Trial Outcomes & Findings for Digital Knee Osteoarthritis Mindset Intervention (NCT NCT05698368)

NCT ID: NCT05698368

Last Updated: 2025-02-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 458 participants
• Primary outcome timeframe: Change from Baseline at 1 month
• Results posted on: 2025-02-13

Participant Flow

Participant milestones

Measure	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.	Active Comparator (Education) 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.	No-intervention (Survey-only) Control Group This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
Overall Study STARTED	151	152	155
Overall Study COMPLETED	130	135	143
Overall Study NOT COMPLETED	21	17	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Digital Knee Osteoarthritis Mindset Intervention

Baseline characteristics by cohort

Measure	Active Comparator Group n=135 Participants 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.	Mindset Intervention Group n=130 Participants 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.	Survey-only Group n=143 Participants This group will take the same surveys as the other groups at the same time points but will not receive any additional content.	Total n=408 Participants Total of all reporting groups
Age, Continuous	63.6 years STANDARD_DEVIATION 9.2 • n=5 Participants	64.1 years STANDARD_DEVIATION 8.0 • n=7 Participants	63.0 years STANDARD_DEVIATION 9.0 • n=5 Participants	63.5 years STANDARD_DEVIATION 8.8 • n=4 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	79 Participants n=7 Participants	85 Participants n=5 Participants	245 Participants n=4 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	51 Participants n=7 Participants	58 Participants n=5 Participants	163 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaskan NativeAmerican Indian or Alaskan Native	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Asian	7 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	16 Participants n=4 Participants
Race/Ethnicity, Customized Black or African-American	6 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	19 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants	14 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized White	118 Participants n=5 Participants	118 Participants n=7 Participants	128 Participants n=5 Participants	364 Participants n=4 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants

PRIMARY outcome

Timeframe: Change from Baseline at 1 month

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

Outcome measures

Measure	Active Comparator Group n=135 Participants 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.	Mindset Intervention Group n=130 Participants 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.	Survey-only Group n=143 Participants This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale	-0.2 units on a scale Interval -0.5 to 0.0	-0.5 units on a scale Interval -0.8 to -0.1	-0.1 units on a scale Interval -0.4 to 0.2

