Access to Genetic Information Leveraging Innovative Technology (AGILITY)

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-31

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Genetic Testing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional chat bot

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators

Investigator masked from randomization until results analysis.

Study Groups

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Usual Care

Virtual Genetic Counseling

Group Type NO_INTERVENTION

No interventions assigned to this group

Chatbot

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

Group Type OTHER

AGILITY (Access to Genetic Information Leveraging Innovative TechnologY)

Intervention Type BEHAVIORAL

information about genetic testing through technology

Interventions

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AGILITY (Access to Genetic Information Leveraging Innovative TechnologY)

information about genetic testing through technology

Intervention Type BEHAVIORAL

Other Intervention Names

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Chatbot

Eligibility Criteria

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Inclusion Criteria

* 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