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

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02611011
• Other study ID #: 4005B
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: December 2018
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: December 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 50 Years

Eligibility

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:

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Device:
• Congo Red Test (GV-005)
The GV-005 is a simple test has been developed to detect unfolded or misfolded proteins in urine.

Locations

Country	Name	City	State
Mexico	Centro de Slaud Beatriz Velasco de Aleman	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRD Test Comprehension	proportion of women who demonstrated various levels of understanding of the instructions for the CRD Test	within 5 minutes of reading test instructions
Secondary	CRD Test Usability	the proportion of women able to correctly use the CRD test	within 5 minutes of performing test