University of Texas At Austin
Austin, Texas, 78712, United States
NCT Number: NCT07669532
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.
Trial opening soon.
Get Notified18 year–89 year
All sexes
Interventional
Not applicable
Austin, Texas, 78712, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients review a health aid addressing misconceptions about knee osteoarthritis during the visit
Patients review a decision aid describing treatment options for knee osteoarthritis during the visit
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.
Time frame: Measured once, immediately following consultation with the musculoskeletal specialist
Rated from 0 (I definitely will not schedule a return visit) to 10 (I definitely will schedule a return visit).
Time frame: Measured once, immediately following consultation with the musculoskeletal specialist
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).
Time frame: Measured once, immediately following consultation with the musculoskeletal specialist
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).
Time frame: Measured once, immediately following consultation with the musculoskeletal specialist
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)
Time frame: Immediately after the clinic visit
Rated from 0 (I am definitely not interested in knee replacement surgery) to 10 (I am definitely interested in knee replacement surgery).
Time frame: Measured once, immediately following consultation with the musculoskeletal specialist
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.
Contact information is provided by the study sponsor or research team.
David Ring
Other
A Randomized Controlled Trial of a Health Aids for Knee Osteoarthritis
Acronym: KOA-HAID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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