Clinical Trials Logo
  1. Home
  2. Genetic Testing
  3. NCT05159011

Access to Genetic Information Leveraging Innovative Technology (AGILITY) — AGILITY  

Genetic Testing Clinical Trial

Official title:
Access to Genetic Information Leveraging Innovative Technology

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05159011
Study type Interventional
Source RTI International
Contact Barbara Biesecker, PhD
Phone 301-571-0045
Email bbiesecker@rti.org
Status Not yet recruiting
Phase N/A
Start date October 2022
Completion date September 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT03988504 - Impact of Predictive Genetic Testing
Recruiting NCT02691689 - Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions N/A
Completed NCT04704193 - Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes N/A
Completed NCT05545254 - Health-promoting Lifestyle in a Genetic Counseling Clinic
Recruiting NCT05348564 - Comparing Direct vs Indirect Methods for Cascade Screening N/A
Recruiting NCT05360095 - Comparing Game Facilitated Interactivity to Genetic Counseling for Prenatal Screening Education N/A
Active, not recruiting NCT03869515 - Genetic Causes and Clinical Features of Childhood Interstitial Lung Diseases in China
Recruiting NCT04856696 - Clinical Application of Non-invasive PGT-A N/A
Not yet recruiting NCT06073626 - Personalized Oncology Promoting Equity for Black Lives N/A
Recruiting NCT04481061 - Engaging Adolescents in Decisions About Return of Genomic Research Results N/A
Recruiting NCT04656028 - Genetic Testing and Motivational Counseling for FH N/A
Completed NCT02742116 - Evaluation of the Implementation of Expanded Carrier Screening Before Pregnancy in Hong Kong N/A
Recruiting NCT03396341 - Responses to Genetic Risk Modifier Testing Among Women With BRCA1/2 Mutations
Active, not recruiting NCT04245176 - Genetic Testing for All Breast Cancer Patients (GET FACTS) N/A
Active, not recruiting NCT02665195 - Prospective Registry of Multiplex Testing (PROMPT)
Recruiting NCT05225428 - Video Education With Result Dependent dIsclosure N/A
Recruiting NCT05265624 - The Moran AMD Genetic Testing Assessment Study Phase 2
Withdrawn NCT01663584 - Multi-disease Carrier Screening Test Validation N/A
Recruiting NCT05055700 - Impact of a Mobile App on Pregnant Women's Prenatal Genetic Testing Decision-making N/A