Risk and Risk Perception of Knee Osteoarthritis in the US

Knee Osteoarthritis Clinical Trial

Official title:

Raising Awareness of Knee Osteoarthritis (OA) and Willingness to Undertake Behavioral Changes to Reduce Risk of Knee OA: Online Recruitment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704286
• Other study ID #: 2015P000249
• Status: Completed
• Phase: N/A
• First received: March 1, 2016
• Last updated: March 4, 2016
• Start date: April 2015
• Est. completion date: May 2015

Study information

• Verified date: March 2016
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators have created an interactive knee osteoarthritis (OA) risk calculator that estimates a user's risk of developing symptomatic knee OA as well as the user's risk for undergoing a total knee replacement (TKR) within their lifetime. To test the impact of the calculator, the investigators recruited OA-free subjects from Amazon's Mechanical Turk. Participants were randomized to either access general information about OA or use the risk calculator in addition to accessing general OA information. The investigators hypothesized that participants randomized to the risk calculator arm would have more accurate perception of their knee OA risk and would have increased willingness to change risky behavior compared to the general OA information group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• Participants must be between the ages of 25 and 45

• Participants must live in the United States

• Participants must not be diagnosed with osteoarthritis

Exclusion Criteria:

• All participants who did not meet the inclusion criteria

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Internet-Based Osteoarthritis Risk Calculator
The investigators have developed a personalized risk calculator for knee osteoarthritis. This risk calculator uses the Osteoarthritis Policy Model to estimate an individual's risk of developing knee osteoarthritis within their lifetime based on demographic information and risk factors. It shows this information to the user with interactive graphs and compares their risk to the risk of an average American of the same age.
• Generic osteoarthritis information
Subjects viewed generic (i.e. not personalized) information about osteoarthritis risk factors

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

References & Publications (2)

Losina E, Klara K, Michl GL, Collins JE, Katz JN. Development and feasibility of a personalized, interactive risk calculator for knee osteoarthritis. BMC Musculoskelet Disord. 2015 Oct 22;16:312. doi: 10.1186/s12891-015-0771-3. — View Citation

Michl GL, Katz JN, Losina E. Risk and risk perception of knee osteoarthritis in the US: a population-based study. Osteoarthritis Cartilage. 2015 Nov 7. pii: S1063-4584(15)01372-2. doi: 10.1016/j.joca.2015.11.001. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in estimated lifetime knee OA risk	The difference between average lifetime knee osteoarthritis risk estimated by participants at baseline and average lifetime knee osteoarthritis risk estimated by participants after the intervention.	1 day	No
Primary	Change in estimated 10-year knee OA risk	The difference between average 10-year knee osteoarthritis risk estimated by participants at baseline and average 10-year knee osteoarthritis risk estimated by participants after the intervention.	1 day	No
Secondary	Reaching an Action Stage on Diet Contemplation Ladder	The percentage of subjects who originally ranked themselves below an action stage (8 or higher) on a contemplation ladder for changing diet related behaviors and who moved to an action stage after the intervention.	1 day	No
Secondary	Reaching an Action Stage on Exercise Contemplation Ladder	The percentage of subjects who originally ranked themselves below an action stage (8 or higher) on a contemplation ladder for changing exercise related behaviors and who moved to an action stage after the intervention.	1 day	No
Secondary	Reaching an Action Stage on Weight Control Contemplation Ladder	The percentage of subjects who originally ranked themselves below an action stage (8 or higher) on a contemplation ladder for changing weight control behaviors and who moved to an action stage after the intervention.	1 day	No