Access to Genetic Information Leveraging Innovative Technology (AGILITY)

NCT05159011 | Withdrawn

• 1 other identifier: 202100637
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Genetic Testing

Outcome Measures

Primary Outcomes (1)

• Informed Choice

  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).

  Immediately after arm completion

Secondary Outcomes (4)

• Test-related Affect

  3 months

• Test-related Affect

  6 months

• Decisional Conflict

  3 months

• Decisional Conflict

  6 months

Study Arms (2)

Usual Care

NO INTERVENTION

Virtual Genetic Counseling

Chatbot

OTHER

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

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

Interventions

AGILITY (Access to Genetic Information Leveraging Innovative TechnologY) BEHAVIORAL

information about genetic testing through technology

Also known as: Chatbot

Chatbot

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• RTI International: lead
• University of Florida: collaborator

Related Publications (7)

• Turbitt E, Chrysostomou PP, Peay HL, Heidlebaugh AR, Nelson LM, Biesecker BB. A randomized controlled study of a consent intervention for participating in an NIH genome sequencing study. Eur J Hum Genet. 2018 May;26(5):622-630. doi: 10.1038/s41431-018-0105-7. Epub 2018 Feb 16.

  PMID: 29453419 BACKGROUND

• Lewis MA, Paquin RS, Roche MI, Furberg RD, Rini C, Berg JS, Powell CM, Bailey DB Jr. Supporting Parental Decisions About Genomic Sequencing for Newborn Screening: The NC NEXUS Decision Aid. Pediatrics. 2016 Jan;137 Suppl 1(Suppl 1):S16-23. doi: 10.1542/peds.2015-3731E.

  PMID: 26729698 BACKGROUND

• Dormandy E, Hooper R, Michie S, Marteau TM. Informed choice to undergo prenatal screening: a comparison of two hospitals conducting testing either as part of a routine visit or requiring a separate visit. J Med Screen. 2002;9(3):109-14. doi: 10.1136/jms.9.3.109.

  PMID: 12370321 BACKGROUND

• Li M, Bennette CS, Amendola LM, Ragan Hart M, Heagerty P, Comstock B, Tarczy-Hornoch P, Fullerton SM, Regier DA, Burke W, Trinidad SB, Jarvik GP, Veenstra DL, Patrick DL. The Feelings About genomiC Testing Results (FACToR) Questionnaire: Development and Preliminary Validation. J Genet Couns. 2019 Apr;28(2):477-490. doi: 10.1007/s10897-018-0286-9. Epub 2018 Dec 14.

  PMID: 30964586 BACKGROUND

• O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.

  PMID: 7898294 BACKGROUND

• Ames AG, Jaques A, Ukoumunne OC, Archibald AD, Duncan RE, Emery J, Metcalfe SA. Development of a fragile X syndrome (FXS) knowledge scale: towards a modified multidimensional measure of informed choice for FXS population carrier screening. Health Expect. 2015 Feb;18(1):69-80. doi: 10.1111/hex.12009. Epub 2012 Oct 15.

  PMID: 23067225 BACKGROUND

• Jaques AM, Sheffield LJ, Halliday JL. Informed choice in women attending private clinics to undergo first-trimester screening for Down syndrome. Prenat Diagn. 2005 Aug;25(8):656-64. doi: 10.1002/pd.1218.

  PMID: 16049990 BACKGROUND

Study Officials

• Barbara Biesecker, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

• Alexander S Parker, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator masked from randomization until results analysis.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional chat bot

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: December 15, 2021
• Study Start: January 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11