An interventional study of Mindset intervention and Active comparator in Knee Osteoarthritis, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Stanford University · Not applicable, Interventional, and Supportive care
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's enrollment of 458 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
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Exclusion criteria:
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
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
This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
Participants receive a digital mindset intervention to improve mindsets about osteoarthritis and exercise.
Participants receive a series of osteoarthritis education videos and reflective questions that matches the digital mindset intervention in duration and attention.
Also known as: Educational content
Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale
Knee pain scored from 0 - 10 (0 being no pain and 10 being the worst pain)
Time frame: Change from Baseline at 1 month
Change From Baseline in Physical Activity Measured by Physical Activity Scale for the Elderly
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).
Time frame: Change from Baseline at 1 month
Change From Baseline in Mindset About the Process of Health - Physical Activity (MPH-Physical Activity) Scale
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.
Time frame: Change from Baseline at Post-intervention (immediately following intervention completion)
Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory
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.
Time frame: Change from Baseline at Post-intervention (immediately following intervention completion)
Change From Baseline in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC)
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).
Time frame: Change from Baseline at 1 month
Change From Baseline in Knee Osteoarthritis Knowledge by the Knee Osteoarthritis Knowledge Scale
The Knee Osteoarthritis Knowledge Scale is scored from 11-55 and measures knowledge about osteoarthritis in individuals with knee or hip osteoarthritis.
Time frame: Change from Baseline at Post-intervention (immediately following intervention completion)
Change From Baseline in Perceived Need for Surgery by a Surgery Perception Question
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.
Time frame: 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.
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.
Time frame: Change from Baseline at 1 month
Change From Baseline in Fear of Movement by the Brief Fear of Movement Scale for Osteoarthritis
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).
Time frame: 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
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.
Time frame: 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)
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).
Time frame: Change from Baseline at 1 month
Change From Baseline in Body Mindset by the Illness Mindset Inventory
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.
Time frame: Change from Baseline at Post-intervention (immediately following intervention completion)
Change From Baseline in Adequacy Mindset by the Adequacy of Activity Mindset Measure
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.
Time frame: Change from Baseline at Post-intervention (immediately following intervention completion)
| Milestone | Mindset Intervention Group | Active Comparator (Education) Group | No-intervention (Survey-only) Control Group |
|---|---|---|---|
| Started | 151 | 152 | 155 |
| Completed | 130 | 135 | 143 |
| Not completed | 21 | 17 | 12 |
Knee pain scored from 0 - 10 (0 being no pain and 10 being the worst pain)
| units on a scale | Active Comparator Group | Mindset Intervention Group | Survey-only Group |
|---|---|---|---|
| Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale | -0.2 (-0.5 to 0.0) | -0.5 (-0.8 to -0.1) | -0.1 (-0.4 to 0.2) |
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).
| units on a scale | Active Comparator Group | Mindset Intervention Group | Survey-only Group |
|---|---|---|---|
| Change From Baseline in Physical Activity Measured by Physical Activity Scale for the Elderly | 32.6 (18.7 to 46.3) | 38.9 (24.3 to 53.6) | 10.3 (2.0 to 22.6) |
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.
| units on a scale | Active Comparator Group | Mindset Intervention Group | Survey-only Group |
|---|---|---|---|
| Change From Baseline in Mindset About the Process of Health - Physical Activity (MPH-Physical Activity) Scale | 0.3 (0.2 to 0.3) | 0.5 (0.4 to 0.6) | 0.1 (0.0 to 0.1) |
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.
| units on a scale | Active Comparator Group | Mindset Intervention Group | Survey-only Group |
|---|---|---|---|
| Osteoarthritis is Catastrophic | -0.5 (-0.6 to -0.3) | -1.1 (-1.3 to -1.0) | -0.2 (-0.3 to -0.1) |
| Osteoarthritis is Manageable | 0.7 (0.5 to 0.8) | 1.1 (0.9 to 1.2) | 0.2 (0.1 to 0.3) |
| Osteoarthritis is Opportunistic | 0.7 (0.6 to 0.8) | 1.1 (1.0 to 1.2) | 0.2 (0.0 to 0.3) |
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).
| score on a scale | Active Comparator Group | Mindset Intervention Group | Waitlist Control Group |
|---|---|---|---|
| Pain | -0.6 (-1.0 to -0.2) | -0.8 (-1.2 to -0.4) | -0.4 (-0.7 to 0.0) |
| Function | -0.7 (-1.3 to -0.2) | -1.0 (-1.5 to -0.4) | -0.5 (-1.1 to 0.0) |
The Knee Osteoarthritis Knowledge Scale is scored from 11-55 and measures knowledge about osteoarthritis in individuals with knee or hip osteoarthritis.
| score on a scale | Mindset Intervention Group | Active Comparator (Education) Group | No-intervention (Survey-only) Control Group |
|---|---|---|---|
| Change From Baseline in Knee Osteoarthritis Knowledge by the Knee Osteoarthritis Knowledge Scale | 10.5 (9.4 to 11.6) | 3.1 (2.2 to 4.0) | 0.6 (-0.1 to 1.4) |
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.
| score on a scale | Mindset Intervention Group | Active Comparator (Education) Group | No-intervention (Survey-only) Control Group |
|---|---|---|---|
| Change From Baseline in Perceived Need for Surgery by a Surgery Perception Question | -0.6 (-0.7 to -0.4) | -0.2 (-0.4 to 0.0) | 0.0 (-0.2 to 0.1) |
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.
