Conversations in Health Literacy Using AI Technology for Osteoarthritis Patients

Not Applicable

Recruiting

• Conditions: Osteoarthritis; Osteoarthritis of the Hip or Knee

• Registration Number: NCT06778486
• Lead Sponsor: University of California, Davis

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-22
• Study Start: 2025-01-06
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decisional Conflict Scale	At three time points: Within one week after the clinic visit, 1 month after the clinic visit, 6 months after the clinic visit.	16 questions with Likert scale style answers ranging from 0 to 4. The raw score is converted to a score out of 100. The score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Beck Anxiety Inventory	At three time points: Within one week after the clinic visit, 1 month after the clinic visit, 6 months after the clinic visit.	21 questions with Likert scale style answers ranging from 0 to 4. The raw score is the sum of the answers, which is converted to a score out of 100. The score ranges from 0 (low anxiety) to 63 (high anxiety).

Secondary Outcome Measures

Name	Time	Method
Knee injury and Osteoarthritis Outcome Score for Joint Replacement	At enrollment	7 questions with Likert scale style answers ranging from 0 to 4. The raw score is the sum of the answers, which is converted to a score out of 100. The score ranges from 0 (total knee disability) to 100 (perfect knee health).
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement	At enrollment	6 questions with Likert scale style answers ranging from 0 to 4. The raw score is the sum of the answers, which is converted to a score out of 100. The score ranges from 0 (total hip disability) to 100 (perfect hip health).
Patient-Reported Outcomes Measurement Information System Global Health Version 1.2	At enrollment	10 questions with Likert scale style answers ranging from 1 to 5 and 1 question about pain with answers from 0 to 10. The questions are grouped into 4 sub-groups corresponding to physical and mental health main groups, in addition to the pain score. The raw scores are a sum of the answers for both physical and mental health range from 4 (poor physical or mental health) to 20 (best possible physical or mental health). The raw score is then converted to a t-score using the associated tables with the range 16.2 (worst possible physical or mental health) to 67.7 (best possible physical or mental health). The t-score is interpreted in comparison to the general population that has a mean of 50 and standard deviation of 10.

Trial Locations

Locations (1)

University of California Davis Health; 🇺🇸 Sacramento, California, United States