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

NCT06464094 | Not Yet Recruiting

• 1 other identifier: 3.0_2023.05.31
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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 user experiences, while soliciting user feedback on wearability compliance and proposed clinical workflows.

Conditions

Surgery

Keywords

User-testing; Device

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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.

  72 hours

• 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.

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

• 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.

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

• 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.

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

Study Arms (1)

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

OTHER

Participants 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.

Other: User-testing of Vitaliti Continuous Vital Sign Monitor Model CVSM-1A

Interventions

User-testing of Vitaliti Continuous Vital Sign Monitor Model CVSM-1A OTHER

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.

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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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):
• a. 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

You may not qualify if:

• Intolerance/allergy to adhesive
• Hearing aid/Cochlear Implant
• 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
• Age \>18 years
• Family or non-family member, residing in the same household as the patient or closely involved in the patient's postoperative recovery
• Provide written informed consent to participate in the VERDICT-2 Study
• \) 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
• Registered Nurse or Physician engaged in perioperative care
• Employed at Hamilton Health Sciences
• Provide written informed consent to participate in the VERDICT-2 Study
• 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
• Non-practicing class of licensure

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster University: collaborator
• Population Health Research Institute: collaborator
• Cloud DX Inc.: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S4L8, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 18, 2024
• Study Start: June 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

CA (1)