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

2020년 11월 3일 업데이트: Women and Infants Hospital of Rhode Island
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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

162

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Rhode Island
      • Providence, Rhode Island, 미국, 02905
        • Women and Infants Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

여성

설명

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Control
The control arm will receive standard education about cell-free DNA screening that would typically be presented during a prenatal visit.
행동: Standard (control) education.
See arm description.
실험적: Experimental
The experimental arm will receive additional education about federal legislation that protects the privacy of genetic information (Genetic Information Nondiscrimination Act, GINA).
행동: Enhanced (experimental) education
See arm description.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Knowledge about broad sharing of genetic data for non-clinical research purposes
기간: This outcome will be assessed immediately after exposure to education (day 0)
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.
This outcome will be assessed immediately after exposure to education (day 0)
Acceptability of broad sharing of genetic data for non-clinical research purposes
기간: This outcome will be assessed immediately after exposure to education (day 0)
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.
This outcome will be assessed immediately after exposure to education (day 0)

2차 결과 측정

결과 측정
측정값 설명
기간
Acceptability of retention of genetic data for non-clinical purposes
기간: This outcome will be assessed immediately after exposure to education (day 0)
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.
This outcome will be assessed immediately after exposure to education (day 0)
Acceptability of use of genetic data for non-clinical purposes
기간: This outcome will be assessed immediately after exposure to education (day 0)
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.
This outcome will be assessed immediately after exposure to education (day 0)
Knowledge and understanding of aneuploidy screening and results
기간: This outcome will be assessed immediately after exposure to education (day 0)
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.
This outcome will be assessed immediately after exposure to education (day 0)
Knowledge and understanding of carrier testing and results
기간: This outcome will be assessed immediately after exposure to education (day 0)
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.
This outcome will be assessed immediately after exposure to education (day 0)
Acceptability of retention, use, and broad sharing of fetal genetic data for non-clinical research purposes
기간: This outcome will be assessed immediately after exposure to education (day 0)
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.
This outcome will be assessed immediately after exposure to education (day 0)
Maternal rationale for pursuing cfDNA
기간: This outcome will be assessed immediately after exposure to education (day 0)
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.
This outcome will be assessed immediately after exposure to education (day 0)
Maternal knowledge of different commercial cfDNA providers
기간: This outcome will be assessed immediately after exposure to education (day 0)
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.
This outcome will be assessed immediately after exposure to education (day 0)
Maternal knowledge pertaining to Down Syndrome and the genetics of trisomies.
기간: This outcome will be assessed immediately after exposure to education (day 0)
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.
This outcome will be assessed immediately after exposure to education (day 0)
Maternal perceptions of the de-identifiability of genetic data
기간: This outcome will be assessed immediately after exposure to education (day 0)
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.
This outcome will be assessed immediately after exposure to education (day 0)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Women and Infants Hospital of Rhode Island

수사관

  • 수석 연구원: Christian Parobek, Department of OB/GYN, Women and Infants Hospital

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 7월 21일

기본 완료 (실제)

2020년 10월 16일

연구 완료 (실제)

2020년 10월 16일

연구 등록 날짜

최초 제출

2020년 5월 18일

QC 기준을 충족하는 최초 제출

2020년 6월 3일

처음 게시됨 (실제)

2020년 6월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 11월 3일

마지막으로 확인됨

2020년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1500909-1

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

IPD 공유 기간

De-identified study data will be available after publication and for a time period of 6 years after enrollment of the final volunteer.

IPD 공유 액세스 기준

De-identified study data will be shared with researchers upon request.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

임신 관련에 대한 임상 시험

Standard (control) education.에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Turkmenistan

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다