Clinical trial NCT04626271: Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands
Official title: Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Albuminuria
Lead sponsor: Healthy.io Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Eligible subjects meeting the pathological profile will be recruited at the designated site by the study personnel. Following subject consent, the subjects will be evaluated for eligibility based on their health condition and history.

The ACR \| U.S. kit, in its original packaging, along with the ACR \| U.S. smartphone application will be provided to the subject in a simulated home- use environment. All subjects will be provided with a list of tasks to complete, including providing a urine sample and operating the ACR \| U.S. device on 2 mobile phones. After completing the test, the lay user will complete a post-test questionnaire. The study observer will also complete a questionnaire to collect information regarding the lay users' use of the ACR \| U.S.

The device use will be compared with identified risks to determine if the percentage of failures is acceptable. Additionally, measurable usability criteria for specific, critical steps will be evaluated.

Following the usability test performed by the lay user, the subjects' urine samples will be tested by the study staff using the comparator device. These results will be considered as the "true value".


Eligibility criteria: Inclusion Criteria:

* Males and Females 18-80 years of age.
* Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of albumin:

  * Diabetes Type I/Type II,
  * Hypertension,
  * any kidney disease,
  * other relevant conditions,
* or, subjects who are healthy or pregnant.
* Subject is familiar with the use of a smartphone.
* Subject is capable of comprehending and following instructions in English.
* Subject has facility with both hands.
* Subject is capable and willing to adhere to the study procedures.
* Subject is capable and willing to provide informed consent.

Exclusion Criteria:

* Subject has dementia.
* Subject has severe mental disorders.
* Subject cannot collect urine in a receptacle.
* Subject is visually impaired (cannot read the user manual).
* Any additional reason the study physician believes disqualifies the subject from participating in the study.

Primary outcomes:
measure: Accuracy Evaluation: The Degree of Agreement (%) of the ACR | U.S. Urine Analysis Test System as Compared to the Comparator Device
timeFrame: 2 months
Secondary outcomes:
measure: Usability Evaluation: User Performance Analysis
timeFrame: 2 months
Other outcomes:
Locations:
city: Garden City
country: United States
facility: AccuMed research associates
state: New York
city: Charleston
country: United States
facility: PMG Research of Charleston
state: South Carolina
Study officials:
References: