Validation of Texture Changing Coatings for Use in At-Home Rapid Tests

NCT06539728 | Not Yet Recruiting FDA Device

• 1 other identifier: 2181777
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vision, Low; Blindness

Keywords

Tactile Aid

Outcome Measures

Primary Outcomes (4)

• 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.

  Through study completion, an average of 1 year

• 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.

  Through study completion, an average of 1 year

• 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.

  Through study completion, an average of 1 year

• 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.

  Through study completion, an average of 1 year

Study Arms (1)

Interaction with Coated Surfaces

EXPERIMENTAL

Participants in this arm will interact with the device and surface coated with the polymer-antibody coating. Subjects will be trained with a "positive" test and "negative" test prior to device testing. Subjects will then administer the synthetic saliva themselves and asked to determine if there was COVID antigen in the saliva by touching the device to compare the test patch to the positive and negative control patches. Subjects will also rate device usability.

Diagnostic Test: Interaction with Mock COVID-19 Rapid Antigen Test and Reference Surfaces; Diagnostic Test: Biomechanical Measurements; Behavioral: Psychophysical Tasks

Interventions

Interaction with Mock COVID-19 Rapid Antigen Test and Reference Surfaces DIAGNOSTIC_TEST

Participants 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.

Interaction with Coated Surfaces

Biomechanical Measurements DIAGNOSTIC_TEST

Participants 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.

Interaction with Coated Surfaces

Psychophysical Tasks BEHAVIORAL

Participants 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.

Interaction with Coated Surfaces

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Limb Conditions: Participants with amputations or outer extremity conditions affecting hand use will be excluded.

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19711, United States

Location

MeSH Terms

Conditions

Vision, Low; Blindness

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmacological Phenomena; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Central Study Contacts

Charles Dhong, PhD

CONTACT

302-831-2828; cdhong@udel.edu

Cynthia Papettas

CONTACT

302-279-6766; cpap@Udel.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: August 6, 2024
• Study Start: June 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)