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

Completed

• Conditions: Preeclampsia
• Interventions: Device: Congo Red Test (GV-005)

• Registration Number: NCT02611011
• Lead Sponsor: Gynuity Health Projects

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.

Study Timeline

• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Study Start: 2018-03-01
• Primary Completion: 2018-06-30
• Status Verified: 2018-12
• Study Completion: 2018-12-30
• Last Update Submitted: 2018-12-31
• Last Update Posted: 2019-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 198

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
CRD Test Comprehension	within 5 minutes of reading test instructions	proportion of women who demonstrated various levels of understanding of the instructions for the CRD Test

Secondary Outcome Measures

Name	Time	Method
CRD Test Usability	within 5 minutes of performing test	the proportion of women able to correctly use the CRD test

Trial Locations

Locations (1)

Centro de Slaud Beatriz Velasco de Aleman; 🇲🇽 Mexico City, Mexico