Digital Knee Osteoarthritis Mindset Intervention

February 11, 2025 updated by: Melissa Boswell, Stanford University

A Digital Mindset Intervention to Improve Pain and Exercise Participation in Individuals With Knee Osteoarthritis: A Randomized, Parallel-group Study

The aim of our clinical trial is to test if an online mindset intervention improves mindsets and physical activity levels more than an education intervention in individuals with knee osteoarthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Osteoarthritis affects 7% of the global population and is a leading cause of disability globally. Physical activity improves health outcomes, weight management, and knee function for people with knee osteoarthritis and should be considered first-line treatment. Yet, physical activity levels in this population are low compared to those without knee osteoarthritis.

Existing knowledge: Emerging research has highlighted the powerful influence of mindsets about exercise on engagement in physical activity. Mindsets are core assumptions about a domain or category that orient individuals to a particular set of attributions, expectations, and goals (a "meaning system"). In individuals with knee osteoarthritis, mindsets about the appeal of physical activity relate to future physical activity levels and one's chosen symptom management strategy, and mindsets about osteoarthritis relate to knee symptoms.

The investigators developed a digital mindset intervention to improve mindsets about exercise and osteoarthritis in individuals with knee osteoarthritis. The investigators piloted the intervention on 21 individuals with knee osteoarthritis throughout the United States. Participants improved in exercise and osteoarthritis mindsets. However, this was a small sample size, a control group was not used, and it was cross-sectional, thus, not able to evaluate changes in physical activity and osteoarthritis symptoms.

Need for a trial: A digital, low-cost, and, thus, scalable intervention to improve mindsets about osteoarthritis and exercise may improve pain and function and physical activity levels for the millions of individuals affected with knee osteoarthritis. A large randomized trial is therefore needed to evaluate if our mindset intervention leads to improvements in physical activity levels and osteoarthritis symptoms and, further, if these changes are due to more adaptive mindsets about exercise and osteoarthritis.

Study Type

Interventional

Enrollment (Actual)

458

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Over 45 years of age
  • Self-reported doctor's diagnosis of knee osteoarthritis OR meets the National Institute for - - Health and Care Excellence osteoarthritis clinical criteria (activity-related knee pain and no knee morning stiffness lasting ≥ 30 minutes)
  • Knee pain for at least 3 months
  • Ability to walk unaided
  • Can read and write in English
  • Consistent internet access
  • Willingness and ability to comply with the study requirements

Exclusion criteria:

  • Past total knee arthroplasty or scheduled surgical procedure on any back or lower limb with osteoarthritis within the next 12 months
  • Recent serious injury (within the past 2 months) on the knee(s) with osteoarthritis
  • Any condition making it unsafe to participate in physical activity
  • Intra-articular therapy within the past 6 months (e.g. injections such as corticosteroids and hyaluronic acid)
  • Participates in physical exercise for 30 minutes or more 5 days per week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active comparator group
A series of educational videos and reflective questions of the same duration and required attention as the mindset intervention program. The videos are sourced videos from YouTube that educate about osteoarthritis. The content consists of information about osteoarthritis that patients would typically receive if looking for more information about the disease, including disease pathology, risks, symptoms, and treatment strategies. The included videos contain factual content with a similar format to the mindset intervention videos, including live experts sharing information with animations and supplementary b-roll footage.
Other: Active comparator
Participants receive a series of osteoarthritis education videos and reflective questions that matches the digital mindset intervention in duration and attention.
Other Names:
  • Educational content
Experimental: Mindset intervention group
Four modules, each with a series of videos and reflective questions. Each module takes approximately 20-60 minutes to complete, with a total of about two hours to complete the entire program. Participants have one week to complete the program at their own pace. Participants are suggested to complete one module per day but are encouraged to go at the pace that works best for them.
Behavioral: Mindset intervention
Participants receive a digital mindset intervention to improve mindsets about osteoarthritis and exercise.
No Intervention: Waitlist control group
This group will take the same surveys as the other groups at the same time points but will not receive any additional content.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale
Time Frame: Change from Baseline at 1 month
Knee pain scored from 0 - 10 (0 being no pain and 10 being the worst pain)
Change from Baseline at 1 month
Change From Baseline in Physical Activity Measured by Physical Activity Scale for the Elderly
Time Frame: Change from Baseline at 1 month
The Physical Activity Scale for the Elderly (PASE) asks respondents about the frequency of light, moderate, and strenuous work and leisure activities and is a validated measure of self-reported physical activity for individuals with osteoarthritis. The scale is scored from 0 (no physical activity) to 793 (very high physical activity).
Change from Baseline at 1 month
Change From Baseline in Mindset About the Process of Health - Physical Activity (MPH-Physical Activity) Scale
Time Frame: Change from Baseline at Post-intervention (immediately following intervention completion)
The Process of Health Mindset -- Exercise measure is a one-factor scale developed and validated to assess mindset about the process of engaging in physical activity (e.g., physical activity is difficult/easy, unpleasant/pleasurable, boring/fun). The scale consists of 7 items scored from 1 to 4, with a higher score reflecting a more appeal-focused mindset about physical activity, and then averaged for a total score between 1 to 4.
Change from Baseline at Post-intervention (immediately following intervention completion)
Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory
Time Frame: Change from Baseline at Post-intervention (immediately following intervention completion)
The Illness Mindset Inventory measures three mindsets about the nature and meaning of illness: that it is a catastrophe, manageable, or an opportunity. The scale consists of 20 items measured on a 6-point scale and scored from 1 to 6, with 10 of those questions capturing mindsets about osteoarthritis. The extent to which a participant endorses a particular mindset can be obtained by calculating the mean score for each mindset. A higher score indicates greater agreement with the mindset. The investigators adapted the scale to focus on mindsets about "knee osteoarthritis" as opposed to "chronic disease." There are three subscales, Osteoarthritis is Castrophic, Osteoarthritis is Manageable, and Osteoarthritis is Opportunistic. The questions pertaining to each subscale are averaged for a total score from 1 to 6 for each subscale.
Change from Baseline at Post-intervention (immediately following intervention completion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC)
Time Frame: Change from Baseline at 1 month
The short-version of the Western Ontario and McMaster Universities Osteoarthritis Index (ShortMAC) is a disease-specific 12-item measure of knee pain, stiffness, and function. It has been validated and shown to be reliable in patients with knee osteoarthritis. It is measured on the Likert scale and can be divided into two subscales: pain and function. Pain subscore range, 0 (low pain) to 20 (high pain); Function subscore range, 0 (low difficulty) to 28 (high difficulty).
Change from Baseline at 1 month
Change From Baseline in Knee Osteoarthritis Knowledge by the Knee Osteoarthritis Knowledge Scale
Time Frame: Change from Baseline at Post-intervention (immediately following intervention completion)
The Knee Osteoarthritis Knowledge Scale is scored from 11-55 and measures knowledge about osteoarthritis in individuals with knee or hip osteoarthritis.
Change from Baseline at Post-intervention (immediately following intervention completion)
Change From Baseline in Perceived Need for Surgery by a Surgery Perception Question
Time Frame: Change from Baseline at 1 month
Perceived need for surgery will be assessed by the single question, "How likely do you think you are of needing knee replacement surgery in the future?" It is answered on the Likert scale from 1 (very unlikely) to 5 (very likely). All items are averaged together for a final score between 1 to 5.
Change from Baseline at 1 month
Change From Baseline in Symptom Management Strategy by an Osteoarthritis Symptom Management Question. The Variable is Reported as a % of Participants Who Reported Using the Symptom Management Strategy.
Time Frame: Change from Baseline at 1 month
Chosen symptom management strategy(ies) will be assessed by the single question, "Which of the following are ways in which you manage and/or improve your osteoarthritis symptoms? Please select all that apply." It is answer via multiple choice with multiple selection option. The options available are the most common strategies as determined by previous studies with an additional option for fill in. The reported value is the percentage of participants that selected the management strategy as a strategy they implement.
Change from Baseline at 1 month
Change From Baseline in Fear of Movement by the Brief Fear of Movement Scale for Osteoarthritis
Time Frame: Change from Baseline at 1 month
The Brief Fear of Movement Scale for Osteoarthritis is a 6-item scale validated to assess fear of movement in individuals with osteoarthritis. All items are averaged for a final score range of 1 (low fear) to 4 (high fear).
Change from Baseline at 1 month
Change From Baseline in Arthritis Self-efficacy: Pain and Other Symptoms by the Arthritis Self-efficacy Pain and Other Symptoms Subscales
Time Frame: Change from Baseline at 1 month
The Arthritis-Self Efficacy Scale is scored from a 1 to 10 with higher scores indicating greater self-efficacy. The scale will be divided into the "pain" and "other symptoms" subscales. The items on each subscale are averaged for a final score from 1 to 10.
Change from Baseline at 1 month
Change From Baseline in Physical and Mental Health: Global Health: Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health (Physical and Mental Health Sub-scales)
Time Frame: Change from Baseline at 1 month
The PROMIS v.1.1 Global Health Short Form is a 10-item survey that measures overall physical function, fatigue, pain, emotional distress, and social health in healthy and clinical adult populations. It will be divided into two subscales: physical health and mental health. The Physical Health subscore ranges from 1 (poor) to 5 (excellent). The Mental Health subscore ranges from 1 (poor) to 5 (excellent).
Change from Baseline at 1 month
Change From Baseline in Body Mindset by the Illness Mindset Inventory
Time Frame: Change from Baseline at Post-intervention (immediately following intervention completion)
The Illness Mindset Inventory measures three mindsets about the nature of the body in the context of a chronic illness: that it is adversarial, responsive, or resilient. The scale consists of 20 items measured on a 6-point scale and scored from 1 to 6, with 10 of those questions capturing mindsets about the body. The extent to which a participant endorses a particular mindset can be obtained by calculating the mean score for each mindset. A higher score indicates greater agreement with the mindset. The investigators adapted the scale to focus on mindsets about "knee osteoarthritis" as opposed to "chronic disease." The three subscales are The Body is Adversarial, The Body is Capable, and the Body is Responsive. The items from each subscale are averaged for a final score between 1-6.
Change from Baseline at Post-intervention (immediately following intervention completion)
Change From Baseline in Adequacy Mindset by the Adequacy of Activity Mindset Measure
Time Frame: Change from Baseline at Post-intervention (immediately following intervention completion)
The Adequacy of Activity Mindset Measure is a scale developed to assess mindsets about the adequacy and benefits of ones' physical activity as it relates to health. The scale consists of 5 items measured on a 7-point scale and scored from 1 to 7, with a higher score reflecting a more adaptive mindset about the benefits and risks associated with current levels of physical activity. All items are averaged for a final score between 1 to 7.
Change from Baseline at Post-intervention (immediately following intervention completion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Alia Crum, PhD, Stanford University
  • Principal Investigator: Melissa Boswell, PhD, Stanford University
  • Principal Investigator: Scott Delp, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Actual)

September 19, 2023

Study Completion (Actual)

September 19, 2023

Study Registration Dates

First Submitted

September 9, 2022

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data, including participant characteristics and outcome measures, will be made available after de-identification.

IPD Sharing Time Frame

Upon manuscript submission

IPD Sharing Access Criteria

Open-source

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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