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Active Comparator Group n=135 Participants 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.	Mindset Intervention Group n=130 Participants 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.	Survey-only Group n=143 Participants This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
Change From Baseline in Physical Activity Measured by Physical Activity Scale for the Elderly	32.6 units on a scale Interval 18.7 to 46.3	38.9 units on a scale Interval 24.3 to 53.6	10.3 units on a scale Interval 2.0 to 22.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Comparator Group n=135 Participants 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.	Mindset Intervention Group n=130 Participants 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.	Survey-only Group n=143 Participants This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
Change From Baseline in Mindset About the Process of Health - Physical Activity (MPH-Physical Activity) Scale	0.3 units on a scale Interval 0.2 to 0.3	0.5 units on a scale Interval 0.4 to 0.6	0.1 units on a scale Interval 0.0 to 0.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Comparator Group n=135 Participants 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.	Mindset Intervention Group n=130 Participants 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.	Survey-only Group n=143 Participants This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory Osteoarthritis is Catastrophic	-0.5 units on a scale Interval -0.6 to -0.3	-1.1 units on a scale Interval -1.3 to -1.0	-0.2 units on a scale Interval -0.3 to -0.1
Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory Osteoarthritis is Manageable	0.7 units on a scale Interval 0.5 to 0.8	1.1 units on a scale Interval 0.9 to 1.2	0.2 units on a scale Interval 0.1 to 0.3
Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory Osteoarthritis is Opportunistic	0.7 units on a scale Interval 0.6 to 0.8	1.1 units on a scale Interval 1.0 to 1.2	0.2 units on a scale Interval 0.0 to 0.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Active Comparator Group n=135 Participants 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.	Mindset Intervention Group n=130 Participants 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.	Survey-only Group n=143 Participants This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
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 Interval -1.0 to -0.2	-0.8 score on a scale Interval -1.2 to -0.4	-0.4 score on a scale Interval -0.7 to 0.0
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 Interval -1.3 to -0.2	-1.0 score on a scale Interval -1.5 to -0.4	-0.5 score on a scale Interval -1.1 to 0.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Comparator Group n=130 Participants 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.	Mindset Intervention Group n=135 Participants 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.	Survey-only Group n=143 Participants This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
Change From Baseline in Knee Osteoarthritis Knowledge by the Knee Osteoarthritis Knowledge Scale	10.5 score on a scale Interval 9.4 to 11.6	3.1 score on a scale Interval 2.2 to 4.0	0.6 score on a scale Interval -0.1 to 1.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Comparator Group n=130 Participants 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.	Mindset Intervention Group n=135 Participants 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.	Survey-only Group n=143 Participants This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
Change From Baseline in Perceived Need for Surgery by a Surgery Perception Question	-0.6 score on a scale Interval -0.7 to -0.4	-0.2 score on a scale Interval -0.4 to 0.0	0.0 score on a scale Interval -0.2 to 0.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Comparator Group n=130 Participants 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.	Mindset Intervention Group n=135 Participants 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.	Survey-only Group n=143 Participants This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
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 Interval -28.3 to -10.1	5.2 percentage Interval -4.3 to 14.7	-7.7 percentage Interval -16.8 to 1.4
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 Interval 1.0 to 19.0	0.7 percentage Interval -8.6 to 10.1	-2.1 percentage Interval -10.0 to 5.8
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 Interval 12.8 to 28.7	16.3 percentage Interval 7.2 to 25.3	6.3 percentage Interval -1.5 to 14.1
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. Supervised physical therapy	-2.3 percentage Interval -9.2 to 4.6	4.4 percentage Interval -2.7 to 11.5	-2.8 percentage Interval -10.3 to 4.7
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 Interval -10.7 to 7.0	11.1 percentage Interval 3.2 to 19.0	-1.4 percentage Interval -8.9 to 6.1
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. Diet or weight management	17.7 percentage Interval 8.2 to 27.0	14.8 percentage Interval 7.0 to 22.7	11.2 percentage Interval 3.1 to 19.2
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 Interval -1.5 to 16.9	-2.2 percentage Interval -11.3 to 6.9	-6.3 percentage Interval -14.8 to 2.2
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 Interval -4.3 to 4.3	-0.7 percentage Interval -5.1 to 3.6	-2.1 percentage Interval -5.2 to 1.0
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 Interval -12.5 to 4.8	4.4 percentage Interval -0.1 to 9.0	-9.1 percentage Interval -16.1 to -2.1
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. Injections	-6.2 percentage Interval -13.8 to 1.5	3.7 percentage Interval -4.1 to 11.5	0.7 percentage Interval -5.9 to 7.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Active Comparator Group n=130 Participants 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.	Mindset Intervention Group n=135 Participants 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.	Survey-only Group n=143 Participants This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
Change From Baseline in Fear of Movement by the Brief Fear of Movement Scale for Osteoarthritis	-0.4 score on a scale Interval -0.5 to -0.3	-0.2 score on a scale Interval -0.7 to 0.5	0.0 score on a scale Interval 0.0 to 0.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Comparator Group n=130 Participants 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.	Mindset Intervention Group n=135 Participants 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.	Survey-only Group n=143 Participants This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
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 Interval 0.9 to 1.4	0.6 score on a scale Interval 0.3 to 0.9	0.5 score on a scale Interval 0.3 to 0.8
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 Interval 1.1 to 1.7	0.6 score on a scale Interval 0.4 to 0.9	0.1 score on a scale Interval 0.0 to 0.5

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Active Comparator Group n=130 Participants 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.	Mindset Intervention Group n=135 Participants 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.	Survey-only Group n=143 Participants This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
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 Interval 0.1 to 0.2	0.1 score on a scale Interval 0.0 to 0.2	0.0 score on a scale Interval 0.0 to 0.1
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 Interval 0.0 to 0.2	0.0 score on a scale Interval -0.5 to 0.5	0.0 score on a scale Interval -0.1 to 0.06

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Comparator Group n=130 Participants 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.	Mindset Intervention Group n=135 Participants 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.	Survey-only Group n=143 Participants This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
Change From Baseline in Body Mindset by the Illness Mindset Inventory The Body is Adversarial	-0.6 score on a scale Interval -0.8 to -0.5	-0.4 score on a scale Interval -0.5 to -0.2	-0.1 score on a scale Interval -0.1 to 0.0
Change From Baseline in Body Mindset by the Illness Mindset Inventory The Body is Capable	1.3 score on a scale Interval 1.2 to 1.5	0.6 score on a scale Interval 0.4 to 0.7	0.2 score on a scale Interval 0.0 to 0.3
Change From Baseline in Body Mindset by the Illness Mindset Inventory The Body is Responsive	0.7 score on a scale Interval 0.5 to 0.8	0.4 score on a scale Interval 0.3 to 0.5	0.2 score on a scale Interval 0.0 to 0.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Active Comparator Group n=130 Participants 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.	Mindset Intervention Group n=135 Participants 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.	Survey-only Group n=143 Participants This group will take the same surveys as the other groups at the same time points but will not receive any additional content.
Change From Baseline in Adequacy Mindset by the Adequacy of Activity Mindset Measure	0.3 score on a scale Interval 0.1 to 0.5	0.2 score on a scale Interval 0.1 to 0.4	0.0 score on a scale Interval -0.1 to 0.1

Adverse Events

Active Comparator Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mindset Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Survey-Only Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Melissa Boswell

Stanford University

Phone: (650) 725-4009

Email: boswellm@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place