PreeclampsiaNCT02611011
Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Survey
An observational study of Preeclampsia, run by Gynuity Health Projects at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 10 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Congo Red Test (GV-005)
- Type of treatment
- Medical device
- How many people
- 198 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2018to 30 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women attending Centre de Salud Beatriz Velasco de Aleman for health services
Who may be able to join
- Eligible to consent for research
- Able to read Spanish well enough to read the test instructions
- Able to give informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
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.
Read the 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.
- Conditions
- Preeclampsia
- Being tested
- Congo Red Test (GV-005)
- Keywords
- Congo Red Dot Test
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Congo Red Test (GV-005)Device
The GV-005 is a simple test has been developed to detect unfolded or misfolded proteins in urine.
| Study group | Role | What they receive |
|---|---|---|
| Women | Women seeking health services will perform the Congo Red Dot test (GV-005) individually by following the the test instructions Receives: Device: Congo Red Test (GV-005) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRD Test Comprehension
proportion of women who demonstrated various levels of understanding of the instructions for the CRD Test
Measured: within 5 minutes of reading test instructions
Secondary outcomes (1)
CRD Test Usability
the proportion of women able to correctly use the CRD test
Measured: within 5 minutes of performing test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start1 Mar 2018
- Primary completion30 Jun 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, Dr, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611011
- Sponsor's protocol ID
- 4005B
- Status last verified
- Dec 2018
- First submitted
- 18 Nov 2015
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Usability and Clinical Utility of the Congo Red Dot Test: A Survey
- ClinicalTrials.gov ID
- NCT02611011
- Acronym / sponsor ID
- 4005B
- Conditions
- Preeclampsia
- Keywords
- Congo Red Dot Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women | – | Device: 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 |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women attending Centre de Salud Beatriz Velasco de Aleman for health services
Key inclusion criteria (3 listed)
- Eligible to consent for research
- Able to read Spanish well enough to read the test instructions
- Able to give informed consent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Congo Red Test (GV-005)The GV-005 is a simple test has been developed to detect unfolded or misfolded proteins in urine. | Device | Women |
Primary outcome
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
1 secondary outcome
CRD Test Usability
Time frame: within 5 minutes of performing test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverly Winikoff, Dr principal investigator
Gynuity Health Projects
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Gynuity Health Projects at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRD Test Comprehension (time frame: within 5 minutes of reading test instructions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.