Clinical trial NCT05698368: Digital Knee Osteoarthritis Mindset Intervention
Official title: A Digital Mindset Intervention to Improve Pain and Exercise Participation in Individuals With Knee Osteoarthritis: A Randomized, Parallel-group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Mindset
Physical Activity
Exercise
Psychology
Pain
Digital Health
Osteoarthritis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 458
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of three groups in parallel for the duration of the study.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale
timeFrame: Change from Baseline at 1 month
measure: Change From Baseline in Physical Activity Measured by Physical Activity Scale for the Elderly
timeFrame: Change from Baseline at 1 month
measure: Change From Baseline in Mindset About the Process of Health - Physical Activity (MPH-Physical Activity) Scale
timeFrame: Change from Baseline at Post-intervention (immediately following intervention completion)
measure: Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory
timeFrame: Change from Baseline at Post-intervention (immediately following intervention completion)
Secondary outcomes:
measure: Change From Baseline in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC)
timeFrame: Change from Baseline at 1 month
measure: Change From Baseline in Knee Osteoarthritis Knowledge by the Knee Osteoarthritis Knowledge Scale
timeFrame: Change from Baseline at Post-intervention (immediately following intervention completion)
measure: Change From Baseline in Perceived Need for Surgery by a Surgery Perception Question
timeFrame: Change from Baseline at 1 month
measure: 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.
timeFrame: Change from Baseline at 1 month
measure: Change From Baseline in Fear of Movement by the Brief Fear of Movement Scale for Osteoarthritis
timeFrame: Change from Baseline at 1 month
measure: Change From Baseline in Arthritis Self-efficacy: Pain and Other Symptoms by the Arthritis Self-efficacy Pain and Other Symptoms Subscales
timeFrame: Change from Baseline at 1 month
measure: 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)
timeFrame: Change from Baseline at 1 month
measure: Change From Baseline in Body Mindset by the Illness Mindset Inventory
timeFrame: Change from Baseline at Post-intervention (immediately following intervention completion)
measure: Change From Baseline in Adequacy Mindset by the Adequacy of Activity Mindset Measure
timeFrame: Change from Baseline at Post-intervention (immediately following intervention completion)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Melissa Boswell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Scott Delp, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Alia Crum, PhD
role: PRINCIPAL_INVESTIGATOR
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