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AzTrials

AneuploidyNCT04420858

Effect of Video Education on Patients' Knowledge and Attitudes of Privacy in Prenatal Genetics

A study testing Enhanced (experimental) education in people with Aneuploidy and Genetic Disease, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators propose a randomized controlled trial to assess baseline maternal knowledge of and attitudes toward commercial prenatal genetic testing laboratories' genetic privacy practices, and to determine whether a brief educational intervention alters these attitudes. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Aneuploidy, Genetic Disease, Pregnancy Related
What is being tested?
Enhanced (experimental) education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 siteUnited States
Study dates
21 Jul 2020to 16 Oct 2020
Phase
Interventional
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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Pregnant patients undergoing a scheduled L2 ultrasound at the Women and Infants Prenatal Diagnosis Center (PDC)
  • Singleton pregnancies
  • English speaking
  • Results available from cell-free DNA screening for this pregnancy

Who cannot join

  • Prior L2 ultrasound at the PDC during the current pregnancy (to avoid test-retest or multiple approach)
  • Prior participation in this study
  • Gestational age <17'0 weeks or >23'6 weeks
  • Suboptimally dated pregnancies (i.e. dated by ultrasound after 22 weeks gestation)
  • Unscheduled / add-on L2 ultrasounds

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

Other trials in United States

About this study

The investigators propose a randomized controlled trial to assess baseline maternal knowledge of and attitudes toward commercial prenatal genetic testing laboratories' genetic privacy practices, and to determine whether a brief educational intervention alters these attitudes.

Read the detailed description

The investigators propose a randomized controlled trial to assess baseline maternal knowledge of and attitudes toward commercial prenatal genetic testing laboratories' genetic privacy practices, and to determine whether a brief educational intervention alters these attitudes. Pregnant women undergoing specialized fetal anatomic ultrasound surveys at Women and Infants' maternal fetal medicine prenatal diagnostic imaging centers will be recruited to participate. Volunteers will be randomized to receive either standard education about prenatal genetic testing or standard education plus additional education about federal genetic privacy protections. Next, the participants view the educational materials to which they were randomized. Finally, all volunteers will take the same survey, which will assess baseline demographic variables as well as their knowledge of and attitudes toward broad sharing of data obtained from prenatal genetic testing. Once finished with the survey, volunteers will have completed their participation in this study.

Being tested
Enhanced (experimental) education, Standard (control) education.
Keywords
Genetic privacy, Aneuploidy screening, Pregnancy, Data use, Data sharing, Protected health information
Medical subject headings
Aneuploidy, Genetic Diseases, Inborn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced (experimental) educationBehavioural

    See arm description.

  • Standard (control) education.Behavioural

    See arm description.

Study groups in NCT04420858
Study groupRoleWhat they receive
ControlOtherThe control arm will receive standard education about cell-free DNA screening that would typically be presented during a prenatal visit.
Receives: Behavioral: Standard (control) education.
ExperimentalExperimentalThe experimental arm will receive additional education about federal legislation that protects the privacy of genetic information (Genetic Information Nondiscrimination Act, GINA).
Receives: Behavioral: Enhanced (experimental) education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knowledge about broad sharing of genetic data for non-clinical research purposes

    Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient knowledge about the potential sharing of their genetic data for non-clinical research purposes? Outcome will be measured on the Likert scale.

    Measured: This outcome will be assessed immediately after exposure to education (day 0)

  2. Acceptability of broad sharing of genetic data for non-clinical research purposes

    Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient acceptance of laboratory-initiated sharing of their de-identified genetic data for non-clinical purposes? Outcome will be measured on the Likert scale.

    Measured: This outcome will be assessed immediately after exposure to education (day 0)

Secondary outcomes (9)

  1. Acceptability of retention of genetic data for non-clinical purposes

    Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient acceptance of retaining their de-identified genetic data to potentially use it for non-clinical purposes? Outcome will be measured on the Likert scale.

