Digital Knee Osteoarthritis Mindset Intervention

Study Overview
=================
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.

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

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Behavioral: Mindset intervention
* Other: Active comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to one of three groups in parallel for the duration of the study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active comparator group<br>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<br>* Participants receive a series of osteoarthritis education videos and reflective questions that matches the digital mindset intervention in duration and attention.<br>* Other names: Educational content;|
| Experimental: Mindset intervention group<br>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<br>* Participants receive a digital mindset intervention to improve mindsets about osteoarthritis and exercise.<br>|
| No Intervention: Waitlist control group<br>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 | 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 | 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 to over 400 with higher scores indicating higher levels of physical activity. | 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 measured on a 4-point scale and scored from 1 to 4, with a higher score reflecting a more appeal-focused mindset about physical activity. | 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. | 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) | 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. | 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. | 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) | Change from Baseline at 1 month | 
| Change from baseline in symptom management strategy by an osteoarthritis symptom management question | 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. | 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. | 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. | 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 sub-scales: physical health and mental health. | 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. | Change from Baseline at Post-intervention (immediately following intervention completion) | 
| Change from baseline in self-fulfilling meta-mindset by the Self-fulfilling Meta-Mindset Scale | The Self-fulfilling Meta-Mindset Scale is a 4-item survey that measures the extent to which one believes that having a mindset about something might change its outcome. | Change from Baseline at Post-intervention (immediately following intervention completion) | 
| Change from baseline in controllable meta-mindset by the Controllable Meta-Mindset Scale | The Controllable Meta-Mindset Scale is a 4-item survey that measures one's beliefs about your ability to change and control their mindsets. | 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. | Change from Baseline at Post-intervention (immediately following intervention completion) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mindset, Physical Activity, Exercise, Psychology, Pain, Digital Health, Osteoarthritis