Validation of Texture Changing Coatings for Use in At-Home Rapid Tests
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorUniversity of Delaware
About this trial
At-home testing is an important part of mitigating the spread of COVID-19, but these tests are not accessible to people with low vision or blindness. Instead of adapting to a technology originally built for sighted people, investigators propose a no-power version that reports test results through a texture change, which people can feel by touch. This platform could be used not only for COVID, but also for other diagnostics, and will promote the independence and privacy for people with low vision or blindness by removing the need for human assistance or an internet connection.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Visual Impairment: Participants should be blind or visually impaired for greater than 10 years, either congenitally or acquired.
Tactile Aid Usage: Participants must use tactile aids regularly.
Mathematical Knowledge: Participants should have a basic understanding of mathematical plots, equivalent to at least high school geometry.
Disqualifiers
Limb Conditions: Participants with amputations or outer extremity conditions affecting hand use will be excluded.
Trial design
Design model
Single group
Treatments tested in this trial
Interaction with Mock COVID-19 Rapid Antigen Test and Reference Surfaces
Diagnostic testParticipants will drop a saline solution with proteins onto the testing device. They will wait for it to dry and then report on the tactile sensation and overall feel of the surface. Feedback will include comparisons with the two reference surfaces. The primary goal is to determine the presence of mock COVID antigen in synthetic saliva using the device, which aligns with the goals of diagnostic testing.
Biomechanical Measurements
Diagnostic testParticipants may have biomechanical measurements recorded, such as placing samples on a scale to measure downward force or using medical tape with a flexible wire to track finger motion. These measurements are likely aimed at objectively assessing how participants interact with the surfaces and their physical responses to tactile stimuli.
Psychophysical Tasks
BehavioralParticipants may alternatively be asked to perform standardized psychophysical tasks, such as Two Alternative Forced Choice tests, Odd-Man Out tests, or Magnitude Estimation tests. These tasks will provide structured comparisons and quantitative data on participants' perception and preferences regarding tactile qualities. The tasks are designed to evaluate participants' perception and preferences regarding tactile qualities, which involves behavioral responses to sensory stimuli.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Interaction with Coated SurfacesExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Success rate of identifying whether the model test is positive or negative
After familiarization, test trials will involve participants dropping a test solution onto the device with a test slab as well as positive and negative control slabs. They will be asked to identify whether the test is positive or negative, based on how the test slab feels to the touch compared to the controls. Participants will be evaluated on whether or not their response is correct. This will be repeated 10 times per participant to record a percentage of success.
Time frame
Through study completion, an average of 1 year2
Response time of each trial of a participant identifying whether the model test is positive or negative
A Qualtrics form will be used to record participant responses. Each trial will have its own page on the form during data collection. A trial will begin when the test administrator opens its page, and participants will be prompted to decide whether the device is displaying a positive or negative result. Once participants choose, the administrator will select their answers on the form, and the time to the last click will be recorded as their response time. This will be repeated 10 times.
Time frame
Through study completion, an average of 1 year3
Usability feedback
Subjects participating in the clinical trial will be invited to provide feedback on the usability and their preferences regarding the tactile aid introduced in the study. The assessment will be conducted using a modified Likert scale. This outcome aims to gather subjective experiences related to the use of new tactile aids throughout the trials. Throughout the study, participants will be consistently asked to comment on the usability and their preferences based on the tactile aid. This ongoing feedback will enable a comprehensive understanding of their experiences over time. Modified Likert Scale: Strongly Disagree Disagree Somewhat Disagree Neutral Somewhat Agree Agree Strongly Agree Extremely Agree Exceptionally Agree Title: Usability of Tactile Aid Min: 1 Max: 9 Higher the score, the better the outcome/ usability of the tactile aid.
Time frame
Through study completion, an average of 1 year4
General feedback
Subjects participating in the clinical trial will be invited to provide feedback on the usability and their preferences regarding the tactile aid introduced in the study. The assessment will be conducted by asking participants for general feedback on the device they used. Throughout the study, participants will be consistently asked to comment on the usability and their preferences based on the tactile aid. This ongoing feedback will enable a comprehensive understanding of their experiences over time.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: