跳至主要内容
临床试验/NCT05159011
NCT05159011撤回不适用

Access to Genetic Information Leveraging Innovative Technology

RTI International0 个研究点目标入组 2,400 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
2,400
主要终点
Informed Choice

研究概览

简要总结

AGILITY is a type 1 hybrid trial that will test the effectiveness of a chatbot to provide pre-test information about genetic screening for tier 1 conditions. A randomized control trial of 2400 adult participants from diverse primary care clinics at the University of Florida Gainesville to receive virtual information about tier 1 condition genetic testing from a chatbot or traditional genetic counseling. The assessment of the outcome of the trial is to determine whether the chatbot is inferior to genetic counseling. Non-inferiority will be determined based on informed choice to undergo testing (or not). Implementation outcomes of acceptability, feasibility, and appropriateness will be evaluated to inform future potential through interviews with patients, primary care providers and GCs.

详细描述

AGILITY is a type 1 hybrid trial that will test the effectiveness of a chatbot to provide pre-test information about genetic screening for tier 1 conditions. A randomized control trial of 2400 adult participants from diverse primary care clinics at the University of Florida Gainesville to receive virtual information about tier 1 condition genetic testing from a chatbot or traditional genetic counseling. The assessment of the outcome of the trial is to determine whether the chatbot is inferior to genetic counseling. Non-inferiority will be determined based on informed choice to undergo testing (or not). Implementation outcomes of acceptability, feasibility, and appropriateness will be evaluated to inform future potential through interviews with patients, primary care providers and GCs. This trial will provide evidence of whether chatbots can serve to address a shortage of genetic counselors by extending pre-test education in a population screening environment to alternate sources such as chatbots. Inclusion of an observation arm for individuals with positive family history who then are offered traditional clinical genetic service is a strength of the design that will allow for contrast between populations and service models as well. Inclusion of assessments of feasibility, acceptability, and appropriateness from multiple stakeholders is critical to future study design and implementation potential.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Investigator)

盲法说明

Investigator masked from randomization until results analysis.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 years or older
  • •Male or Female
  • •University of Florida Gainesville primary care patients
  • •Negative family history for hereditary breast and ovarian cancer, and Lynch syndrome and familial hypercholesterolemia

排除标准

  • •Positive family history of hereditary breast and ovarian cancer, and Lynch syndrome, and familial hypercholesterolemia

研究组 & 干预措施

Usual Care

No Intervention

Virtual Genetic Counseling

Chatbot

Other

computer program that that uses machine learning to provide tailored counseling to patients

干预措施: AGILITY (Access to Genetic Information Leveraging Innovative TechnologY) (Behavioral)

结局指标

主要结局

Informed Choice

时间窗: Immediately after arm completion

The number of participants that made an informed choice (Multi-dimensional Model of Informed Choice) following a chatbot intervention compared to the number of participants that made an informed choice following genetic counseling. Informed choice is measured using a composite tool that includes understanding of relevant knowledge (1-8 items-higher scores indicate greater knowledge), attitudes toward testing (1-5 items-higher scores represent more positive attitudes), and whether the test decision is congruent with personal values (positive or negative about testing in relation to whether testing was accepted or declined).

次要结局

  • Test-related Affect(6 months)
  • Decisional Conflict(6 months)
  • Test-related Affect(3 months)
  • Decisional Conflict(3 months)

研究者

申办方类型
Other
责任方
Sponsor

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