OsteoarthritisCHAT-OANCT06778486
Conversations in Health Literacy Using AI Technology for Osteoarthritis Patients
A study testing Artificial Intelligence Chatbot in people with Osteoarthritis and Osteoarthritis of the Hip or Knee, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Osteoarthritis, Osteoarthritis of the Hip or Knee
- What is being tested?
- Artificial Intelligence Chatbot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- Ability to read and write in English
- All races and ethnicities
- Clinical symptoms of hip and/or knee osteoarthritis
Who cannot join
- Inability to read and write in English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Health
Sacramento, California, 95817
About this study
Official title: CHAT-OA: Conversations in Health Literacy Using AI Technology for Osteoarthritis Patients
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
- Being tested
- Artificial Intelligence Chatbot
- Keywords
- artificial intelligence, health literacy, decisional conflict
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence ChatbotOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Artificial Intelligence Chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
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).
Measured: At enrollment
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement
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).
Measured: At enrollment
Patient-Reported Outcomes Measurement Information System Global Health Version 1.2
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start6 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zachary C Lum, DO, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778486
- Sponsor's protocol ID
- 2169004
- Acronym
- CHAT-OA
- Status last verified
- Sep 2026
- First submitted
- 22 Nov 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHAT-OA: Conversations in Health Literacy Using AI Technology for Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT06778486
- Acronym / sponsor ID
- CHAT-OA / 2169004
- Conditions
- Osteoarthritis, Osteoarthritis of the Hip or Knee
- Keywords
- artificial intelligence, health literacy, decisional conflict
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Jan 2025 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –This arm will undergo standard clinical care without the intervention. |
| Artificial Intelligence Chatbot | Experimental | Other: Artificial Intelligence ChatbotThis arm will interact with an artificial intelligence chatbot prior to their clinic visit. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult
- Ability to read and write in English
- All races and ethnicities
- Clinical symptoms of hip and/or knee osteoarthritis
Key exclusion criteria (1 listed)
- Inability to read and write in English
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 |
|---|---|---|
| Artificial Intelligence ChatbotThe 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. | Other | Artificial Intelligence Chatbot |
Primary outcome
Decisional Conflict Scale
Time frame: 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
Time frame: 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).
3 secondary outcomes
Knee injury and Osteoarthritis Outcome Score for Joint Replacement
Time frame: At enrollment
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement
Time frame: At enrollment
Patient-Reported Outcomes Measurement Information System Global Health Version 1.2
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Zachary C Lum, DO principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence Chatbot in people with Osteoarthritis and Osteoarthritis of the Hip or Knee, run by University of California, Davis at 1 site in United States.
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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Decisional Conflict Scale (time frame: At three time points: Within one week after the clinic visit, 1 month after the clinic visit, 6 months after the clinic visit.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.