[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07669532":3,"trial-entities:NCT07669532":117,"trial-summary:NCT07669532":121},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":41,"secondary_outcomes":46,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":15,"eligibility_criteria":69,"std_ages":78,"locations":81,"central_contacts":97,"overall_officials":104,"references":108,"see_also_links":116},"NCT07669532","STUDY00004831.4","Health Aid for Knee Osteoarthritis","A Randomized Controlled Trial of a Health Aids for Knee Osteoarthritis","NOT_YET_RECRUITING","2026-12-31","2026-06","2026-06-25","2026-07-01","David Ring","OTHER",false,"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.\n\nThis 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.\n\nThe 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.\n\nThe 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.","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.\n\nTraditional 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.\n\nThis 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.\n\nParticipants 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.\n\nThe 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).\n\nThe 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.",[19],"Knee Osteoarthritis",[21,22,23,24],"Knee osteoarthritis","Health aid","Patient education","Decision aid","INTERVENTIONAL","SUPPORTIVE_CARE",[28],"NA",{"count":30,"type":31},159,"ESTIMATED",[33,37],{"type":14,"name":34,"description":35,"armGroupLabels":36},"Health Aid","Patients review a health aid addressing misconceptions about knee osteoarthritis during the visit",[34],{"type":14,"name":38,"description":39,"armGroupLabels":40},"Decision Aid","Patients review a decision aid describing treatment options for knee osteoarthritis during the visit",[38],[42],{"measure":43,"description":44,"timeFrame":45},"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 once, immediately following consultation with the musculoskeletal specialist",[47,50,53,56,59,63],{"measure":48,"description":49,"timeFrame":45},"Interest in return visit","Rated from 0 (I definitely will not schedule a return visit) to 10 (I definitely will schedule a return visit).",{"measure":51,"description":52,"timeFrame":45},"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).",{"measure":54,"description":55,"timeFrame":45},"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).",{"measure":57,"description":58,"timeFrame":45},"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)",{"measure":60,"description":61,"timeFrame":62},"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).","Immediately after the clinic visit",{"measure":64,"description":65,"timeFrame":45},"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.\n\nSource: 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.","ALL","18 Years","89 Years",{"inclusion":70,"exclusion":75,"raw_text":77},[71,72,73,74],"New patient seeking musculoskeletal specialty care","English literacy","Aged 18-89 years","Diagnosed with knee osteoarthritis",[76],"Cognitive or physical impairment precluding tablet use","Inclusion Criteria:\n\n* New patient seeking musculoskeletal specialty care\n* English literacy\n* Aged 18-89 years\n* Diagnosed with knee osteoarthritis\n\nExclusion Criteria:\n\n* Cognitive or physical impairment precluding tablet use",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":94},"University of Texas At Austin","Austin","Texas","78712","United States",[89],{"name":90,"role":91,"phone":92,"email":93},"David Ring, MD,PHD","CONTACT","617-792-9848","David.ring@austin.utexas.edu",{"lat":95,"lon":96},30.26715,-97.74306,[98,101],{"name":99,"role":91,"phone":100,"email":93},"David Ring, MD, PhD","6177929848",{"name":102,"role":91,"email":103},"Nadia Azib","Nadia.azib@austin.utexas.edu",[105],{"name":99,"affiliation":106,"role":107},"University of Texas at Austin","PRINCIPAL_INVESTIGATOR",[109,113],{"pmid":110,"type":111,"citation":112},"30031600","BACKGROUND","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\u002Fj.jhsa.2018.06.004. Epub 2018 Jul 18.",{"pmid":114,"type":111,"citation":115},"33162270","Kleiss 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\u002Fj.jhsa.2020.09.003. Epub 2020 Nov 6.",[],{"nct_id":4,"conditions":118,"biomarkers":120},[119],"Osteoarthritis of knee",[],{"nct_id":4,"found":122,"summary":123,"prompt_version":133},true,{"design":124,"status":125,"heading":126,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This is an interventional study that plans to enroll 159 participants. It compares three different approaches: a Health Aid, a Decision Aid, and usual care.","completed","Health Aids for Knee Osteoarthritis","This study is looking at different ways to help people with knee osteoarthritis (a condition causing pain and stiffness in the knee joint) understand their condition and treatment options better. Many people with knee osteoarthritis believe their symptoms mean their joint is constantly being damaged, which can affect their choices. This study will compare three approaches during a routine doctor's visit: a Health Aid, which helps correct common misunderstandings about knee osteoarthritis; a Decision Aid, which provides information about treatment options; and usual care. The main goal is to see if the Health Aid can improve your understanding of knee osteoarthritis right after your visit. You might be able to join if you are a new patient seeking care for knee osteoarthritis, are between 18 and 89 years old, and can read English. The study aims to include 159 participants, but its current status is unclear.","Your understanding of knee osteoarthritis will be measured immediately after your consultation with the specialist.",146,"Patients will review either a Health Aid or a Decision Aid during their visit with a musculoskeletal specialist. The primary endpoint is measured once, immediately following this consultation.","Not stated in the trial record.",[34,38],"v2"]