Knee OsteoarthritisNCT02704286
Risk and Risk Perception of Knee Osteoarthritis in the US
A study testing Internet-Based Osteoarthritis Risk Calculator and Generic osteoarthritis information in people with Knee Osteoarthritis, run by Brigham and Women's Hospital.
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. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Internet-Based Osteoarthritis Risk Calculator and Generic osteoarthritis information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be between the ages of 25 and 45
- Participants must live in the United States
- Participants must not be diagnosed with osteoarthritis
Who cannot join
- All participants who did not meet the inclusion criteria
About this study
Official title: Raising Awareness of Knee Osteoarthritis (OA) and Willingness to Undertake Behavioral Changes to Reduce Risk of Knee OA: Online Recruitment
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Internet-Based Osteoarthritis Risk Calculator, Generic osteoarthritis information
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based Osteoarthritis Risk CalculatorBehavioural
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 informationBehavioural
Subjects viewed generic (i.e. not personalized) information about osteoarthritis risk factors
| Study group | Role | What they receive |
|---|---|---|
| Generic Osteoarthritis Risk Information | Sham comparator | Participants in this arm received generic osteoarthritis information that was not personalized. Receives: Behavioral: Generic osteoarthritis information |
| Personalized Osteoarthritis Risk | Experimental | Participants in this arm obtained their personalized osteoarthritis risk from the internet-based Osteoarthritis Risk Calculator. Receives: Behavioral: Internet-Based Osteoarthritis Risk Calculator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day
Secondary outcomes (3)
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startApr 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Losina, Brigham and Women's Hospital
- Investigators
- Elena Losina, PHD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704286
- Sponsor's protocol ID
- 2015P000249
- Status last verified
- Mar 2016
- First submitted
- 1 Mar 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26494421Michl 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.
PubMed 26555504Losina 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.
PubMed 27788299
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raising Awareness of Knee Osteoarthritis (OA) and Willingness to Undertake Behavioral Changes to Reduce Risk of Knee OA: Online Recruitment
- ClinicalTrials.gov ID
- NCT02704286
- Acronym / sponsor ID
- 2015P000249
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generic Osteoarthritis Risk Information | Sham comparator | Behavioral: Generic osteoarthritis informationParticipants in this arm received generic osteoarthritis information that was not personalized. |
| Personalized Osteoarthritis Risk | Experimental | Behavioral: Internet-Based Osteoarthritis Risk CalculatorParticipants in this arm obtained their personalized osteoarthritis risk from the internet-based Osteoarthritis Risk Calculator. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must be between the ages of 25 and 45
- Participants must live in the United States
- Participants must not be diagnosed with osteoarthritis
Key exclusion criteria (1 listed)
- All participants who did not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-Based Osteoarthritis Risk CalculatorThe 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. | Behavioural | Personalized Osteoarthritis Risk |
| Generic osteoarthritis informationSubjects viewed generic (i.e. not personalized) information about osteoarthritis risk factors | Behavioural | Generic Osteoarthritis Risk Information |
Primary outcome
Change in estimated lifetime knee OA risk
Time frame: 1 day
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
Time frame: 1 day
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.
3 secondary outcomes
Reaching an Action Stage on Diet Contemplation Ladder
Time frame: 1 day
Reaching an Action Stage on Exercise Contemplation Ladder
Time frame: 1 day
Reaching an Action Stage on Weight Control Contemplation Ladder
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Background: PubMed 26494421Losina 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.
- Background: PubMed 26555504Michl 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.
- Derived from this study: PubMed 27788299Losina 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Losina, PHD principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Osteoarthritis Risk Calculator and Generic osteoarthritis information in people with Knee Osteoarthritis, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in estimated lifetime knee OA risk (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02704286, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.