Conversations in Health Literacy Using AI Technology for Osteoarthritis Patients

NCT06778486 | Active Not Recruiting

• 1 other identifier: 2169004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Osteoarthritis of the Hip or Knee

Keywords

artificial intelligence; health literacy; decisional conflict

Outcome Measures

Primary Outcomes (2)

• Decisional Conflict Scale

  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).

  At three time points: Within one week after the clinic visit, 1 month after the clinic visit, 6 months after the clinic visit.

• Beck Anxiety Inventory

  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).

  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 (3)

• Knee injury and Osteoarthritis Outcome Score for Joint Replacement

  At enrollment

• Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement

  At enrollment

• Patient-Reported Outcomes Measurement Information System Global Health Version 1.2

  At enrollment

Other Outcomes (8)

• Visual Analog Scale Pain Score

  At enrollment

• Health Literacy Single Item Screener

  At enrollment

• Newest Vital Sign

  At enrollment

Study Arms (2)

Standard of care

NO INTERVENTION

This arm will undergo standard clinical care without the intervention.

Artificial Intelligence Chatbot

EXPERIMENTAL

This arm will interact with an artificial intelligence chatbot prior to their clinic visit.

Other: Artificial Intelligence Chatbot

Interventions

Artificial Intelligence Chatbot OTHER

The intervention is a generative artificial intelligence large language model chatbot that has a structured prompt with fill-in-the-blank style questions that the participant will complete.

Artificial Intelligence Chatbot

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to read and write in English

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Health

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Zachary C Lum, DO

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: January 16, 2025
• Study Start: January 6, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)