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SurgeryVERDICT-2NCT06464094

Vitaliti Continuous Vital Signs Monitor User-Testing Protocol: VERDICT-2

A study testing User-testing of Vitaliti Continuous Vital Sign Monitor Model CVSM-1A in people with Surgery, run by Hamilton Health Sciences Corporation at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The VERDICT-2 user testing study will user test the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) in an ambulatory context with post-surgical participants, their family members (caregiver support role) and clinicians (nurses and physicians) at Hamilton Health Sciences to examine user acceptance and… Read more about this study

Who is it for?
Ages 45 years and olderHealthy volunteers can take part
Conditions the study is for
Surgery
What is being tested?
User-testing of Vitaliti Continuous Vital Sign Monitor Model CVSM-1A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteCanada
Study dates
Jun 2024to Sep 2024
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 45 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Patient Inclusion Criteria

  1. Age ≥45 years; 2) Undergoing inpatient non-cardiac surgery with general or regional anesthesia; 3) Expected to spend at least two nights in hospital after surgery; 4) Provide written informed consent to participate in the VERDICT-2 Study, AND 5) Fulfill ≥ 1 of the following criteria (a-e):
  2. History of coronary heart disease; b. History of stroke; c. History of peripheral arterial disease; d. Preoperative NT-proBNP value ≥200 ng/L e. OR fulfill ≥3 of the following 9 risk factors: i) Undergoing major surgery ii) Undergoing urgent or emergent surgery iii) History of hypertension iv) History of congestive heart failure v) History of transient ischemic attack vi) History of smoking within 2 years of surgery vii) Diabetes and currently taking an oral hypoglycemic agent or insulin viii) Age >70 years

Patient Exclusion Criteria

  1. Intolerance/allergy to adhesive
  2. Hearing aid/Cochlear Implant
  3. Patients with cognitive or physical impairments hindering understanding the scope of the device or ability to interact with the device or unable to communicate with research staff, complete study surveys, or undertake an interview using technology will not be eligible for recruitment

Family/Care Giver Inclusion Criteria:

  1. Age >18 years
  2. Family or non-family member, residing in the same household as the patient or closely involved in the patient's postoperative recovery
  3. Provide written informed consent to participate in the VERDICT-2 Study

Family/Care Giver Exclusion Criteria:

  1. Caregivers with cognitive or physical impairments hindering understanding the scope of the device or ability to interact with the device or unable to communicate with research staff, complete study surveys, or undertake an interview using technology will not be eligible for recruitment

Clinician Inclusion Criteria:

  1. Registered Nurse or Physician engaged in perioperative care
  2. Employed at Hamilton Health Sciences
  3. Provide written informed consent to participate in the VERDICT-2 Study

Clinician Exclusion Criteria:

  1. Clinicians unable to understand the scope of the device or ability to interact with the device or unable to communicate with research staff, complete study surveys, or undertake an interview using technology due to language barriers will not be eligible for recruitment
  2. Non-practicing class of licensure

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McMaster University

    Hamilton, Ontario, L8S4L8

    Carley Ouellette, MSc, 905-521-2100, ouellc1@mcmaster.ca

Other trials in Canada

About this study

Official title: User-Testing Protocol for the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model CVSM-1A) for Clinical Use and Self Measurement in Ambulatory Settings

The VERDICT-2 user testing study will user test the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) in an ambulatory context with post-surgical participants, their family members (caregiver support role) and clinicians (nurses and physicians) at Hamilton Health Sciences to examine user acceptance and user experiences, while soliciting user feedback on wearability compliance and proposed clinical workflows.

Read the detailed description

Effective postoperative care is faced with several challenges- patients experience major complications following surgery, which often require re-hospitalization or utilization of healthcare services (i.e., emergency room visits) once discharged into the community. New remote automated monitoring (RAM) technologies that enable data integration, synthesis, and real-time alerts to clinicians have the potential to transform postoperative care, similar to how intraoperative care has evolved.

The Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) is a continuous vital sign monitor intended to measure vital metrics including systolic and diastolic blood pressures (via ECG/ photoplethysmography [PPG]), pulse (via PPG), respiration rate (via impedance respiration waveform), core body temperature (via infrared sensor), and blood oxygen saturation levels (via PPG) of an adult individual using non-invasive techniques.