    Measured: This outcome will be assessed immediately after exposure to education (day 0)

  2. Acceptability of use of genetic data for non-clinical purposes

    Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What is patient acceptance of using their de-identified genetic data for non-clinical purposes such as research and development? Outcome will be measured on the Likert scale.

    Measured: This outcome will be assessed immediately after exposure to education (day 0)

  3. Knowledge and understanding of aneuploidy screening and results

    Are patients aware that they underwent aneuploidy screening with cell-free fetal DNA (cfDNA)? Are they aware of their results? Outcome will be measured on the Likert scale.

    Measured: This outcome will be assessed immediately after exposure to education (day 0)

  4. Knowledge and understanding of carrier testing and results

    Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: Are patients aware that they underwent carrier testing? Are they aware of their results? Outcome will be measured on the Likert scale.

    Measured: This outcome will be assessed immediately after exposure to education (day 0)

  5. Acceptability of retention, use, and broad sharing of fetal genetic data for non-clinical research purposes

    Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: Assess maternal acceptance of each of these outcomes. Outcome will be measured on the Likert scale.

    Measured: This outcome will be assessed immediately after exposure to education (day 0)

  6. Maternal rationale for pursuing cfDNA

    Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: What prompted patient to pursue cfDNA testing? Outcome will be measured on the Likert scale.

    Measured: This outcome will be assessed immediately after exposure to education (day 0)

  7. Maternal knowledge of different commercial cfDNA providers

    Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: Are patents who have undergone cfDNA testing aware that multiple companies offer this service? Outcome will be measured on the Likert scale.

    Measured: This outcome will be assessed immediately after exposure to education (day 0)

  8. Maternal knowledge pertaining to Down Syndrome and the genetics of trisomies.

    Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: To what extent do mothers who have undergone cfDNA screening and are participating in this study understand these topics? Outcome will be measured on the Likert scale.

    Measured: This outcome will be assessed immediately after exposure to education (day 0)

  9. Maternal perceptions of the de-identifiability of genetic data

    Using a newly designed survey instrument (the Prenatal Testing Opinions Survey), the investigators aim to answer the following question: To what extent do mothers who have undergone cfDNA screening believe that deidentified genetic information is not re-identifiable? Outcome will be measured on the Likert scale.

    Measured: This outcome will be assessed immediately after exposure to education (day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start21 Jul 2020
  3. Primary completion16 Oct 2020
  4. Study completion16 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04420858
Sponsor's protocol ID
1500909-1
Status last verified
Nov 2020
First submitted
18 May 2020
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Non-identifiable data will be freely shared with other researchers upon request for facilitate reproducibility or future systemic review, pending approval from local institutional review board.

Publications

  • Parobek CM, Thorsen MM, Has P, Lorenzi P, Clark MA, Russo ML, Lewkowitz AK. Video education about genetic privacy and patient perspectives about sharing prenatal genetic data: a randomized trial. Am J Obstet Gynecol. 2022 Jul;227(1):87.e1-87.e13. doi: 10.1016/j.ajog.2022.03.047. Epub 2022 Mar 26.

    PubMed 35351406

  • Parobek CM, Has P, Lorenzi P, Russo ML, Clark MA, Lewkowitz AK. What test did I have? Patient uncertainty about prenatal genetic screening. Am J Obstet Gynecol. 2021 Sep;225(3):341-342. doi: 10.1016/j.ajog.2021.05.030. Epub 2021 May 27. No abstract available.

    PubMed 34051169

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced (experimental) education in people with Aneuploidy and Genetic Disease, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

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 4 inclusion and 5 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 4 Nov 2020. 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 United States. 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?

Knowledge about broad sharing of genetic data for non-clinical research purposes (time frame: This outcome will be assessed immediately after exposure to education (day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04420858, which also lists 2 linked publications.

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 4 Nov 2020.

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