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

NCT ID: NCT02611011

Last Updated: 2019-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2018-12-30

Brief Summary

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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

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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.

Conditions

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Preeclampsia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Women

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

Congo Red Test (GV-005)

Intervention Type DEVICE

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

Interventions

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Congo Red Test (GV-005)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gynuity Health Projects

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beverly Winikoff, Dr

Role: PRINCIPAL_INVESTIGATOR

Gynuity Health Projects

Locations

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Centro de Slaud Beatriz Velasco de Aleman

Mexico City, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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4005B

Identifier Type: -

Identifier Source: org_study_id

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