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OpenTrials
Completed

NCT Number: NCT02611011

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

10 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Centro de Slaud Beatriz Velasco de Aleman

Mexico City, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Congo Red Test (GV-005)

Device

The GV-005 is a simple test has been developed to detect unfolded or misfolded proteins in urine.

Primary outcomes

  1. CRD Test Comprehension

    Time frame: within 5 minutes of reading test instructions

    proportion of women who demonstrated various levels of understanding of the instructions for the CRD Test

Secondary outcomes

  1. CRD Test Usability

    Time frame: within 5 minutes of performing test

    the proportion of women able to correctly use the CRD test

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2015
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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