The VERDICT-2 user testing study will user test the Cloud DX Vitaliti Continuous Vital Signs Monitor (Model: CVSM-1A) in an ambulatory context with post-surgical participants, their family members (caregiver support role) and clinicians (nurses and physicians) at Hamilton Health Sciences to examine user acceptance and user experiences, while soliciting user feedback on wearability compliance and proposed clinical workflows.

Conditions
Surgery
Being tested
User-testing of Vitaliti Continuous Vital Sign Monitor Model CVSM-1A
Keywords
User-testing, Device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • User-testing of Vitaliti Continuous Vital Sign Monitor Model CVSM-1AOther

    Single group enrollment to examine user-acceptance and user experiences, while soliciting user feedback on wearability compliance (patient) and proposed clinical workflows using the most recent Vitaliti™ CVSM device.

Study groups in NCT06464094
Study groupRoleWhat they receive
User-testing of Vitaliti Continuous Vital Sign Monitor Model CVSM-1AOtherParticipants enrolled to engage in user-testing of the Vitaliti Continuous Vital Sign Monitor Model CVSM-1A to examine user-acceptance and user experiences, while soliciting user feedback on wearability compliance (patient) and proposed clinical workflows using the most recent Vitaliti™ CVSM device.
Receives: Other: User-testing of Vitaliti Continuous Vital Sign Monitor Model CVSM-1A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Task analysis

    Assessment of all users' (patient, caregiver, clinician) performance of the required tasks during Vitaliti™ CVSM user testing according to the following designations: 'completed', 'completed with difficulty', or 'missed'. Descriptive data will be generated to summarize operational tasks that required the most support to complete.

    Measured: During user testing (Single sitting; 30-60 Minute duration)

  2. Wearability (Patients)

    Participant journal used to record any device removal occurrences reason why it was taken off, and for how long. Participants will also be asked to keep track of any experiential information they note while wearing the device, which will then be provided to the research team for review.

    Measured: 72 hours

  3. Impressions of usability (Patients)

    In-person post-test debrief interviews for patients, caregivers, and clinicians will be conducted using semi-structured interview methods following the task analysis user-testing exercise. These interviews will focus on perceptions of usability as they relate to root causes of sources of difficulty and particular events that may have occurred. Participants' overall impressions of the usability of the Vitaliti™ system will also be captured, focusing on perceived successes and failures, impressions of what may be done differently next time, as well as feedback on the in-service and training materials provided. Analysis by qualitative methods.

    Measured: 72 hours (single sitting; 30-60 Minute interview)

  4. Impressions of usability (Caregivers)

    In-person post-test debrief interviews for patients, caregivers, and clinicians will be conducted using semi-structured interview methods following the task analysis user-testing exercise. These interviews will focus on perceptions of usability as they relate to root causes of sources of difficulty and particular events that may have occurred. Participants' overall impressions of the usability of the Vitaliti™ system will also be captured, focusing on perceived successes and failures, impressions of what may be done differently next time, as well as feedback on the in-service and training materials provided. Analysis by qualitative methods.

    Measured: 72 hour (single sitting; 30-60 Minute interview)

  5. Impressions of usability (Clinicians)

    In-person post-test debrief interviews for patients, caregivers, and clinicians will be conducted using semi-structured interview methods following the task analysis user-testing exercise. These interviews will focus on perceptions of usability as they relate to root causes of sources of difficulty and particular events that may have occurred. Participants' overall impressions of the usability of the Vitaliti™ system will also be captured, focusing on perceived successes and failures, impressions of what may be done differently next time, as well as feedback on the in-service and training materials provided. Analysis by qualitative methods.

    Measured: During user testing (single sitting; 30-60 Minute interview)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2024
  2. Study startJun 2024 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06464094
Sponsor's protocol ID
3.0_2023.05.31
Acronym
VERDICT-2
Status last verified
Jun 2024
First submitted
5 Jun 2024
Last updated
18 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing User-testing of Vitaliti Continuous Vital Sign Monitor Model CVSM-1A in people with Surgery, run by Hamilton Health Sciences Corporation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Task analysis (time frame: During user testing (Single sitting; 30-60 Minute duration)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06464094.

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 18 Jun 2024.

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