Genetic TestingAGILITYNCT05159011
Access to Genetic Information Leveraging Innovative Technology (AGILITY)
A study testing AGILITY (Access to Genetic Information Leveraging Innovative TechnologY) in people with Genetic Testing, run by RTI International.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genetic Testing
- What is being tested?
- AGILITY (Access to Genetic Information Leveraging Innovative TechnologY)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Positive family history of hereditary breast and ovarian cancer, and Lynch syndrome, and familial hypercholesterolemia
About this study
Official title: Access to Genetic Information Leveraging Innovative Technology
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.
Read the detailed 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.
- Conditions
- Genetic Testing
- Being tested
- AGILITY (Access to Genetic Information Leveraging Innovative TechnologY)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGILITY (Access to Genetic Information Leveraging Innovative TechnologY)Behavioural
Also called Chatbot
information about genetic testing through technology
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Virtual Genetic Counseling |
| Chatbot | Other | computer program that that uses machine learning to provide tailored counseling to patients Receives: Behavioral: AGILITY (Access to Genetic Information Leveraging Innovative TechnologY) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately after arm completion
Secondary outcomes (4)
Test-related Affect
Compare Test-related affect scale response assessed by the Feelings About Genomic Testing Results Scale (Response ranges 0-12 on the negative emotions subscale, 0-16 on the positive feelings subscale, 0-12 on the uncertainty subscale, and 0-8 on the privacy concerns subscale, all with a higher score indicating greater functional impairment.) between usual care and the intervention group at 3 months.
Measured: 3 months
Test-related Affect
ompare Test-related affect scale response assessed by the Feelings About Genomic Testing Results Scale (Response ranges 0-12 on the negative emotions subscale, 0-16 on the positive feelings subscale, 0-12 on the uncertainty subscale, and 0-8 on the privacy concerns subscale, all with a higher score indicating greater functional impairment.) between usual care and the intervention group at 6 months.
Measured: 6 months
Decisional Conflict
Compare Decisional conflict assessed by the Ottawa Decisional Conflict Scale (Response range 1-10 higher scores denote greater decisional conflict) between usual care and the intervention group at 3 months.
Measured: 3 months
Decisional Conflict
Compare Decisional conflict assessed by the Ottawa Decisional Conflict Scale (Response range 1-10 higher scores denote greater decisional conflict) between usual care and the intervention group at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study startJan 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2025 (estimated)
Why it stopped: Study never enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Genetic TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional chat bot
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida
- Responsible party
- Sponsor
- Investigators
- Barbara Biesecker, PhD, Principal investigator, RTI InternationalAlexander S Parker, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159011
- Sponsor's protocol ID
- 202100637
- Acronym
- AGILITY
- Status last verified
- Nov 2024
- First submitted
- 27 Oct 2021
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29453419Lewis 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.
PubMed 26729698Dormandy 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.
PubMed 12370321Li 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.
PubMed 30964586O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
PubMed 7898294Ames 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.
PubMed 23067225Jaques 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.
PubMed 16049990
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access to Genetic Information Leveraging Innovative Technology
- ClinicalTrials.gov ID
- NCT05159011
- Acronym / sponsor ID
- AGILITY / 202100637
- Conditions
- Genetic Testing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- University of Florida
- Study start
- Jan 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Interventional chat bot
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Virtual Genetic Counseling |
| Chatbot | Other | Behavioral: AGILITY (Access to Genetic Information Leveraging Innovative TechnologY)computer program that that uses machine learning to provide tailored counseling to patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Positive family history of hereditary breast and ovarian cancer, and Lynch syndrome, and familial hypercholesterolemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGILITY (Access to Genetic Information Leveraging Innovative TechnologY)Also: Chatbotinformation about genetic testing through technology | Behavioural | Chatbot |
Primary outcome
Informed Choice
Time frame: 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).
4 secondary outcomes
Test-related Affect
Time frame: 3 months
Test-related Affect
Time frame: 6 months
Decisional Conflict
Time frame: 3 months
Decisional Conflict
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 29453419Turbitt 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.
- Background: PubMed 26729698Lewis 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.
- Background: PubMed 12370321Dormandy 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.
- Background: PubMed 30964586Li 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.
- Background: PubMed 7898294O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
- Background: PubMed 23067225Ames 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.
- Background: PubMed 16049990Jaques 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Biesecker, PhD principal investigator
RTI International
Alexander S Parker, PhD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A study testing AGILITY (Access to Genetic Information Leveraging Innovative TechnologY) in people with Genetic Testing, run by RTI International.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Informed Choice (time frame: Immediately after arm completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05159011, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.