Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands

Completed · Not applicable

Conditions studied: Albuminuria

In brief

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".

Key facts

Study ID

NCT04626271

Run by

Healthy.io Ltd.

People needed

250

Starts

2020-08-31

Expected to finish

2020-10-25

Last updated by the study team

2023-05-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• AccuMed research associates — Garden City, New York, United States
• PMG Research of Charleston — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.