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Risk and Risk Perception of Knee Osteoarthritis in the US

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet-Based Osteoarthritis Risk Calculator
Generic osteoarthritis information
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Knee Osteoarthritis

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Generic Osteoarthritis Risk Information

    Personalized Osteoarthritis Risk

    Arm Description

    Participants in this arm received generic osteoarthritis information that was not personalized.

    Participants in this arm obtained their personalized osteoarthritis risk from the internet-based Osteoarthritis Risk Calculator.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    March 1, 2016
    Last Updated
    March 4, 2016
    Sponsor
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02704286
    Brief Title
    Risk and Risk Perception of Knee Osteoarthritis in the US
    Official Title
    Raising Awareness of Knee Osteoarthritis (OA) and Willingness to Undertake Behavioral Changes to Reduce Risk of Knee OA: Online Recruitment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    380 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Generic Osteoarthritis Risk Information
    Arm Type
    Sham Comparator
    Arm Description
    Participants in this arm received generic osteoarthritis information that was not personalized.
    Arm Title
    Personalized Osteoarthritis Risk
    Arm Type
    Experimental
    Arm Description
    Participants in this arm obtained their personalized osteoarthritis risk from the internet-based Osteoarthritis Risk Calculator.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Internet-Based Osteoarthritis Risk Calculator
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Generic osteoarthritis information
    Intervention Description
    Subjects viewed generic (i.e. not personalized) information about osteoarthritis risk factors
    Primary Outcome Measure Information:
    Title
    Change in estimated lifetime knee OA risk
    Description
    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.
    Time Frame
    1 day
    Title
    Change in estimated 10-year knee OA risk
    Description
    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.
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Reaching an Action Stage on Diet Contemplation Ladder
    Description
    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.
    Time Frame
    1 day
    Title
    Reaching an Action Stage on Exercise Contemplation Ladder
    Description
    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.
    Time Frame
    1 day
    Title
    Reaching an Action Stage on Weight Control Contemplation Ladder
    Description
    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.
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elena Losina, PHD
    Organizational Affiliation
    Brigham and Women's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26494421
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26555504
    Citation
    Michl GL, Katz JN, Losina E. Risk and risk perception of knee osteoarthritis in the US: a population-based study. Osteoarthritis Cartilage. 2016 Apr;24(4):593-6. doi: 10.1016/j.joca.2015.11.001. Epub 2015 Nov 7.
    Results Reference
    background
    PubMed Identifier
    27788299
    Citation
    Losina E, Michl GL, Smith KC, Katz JN. Randomized Controlled Trial of an Educational Intervention Using an Online Risk Calculator for Knee Osteoarthritis: Effect on Risk Perception. Arthritis Care Res (Hoboken). 2017 Aug;69(8):1164-1170. doi: 10.1002/acr.23136. Epub 2017 Jul 10.
    Results Reference
    derived

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    Risk and Risk Perception of Knee Osteoarthritis in the US

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