Health Aid for Knee Osteoarthritis

NCT07669532 | Not Yet Recruiting

• 1 other identifier: STUDY00004831.4
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis; Health aid; Patient education; Decision aid

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Interest in return visit

  Measured once, immediately following consultation with the musculoskeletal specialist

• Interest in an imaging test

  Measured once, immediately following consultation with the musculoskeletal specialist

• Interest in physical therapy referral

  Measured once, immediately following consultation with the musculoskeletal specialist

• Interest in steroid injection

  Measured once, immediately following consultation with the musculoskeletal specialist

• Interest in surgery

  Immediately after the clinic visit

Study Arms (3)

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

Other: Health Aid

Decision Aid

OTHER

Patients review a decision aid describing treatment options for knee osteoarthritis during the visit

Other: Decision Aid

Interventions

Health Aid OTHER

Patients review a health aid addressing misconceptions about knee osteoarthritis during the visit

Health Aid

Decision Aid OTHER

Patients review a decision aid describing treatment options for knee osteoarthritis during the visit

Decision Aid

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cognitive or physical impairment precluding tablet use

Sponsors & Collaborators

• David Ring: lead

Study Sites (1)

University of Texas At Austin

Austin, Texas, 78712, United States

Location

Related Publications (2)

• 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.

  PMID: 30031600 BACKGROUND

• 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/j.jhsa.2020.09.003. Epub 2020 Nov 6.

  PMID: 33162270 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• David Ring, MD, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Ring, MD, PhD

CONTACT

6177929848; David.ring@austin.utexas.edu

Nadia Azib

CONTACT

Nadia.azib@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Associate Chair for Faculty Academic Affairs Department of Surgery and Perioperative Care Courtesy Professor of Psychiatry and Behavioral Sciences

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)