- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07325617
Tracking AI/LLM Literacy and Knowledge in Urology Outpatients (TALK-U) (TALK-U)
The TALK-U Study: Tracking AI/LLM Knowledge and Use in Urology Outpatients and Its Association With Anxiety, Satisfaction, and Health Awareness-A Cross-Sectional Study
This study is a one-time, questionnaire-based survey of adults attending a urology outpatient clinic. The investigators will examine whether patients who use AI chat tools based on large language models (LLMs), such as ChatGPT, before seeking care differ from non-users in (1) anxiety, (2) satisfaction with the clinic visit, and (3) awareness/understanding of their health condition.
Participants who provide written informed consent will complete a brief survey during their clinic visit (about 5-7 minutes). The survey includes a standardized anxiety scale (GAD-7), visual analog scales (0-10) for anxiety before and after the visit, satisfaction, and disease awareness, as well as questions about AI/LLM knowledge and use. Treating clinicians will not have access to participants' survey responses, and participation will not affect clinical care.
Study Overview
Status
Conditions
Detailed Description
The TALK-U study is a cross-sectional, observational survey conducted in the urology outpatient clinic of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. The primary exposure is self-reported AI/LLM knowledge and use for health information (e.g., whether participants have used ChatGPT or similar tools, frequency, awareness of AI, and purpose of use). The primary outcome is anxiety measured by GAD-7 at the time of the clinic encounter. Secondary outcomes include (i) anxiety assessed on a 0-10 visual analog scale before and after the visit, (ii) outpatient visit satisfaction (0-10 VAS), and (iii) perceived disease awareness/understanding (0-10 VAS).
Eligible adult first-time urology outpatients who can complete the survey independently and provide informed consent will be invited during a 2-month recruitment period. Analyses will compare outcomes between AI/LLM users and non-users and explore associations with age group (<40, 40-60, >60), education level, and urology subspecialty category. Data will be analyzed using appropriate parametric/nonparametric tests depending on distribution, with p < 0.05 considered statistically significant.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Tuncel Uzel, MD
- Phone Number: 5622 +90 312 336 09 09
- Email: tunceluzelmd@gmail.com
Study Contact Backup
- Name: Mehmet Duvarcı, MD
- Phone Number: 5616 +90 312 336 09 09
- Email: mehmet_duvarci@hotmail.com
Study Locations
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Yenimahalle/Ankara
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Ankara, Yenimahalle/Ankara, Turkey (Türkiye), 06200
- Dr.Abdurrahman Yurtaslan Ankara Oncology Research and Training Hospital
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Contact:
- Tuncel Uzel, MD
- Phone Number: 5622 +90 312 336 09 09
- Email: tunceluzelmd@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or older
- First-time visit to the Urology Outpatient Clinic
- Able to read and write and complete the questionnaire independently
- Able to provide written informed consent
Exclusion Criteria:
- Age under 18 years
- Insufficient literacy to understand and complete the questionnaire
- Severe hearing or visual impairment, or a neurological/psychiatric condition that prevents understanding and completing the survey
- Refusal or inability to provide informed consent
- Currently under follow-up for a known urologic condition (i.e., not a first-time urology outpatient visit)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
AI/LLM users
Participants who report prior use of AI chat tools based on large language models (e.g., ChatGPT or similar) for health information before the outpatient urology visit, as assessed by the study questionnaire.
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non AI/LLM users
Participants who report no prior use of AI/LLM chat tools (e.g., ChatGPT or similar) for health information before the outpatient urology visit, as assessed by the study questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-visit Anxiety (VAS 0-10)
Time Frame: Day 0 (immediately before the outpatient visit)
|
Self-rated anxiety on a 0-10 visual analog scale (VAS), where 0 indicates no anxiety and 10 indicates the highest possible anxiety.
This measure reflects visit-related state anxiety prior to clinician encounter.
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Day 0 (immediately before the outpatient visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-visit Anxiety (VAS 0-10)
Time Frame: Day 0 (immediately after the outpatient visit)
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Self-rated anxiety on a 0-10 VAS (0 = none, 10 = highest).
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Day 0 (immediately after the outpatient visit)
|
|
Visit Satisfaction (VAS 0-10)
Time Frame: Day 0 (immediately after the outpatient visit)
|
Self-rated satisfaction with the outpatient visit on a 0-10 VAS (0 = not satisfied at all, 10 = maximum satisfaction).
|
Day 0 (immediately after the outpatient visit)
|
|
Disease Awareness/Understanding (VAS 0-10)
Time Frame: Day 0 (during the outpatient clinic visit)
|
Self-rated awareness/understanding of one's condition on a 0-10 VAS (0 = none, 10 = complete).
|
Day 0 (during the outpatient clinic visit)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline General Anxiety Symptoms (GAD-7 Total Score)
Time Frame: Day 0 (at enrollment; prior to or during the clinic visit)
|
Total score on the 7-item GAD-7 questionnaire (range 0-21; higher scores indicate greater generalized anxiety symptoms).
This measure will be used to account for baseline anxiety (trait-like symptoms) and to adjust analyses of VAS-based state anxiety out
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Day 0 (at enrollment; prior to or during the clinic visit)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-06/98
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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