跳至主要内容
临床试验/NCT07669532
NCT07669532尚未招募不适用

A Randomized Controlled Trial of a Health Aids for Knee Osteoarthritis

David Ring1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
159
试验地点
1

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • New patient seeking musculoskeletal specialty care
  • English literacy
  • Aged 18-89 years
  • Diagnosed with knee osteoarthritis

排除标准

  • Cognitive or physical impairment precluding tablet use

研究者

发起方
David Ring
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Ring

Professor and Associate Chair for Faculty Academic Affairs Department of Surgery and Perioperative Care Courtesy Professor of Psychiatry and Behavioral Sciences

University of Texas at Austin

研究点 (1)

Loading locations...

相似试验