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

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 Overview

• Status: Completed
• Conditions: Preeclampsia
• Intervention / Treatment: Device: Congo Red Test (GV-005)

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 Type: Observational
• Enrollment (Actual): 198

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Centro de Slaud Beatriz Velasco de Aleman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women attending Centre de Salud Beatriz Velasco de Aleman for health services

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women; Women seeking health services will perform the Congo Red Dot test (GV-005) individually by following the the test instructions	Device: Congo Red Test (GV-005); The GV-005 is a simple test has been developed to detect unfolded or misfolded proteins in urine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRD Test Usability	the proportion of women able to correctly use the CRD test	within 5 minutes of performing test

Collaborators and Investigators

• Sponsor: Gynuity Health Projects

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): December 30, 2018

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 18, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): January 3, 2019
• Last Update Submitted That Met QC Criteria: December 31, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Congo Red Dot Test
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: 4005B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided