Knee OsteoarthritisKOA-HAIDNCT07669532
Health Aid for Knee Osteoarthritis
A study testing Health Aid and Decision Aid in people with Knee Osteoarthritis, run by David Ring at 1 site in United States.
Trial summary
Knee osteoarthritis is a common condition that can cause pain, stiffness, and difficulty with daily activities. Many patients interpret these symptoms as signs of ongoing joint damage, which can influence their expectations and decisions about treatment. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Health Aid and Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 31 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New patient seeking musculoskeletal specialty care
- English literacy
- Aged 18-89 years
- Diagnosed with knee osteoarthritis
Who cannot join
- Cognitive or physical impairment precluding tablet use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nadia Azib contact
United States1 site
University of Texas At Austin
Austin, Texas, 78712
David Ring, MD,PHD, 617-792-9848, David.ring@austin.utexas.edu
About this study
Official title: A Randomized Controlled Trial of a Health Aids for Knee Osteoarthritis
Knee osteoarthritis is a common condition that can cause pain, stiffness, and difficulty with daily activities. Many patients interpret these symptoms as signs of ongoing joint damage, which can influence their expectations and decisions about treatment.
This randomized controlled trial compares three approaches used during a routine orthopedic visit: a health aid, a decision aid, and usual care. The health aid is designed to improve patients' understanding of knee osteoarthritis by addressing common misconceptions and helping patients develop a more accurate and less distressing understanding of their condition. The decision aid provides structured information about treatment options. In the usual care group, patients receive standard clinical consultation without additional educational materials.
Read more
The main goal of the study is to evaluate differences in patients' understanding of knee osteoarthritis immediately after the clinic visit. Secondary outcomes include patients' interest in additional care options such as imaging, physical therapy, injections, and surgery, as well as measures of trust in the clinician and care experience.
The results of this study may help improve how information is communicated to patients with knee osteoarthritis and guide future approaches to patient education and shared decision-making.
Read the detailed description
Knee osteoarthritis is a highly prevalent musculoskeletal condition and a leading cause of pain and disability in adults. Patients often interpret symptoms such as pain, stiffness, and functional limitation as evidence of progressive structural damage or "wear and tear." These interpretations may contribute to distress, increased demand for imaging or invasive treatments, and misalignment between patient expectations and evidence-based care.
Traditional decision aids are designed to support shared decision-making by presenting information about treatment options and potential outcomes. However, these tools primarily assume that patients make rational decisions based on accurate information. Emerging evidence from cognitive psychology suggests that decision-making is also influenced by automatic, intuitive processes, prior beliefs, emotional responses, and cognitive biases. As a result, providing information alone may not be sufficient to meaningfully shift misconceptions or improve alignment between patient values and treatment choices.
This randomized controlled trial evaluates the impact of a novel "health aid" compared with a standard decision aid and usual care in patients presenting for an initial consultation for knee osteoarthritis. The health aid is designed not only to provide information but also to address common misconceptions about knee osteoarthritis, reduce unnecessary fear related to symptoms, and support a more adaptive understanding of aging-related joint changes. In contrast, the decision aid focuses on presenting structured information about available treatment options.
Participants will be randomized in a 1:1:1 ratio to receive either the health aid, the decision aid, or usual care during their clinic visit. The intervention is delivered immediately after diagnosis is established, and patients complete outcome assessments immediately following the visit.
The primary outcome is post-visit understanding of knee osteoarthritis, measured using a misconception questionnaire. Secondary outcomes include patient-reported interest in subsequent healthcare utilization (including imaging, physical therapy, injections, and surgery), as well as measures of trust and care experience (TRECS).
The study aims to determine whether addressing cognitive and perceptual aspects of illness understanding through a health aid leads to improved patient understanding and potentially influences downstream healthcare preferences compared with traditional decision support tools and usual care.
- Conditions
- Knee Osteoarthritis
- Being tested
- Health Aid, Decision Aid
- Keywords
- Knee osteoarthritis, Health aid, Patient education, Decision aid
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health AidOther
Patients review a health aid addressing misconceptions about knee osteoarthritis during the visit
Decision AidOther
Patients review a decision aid describing treatment options for knee osteoarthritis during the visit
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (Control) | No intervention | Standard clinical visit without additional educational material |
| Health Aid | Other | Patients review a health aid addressing misconceptions about knee osteoarthritis during the visit Receives: Other: Health Aid |
| Decision Aid | Other | Patients review a decision aid describing treatment options for knee osteoarthritis during the visit Receives: Other: Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-visit misconception score
Difference in post-visit misconception scores among patients with knee osteoarthritis randomized to a health aid, decision aid, or usual care group. Scores range from 0 to 16, with higher scores indicating a more accurate understanding of knee osteoarthritis.
Measured: Measured once, immediately following consultation with the musculoskeletal specialist
Secondary outcomes (6)
Interest in return visit
Rated from 0 (I definitely will not schedule a return visit) to 10 (I definitely will schedule a return visit).
Measured: Measured once, immediately following consultation with the musculoskeletal specialist
Interest in an imaging test
Rated from 0 (I am definitely not interested in scheduling an imaging test for my condition) to 10 (I am definitely interested in scheduling an imaging test for my condition).
Measured: Measured once, immediately following consultation with the musculoskeletal specialist
Interest in physical therapy referral
Rated from 0 (I am definitely not interested in being referred to a physical therapist) to 10 (I am definitely interested in being referred to a physical therapist).
Measured: Measured once, immediately following consultation with the musculoskeletal specialist
Interest in steroid injection
Rated from 0 (I am definitely not interested in having a knee steroid injection) to 10 (I am definitely interested in having a knee steroid injection)
Measured: Measured once, immediately following consultation with the musculoskeletal specialist
Interest in surgery
Rated from 0 (I am definitely not interested in knee replacement surgery) to 10 (I am definitely interested in knee replacement surgery).
Measured: Immediately after the clinic visit
TRECS score
The Trust and Experience with the Clinician Scale (TRECS-7) is a validated 7-item scale that measures patients' trust in and experience with their clinician during a medical consultation. Designed to minimize ceiling effects, it enables more sensitive detection of variation in patient experience across different clinical interactions (Brinkman et al.). Each of 7 statements is scored from 0-4 (strongly disagree, disagree, neutral, agree, strongly agree), resulting in a total score between 0 and 28. Higher scores indicate greater perceived trust in the clinician.
Source: Brinkman N, Looman R, Jayakumar P, Ring D, Choi S. Is It Possible to Develop a Patient-reported Experience Measure With Lower Ceiling Effect? Clin Orthop Relat Res. 2025 Apr 1;483(4):693-703.
Measured: Measured once, immediately following consultation with the musculoskeletal specialist
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1:1 ratio to one of three parallel groups: health aid, decision aid, or usual care. The intervention is delivered immediately during the clinical encounter after the diagnosis of knee osteoarthritis is established. Participants assigned to the health aid or decision aid groups will review the respective educational material during the visit while the clinician steps out briefly. Participants in the usual care group will receive standard clinical consultation without exposure to additional educational materials. All participants complete post-visit outcome assessments immediately after the encounter.
- Masking
- None (open label)
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Ring
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Ring, University of Texas at Austin
- Investigators
- David Ring, MD, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669532
- Sponsor's protocol ID
- STUDY00004831.4
- Acronym
- KOA-HAID
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. The study involves patient-reported outcomes collected during clinical encounters, including measures of health perceptions, treatment preferences, and trust. Due to the sensitive nature of these data and the absence of a predefined data-sharing infrastructure or funding mandate for data deposition, individual participant data will not be made publicly available. Aggregate study findings will be reported in peer-reviewed publications.
Publications
Wilkens SC, Ring D, Teunis T, Lee SP, Chen NC. Decision Aid for Trapeziometacarpal Arthritis: A Randomized Controlled Trial. J Hand Surg Am. 2019 Mar;44(3):247.e1-247.e9. doi: 10.1016/j.jhsa.2018.06.004. Epub 2018 Jul 18.
PubMed 30031600Kleiss IIM, Kortlever JTP, Ring D, Vagner GA, Reichel LM. A Randomized Controlled Trial of Decision Aids for Upper-Extremity Conditions. J Hand Surg Am. 2021 Apr;46(4):338.e1-338.e15. doi: 10.1016/j.jhsa.2020.09.003. Epub 2020 Nov 6.
PubMed 33162270
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Health Aids for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07669532
- Acronym / sponsor ID
- KOA-HAID / STUDY00004831.4
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Health aid, Patient education, Decision aid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- David RingUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jun 2026 (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.
Knee osteoarthritis is a common condition that can cause pain, stiffness, and difficulty with daily activities. Many patients interpret these symptoms as signs of ongoing joint damage, which can influence their expectations and decisions about treatment.
This randomized controlled trial compares three approaches used during a routine orthopedic visit: a health aid, a decision aid, and usual care. The health aid is designed to improve patients' understanding of knee osteoarthritis by addressing common misconceptions and helping patients develop a more accurate and less distressing understanding of their condition. The decision aid provides structured information about treatment options. In the usual care group, patients receive standard clinical consultation without additional educational materials.
The main goal of the study is to evaluate differences in patients' understanding of knee osteoarthritis immediately after the clinic visit. Secondary outcomes include patients' interest in additional care options such as imaging, physical therapy, injections, and surgery, as well as measures of trust in the clinician and care experience.
The results of this study may help improve how information is communicated to patients with knee osteoarthritis and guide future approaches to patient education and shared decision-making.
Detailed description
Knee osteoarthritis is a highly prevalent musculoskeletal condition and a leading cause of pain and disability in adults. Patients often interpret symptoms such as pain, stiffness, and functional limitation as evidence of progressive structural damage or "wear and tear." These interpretations may contribute to distress, increased demand for imaging or invasive treatments, and misalignment between patient expectations and evidence-based care.
Traditional decision aids are designed to support shared decision-making by presenting information about treatment options and potential outcomes. However, these tools primarily assume that patients make rational decisions based on accurate information. Emerging evidence from cognitive psychology suggests that decision-making is also influenced by automatic, intuitive processes, prior beliefs, emotional responses, and cognitive biases. As a result, providing information alone may not be sufficient to meaningfully shift misconceptions or improve alignment between patient values and treatment choices.
This randomized controlled trial evaluates the impact of a novel "health aid" compared with a standard decision aid and usual care in patients presenting for an initial consultation for knee osteoarthritis. The health aid is designed not only to provide information but also to address common misconceptions about knee osteoarthritis, reduce unnecessary fear related to symptoms, and support a more adaptive understanding of aging-related joint changes. In contrast, the decision aid focuses on presenting structured information about available treatment options.
Participants will be randomized in a 1:1:1 ratio to receive either the health aid, the decision aid, or usual care during their clinic visit. The intervention is delivered immediately after diagnosis is established, and patients complete outcome assessments immediately following the visit.
The primary outcome is post-visit understanding of knee osteoarthritis, measured using a misconception questionnaire. Secondary outcomes include patient-reported interest in subsequent healthcare utilization (including imaging, physical therapy, injections, and surgery), as well as measures of trust and care experience (TRECS).
The study aims to determine whether addressing cognitive and perceptual aspects of illness understanding through a health aid leads to improved patient understanding and potentially influences downstream healthcare preferences compared with traditional decision support tools and usual care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized in a 1:1:1 ratio to one of three parallel groups: health aid, decision aid, or usual care. The intervention is delivered immediately during the clinical encounter after the diagnosis of knee osteoarthritis is established. Participants assigned to the health aid or decision aid groups will review the respective educational material during the visit while the clinician steps out briefly. Participants in the usual care group will receive standard clinical consultation without exposure to additional educational materials. All participants complete post-visit outcome assessments immediately after the encounter.
| Arm | Type | Receives |
|---|---|---|
| Usual Care (Control) | No intervention | –Standard clinical visit without additional educational material |
| Health Aid | Other | Other: Health AidPatients review a health aid addressing misconceptions about knee osteoarthritis during the visit |
| Decision Aid | Other | Other: Decision AidPatients review a decision aid describing treatment options for knee osteoarthritis during the visit |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- New patient seeking musculoskeletal specialty care
- English literacy
- Aged 18-89 years
- Diagnosed with knee osteoarthritis
Key exclusion criteria (1 listed)
- Cognitive or physical impairment precluding tablet use
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 |
|---|---|---|
| Health AidPatients review a health aid addressing misconceptions about knee osteoarthritis during the visit | Other | Health Aid |
| Decision AidPatients review a decision aid describing treatment options for knee osteoarthritis during the visit | Other | Decision Aid |
Primary outcome
Post-visit misconception score
Time frame: Measured once, immediately following consultation with the musculoskeletal specialist
Difference in post-visit misconception scores among patients with knee osteoarthritis randomized to a health aid, decision aid, or usual care group. Scores range from 0 to 16, with higher scores indicating a more accurate understanding of knee osteoarthritis.
6 secondary outcomes
Interest in return visit
Time frame: Measured once, immediately following consultation with the musculoskeletal specialist
Interest in an imaging test
Time frame: Measured once, immediately following consultation with the musculoskeletal specialist
Interest in physical therapy referral
Time frame: Measured once, immediately following consultation with the musculoskeletal specialist
Interest in steroid injection
Time frame: Measured once, immediately following consultation with the musculoskeletal specialist
Interest in surgery
Time frame: Immediately after the clinic visit
TRECS score
Time frame: Measured once, immediately following consultation with the musculoskeletal specialist
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 25 Jun 2026.
- Background: PubMed 30031600Wilkens SC, Ring D, Teunis T, Lee SP, Chen NC. Decision Aid for Trapeziometacarpal Arthritis: A Randomized Controlled Trial. J Hand Surg Am. 2019 Mar;44(3):247.e1-247.e9. doi: 10.1016/j.jhsa.2018.06.004. Epub 2018 Jul 18.
- Background: PubMed 33162270Kleiss IIM, Kortlever JTP, Ring D, Vagner GA, Reichel LM. A Randomized Controlled Trial of Decision Aids for Upper-Extremity Conditions. J Hand Surg Am. 2021 Apr;46(4):338.e1-338.e15. doi: 10.1016/j.jhsa.2020.09.003. Epub 2020 Nov 6.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. The study involves patient-reported outcomes collected during clinical encounters, including measures of health perceptions, treatment preferences, and trust. Due to the sensitive nature of these data and the absence of a predefined data-sharing infrastructure or funding mandate for data deposition, individual participant data will not be made publicly available. Aggregate study findings will be reported in peer-reviewed publications.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Nadia Azib contact
David Ring, MD, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Aid and Decision Aid in people with Knee Osteoarthritis, run by David Ring 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: opening soon, as of the sponsor's last update on 25 Jun 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?
Contact David Ring, MD, PhD (6177929848, David.ring@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-visit misconception score (time frame: Measured once, immediately following consultation with the musculoskeletal specialist). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07669532, which also lists 2 linked publications.
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 25 Jun 2026.