NCT02611011

Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Survey

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 198 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: 10 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To determine if women can understand the instructions, carry out the test, and interpret the test results. Women will be recruited to complete a test instruction and comprehension assessment and a usability assessment.

Detailed description

To determine if women can understand the instructions, carry out the test, and interpret the test results. Women will be recruited to complete a test instruction and comprehension assessment and a usability assessment. Study participants will be a convenience sample of women seeking health services. Participants will first be asked to review the instructions for the Congo Red Dot Test and complete a short written questionnaire that assesses their comprehension of the test instructions. Participants will then be asked to perform the test using a test control and to interpret the results obtained by answering a second written questionnaire. After the woman performs the test, a healthcare provider will use a matched control to perform a second test.

Conditions

• Preeclampsia

Interventions

Type	Name	Description
DEVICE	Congo Red Test (GV-005)	The GV-005 is a simple test has been developed to detect unfolded or misfolded proteins in urine.

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-06-30
• Completion: 2018-12-30
• First posted: 2015-11-20
• Last updated: 2019-01-03

Locations

1 site across 1 country: Mexico