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

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

Study Description
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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.


Condition or disease
Neutropenia Neutropenia, Febrile Neutropenic Sepsis (Disorder)

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neutrocheck Summative Usability Study
Estimated Study Start Date : August 2023
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: 52 North Health Ltd
ClinicalTrials.gov Identifier: NCT05852249    
Other Study ID Numbers: NeutroUSE
First Posted: May 10, 2023    Key Record Dates
Last Update Posted: July 13, 2023
Last Verified: May 2023

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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
Additional relevant MeSH terms:
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Sepsis
Neutropenia
Febrile Neutropenia
Agranulocytosis
Leukopenia
Cytopenia
 Hematologic Diseases
Leukocyte Disorders
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes