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

G

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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