| percentage | Mindset Intervention Group | Active Comparator (Education) Group | No-intervention (Survey-only) Control Group |
|---|---|---|---|
| Pain medications | -3.8 (-12.5 to 4.8) | 4.4 (-0.1 to 9.0) | -9.1 (-16.1 to -2.1) |
| Injections | -6.2 (-13.8 to 1.5) | 3.7 (-4.1 to 11.5) | 0.7 (-5.9 to 7.3) |
| Exercise | 20.8 (12.8 to 28.7) | 16.3 (7.2 to 25.3) | 6.3 (-1.5 to 14.1) |
| Supervised physical therapy | -2.3 (-9.2 to 4.6) | 4.4 (-2.7 to 11.5) | -2.8 (-10.3 to 4.7) |
| Rest | -1.5 (-10.7 to 7.0) | 11.1 (3.2 to 19.0) | -1.4 (-8.9 to 6.1) |
| Imposing physical limitations | -19.2 (-28.3 to -10.1) | 5.2 (-4.3 to 14.7) | -7.7 (-16.8 to 1.4) |
| Diet or weight management | 17.7 (8.2 to 27.0) | 14.8 (7.0 to 22.7) | 11.2 (3.1 to 19.2) |
| Self-soothing | 10.0 (1.0 to 19.0) | 0.7 (-8.6 to 10.1) | -2.1 (-10.0 to 5.8) |
| Mindset | 7.7 (-1.5 to 16.9) | -2.2 (-11.3 to 6.9) | -6.3 (-14.8 to 2.2) |
| Nothing | 0.0 (-4.3 to 4.3) | -0.7 (-5.1 to 3.6) | -2.1 (-5.2 to 1.0) |
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).
| score on a scale | Mindset Intervention Group | Active Comparator (Education) Group | No-intervention (Survey-only) Control Group |
|---|---|---|---|
| Change From Baseline in Fear of Movement by the Brief Fear of Movement Scale for Osteoarthritis | -0.4 (-0.5 to -0.3) | -0.2 (-0.7 to 0.5) | 0.0 (0.0 to 0.1) |
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.
| score on a scale | Mindset Intervention Group | Active Comparator (Education) Group | No-intervention (Survey-only) Control Group |
|---|---|---|---|
| Pain | 1.4 (1.1 to 1.7) | 0.6 (0.4 to 0.9) | 0.1 (0.0 to 0.5) |
| Other symptoms | 1.1 (0.9 to 1.4) | 0.6 (0.3 to 0.9) | 0.5 (0.3 to 0.8) |
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).
| score on a scale | Mindset Intervention Group | Active Comparator (Education) Group | No-intervention (Survey-only) Control Group |
|---|---|---|---|
| Physical health | 0.2 (0.1 to 0.2) | 0.1 (0.0 to 0.2) | 0.0 (0.0 to 0.1) |
| Mental health | 0.1 (0.0 to 0.2) | 0.0 (-0.5 to 0.5) | 0.0 (-0.1 to 0.06) |
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.
| score on a scale | Mindset Intervention Group | Active Comparator (Education) Group | No-intervention (Survey-only) Control Group |
|---|---|---|---|
| The Body is Adversarial | -0.6 (-0.8 to -0.5) | -0.4 (-0.5 to -0.2) | -0.1 (-0.1 to 0.0) |
| The Body is Capable | 1.3 (1.2 to 1.5) | 0.6 (0.4 to 0.7) | 0.2 (0.0 to 0.3) |
| The Body is Responsive | 0.7 (0.5 to 0.8) | 0.4 (0.3 to 0.5) | 0.2 (0.0 to 0.2) |
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.
| score on a scale | Mindset Intervention Group | Active Comparator (Education) Group | No-intervention (Survey-only) Control Group |
|---|---|---|---|
| Change From Baseline in Adequacy Mindset by the Adequacy of Activity Mindset Measure | 0.3 (0.1 to 0.5) | 0.2 (0.1 to 0.4) | 0.0 (-0.1 to 0.1) |
Collected over 5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Comparator Group | 0/135 (0%) | 0/135 (0%) | 0/135 (0%) |
| Mindset Intervention Group | 0/130 (0%) | 0/130 (0%) | 0/130 (0%) |
| Survey-Only Group | 0/143 (0%) | 0/143 (0%) | 0/143 (0%) |
| Age, Continuous(years) | Active Comparator Group | Mindset Intervention Group | Survey-only Group | Total |
|---|---|---|---|---|
| Mean | 63.6 ± 9.2 | 64.1 ± 8.0 | 63.0 ± 9.0 | 63.5 ± 8.8 |
| Sex: Female, Male(Participants) | Active Comparator Group | Mindset Intervention Group | Survey-only Group | Total |
|---|---|---|---|---|
| Female | 81 | 79 | 85 | 245 |
| Male | 54 | 51 | 58 | 163 |
| Race/Ethnicity, Customized(Participants) | Active Comparator Group | Mindset Intervention Group | Survey-only Group | Total |
|---|---|---|---|---|
| American Indian or Alaskan NativeAmerican Indian or Alaskan Native | 4 | 2 | 3 | 9 |
| Asian | 7 | 7 | 2 | 16 |
| Black or African-American | 6 | 4 | 9 | 19 |
| Hispanic or Latino | 2 | 2 | 10 | 14 |
| Native Hawaiian or Pacific Islander | 0 | 0 | 0 | 0 |
| White | 118 | 118 | 128 | 364 |
| Other | 3 | 4 | 1 | 8 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data, including participant characteristics and outcome measures, will be made available after de-identification.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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