NCT02704286

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable knee-osteoarthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

1 month

First QC Date

March 1, 2016

Last Update Submit

March 4, 2016

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (3)

  • Reaching an Action Stage on Diet Contemplation Ladder

    1 day

  • Reaching an Action Stage on Exercise Contemplation Ladder

    1 day

  • Reaching an Action Stage on Weight Control Contemplation Ladder

    1 day

Study Arms (2)

Generic Osteoarthritis Risk Information

SHAM COMPARATOR

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

Behavioral: Generic osteoarthritis information

Personalized Osteoarthritis Risk

EXPERIMENTAL

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

Behavioral: Internet-Based Osteoarthritis Risk Calculator

Interventions

Internet-Based Osteoarthritis Risk CalculatorBEHAVIORAL

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.

Personalized Osteoarthritis Risk
Generic osteoarthritis informationBEHAVIORAL

Subjects viewed generic (i.e. not personalized) information about osteoarthritis risk factors

Generic Osteoarthritis Risk Information

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants must be between the ages of 25 and 45
  • Participants must live in the United States
  • Participants must not be diagnosed with osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 26494421BACKGROUND

  • 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.

    PMID: 26555504BACKGROUND

  • 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.

    PMID: 27788299DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Elena Losina, PHD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Orthopedic Surgery

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 10, 2016

Study Start

April 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 10, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share