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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02611011
Enrollment
198
Registered
2015-11-20
Start date
2018-03-01
Completion date
2018-12-30
Last updated
2019-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Keywords

Congo Red Dot Test

Brief 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.

Interventions

DEVICECongo Red Test (GV-005)

The GV-005 is a simple test has been developed to detect unfolded or misfolded proteins in urine.

Sponsors

Gynuity Health Projects
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
10 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Eligible to consent for research * Able to read Spanish well enough to read the test instructions * Able to give informed consent

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
CRD Test Comprehensionwithin 5 minutes of reading test instructionsproportion of women who demonstrated various levels of understanding of the instructions for the CRD Test

Secondary

MeasureTime frameDescription
CRD Test Usabilitywithin 5 minutes of performing testthe proportion of women able to correctly use the CRD test

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026