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NCT05698368

Digital Knee Osteoarthritis Mindset Intervention

Completed NA Results posted Last updated 13 February 2025
What this trial tests

NA trial testing Mindset intervention in Knee Osteoarthritis in 458 participants. Completed in 19 September 2023.

Timeline
10 April 2023
Primary endpoint
19 September 2023
19 September 2023

Quick facts

Lead sponsorStanford University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposesupportive care
Enrollment458
Start date10 April 2023
Primary completion19 September 2023
Estimated completion19 September 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Stanford University

Who can join

45 and older, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale Primary · Change from Baseline at 1 month

Knee pain scored from 0 - 10 (0 being no pain and 10 being the worst pain)

GroupValue95% CI
Active Comparator Group-0.2-0.5 – 0.0
Mindset Intervention Group-0.5-0.8 – -0.1
Survey-only Group-0.1-0.4 – 0.2
Change From Baseline in Physical Activity Measured by Physical Activity Scale for the Elderly Primary · 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).

GroupValue95% CI
Active Comparator Group32.618.7 – 46.3
Mindset Intervention Group38.924.3 – 53.6
Survey-only Group10.32.0 – 22.6
Change From Baseline in Mindset About the Process of Health - Physical Activity (MPH-Physical Activity) Scale Primary · 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.

GroupValue95% CI
Active Comparator Group0.30.2 – 0.3
Mindset Intervention Group0.50.4 – 0.6
Survey-only Group0.10.0 – 0.1
Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory Primary · 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

Osteoarthritis is Catastrophic
GroupValue95% CI
Active Comparator Group-0.5-0.6 – -0.3
Mindset Intervention Group-1.1-1.3 – -1.0
Survey-only Group-0.2-0.3 – -0.1
Osteoarthritis is Manageable
GroupValue95% CI
Active Comparator Group0.70.5 – 0.8
Mindset Intervention Group1.10.9 – 1.2
Survey-only Group0.20.1 – 0.3
Osteoarthritis is Opportunistic
GroupValue95% CI
Active Comparator Group0.70.6 – 0.8
Mindset Intervention Group1.11.0 – 1.2
Survey-only Group0.20.0 – 0.3
Change From Baseline in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC) Secondary · 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).

Pain
GroupValue95% CI
Active Comparator Group-0.6-1.0 – -0.2
Mindset Intervention Group-0.8-1.2 – -0.4
Waitlist Control Group-0.4-0.7 – 0.0
Function
GroupValue95% CI
Active Comparator Group-0.7-1.3 – -0.2
Mindset Intervention Group-1.0-1.5 – -0.4
Waitlist Control Group-0.5-1.1 – 0.0
Change From Baseline in Knee Osteoarthritis Knowledge by the Knee Osteoarthritis Knowledge Scale Secondary · 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.

GroupValue95% CI
Mindset Intervention Group10.59.4 – 11.6
Active Comparator (Education) Group3.12.2 – 4.0
No-intervention (Survey-only) Control Group0.6-0.1 – 1.4
Change From Baseline in Perceived Need for Surgery by a Surgery Perception Question Secondary · 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.

GroupValue95% CI
Mindset Intervention Group-0.6-0.7 – -0.4
Active Comparator (Education) Group-0.2-0.4 – 0.0
No-intervention (Survey-only) Control Group0.0-0.2 – 0.1
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. Secondary · 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.

