department/urgent care centre visits (not requiring hospital admission).
4 secondary outcomes
Composite of Major Complications associated with Undetected Hemodynamic Compromise
Time frame: 45 day and 6 months post discharge
User Experience while on the SMArTVIEW Intervention compared to standard of care
Time frame: 45 days and 6 months post discharge.
Econometrics
Time frame: 45 days and 6 months post discharge.
Process & Implementation
Time frame: Through study completion. An average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMArTVIEW in people with Surgery (Cardiac) and Surgery (Major Vascular), run by McMaster University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Readmission Rate (time frame: Readmission within 45 days post discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.