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

Gynuity Health Projects

Status: Completed

Conditions: Preeclampsia

Treatments: Device: Congo Red Test (GV-005)

Study type: Observational

Funder types: Other

Identifiers

NCT02611011

4005B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 patients

Sex: Female

Ages: 10 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

198 participants in 1 patient group

Women

Description:

Women seeking health services will perform the Congo Red Dot test (GV-005) individually by following the the test instructions

Treatment:

Device: Congo Red Test (GV-005)