Pain medications
GroupValue95% CI
Mindset Intervention Group-3.8-12.5 – 4.8
Active Comparator (Education) Group4.4-0.1 – 9.0
No-intervention (Survey-only) Control Group-9.1-16.1 – -2.1
Injections
GroupValue95% CI
Mindset Intervention Group-6.2-13.8 – 1.5
Active Comparator (Education) Group3.7-4.1 – 11.5
No-intervention (Survey-only) Control Group0.7-5.9 – 7.3
Exercise
GroupValue95% CI
Mindset Intervention Group20.812.8 – 28.7
Active Comparator (Education) Group16.37.2 – 25.3
No-intervention (Survey-only) Control Group6.3-1.5 – 14.1
Supervised physical therapy
GroupValue95% CI
Mindset Intervention Group-2.3-9.2 – 4.6
Active Comparator (Education) Group4.4-2.7 – 11.5
No-intervention (Survey-only) Control Group-2.8-10.3 – 4.7
Rest
GroupValue95% CI
Mindset Intervention Group-1.5-10.7 – 7.0
Active Comparator (Education) Group11.13.2 – 19.0
No-intervention (Survey-only) Control Group-1.4-8.9 – 6.1
Imposing physical limitations
GroupValue95% CI
Mindset Intervention Group-19.2-28.3 – -10.1
Active Comparator (Education) Group5.2-4.3 – 14.7
No-intervention (Survey-only) Control Group-7.7-16.8 – 1.4
Diet or weight management
GroupValue95% CI
Mindset Intervention Group17.78.2 – 27.0
Active Comparator (Education) Group14.87.0 – 22.7
No-intervention (Survey-only) Control Group11.23.1 – 19.2
Self-soothing
GroupValue95% CI
Mindset Intervention Group10.01.0 – 19.0
Active Comparator (Education) Group0.7-8.6 – 10.1
No-intervention (Survey-only) Control Group-2.1-10.0 – 5.8
Change From Baseline in Fear of Movement by the Brief Fear of Movement Scale for Osteoarthritis Secondary · 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).

GroupValue95% CI
Mindset Intervention Group-0.4-0.5 – -0.3
Active Comparator (Education) Group-0.2-0.7 – 0.5
No-intervention (Survey-only) Control Group0.00.0 – 0.1
Change From Baseline in Arthritis Self-efficacy: Pain and Other Symptoms by the Arthritis Self-efficacy Pain and Other Symptoms Subscales Secondary · 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.

Pain
GroupValue95% CI
Mindset Intervention Group1.41.1 – 1.7
Active Comparator (Education) Group0.60.4 – 0.9
No-intervention (Survey-only) Control Group0.10.0 – 0.5
Other symptoms
GroupValue95% CI
Mindset Intervention Group1.10.9 – 1.4
Active Comparator (Education) Group0.60.3 – 0.9
No-intervention (Survey-only) Control Group0.50.3 – 0.8
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) Secondary · 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).

Physical health
GroupValue95% CI
Mindset Intervention Group0.20.1 – 0.2
Active Comparator (Education) Group0.10.0 – 0.2
No-intervention (Survey-only) Control Group0.00.0 – 0.1
Mental health
GroupValue95% CI
Mindset Intervention Group0.10.0 – 0.2
Active Comparator (Education) Group0.0-0.5 – 0.5
No-intervention (Survey-only) Control Group0.0-0.1 – 0.06
Change From Baseline in Body Mindset by the Illness Mindset Inventory Secondary · 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

The Body is Adversarial
GroupValue95% CI
Mindset Intervention Group-0.6-0.8 – -0.5
Active Comparator (Education) Group-0.4-0.5 – -0.2
No-intervention (Survey-only) Control Group-0.1-0.1 – 0.0
The Body is Capable
GroupValue95% CI
Mindset Intervention Group1.31.2 – 1.5
Active Comparator (Education) Group0.60.4 – 0.7
No-intervention (Survey-only) Control Group0.20.0 – 0.3
The Body is Responsive
GroupValue95% CI
Mindset Intervention Group0.70.5 – 0.8
Active Comparator (Education) Group0.40.3 – 0.5
No-intervention (Survey-only) Control Group0.20.0 – 0.2

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A randomized clinical trial testing digital mindset intervention for knee osteoarthritis pain and activity improvement.
    Boswell MA, Evans KM, Ghandwani D, Hastie T, et al · · 2024 · cited 4× · PMID 39414999 · DOI 10.1038/s41746-024-01281-8

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Other recruiting trials for Knee Osteoarthritis

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