Knee Osteoarthritis
Conditions
Keywords
Mindset, Physical Activity, Exercise, Psychology, Pain, Digital Health, Osteoarthritis
Brief summary
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.
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.
Interventions
BEHAVIORALMindset intervention
Participants receive a digital mindset intervention to improve mindsets about osteoarthritis and exercise.
OTHERActive comparator
Participants receive a series of osteoarthritis education videos and reflective questions that matches the digital mindset intervention in duration and attention.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Blind investigator and outcomes assessor: does not know group label
Intervention model description
Participants are randomly assigned to one of three groups in parallel for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale | 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 in Physical Activity Measured by Physical Activity Scale for the Elderly | 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 in Mindset About the Process of Health - Physical Activity (MPH-Physical Activity) Scale | 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 in Osteoarthritis Mindset by the Illness Mindset Inventory | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fear of Movement by the Brief Fear of Movement Scale for Osteoarthritis | 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 in Arthritis Self-efficacy: Pain and Other Symptoms by the Arthritis Self-efficacy Pain and Other Symptoms Subscales | 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 in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC) | 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 in Body Mindset by the Illness Mindset Inventory | 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 in Adequacy Mindset by the Adequacy of Activity Mindset Measure | 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 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) | 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 in Knee Osteoarthritis Knowledge by the Knee Osteoarthritis Knowledge Scale | 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 in Perceived Need for Surgery by a Surgery Perception Question | 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 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Active comparator: Participants receive a series of osteoarthritis education videos and reflective questions that matches the digital mindset intervention in duration and attention. | 135 |
| 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.
Mindset intervention: Participants receive a digital mindset intervention to improve mindsets about osteoarthritis and exercise. | 130 |
| Survey-only Group This group will take the same surveys as the other groups at the same time points but will not receive any additional content. | 143 |
| Total | 408 |
Baseline characteristics
| Characteristic | Active Comparator Group | Mindset Intervention Group | Survey-only Group | Total |
|---|---|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 9.2 | 64.1 years STANDARD_DEVIATION 8 | 63.0 years STANDARD_DEVIATION 9 | 63.5 years STANDARD_DEVIATION 8.8 |
| Race/Ethnicity, Customized American Indian or Alaskan NativeAmerican Indian or Alaskan Native | 4 Participants | 2 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants | 7 Participants | 2 Participants | 16 Participants |
| Race/Ethnicity, Customized Black or African-American | 6 Participants | 4 Participants | 9 Participants | 19 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants | 2 Participants | 10 Participants | 14 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 4 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 118 Participants | 118 Participants | 128 Participants | 364 Participants |
| Sex: Female, Male Female | 81 Participants | 79 Participants | 85 Participants | 245 Participants |
| Sex: Female, Male Male | 54 Participants | 51 Participants | 58 Participants | 163 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 135 | 0 / 130 | 0 / 143 |
| other Total, other adverse events | 0 / 135 | 0 / 130 | 0 / 143 |
| serious Total, serious adverse events | 0 / 135 | 0 / 130 | 0 / 143 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator Group | Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale | -0.2 units on a scale |
| Mindset Intervention Group | Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale | -0.5 units on a scale |
| Survey-only Group | Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale | -0.1 units on a scale |
Primary
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator Group | Change From Baseline in Mindset About the Process of Health - Physical Activity (MPH-Physical Activity) Scale | 0.3 units on a scale |
| Mindset Intervention Group | Change From Baseline in Mindset About the Process of Health - Physical Activity (MPH-Physical Activity) Scale | 0.5 units on a scale |
| Survey-only Group | Change From Baseline in Mindset About the Process of Health - Physical Activity (MPH-Physical Activity) Scale | 0.1 units on a scale |
Primary
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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Comparator Group | Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory | Osteoarthritis is Manageable | 0.7 units on a scale |
| Active Comparator Group | Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory | Osteoarthritis is Catastrophic | -0.5 units on a scale |
| Active Comparator Group | Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory | Osteoarthritis is Opportunistic | 0.7 units on a scale |
| Mindset Intervention Group | Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory | Osteoarthritis is Manageable | 1.1 units on a scale |
| Mindset Intervention Group | Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory | Osteoarthritis is Catastrophic | -1.1 units on a scale |
| Mindset Intervention Group | Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory | Osteoarthritis is Opportunistic | 1.1 units on a scale |
| Survey-only Group | Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory | Osteoarthritis is Catastrophic | -0.2 units on a scale |
| Survey-only Group | Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory | Osteoarthritis is Opportunistic | 0.2 units on a scale |
| Survey-only Group | Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory | Osteoarthritis is Manageable | 0.2 units on a scale |
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator Group | Change From Baseline in Physical Activity Measured by Physical Activity Scale for the Elderly | 32.6 units on a scale |
| Mindset Intervention Group | Change From Baseline in Physical Activity Measured by Physical Activity Scale for the Elderly | 38.9 units on a scale |
| Survey-only Group | Change From Baseline in Physical Activity Measured by Physical Activity Scale for the Elderly | 10.3 units on a scale |
Secondary
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator Group | Change From Baseline in Adequacy Mindset by the Adequacy of Activity Mindset Measure | 0.3 score on a scale |
| Mindset Intervention Group | Change From Baseline in Adequacy Mindset by the Adequacy of Activity Mindset Measure | 0.2 score on a scale |
| Survey-only Group | Change From Baseline in Adequacy Mindset by the Adequacy of Activity Mindset Measure | 0.0 score on a scale |
Secondary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Comparator Group | Change From Baseline in Arthritis Self-efficacy: Pain and Other Symptoms by the Arthritis Self-efficacy Pain and Other Symptoms Subscales | Pain | 1.4 score on a scale |
| Active Comparator Group | Change From Baseline in Arthritis Self-efficacy: Pain and Other Symptoms by the Arthritis Self-efficacy Pain and Other Symptoms Subscales | Other symptoms | 1.1 score on a scale |
| Mindset Intervention Group | Change From Baseline in Arthritis Self-efficacy: Pain and Other Symptoms by the Arthritis Self-efficacy Pain and Other Symptoms Subscales | Pain | 0.6 score on a scale |
| Mindset Intervention Group | Change From Baseline in Arthritis Self-efficacy: Pain and Other Symptoms by the Arthritis Self-efficacy Pain and Other Symptoms Subscales | Other symptoms | 0.6 score on a scale |
| Survey-only Group | Change From Baseline in Arthritis Self-efficacy: Pain and Other Symptoms by the Arthritis Self-efficacy Pain and Other Symptoms Subscales | Other symptoms | 0.5 score on a scale |
| Survey-only Group | Change From Baseline in Arthritis Self-efficacy: Pain and Other Symptoms by the Arthritis Self-efficacy Pain and Other Symptoms Subscales | Pain | 0.1 score on a scale |
Secondary
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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Comparator Group | Change From Baseline in Body Mindset by the Illness Mindset Inventory | The Body is Capable | 1.3 score on a scale |
| Active Comparator Group | Change From Baseline in Body Mindset by the Illness Mindset Inventory | The Body is Adversarial | -0.6 score on a scale |
| Active Comparator Group | Change From Baseline in Body Mindset by the Illness Mindset Inventory | The Body is Responsive | 0.7 score on a scale |
| Mindset Intervention Group | Change From Baseline in Body Mindset by the Illness Mindset Inventory | The Body is Capable | 0.6 score on a scale |
| Mindset Intervention Group | Change From Baseline in Body Mindset by the Illness Mindset Inventory | The Body is Adversarial | -0.4 score on a scale |
| Mindset Intervention Group | Change From Baseline in Body Mindset by the Illness Mindset Inventory | The Body is Responsive | 0.4 score on a scale |
| Survey-only Group | Change From Baseline in Body Mindset by the Illness Mindset Inventory | The Body is Adversarial | -0.1 score on a scale |
| Survey-only Group | Change From Baseline in Body Mindset by the Illness Mindset Inventory | The Body is Responsive | 0.2 score on a scale |
| Survey-only Group | Change From Baseline in Body Mindset by the Illness Mindset Inventory | The Body is Capable | 0.2 score on a scale |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator Group | Change From Baseline in Fear of Movement by the Brief Fear of Movement Scale for Osteoarthritis | -0.4 score on a scale |
| Mindset Intervention Group | Change From Baseline in Fear of Movement by the Brief Fear of Movement Scale for Osteoarthritis | -0.2 score on a scale |
| Survey-only Group | Change From Baseline in Fear of Movement by the Brief Fear of Movement Scale for Osteoarthritis | 0.0 score on a scale |
Secondary
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator Group | Change From Baseline in Knee Osteoarthritis Knowledge by the Knee Osteoarthritis Knowledge Scale | 10.5 score on a scale |
| Mindset Intervention Group | Change From Baseline in Knee Osteoarthritis Knowledge by the Knee Osteoarthritis Knowledge Scale | 3.1 score on a scale |
| Survey-only Group | Change From Baseline in Knee Osteoarthritis Knowledge by the Knee Osteoarthritis Knowledge Scale | 0.6 score on a scale |
Secondary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Comparator Group | Change From Baseline in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC) | Pain | -0.6 score on a scale |
| Active Comparator Group | Change From Baseline in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC) | Function | -0.7 score on a scale |
| Mindset Intervention Group | Change From Baseline in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC) | Pain | -0.8 score on a scale |
| Mindset Intervention Group | Change From Baseline in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC) | Function | -1.0 score on a scale |
| Survey-only Group | Change From Baseline in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC) | Pain | -0.4 score on a scale |
| Survey-only Group | Change From Baseline in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC) | Function | -0.5 score on a scale |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Comparator Group | Change From Baseline in Perceived Need for Surgery by a Surgery Perception Question | -0.6 score on a scale |
| Mindset Intervention Group | Change From Baseline in Perceived Need for Surgery by a Surgery Perception Question | -0.2 score on a scale |
| Survey-only Group | Change From Baseline in Perceived Need for Surgery by a Surgery Perception Question | 0.0 score on a scale |
Secondary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Comparator Group | 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) | Physical health | 0.2 score on a scale |
| Active Comparator Group | 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) | Mental health | 0.1 score on a scale |
| Mindset Intervention Group | 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) | Physical health | 0.1 score on a scale |
| Mindset Intervention Group | 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) | Mental health | 0.0 score on a scale |
| Survey-only Group | 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) | Physical health | 0.0 score on a scale |
| Survey-only Group | 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) | Mental health | 0.0 score on a scale |
Secondary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Comparator Group | 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. | Pain medications | -3.8 percentage |
| Active Comparator Group | 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. | Injections | -6.2 percentage |
| Active Comparator Group | 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. | Exercise | 20.8 percentage |
| Active Comparator Group | 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. | Supervised physical therapy | -2.3 percentage |
| Active Comparator Group | 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. | Rest | -1.5 percentage |
| Active Comparator Group | 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. | Imposing physical limitations | -19.2 percentage |
| Active Comparator Group | 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. | Diet or weight management | 17.7 percentage |
| Active Comparator Group | 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. | Self-soothing | 10.0 percentage |
| Active Comparator Group | 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. | Mindset | 7.7 percentage |
| Active Comparator Group | 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. | Nothing | 0.0 percentage |
| Mindset Intervention Group | 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. | Mindset | -2.2 percentage |
| Mindset Intervention Group | 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. | Pain medications | 4.4 percentage |
| Mindset Intervention Group | 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. | Imposing physical limitations | 5.2 percentage |
| Mindset Intervention Group | 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. | Rest | 11.1 percentage |
| Mindset Intervention Group | 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. | Injections | 3.7 percentage |
| Mindset Intervention Group | 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. | Nothing | -0.7 percentage |
| Mindset Intervention Group | 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. | Self-soothing | 0.7 percentage |
| Mindset Intervention Group | 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. | Exercise | 16.3 percentage |
| Mindset Intervention Group | 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. | Diet or weight management | 14.8 percentage |
| Mindset Intervention Group | 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. | Supervised physical therapy | 4.4 percentage |
| Survey-only Group | 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. | Self-soothing | -2.1 percentage |
| Survey-only Group | 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. | Supervised physical therapy | -2.8 percentage |
| Survey-only Group | 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. | Rest | -1.4 percentage |
| Survey-only Group | 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. | Imposing physical limitations | -7.7 percentage |
| Survey-only Group | 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. | Mindset | -6.3 percentage |
| Survey-only Group | 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. | Diet or weight management | 11.2 percentage |
| Survey-only Group | 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. | Pain medications | -9.1 percentage |
| Survey-only Group | 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. | Nothing | -2.1 percentage |
| Survey-only Group | 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. | Injections | 0.7 percentage |
| Survey-only Group | 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. | Exercise | 6.3 percentage |