Clinical trial NCT06778486: Conversations in Health Literacy Using AI Technology for Osteoarthritis Patients
Official title: CHAT-OA: Conversations in Health Literacy Using AI Technology for Osteoarthritis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis
Osteoarthritis of the Hip or Knee
Keywords: artificial intelligence
health literacy
decisional conflict
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to assess the use of a generative artificial intelligence large language model chatbot in improving decision making factors in patients with hip and knee osteoarthritis. The main questions it aims to answer are:

Does the use of an artificial intelligence chatbot have an effect on decisional conflict and anxiety related to decision making? Are changes in decisional conflict correlated with changes in patient reported outcomes? Are changes in decisional conflict correlated with health literacy? Participants will interact with an artificial intelligence chatbot prior to their clinic visit with an orthopaedic surgeon, using a structured prompt.


Eligibility criteria: Inclusion Criteria:

* Adult
* Ability to read and write in English
* All races and ethnicities
* Clinical symptoms of hip and/or knee osteoarthritis

Exclusion Criteria:

* Inability to read and write in English

Primary outcomes:
measure: Decisional Conflict Scale
timeFrame: At three time points: Within one week after the clinic visit, 1 month after the clinic visit, 6 months after the clinic visit.
measure: Beck Anxiety Inventory
timeFrame: At three time points: Within one week after the clinic visit, 1 month after the clinic visit, 6 months after the clinic visit.
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score for Joint Replacement
timeFrame: At enrollment
measure: Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement
timeFrame: At enrollment
measure: Patient-Reported Outcomes Measurement Information System Global Health Version 1.2
timeFrame: At enrollment
Other outcomes:
measure: Visual Analog Scale Pain Score
timeFrame: At enrollment
measure: Health Literacy Single Item Screener
timeFrame: At enrollment
measure: Newest Vital Sign
timeFrame: At enrollment
measure: Literacy in Musculoskeletal Problems
timeFrame: At enrollment
measure: Rapid Estimate of Adult Literacy in Medicine - Short Form
timeFrame: At the first clinic visit after enrollment
measure: Flesch-Kincaid Readability Test
timeFrame: Within 1 month of AI chatbot use
measure: Simple Measure of Gobbleygook
timeFrame: Within 1 month of AI chatbot use
measure: 5-point Likert Safety-Harm Scale
timeFrame: Within 1 week of AI chatbot use
Locations:
city: Sacramento
country: United States
facility: University of California Davis Health
state: California
Study officials:
affiliation: University of California, Davis
name: Zachary C Lum, DO
role: PRINCIPAL_INVESTIGATOR
References: