A Digital Mindset Intervention to Improve Pain and Exercise Participation in Individuals With Knee Osteoarthritis: A Randomized, Parallel-group Study
Phase: NA
Conditions: Knee Osteoarthritis
Sponsor: Stanford University

 
1 
ID: 69227 
    Digital Knee Osteoarthritis Mindset Intervention 
NCT05698368 
March 2023 
 

 
2 
Supplement 1. 
Protocol: A Digital Mindset Intervention to Improve Pain and Exercise 
Participation in Individuals With Knee Osteoarthritis: A Randomized Clinical 
Trial 
SPIRIT Checklist 
Investigators 
Melissa Boswell 
Kris Evans 
Disha Ghandwani 
Trevor Hastie 
Sean Zion 
Paula Moya 
Nick Giori 
Jennifer Hicks 
Alia Crum 
Scott Delp 
Background and Significance 
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. 
 
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. 
 
We developed a digital mindset intervention to improve mindsets about exercise and 
osteoarthritis in individuals with knee osteoarthritis. We 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. A large randomized trial is 
therefore needed to evaluate if our mindset intervention leads to improvements in 

 
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physical activity levels and osteoarthritis symptoms and, further, if these changes are 
due to more adaptive mindsets about exercise and osteoarthritis. 
 
Supplement 1 Table 1. Study Meta-data 
 
Data category 
Information 
Primary registry 
and trial identifying 
number 
ClinicalTrials.gov: NCT05698368 
Date of registration 
in primary registry 
January 2023 
Secondary 
identifying 
numbers 
IRB-69227 
Source(s) of 
monetary or 
material support 
The Wu Tsai Human Performance Alliance at Stanford 
University and the Joe and Clara Tsai Foundation. The Stanford 
Catalyst for Collaborative Solutions; the Mobilize Center, which 
is supported by the National Institute of Biomedical Imaging 
and Bioengineering (NIBIB) and the Eunice Kennedy Shriver 
National Institute Of Child Health & Human Development 
(NICHD) of the National Institutes of Health (NIH) under Grant 
P41EB027060; and the Center for Reliable Sensor Technology- 
Based Outcomes for Rehabilitation (RESTORE), which is 
supported by the Eunice Kennedy Shriver National Institute Of 
Child Health & Human Development (NICHD) and the National 
Institute Of Neurological Disorders And Stroke (NINDS) of the 
National Institutes of Health (NIH) under Grant No. 
P2CHD101913. 

 
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Primary sponsor 
Stanford University 
Contact for public 
queries 
MB, PHD 
Stanford University 
boswellm@stanford.edu 
Contact for 
scientific queries 
MB, PHD 
Stanford University 
boswellm@stanford.edu 
Title 
A Digital Mindset Intervention to Improve Pain and Exercise 
Participation in Individuals With Knee Osteoarthritis: A 
Randomized, Parallel-group Study 
Countries of 
recruitment 
USA 
Health condition(s) 
or problem(s) 
studied 
Knee osteoarthritis 
Study type 
Interventional 
Allocation: randomized 
Intervention model: parallel assignment 
Masking: Subjects not blind; outcomes assessor blind 
Primary purpose: Supportive Care 
Date of first 
enrolment 
April 2023 
Target sample size 
501 
Choice of comparator 
Education and exercise are recommended as first-line treatment for osteoarthritis, but 
often, “treatment as usual” is pain medication and, eventually, surgery. If patients want 
information about osteoarthritis, sometimes they are given a pamphlet about 
osteoarthritis by their doctor. Otherwise, they are left to research osteoarthritis on their 
own. Our comparator is education videos about osteoarthritis that one would typically 
find on the internet. While accurate, this information does not typically (or intentionally) 
target mindset and, as shown in the low physical activity levels and adherence to 
exercise, does not successfully support behavior change. As this does not put 

 
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participants at risk, we expect that it will neither improve nor worsen their physical or 
psychological states. 
 
Supplement 1 Table 2. Study Objectives 
 
Primary Objectives 
 
Primary outcomes 
Primary outcomes assessed at T2 (change from baseline): 
(i) Exercise mindset using the Mindset about the Process of 
Health -- Exercise scale. This one-factor scale was developed 
and validated1 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 and is measured on a 4-point scale and scored from 1 to 
4, with a higher score reflecting a more appeal-focused mindset 
about exercise 
(ii) Osteoarthritis mindsets using 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 chronic illness. The 
extent to which a participant endorsed each mindset was 
obtained by calculating the respective mean scores. A higher 
score indicates greater agreement with the mindset. This Illness 
Mindset Inventory is valid and reliable in individuals with knee 
osteoarthritis2. We adapted the scale to focus on mindsets about 
"knee osteoarthritis" as opposed to "chronic disease." 
 
Primary outcomes assessed at T3 (change from baseline): 
(i) Knee pain using the question, “What was your average 
osteoarthritis-related pain over the past week?” and measured on 
an 11-point Numeric Rating Scale (NRS) from 0 (no pain at all) to 
10 (the worst pain imaginable) 
(ii) Physical activity using the Physical Activity Scale for the 
Elderly (PASE). The 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 osteoarthritis3. The scale is scored from 0 to 793 
with higher scores indicating higher levels of physical activity. 
Secondary 
Objectives 
 
Key secondary 
Secondary outcomes assessed at T2 (change from baseline): 

 
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outcomes 
(i) Knee osteoarthritis knowledge by the Knee Osteoarthritis 
Knowledge Scale4. The Knee Osteoarthritis Knowledge Scale is 
scored 
from 
11-55 
and 
measures 
knowledge 
about 
osteoarthritis in individuals with knee or hip osteoarthritis 
(ii) Body mindsets using the Illness Mindset Inventory. In 
addition to mindsets about chronic illness, 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 
(iii) Activity adequacy mindsets using the Adequacy of Activity 
Mindset Measure5. This scale was developed to assess 
mindsets about the adequacy and benefits of one’s 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. 
 
Secondary outcomes assessed at T3 (change from baseline): 
(i) Knee pain and functioning using the Short version of the 
Western Ontario and McMaster Universities Arthritis Index 
(shortMAC). The shortMAC is a disease-specific 12-item 
measure of knee symptoms and has shown to be valid and 
reliable in patients with knee osteoarthritis6. We evaluated the 
measure divided into two subscales: pain and function 
(ii) Perceived need for surgery using the single question, "How 
likely do you think you are of needing knee replacement surgery in 
the future?" It was answered on the Likert scale from 1 (very 
unlikely) to 5 (very likely) 
(iii) Chosen symptom management strategies using 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 was answered via multiple choice with a multiple-
selection option. The options available were the most commonly 
identified responses as determined by a previous study7 
(iv) Fear of movement using the Brief Fear of Movement Scale 
for Osteoarthritis8. The Brief Fear of Movement Scale for 
Osteoarthritis is a 6-item scale validated to assess fear of 
movement in individuals with osteoarthritis 
(v) Arthritis self-efficacy using the Arthritis-Self Efficacy Scale. 
This scale is scored from 1 to 10, with higher scores indicating 
greater self-efficacy, and was divided into the "pain" and "other 
symptoms" subscales 
(vi) Physical and Mental Health using the PROMIS v.1.1 Global 
Health Short Form9. This scale is a 10-item survey that measures 
overall physical function, fatigue, pain, emotional distress, and 

 
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social health in healthy and clinical adult populations10. We 
evaluated the measure divided into its two subscales: physical 
health and mental health11. 
 
 
 
Key secondary 
outcomes 
Secondary outcomes assessed at T2 (change from baseline): 
(i) Knee osteoarthritis knowledge by the Knee Osteoarthritis 
Knowledge Scale4. The Knee Osteoarthritis Knowledge Scale is 
scored 
from 
11-55 
and 
measures 
knowledge 
about 
osteoarthritis in individuals with knee or hip osteoarthritis 
(ii) Body mindsets using the Illness Mindset Inventory. In 
addition to mindsets about chronic illness, 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 
(iii) Activity adequacy mindsets using the Adequacy of Activity 
Mindset Measure5. This scale was developed to assess 
mindsets about the adequacy and benefits of one’s 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. 
 
Secondary outcomes assessed at T3 (change from baseline): 
(i) Knee pain and functioning using the Short version of the 
Western Ontario and McMaster Universities Arthritis Index 
(shortMAC). The shortMAC is a disease-specific 12-item 
measure of knee symptoms and has shown to be valid and 
reliable in patients with knee osteoarthritis6. We evaluated the 
measure divided into two subscales: pain and function 
(ii) Perceived need for surgery using the single question, "How 
likely do you think you are of needing knee replacement surgery in 
the future?" It was answered on the Likert scale from 1 (very 
unlikely) to 5 (very likely) 
(iii) Chosen symptom management strategies using 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 was answered via multiple choice with a multiple-
selection option. The options available were the most commonly 
identified responses as determined by a previous study7 
(iv) Fear of movement using the Brief Fear of Movement Scale 
for Osteoarthritis8. The Brief Fear of Movement Scale for 

 
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Osteoarthritis is a 6-item scale validated to assess fear of 
movement in individuals with osteoarthritis 
(v) Arthritis self-efficacy using the Arthritis-Self Efficacy Scale. 
This scale is scored from 1 to 10, with higher scores indicating 
greater self-efficacy, and was divided into the "pain" and "other 
symptoms" subscales 
(vi) Physical and Mental Health using the PROMIS v.1.1 Global 
Health Short Form9. This scale is a 10-item survey that measures 
overall physical function, fatigue, pain, emotional distress, and 
social health in healthy and clinical adult populations10. We 
evaluated the measure divided into its two subscales: physical 
health and mental health11. 
Research Hypotheses 
Hypothesis 1. A digital education and mindset intervention will significantly improve 
mindsets about the process of exercising and osteoarthritis among adults aged ≥ 45 
years with knee osteoarthritis compared to an active comparison education intervention 
and no-intervention immediately post-intervention. 
 
Hypothesis 2. A digital education and mindset intervention will significantly reduce knee 
pain and increase physical activity levels among adults aged ≥ 45 years with knee 
osteoarthritis compared to an active comparison education intervention and a no-
intervention control group one-month post-intervention. 
 
Hypothesis 3. A digital education and mindset intervention will significantly improve  
knee osteoarthritis knowledge and mindsets about activity adequacy and the body  
among adults aged ≥ 45 years with knee osteoarthritis compared to an active 
comparison education intervention and a no intervention control group immediately 
post-intervention. 
 
Hypothesis 4. A digital education and mindset intervention will significantly improve  
knee pain and function, perceived need for surgery, symptom management, arthritis 
self-efficacy, fear of movement, physical health, mental health,  among adults aged ≥ 45 
years with knee osteoarthritis compared to an active-comparator education group and a 
no-intervention control group one-month post-intervention. 
Key Personnel 
Trial Coordinator 
Dr. Melissa Boswell, boswellm@stanford.edu 
Department of Bioengineering 
Stanford University, Stanford, California, USA 
 
Statisticians 

 
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Dr. Trevor Hastie 
Department of Statistics 
Stanford University, Stanford, California, USA 
 
Disha Ghandwani 
Department of Statistics 
Stanford University, Stanford, California, USA 
 
Trial Design 
We will randomize 505 individuals aged ≥ 45 years with knee osteoarthritis into one of 
three groups with 1:1:1 group allocation: the Mindset Group (participants receive a 
digital mindset intervention to improve mindsets about osteoarthritis and exercise), the 
Education Group (Participants receive a series of osteoarthritis education videos and 
reflective questions that matches the digital mindset intervention in duration and 
attention), or the No-Intervention Group (participants take the same surveys as the other 
groups at the same time points, but do not receive any additional content). Participants 
will complete an initial baseline survey and be randomized one week later. Those 
randomized to the Mindset and Eduction Groups will have one week to complete the 
self-paced online programs. All groups complete osteoarthritis knowledge and mindset 
surveys at this timepoint. One-month later, participants will receive a follow-up 
questionnaire. 
 
Study Setting 
The study will be conducted entirely online.  
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 

 
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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 
Interventions 
Intervention(s) 
Mindset Group: 
Participants receive a digital mindset intervention to improve 
mindsets about osteoarthritis and exercise. 
 
Education Group (active comparison): 
Participants receive a series of osteoarthritis education videos 
and reflective questions that matches the digital mindset 
intervention in duration and attention. 
 
No-Intervention ( control): 
Participants take the same surveys as the other groups at the 
same time points, but do not receive any additional content. 
Modifications 
Discontinuation of the program due to psychological disturbance. We do not expect 
participants to have a psychological disturbance due to the mindset intervention or 
active comparator program. In the case that someone refuses to continue the study due 
to a psychological disturbance from participation, this should be reported as an adverse 
event. 
Adherence 
Adherence reminders will be in the form of emails. Three reminders will be sent out: 
once before the deadline, on the deadline, and the day after the deadline. Reminders will 
include the importance of completing the section in order to remain in the study. 
Reminders will also include a flow chart of the study timeline and components, with the 
relevant section highlighted. Participants will be able reply to the study coordinator with 
questions. 

 
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Concomitant Care 
Participation is at the discretion of the participants. Thus, the other option for 
participants is to not participate in the study. 
 
Prohibited Concomitant Treatment. Additional physical therapy treatment is not 
permitted during the study as it would interfere with the main outcomes of our study. 
Study Flow and Timeline 
 
Supplement 1 Figure 1. Study flow and timeline. 
Sample Size 
The efficacy of the mindset intervention will be deemed successful if enhancements in 
either or both key outcomes, namely pain intensity (NRS) or physical activity levels 
(PASE), are observed. Anticipating modest effect sizes between the mindset and 
educational cohorts, we conducted a preliminary power analysis, similar to prior online 
education studies for knee osteoarthritis12,13, using G*Power 3.1 with a presumed effect 
size of 0.3 (see below). This analysis involved comparing the mindset group against both 
the education and no-intervention groups, leading to four distinct comparisons. These 
assessments are planned to be executed at a 5% significance level, aiming for an 80% 
probability of discerning a noticeable improvement in delta. Based on Boswell et al.7, we 
estimated the standard deviations for PASE and pain at 70.28 and 1.67, respectively. A 
26-point difference in PASE was selected as the target delta. While no clinically 
significant benchmarks for PASE has been established, the intervention's focus on 
promoting walking and moderate exercise led us to define this delta as the equivalent 
shift in walking and light exercise frequency from “seldom” (<1 hour per day) to 
“sometimes” (1-2 hours per day), as per the PASE scale, giving a goal of 26 points. This 
determination necessitates a sample size of 139 participants per group, totaling 417. To 
compensate for an anticipated 20% dropout rate, we plan to enroll 501 participants. This 
sample size is adequately powered to detect a clinically relevant difference of 2 points in 
NRS pain14. 
 

 
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13 
 
 

 
14 
 

 
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Recruitment 
Participants will be recruited through paid online and social media advertising and local 
flyer postings.  
Allocation 
We will use the randomizer function in Qualitrics to randomize participants into one of 
three groups (1:1:1): the Mindset Group, the Education Group (active comparison), or 
the No–Intervention Group (control). 
Blinding (Masking) 
During the informed consent process, participants will be informed that the purpose of 
the study is to understand the effect of a new online osteoarthritis program and that 
they will be randomized to either a no-intervention group or one of two different sets of 
videos and reflective questions. Participants will be aware of whether they are 
randomized to an online program; however, the differences in content between the two 
programs and the hypotheses of the study will not be revealed. The biostatistician 
performing the data analysis will be blinded to the group labels. 
Data Collection, Management, and Access 
All data will be collected through the Qualitrics online survey software. Qualitrics 
encrypts all transmitted data using Transport Layer Security and hosts data on data 
centers that are independently audited using the industry standard SSAE-18 method. 
Stanford University has a Qualtrics license for research use, and data obtained from the 
Qualitric platform can only be accessed through a secure login. Data will be exported to 
Microsoft Excel and securely stored for use by the research team. Only after de-
identification may the data be shared outside of the research team. 
 
Missing Data 
Participants who did not complete a survey entirely were removed from the study and 
not sent the follow-up survey. Each question of each survey was “force response,” 
meaning that if a participant completed the survey, no answers would be missing from 
the response. Thus, no methods for missing data were implemented. 
 
Statistical Methods 
 
Statistical analysis will be carried out in R15 by a blinded statistician, Disha Ghandwani, 
with no knowledge of group allocation. 
 

 
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Standard descriptive statistics will be presented for all participant characteristic 
measures at baseline. Prior to analysis, t-tests for continuous variables and chi-square 
(χ2) tests for categorical variables will be conducted to test the equality of means of 
baseline characteristics. Additionally, baseline characteristic comparisons between 
participants who completed the study and those who dropped out will be reported.  
 
Changes in primary and secondary mindsets post-intervention will be compared among 
the mindset intervention group versus the active attention control (education group) 
and the no-intervention control group. We will present standard descriptive statistics of 
and calculate changes from baseline to post-intervention for the mindsets and knee 
osteoarthritis knowledge and from baseline to one-month follow-up for all other 
outcome variables. Changes will be presented as the mean change with 95% 
confidence intervals, along with Cohen d, using the following formula: 
 
𝑐𝑜ℎ𝑒𝑛 𝑑 =
𝑥2̄ −𝑥1̄
𝑠  
 
where 𝑥2̄  denotes the mean of variable after intervention, 𝑥1̄  denotes the mean of 
variable before intervention, and 𝑠 denotes the standard deviation of the change in the 
variable due to intervention.  
 
We will perform the t-test to compare the change in outcome variables post-intervention 
and at follow-up between the mindset group and the education and no-intervention 
groups. We assume the equality of variance for the changes. The t-statistic is given by: 
𝑋̄ − 𝑌̄
𝑠𝑝𝑜𝑜𝑙𝑒𝑑√1
𝑚+ 1
𝑛
 , 
where 𝑋̄ is the mean of changes in the first group and 𝑌̄ is the mean of the 
changes in the second group, 𝑠𝑝𝑜𝑜𝑙𝑒𝑑 is the pooled standard deviation from the two 
groups. We assume that there were m people in the first group and n people in the 
second group. After calculating the t-statistics, the p-values will be computed to 
estimate the statistical significance of differences in changes between groups. We will 
perform Bonferonni correction for the four comparisons (e.g., the mindset group vs. the 
education group and the mindset group vs. the no-intervention group for pain and 
physical activity at one-month follow-up), which adjusts the significance threshold to P 
= 0.0125. The comparison of the education group to the no-intervention group will not 
be a primary comparison. 
Data Monitoring 
The trial coordinator will provide ongoing project oversight and will meet regularly with 
the senior investigators throughout the project period to provide study feedback 
including recruitment, retention, and adverse events. During the study, participants have 
access to email the study coordinator at any time to report adverse events. 

 
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Harms 
The potential harms associated with this study include psychological complications 
resulting from the assessments or mindset and education programs or medical risks 
due to increasing physical activity levels. There is a small risk that individuals 
completing psychological questionnaires may become distressed, but there is no 
evidence of resulting psychological dysfunction. We performed pilot testing of the 
program and questionnaires in which there was no evidence of psychological 
complications or the risk of such complications. Further, while the program presents the 
benefits of physical activity, no specific programs are requested for participation and 
participants are encouraged to go slow and listen to their bodies. 
 
Therefore, no harm or adverse events are foreseen in this study. However, if a complaint 
or adverse event arises, the research team will discuss and take appropriate action to 
manage the issue. Any serious adverse event or harm reported by participants will be 
recorded and reported.  
 
Research Ethics Approval 
The study protocol, consent form, and recruitment material will be approved by the 
Stanford University Research Compliance Office Institutional Review Board. 
Protocol Amendments 
Protocol amendments will be documented and reported. 
Consent Or Assent 
Participants will be directed from recruitment materials to a RedCap survey. The survey 
will first be provided with information on the purpose of the study and the requirements 
for participation. After that, participants will be given a survey to determine whether they 
can participate. If participants pass the qualifying survey, they will be directed to the 
online consent form, where they have the option to consent to participate in the study 
digitally. 
Confidentiality 
Personal or identifiable information obtained during this study is considered 
confidential. Participant confidentiality will be ensured by using identification code 
numbers corresponding to data across time points. Identifiable data will not be included 
in the dissemination of the manuscript and its accompanying data. See Data 
Management for additional information on the security of personal data. 
Declaration Of Interests 
None of the investigator team has any financial or other competing interests to declare. 

 
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Ancillary And Post-Trial Care 
Participants who agree to be contacted for future research during the consent process 
may be contacted for ancillary studies. Any ancillary studies will be submitted to the 
Institutional Review Board for approval. 
 
After study completion, all participants will be offered the mindset intervention program.  
Dissemination Policy 
The study will be submitted to peer-reviewed journals for publication. The results will be 
presented at national and international conferences. The results may also be shared in 
news outlets, such as online articles, newspapers, and magazines. Participant identity 
will not be disclosed when publishing or presenting the results. Participants will be 
informed of the results if requested.  
Informed Consent Materials 
FOR QUESTIONS ABOUT THE STUDY, CONTACT: 
Melissa Boswell 
Email: boswellm@stanford.edu 
  
Are you participating in any other research studies? _____ Yes _____No 
DESCRIPTION: You are invited to participate in a research study on the 
use of digital osteoarthritis management programs. The purpose of the 
study is to understand the effect of a new online osteoarthritis program. 
PROCEDURES: If you choose to participate, you will be randomized to 
either a waitlist group or one of two different sets of videos and reflective 
questions. You have a one in three (33.3%) chance of being assigned to 
each group. Each group is equally important for the study. Regardless of 
which group you are assigned to, you will be asked to fill out surveys, 
watch videos, answer reflection questions, and provide feedback on the 
program content. You will also be given the option to perform a functional 
assessment consisting of moving from a seated position to standing 5 
times, which you can record and upload within the online survey. 
DURATION OF STUDY INVOLVEMENT: Each participant will be actively 
enrolled in the study for the one-month duration of the study. 
Enrollment will occur throughout the United States. Stanford University 
expects to enroll 501 research study participants in this research study. 

 
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Identifiers might be removed from identifiable private information, and 
videos will be de-identified with face-blurring. After such removal, the 
information could be used for future research studies or distributed to 
another investigator for future research studies without additional informed 
consent from you. 
  
RISKS AND BENEFITS: The risks associated with this study are minimal, 
but there is a small risk of injury consistent with increasing daily physical 
activity and performing the sit-to-stand movement. Such injuries are 
temporary and minor (i.e., muscle fatigue and soreness). We will do 
everything possible to maintain your confidentiality during the study, but 
there is the potential risk of breach of confidentiality in which your video 
and survey results may be linked to your name. Study data, including 
videos, will be stored securely, in compliance with Stanford University 
standards, minimizing the risk of a confidentiality breach. Again, we will 
do our best to keep your data confidential. 
The benefits which may reasonably be expected to result from this study 
are that you will contribute to improving the program for other people with 
osteoarthritis in the future. You may also benefit from an increased 
understanding of knee osteoarthritis. We cannot and do not guarantee or 
promise that you will receive any benefits from this study. 
TIME INVOLVEMENT: Your participation will take approximately 4 hours 
over the course of five weeks. It will take around 30 minutes for the initial 
survey. You then may be asked to complete a program that will take 
around 3 hours over the course of one week. There will also be a follow-
up survey one month after the start of the study at which you will be 
asked to take another 30-minute survey. 
PAYMENTS: You will receive up to a total of $50 in gift cards as payment 
for your participation, split into three payments: 
·   
$10 after the first survey 
·   
$10 after the second survey 
·   
$30 after the third and final survey 
  
PARTICIPANT’S RIGHTS: If you have read this form and have decided to 
participate in this project, please understand your participation is 

 
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voluntary and you have the right to withdraw your consent or discontinue 
participation at any time without penalty or loss of benefits to which you 
are otherwise entitled. 
  
Your decision not to participate will not have any negative effect on you or 
your medical care. You have the right to refuse to answer particular 
questions. The alternative to participation in this study is to not 
participate. 
  
The results of this research study may be presented at scientific or 
professional meetings or published in scientific journals.  However, your 
identity will not be disclosed. 
  
A description of this clinical trial will be available on 
http://www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will 
not include information that can identify you.  At most, the Web site will 
include a summary of the results.  You can search this website at any 
time. 
  
Authorization To Use Your Health Information For Research Purposes  
Because information about you and your health is personal and private, it 
generally cannot be used in this research study without your written 
authorization.  If you sign this form, it will provide that authorization.  The 
form is intended to inform you about how your health information will be 
used or disclosed in the study.  Your information will only be used in 
accordance with this authorization form and the informed consent form 
and as required or allowed by law.  Please read it carefully before signing it.  
  
What is the purpose of this research study and how will my health 
information be utilized in the study? 
The purpose of this study is to evaluate digital osteoarthritis management 
programs for individuals with knee osteoarthritis. Health information will be 
evaluated over the course of the study and the results may be published in 
a conference and/or research journal. As this is a clinical trial, the 
information provided will, in some form, be submitted to the sponsor and 
other federal agencies as required. 
  
Do I have to sign this authorization form? 

 
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You do not have to sign this authorization form.  But if you do not, you will 
not be able to participate in this research study. Signing the form is not a 
condition for receiving any medical care outside the study. 
  
If I sign, can I revoke it or withdraw from the research later? 
If you decide to participate, you are free to withdraw your authorization 
regarding the use and disclosure of your health information (and to 
discontinue any other participation in the study) at any time.  After any 
revocation, your health information will no longer be used or disclosed in 
the study, except to the extent that the law allows us to continue using your 
information (e.g., necessary to maintain integrity of research).  If you wish 
to revoke your authorization for the research use or disclosure of your 
health information in this study, you must write to: Melissa Boswell 
(boswellm@stanford.edu). 
  
What Personal Information Will Be Obtained, Used or Disclosed? 
Your health information related to this study, may be used or disclosed in 
connection with this research study, including, but not limited to: name; 
email; self-reported health and demographic information including age, 
height, weight, sex, gender, ethnicity, state of residence, education, 
employment status, marital status, medical issues, osteoarthritis status, 
physical activity level, mental health, and physical health; physical activity; 
video of the sit-to-stand test. 
  
Who May Use or Disclose the Information? 
The following parties are authorized to use and/or disclose your health 
information in connection with this research study: 
·   
The Protocol Director, Melissa Boswell 
·   
The Stanford University Administrative Panel on Human 
Subjects in Medical Research and any other unit of Stanford 
University as necessary 
·   
Research Staff 
  
Who May Receive or Use the Information? 
The parties listed in the preceding paragraph may disclose your health 
information to the following persons and organizations for their use in 
connection with this research study: 
  

 
22 
·   
The Office for Human Research Protections in the U.S. 
Department of Health and Human Services 
  
Your information may be re-disclosed by the recipients described above, if 
they are not required by law to protect the privacy of the information. 
  
When will my authorization expire? 
Your authorization for the use and/or disclosure of your health information 
will end on December 31, 2050 or when the research project ends, 
whichever is earlier. 
  
  
Will access to my medical record be limited during the study? 
To maintain the integrity of this research study, you may not have access 
to any health information developed as part of this study until it is 
completed.  At that point, you would have access to such health 
information if it was used to make a medical or billing decision about you 
(e.g., if included in your official medical record). 
You give consent for your video recordings to be used for (describe 
proposed use of the recordings and what will happen to the recordings, 
e.g., shown at scientific meetings; and describe the final disposition of the 
tapes).(Please note, this option is also applicable if the recordings are used 
for purposes that are not part of this research project, e.g. future analysis, 
professional presentations, etc) 
Please initial your choice: ___Yes ___No 
  
  
________________________________         
    
   ______________ 
Signature of Adult Participant                                        Date 
  
  
________________________________         
       
Print Name of Adult Participant                                        
  
 
  

 
23 
WITHDRAWAL FROM STUDY: The Protocol Director may also withdraw 
you from the study and the study medication may be stopped without 
your consent for one or more of the following reasons:   
o   Failure to follow the instructions of the Protocol 
Director and study staff. 
o   The Protocol Director decides that continuing your 
participation could be harmful to you. 
o   The study is cancelled. 
o   Other administrative reasons. 
o   Unanticipated circumstances. 
  
SPONSOR: 
Stanford University is providing financial support for this study. 
  
CONTACT INFORMATION: 
Questions, Concerns, or Complaints: If you have any questions, concerns 
or complaints about this research study, its procedures, risks and 
benefits, or alternative courses of treatment, you should ask the Protocol 
Director, Melissa Boswell. You may contact her now or later at [phone 
number]. 
Injury Notification: If you feel you have been hurt by being a part of this 
study, please contact the Protocol Director, Melissa Boswell, at [phone 
number]. 
  
Independent Contact:  If you are not satisfied with how this study is being 
conducted, or if you have any concerns, complaints, or general questions 
about the research or your rights as a participant, please contact the 
Stanford Institutional Review Board (IRB) to speak to someone 
independent of the research team at (650)-723-5244 or toll free at 1-866-
680-2906.  You can also write to the Stanford IRB, Stanford University, 
1705 El Camino Real, Palo Alto, CA 94306. 
EXPERIMENTAL SUBJECTS BILL OF RIGHTS: As a research participant 
you have the following rights.  These rights include but are not limited to 
the participant's right to: 
● be informed of the nature and purpose of the experiment; 
● be given an explanation of the procedures to be followed in the 
medical experiment, and any drug or device to be utilized; 

 
24 
● be given a description of any attendant discomforts and risks 
reasonably to be expected; 
● be given an explanation of any benefits to the subject reasonably to 
be expected, if applicable; 
● be given a disclosure of any appropriate alternatives, drugs or 
devices that might be advantageous to the subject, their relative risks 
and benefits; 
● be informed of the avenues of medical treatment, if any available to 
the subject after the experiment if complications should arise; 
● be given an opportunity to ask questions concerning the experiment 
or the procedures involved; 
● be instructed that consent to participate in the medical experiment 
may be withdrawn at any time and the subject may discontinue 
participation without prejudice; 
● be given a copy of the signed and dated consent form; and 
● be given the opportunity to decide to consent or not to consent to a 
medical experiment without the intervention of any element of force, 
fraud, deceit, duress, coercion or undue influence on the subject's 
decision. 
  
May we contact you about future studies that may be of interest to you?   
____ Yes  ____ No 
________________________________                          
____________ 
Signature of Adult Participant                                                   Date 
  
_____________________________________         
      
Print Name of Adult Participant                                        
  
Please download the copy of your signed consent form below. 
 
 

 
25 
References 
1. 
Boles DZ, DeSousa M, Turnwald BP, et al. Can Exercising and Eating Healthy Be Fun and 
Indulgent Instead of Boring and Depriving? Targeting Mindsets About the Process of 
Engaging in Healthy Behaviors. Frontiers in Psychology. 2021;12. 
doi:10.3389/fpsyg.2021.745950 
2. 
Zion S. From Cancer to COVID-19: The Self-Fulfilling Effects of Illness Mindsets on Physical, 
Social, and Emotional Functioning. Stanford University; 2021. 
3. 
Smith RD, Healey EL, McHugh GA. Measurement Properties of Self-Reported Physical 
Activity Instruments Suitable for Osteoarthritis (OA) or Joint Pain Populations: A 
Systematic Review. Annals of the. Published online 2013. 
https://ard.bmj.com/content/72/Suppl_3/A700.1.abstract?casa_token=sxLNwI0e9OcAAA
AA:uwTvM8u2yNPNSvw4JMJeR1jLD-
GPEFlZQMjjZd150JYWEpWxbX5St0KbAWlXThiFIDst6znM 
4. 
Darlow B, Abbott H, Bennell K, et al. Knowledge about osteoarthritis: Development of the 
Hip and Knee Osteoarthritis Knowledge Scales and protocol for testing their measurement 
properties. Osteoarthritis and Cartilage Open. 2021;3(2):100160. 
5. 
Zahrt OH, Evans K, Murnane E, et al. Effects of Wearable Fitness Trackers and Activity 
Adequacy Mindsets on Affect, Behavior, and Health: Longitudinal Randomized Controlled 
Trial. J Med Internet Res. 2023;25:e40529. 
6. 
Abbott JH, Hobbs C, Gwynne-Jones D, MOA Trial Team. The ShortMAC: Minimum 
Important Change of a Reduced Version of the Western Ontario and McMaster Universities 
Osteoarthritis Index. J Orthop Sports Phys Ther. 2018;48(2):81-86. 
7. 
Boswell MA, Evans KM, Zion SR, et al. Mindset is associated with future physical activity 
and management strategies in individuals with knee osteoarthritis. Ann Phys Rehabil Med. 
2022;65(6):101634. 
8. 
Shelby RA, Somers TJ, Keefe FJ, et al. Brief Fear of Movement Scale for osteoarthritis. 
Arthritis Care Res . 2012;64(6):862-871. 
9. 
Cella D, Riley W, Stone A, et al. The Patient-Reported Outcomes Measurement Information 
System (PROMIS) developed and tested its first wave of adult self-reported health outcome 
item banks: 2005-2008. J Clin Epidemiol. 2010;63(11):1179-1194. 
10. Gregory JJ, Werth PM, Reilly CA, Jevsevar DS. Cross-specialty PROMIS-global health 
differential item functioning. Qual Life Res. 2021;30(8):2339-2348. 
11. Parker DJ, Werth PM, Christensen DD, Jevsevar DS. Differential item functioning to validate 
setting of delivery compatibility in PROMIS-global health. Qual Life Res. 2022;31(7):2189-
2200. 
12. Bennell KL, Lawford BJ, Keating C, et al. Comparing Video-Based, Telehealth-Delivered 
Exercise and Weight Loss Programs With Online Education on Outcomes of Knee 
Osteoarthritis : A Randomized Trial. Ann Intern Med. 2022;175(2):198-209. 

 
26 
13. Egerton T, Bennell KL, McManus F, Lamb KE, Hinman RS. Comparative effect of two 
educational videos on self-efficacy and kinesiophobia in people with knee osteoarthritis: an 
online randomised controlled trial. Osteoarthritis Cartilage. Published online June 22, 2022. 
doi:10.1016/j.joca.2022.05.010 
14. Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes 
in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 
2004;8(4):283-291. 
15. Core Team R. R: A language and environment for statistical computing. Version 3.6. 0. 
Vienna, Austria. /ra-language-and-environment-for-statistical-computing. 
16. Bunzli S, O’Brien P, Ayton D, et al. Misconceptions and the Acceptance of Evidence-based 
Nonsurgical Interventions for Knee Osteoarthritis. A Qualitative Study. Clin Orthop Relat Res. 
2019;477(9):1975-1983. 
17. Hendry M, Williams NH, Markland D, Wilkinson C, Maddison P. Why should we exercise 
when our knees hurt? A qualitative study of primary care patients with osteoarthritis of the 
knee. Fam Pract. 2006;23(5):558-567. 
18. MacKay C, Jaglal SB, Sale J, Badley EM, Davis AM. A qualitative study of the consequences 
of knee symptoms: “It”s like you’re an athlete and you go to a couch potato'. BMJ Open. 
2014;4(10):e006006. 
19. Darlow B, Brown M, Thompson B, et al. Living with osteoarthritis is a balancing act: an 
exploration of patients’ beliefs about knee pain. BMC Rheumatol. 2018;2:15. 
20. Crum AJ, Langer EJ. Mind-set matters: exercise and the placebo effect. Psychol Sci. 
2007;18(2):165-171. 
21. Crum AJ, Santoro E, Handley-Miner I, et al. Evaluation of the “rethink stress” mindset 
intervention: A metacognitive approach to changing mindsets. J Exp Psychol Gen. 
2023;152(9):2603-2622.