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

NCT05852249 | Unknown

• 1 other identifier: NeutroUSE
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neutropenia; Neutropenia, Febrile; Neutropenic Sepsis (Disorder)

Outcome Measures

Primary Outcomes (2)

• Identification of use errors, close calls and use difficulties associated with selected hazard-related use scenarios and participant's perceived root causes of these.

  2 months

• Administration of a questionnaire to assess the effectiveness of key information for safety.

  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.

  2 months

Secondary Outcomes (3)

• Administration of a questionnaire to measure user satisfaction with the use of Neutorcheck

  2 months

• 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.

  2 months

• Comparison of user satisfaction, measured through a questionnaire, between two study groups: one group using paper instructions and the other using app instructions.

  2 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• 52 North Health Ltd: lead

MeSH Terms

Conditions

Neutropenia; Febrile Neutropenia

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 10, 2023
• Study Start: August 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-05