Investigation of the Usability of Neutrocheck Amongst Healthy Volunteers and Healthcare Professionals. (NeutroUSE)

• ClinicalTrials.gov Identifier: NCT05852249
• Recruitment Status: Not yet recruiting
• First Posted: May 10, 2023
• Last Update Posted: July 13, 2023
• Sponsor: 52 North Health Ltd
• Information provided by (Responsible Party): 52 North Health Ltd

Tracking Information

• First Submitted Date: April 19, 2023
• First Posted Date: May 10, 2023
• Last Update Posted Date: July 13, 2023
• Estimated Study Start Date: August 2023
• Estimated Primary Completion Date: October 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 1, 2023)

• Identification of use errors, close calls and use difficulties associated with selected hazard-related use scenarios and participant's perceived root causes of these. [ Time Frame: 2 months ]
• Administration of a questionnaire to assess the effectiveness of key information for safety. [ Time Frame: 2 months ]
  Participants will be asked to complete a questionnaire consisting of multiple choice questions related to key safety information for use of Neutrocheck. For example, this includes questions on storage of the device, expiry date and when to contact a healthcare professional. The data collected from the questionnaire will be summarised using descriptive statistics.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 1, 2023)

• Administration of a questionnaire to measure user satisfaction with the use of Neutorcheck [ Time Frame: 2 months ]
  Participants will be asked to complete a questionnaire consisting of interval questions related to user satisfaction following use of Neutrocheck. The data collected from the questionnaire will be summarised using descriptive statistics.
• Comparison of descriptive statistics for task completion rates, measured through observation, between two study groups, one using paper instructions and the other using app instructions. [ Time Frame: 2 months ]
  Fisher's exact test will be used to determine the statistical significance of the differences in mean values between the two groups. To perform this analysis, we will utilise a statistical software such as R.
• Comparison of user satisfaction, measured through a questionnaire, between two study groups: one group using paper instructions and the other using app instructions. [ Time Frame: 2 months ]
  Fisher's exact test will be used to determine the statistical significance of the differences in mean values of responses between the two study groups completing the questionnaire. To perform this analysis, we will utilise a statistical software such as R.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Investigation of the Usability of Neutrocheck Amongst Healthy Volunteers and Healthcare Professionals.
• Official Title: Neutrocheck Summative Usability Study

Brief Summary

This study proposes to assess the usability of the Neutrocheck device and test kit amongst healthy volunteers and healthcare professionals (HCPs).

Neutrocheck is a portable, single-use diagnostic test intended to aid the diagnosis of neutropenia, febrile neutropenia and neutropenic sepsis using a finger prick blood sample.

Neutropenia is when the number of infection-fighting neutrophil cells in the blood are lower than normal. It can be caused by treatments such as chemotherapy or by certain medical conditions. Neutropenic sepsis is a life-threatening medical emergency that occurs when patients with neutropenia develop an infection. There is currently no way to test for neutropenic sepsis outside of hospitals. Neutrocheck is being developed for use as a self-test by patients at home alongside remote consultation with a HCP or at point-of-care by a HCP. This will allow rapid identification of patients requiring urgent intravenous antibiotics and medical assessment. In cases where Neutrocheck has eliminated the possibility of neutropenic sepsis, patients can avoid unnecessary and stressful hospital visits and valuable hospital resources will be saved.

Participants in this study will be invited to use the Neutrocheck test kit in a setting similar to a home environment to carry out a test, whilst being observed by a study moderator.

The Neutrocheck devices used in the study will be for investigational use only. This study will not be testing the accuracy of the Neutrocheck result, rather if Neutrocheck can be used safely and in a user-friendly way. Results will not be considered valid. Planned study duration is 2 months. This approach will enable us to complete the current phase of development and advance to a clinical validation study of Neutrocheck, assessing the diagnostic accuracy of Neutrocheck amongst users including those at risk of neutropenia and neutropenic sepsis.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Community sample

Condition

• Neutropenia
• Neutropenia, Febrile
• Neutropenic Sepsis (Disorder)

• Intervention: Not Provided

Study Groups/Cohorts

• Paper instruction
  Participants in this group will use paper instructions to use Neutrocheck.
• App instruction
  Participants in this group will use App instructions to use Neutrocheck.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: May 1, 2023): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2023
• Estimated Primary Completion Date: October 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Provide informed consent to participate
• Age 18 years or over

Exclusion Criteria:

• Known HIV or active Hep B or Hep C infection
• Phobia of needles or blood
• Currently undergoing immunosuppressive medical treatment or have received immunosuppressive treatment in the previous 3 months.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05852249
• Other Study ID Numbers: NeutroUSE
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: 52 North Health Ltd
• Original Responsible Party: Same as current
• Current Study Sponsor: 52 North Health Ltd
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: 52 North Health Ltd
• Verification Date: May 2023