STepped Exercise Program for Knee Osteoarthritis (STEP-KOA)
Phase: NA
Conditions: Osteoarthritis, Knee
Sponsor: VA Office of Research and Development

NCT02653768 
 
STepped Exercise Program for Knee Osteoarthritis (STEP-KOA) 
 
March 14, 2018 

 
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Specific Aims  
 
Osteoarthritis (OA) is one of the most prevalent chronic conditions and a leading cause of pain and 
disability. Knee OA is particularly common, with a lifetime risk of 45%.  The risk of disability attributable to knee 
OA is as great as that due to cardiovascular disease and greater than any other medical condition.  Veterans 
have a higher prevalence of OA and more pain and functional limitations than the general population; among 
Veterans, users of the Department of Veterans Affairs (VA) health care system are the most severely affected.   
 
Guidelines for treating knee OA consistently include both exercise programs and physical therapy (PT) as 
core components, based on many studies supporting their effectiveness. However, the vast majority of patients 
with knee OA are physically inactive, and PT is associated with significant and increasing costs to the VA. 
Exercise programs and PT share common aims of improving the use of safe and effective exercises for knee 
OA and increasing overall physical activity, but PT provides more specialized treatment that also addresses 
specific functional and biomechanical impairments that may prevent successful engagement in activity.  It is 
likely that some patients with knee OA can achieve clinically meaningful improvements in pain and function 
with relatively low resource exercise programs for knee OA, with a subset of patients requiring additional 
attention from a physical therapist. However, there are no evidence-based models for delivering these differing 
types of exercise-related services for knee OA efficiently and according to patient needs.   
 
In this study we propose to evaluate a STepped Exercise Program for Knee Osteoarthritis (STEP-KOA) in 
Veterans. STEP-KOA begins with a low-resource exercise intervention, with increasing intensity of the 
intervention approach for patients who do not meet benchmarks for improvement.  Specifically, Step 1 involves 
three months of access to an internet-based exercise program that uses patient-specific information to tailor 
exercise plans. Patient who do not meet criteria for clinically relevant improvement in pain and function after 
Step 1 will progress to a more intensive Step 2, which adds three months of biweekly telephone support that 
addresses symptom-related, health-related and other barriers to physical activity.  Participants who do not 
meet response criteria after Step 2 will progress to Step 3, which involves in-person PT visits; this final Step 
allows evaluation of specific functional impairments, further tailoring of exercises, and assessment of the need 
for knee braces or other assistive devices.  This stepped intervention is matched with patient needs, and it also 
provides the VA with a potential approach for focusing limited PT resources on patients who do not respond 
adequately to initial, less resource intensive and costly strategies to improve physical activity and related 
outcomes.  We will conduct a randomized clinical trial with the following specific aims and hypotheses:   
Specific Aim 1:  To examine the effectiveness of STEP-KOA on key patient-centered outcomes among 
Veterans with symptomatic knee OA.  
Hypothesis 1:  Veterans who receive STEP-KOA will have clinically relevant improvements in self-reported 
pain, stiffness, and function, measured by the Western Ontario and McMasters Universities Osteoarthritis 
Index (WOMAC), immediately following the 9-month program, compared with Veterans in an Arthritis 
Education (AE) control group.  Similarly, we expect clinically relevant improvement in secondary outcomes of 
objectively assessed physical function. 
Specific Aim 2:  To estimate maintenance effects of  STEP-KOA at 15 month follow-up, six months following 
completion of the program.   
Hypothesis 2:  At 15-months, Veterans in the STEP-KOA group will maintain improvements in WOMAC scores 
achieved at 9 months (i.e. there will be no estimated mean difference in WOMAC scores between 9 and 15 
months). We will estimate these differences in WOMAC scores for the full STEP-KOA group as well as for 
subgroups defined by the combination of steps received during the STEP-KOA program.     
Specific Aim 3: To describe patients who are non-responders at each Step in the STEP-KOA group, and to 
examine patient characteristics associated with non-response. 
Specific Aim 4:  To examine the cost effectiveness of overall STEP-KOA intervention, compared with the AE 
control group.  
This study will have an important impact for Veterans because it evaluates a novel, patient-centered 
approach to improving physical activity and related outcomes for knee OA – one of the most common and 
disabling health problems.  The study will have an important impact for the VA because the STEP-KOA could 
be a practical approach for both improving access to physical activity interventions and targeting more costly 
and limited PT resources for knee OA in an evidence-based manner.   
 

 
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RESEARCH PLAN 
A. BACKGROUND AND CONTEXT 
 
1.0  Osteoarthritis (OA) is Highly Prevalent and Disabling.  
 
Osteoarthritis is one of the most prevalent chronic conditions in the U.S.  Knee OA is particularly common, 
with one study indicating a lifetime risk of 45%,1,2 and the prevalence of knee OA is expected to rise 
dramatically over the next several decades3.  OA is associated with significant pain, functional limitations, and 
reduced health-related quality of life 4.  It is the most frequently reported cause of disability in the U.S.5.  
Among older adults, the risk of disability attributable to knee OA is as great as that due to cardiovascular 
disease and greater than any other medical condition6.  OA is also associated with significant costs to both 
patients and health care systems.  Annual health care expenditures of individuals with OA are about twice as 
high as individuals without OA, even when adjusting for age and gender7.   
 
 2.0  Osteoarthritis is a Particular Burden in Veterans.  
 
Veterans are at greater risk for OA 8, likely due in part to high rates of joint injuries and loading.  Data from 
the 2001 National Survey of Veterans showed that over 25% of all Veterans report having arthritis (of which 
OA is by far the most common type), making this the third most prevalent health condition 9.  Data from 
Centers for Disease Control and Prevention (CDC) showed that 32% of Veterans had a doctor’s diagnosis of 
arthritis, compared with only 22% of non-Veterans10.  Among active duty military personnel, OA incidence rates 
are 1.26-2.17 times higher than comparable age groups in the general population11.  
 
Veterans with OA often report significant and limiting symptoms 12.  For example, among Veterans Health 
Study participants with arthritis (primarily OA), 85% reported that pain and stiffness were present on most 
days, and moderate to high levels of pain and stiffness were common 13.  Veterans who receive care within the 
VA health care system are at particular risk for debilitating OA.  Veterans with lower extremity OA in several of 
our prior studies14-16 have reported greater pain and functional limitations 
 than samples of patients with OA in the general population.  CDC data also show that VA health care users 
are more likely to report a diagnosis of arthritis compared to Veterans who receive care outside the VA health 
care system (43% vs. 30%, p<0.001), even when adjusting for demographic characteristics 10.  Among 
Veterans with arthritis, VA health care users are also more likely to report limitation in their daily activities 
because of joint symptoms (63% vs. 42%, p<0.001).  
 
3.0 Exercise and Physical Therapy are Key Components of Managing Knee OA but are Underutilized. 
 
Guidelines consistently recommend both exercise programs and physical therapy (PT) as core 
components of managing knee OA 17-19, based on strong evidence for their effectiveness.  A meta-analysis of 
trials of exercise for knee OA found that effect sizes for aerobic exercise were 0.52 and 0.46 for pain and 
disability, respectively; for strengthening exercises, effect sizes were 0.39 and 0.3220. These are moderate to 
large effect sizes and are comparable to those observed for pharmacological treatment of OA 21.  Systematic 
reviews also support the effectiveness of PT for improving knee OA outcomes22,23. Although exercise programs 
and PT are different treatment strategies, they share common aims of improving the use of safe and 
appropriate exercises and addressing OA-related barriers to overall physical activity.  PT is a more specialized 
treatment that, in addition to providing tailored exercise prescription, incorporates evaluation of needs for 
devices such as knee braces, shoe lifts / orthotics, and walking aids; some patients with biomechanical and 
functional impairments may require these before effectively engaging in increased physical activity.  
 
Despite strong evidence for exercise programs and PT in managing OA symptoms, both are substantially 
under-utilized 24,25.  In a study of adults who had or were at risk for knee OA, only 2% of African Americans and 
13% of whites were currently meeting physical activity recommendations 25. In our recent study of VA health 
care users with knee OA 26, less than half had ever received PT, despite a relatively long average duration of 
disease (14 years).  Although the reasons for low use of PT for knee OA have not been fully elucidated, there 
are two likely contributors that are particularly germane to this proposed study.  First, neither treatment 
guidelines nor prior studies indicate which patients with knee OA have the greatest need for or may benefit 
most from PT visits (versus lower resource approaches to enhance physical activity) 17-19.  Although it is likely 
that patients with worse symptoms or overall poorer health may have the greatest need for the specialized 
focus of PT, the lack of evidence leaves primary care providers without guidance for making these referrals. In 
our ongoing OA studies26, this has been a common question raised by primary care providers. Second, 

 
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outpatient PT visits are a limited resource in many healthcare systems, including the VA, with demand 
exceeding supply. A recent model projecting the supply and demand of physical therapists between 2010 and 
2020 indicates a shortage between 9,000 and 41,000 therapists in the US 27.  This further emphasizes the 
need for an evidence base for focusing this limited resource and identifying other, lower resource strategies 
that help to improve physical activity and associated outcomes in a subset of patients.  
 
There is widespread consensus that evidence-based strategies are still needed to help adults with OA to 
adopt and maintain adequate levels of physical activity 28. In the VA healthcare system, the MOVE! program 
incorporates physical activity into a broader program for Veterans who are overweight.  Although Veterans with 
knee OA may benefit from this program, these patients face particular barriers that hinder physical activity and 
require specific guidance on appropriate, graded exercise that accounts for pain and activity limitations 29.  In 
summary, there is a need for novel, evidence-based physical activity programs for Veterans with knee OA that 
complement and help to focus PT treatment for this condition.   
 
4.0 STepped Exercise Program for Knee OsteoArthritis (STEP-KOA): A Novel Approach 
 
The proposed study will evaluate a stepped approach to improving physical activity and associated 
outcomes for Veterans with knee OA.  Stepped care interventions are attractive from both patient and resource 
allocation perspectives 30,31. From the patient perspective, stepped care allows the intervention to be guided by 
patient-centered outcomes; the intensity of the intervention approach can be increased until a clinically relevant 
outcome is achieved whenever possible32.  From a resource allocation perspective, stepped care allows more 
costly or limited resources to be reserved for patients who do not respond adequately to other approaches. To 
our knowledge, no studies have previously examined a stepped approach to increasing physical activity for 
patients with OA.  However, stepped care interventions have proven successful in other areas, including 
weight loss33, comorbid pain and depression34, and mental health treatment 35.  We believe a stepped 
approach is particularly appropriate in this context for several reasons.  First, knee OA is highly common, and 
there is a need for an efficient approach to fostering physical activity in this large group of Veterans. Second, 
among patients with knee OA there is considerable variability in pain severity, physical function, exercise 
abilities, and other factors that likely influence the intensiveness of physical activity intervention needed. A 
stepped care approach will address this heterogeneity.  Third, outpatient PT costs for knee OA are increasing 
for the VA, with the growing number of Veterans who suffer from this condition.  A stepped intervention could 
guide more focused use of these visits for knee OA.  Questions surrounding when to refer Veterans with OA 
for outpatient PT are a high priority for the VA National Physical Medicine and Rehabilitation Service, 
evidenced by two recent calls on this topic. Results of this project would inform those decisions by evaluating 
whether a stepped approach may be an effective alternative to immediate PT referral, at least for some 
patients. 
 
As described below, STEP-KOA begins with a low-resource intervention, involving access to an internet-
based exercise program for knee OA (Step 1).  Patients who do not meet response criteria for pain and 
function, established by the Outcome Measures in Rheumatology group and the Osteoarthritis Research 
Society International (OMERACT-OARSI36), after Step 1 will progress to a more intensive intervention 
approach, adding telephone counseling to address barriers to physical activity (Step 2).  Patients who still do 
not meet response criteria after Step 2 will progress to a more intensive Step 3, involving in-person PT visits.  
These visits will provide evaluation of functional impairments, further tailoring of exercises, and assessment of 
the need for devices that may also be needed to improve overall activity, as well as pain and function. 
 
5.0 Theoretical Model of Physical 
Activity Behavior.   
 
We have based STEP-KOA on Social 
Cognitive Theory (SCT; Figure 1) because 
of its comprehensive framework and its 
wide use in physical activity literature and 
other effective behavioral interventions for 
OA 37.  SCT emphasizes that cognitive, 
behavioral, personal and environmental 
factors interact to influence motivation and 

 
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behavior. Self-efficacy, a central concept of SCT, is a powerful predictor of physical activity 38. Self-efficacy 
refers to one’s belief in their ability to successfully complete a course of action, such as increasing physical 
activity.  There are two types of self-efficacy that are important for physical activity behavior 39; task self-
efficacy (e.g., exercise self-efficacy) is the belief that one can actually do the behaviors in question, and 
barriers self-efficacy is the belief that one can regularly perform a behavior in the face of common barriers such 
as lack of time, pain, etc.  Each component of STEP-KOA addresses both types of self-efficacy. A second 
central concept of SCT is that of outcome expectations, defined as the anticipated results of a given behavior 
such as physical activity.  SCT posits that individuals are more likely to engage in if they believe it will result in 
positive changes to valued outcomes (e.g. pain relief) 40. Each component of STEP-KOA also addresses 
outcome expectations.  Overall, STEP-KOA provides augmented strategies for addressing SCT constructs for 
patients who do not have a clinically meaningful response to earlier steps.  
  
6.0 Preliminary Studies 
 
6.1 Virtual Exercise Trainer for Patients with Knee OA (VET-KOA):  Step 1 Intervention.  The internet-based 
exercise training system we will employ in Step 1 has been developed and tested by Visual Health Information 
(VHI), through a Small Business Innovations Research Grant from NIH41. VET-KOA was developed by a 
multidisciplinary team of patients, physicians, and physical therapists, with a goal of mirroring a rehabilitation 
experience that provides personalized exercise recommendations and ongoing monitoring and progression of 
activities. The program includes the following components: 
 
1.  Tailored Exercise Routines. VET-KOA includes five exercise levels that span a continuum of functional 
abilities. Initial assignment to an exercise level is based on patients’ responses to a 14-item measure of pain 
and function (modified short form of the Western Ontario and McMaster Universities Osteoarthritis Index; mSF-
WOMAC,)42 and other items assessing exercise abilities and function.  The algorithm for assigning patients 
exercise levels was validated against recommended assignments by physical therapists familiar with the 
exercise levels. Exercises within each level are based on clinical guidelines and selection by a panel of 
orthopedic surgeons, physiatrists, rheumatologists and physical therapists. Exercise routines, randomly 
generated within each level, include strengthening exercises that target multiple muscle groups (with a focus 
on those supporting the knee), as well as stretching exercises.  Patients are also prescribed aerobic exercises 
appropriate for each level. 
 
2.  Animations of Strengthening and Stretching Exercises.  When patients log in to VET-KOA, a static version 
of their strengthening and stretching exercises is displayed. Patients can click on each exercise to view the 
animated version. These files use vector graphics, which allow for nearly instantaneous presentation of the 
animations even with slow Internet connections. These video presentations are important for instructing 
patients in safe, appropriate ways to perform each exercise.  
 
3.  Monitoring and Progression of Exercise Routine.  Participants are asked to record their exercises after each 
session. Patients can request at any time to move to a harder or easier exercise level; they are enabled to 
move to a harder exercise level as long as their mSF-WOMAC score is better than or equal to their previous 
score.  If this score is worse than previously, they are given a new exercise routine at their current level. If 
patients have difficulty with any particular exercises, the system also provides an option to exchange that 
exercise for another within the same level.  
 
4.  Pain Monitoring. Patients are also asked to report any increases in pain as a result of their exercises.  If 
patients record increased pain for three consecutive sessions without requesting a lower exercise level, a 
suggestion is given to consider trying an easier exercise level.  If patients do not record increased pain for two 
weeks but have not requested an increase in exercise level in that interval, they are encouraged to try a more 
difficult level.   
 
VET-KOA Preliminary Data.  

 
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Participants and Procedures.  A pre- and post-training study was conducted to assess the acceptability, 
feasibility, and efficacy of the virtual exercise training website41.  Participants were 52 patients with diagnoses 
of knee OA, referred by their physicians.  Eligible patients were given access to VET-KOA for eight weeks. 
Results.  Participants had an average age of 63 years (SD=10); 52% were male; 38% had less education than 
a 4-year college degree.  Use of the website was high; on average participants logged into the website an 
average of 47.2 (SD=12) of the 
possible 56 program days. 
Participants recorded completing 
strengthening /  
exercises an average of 37.8 
(SD=12.5) days and aerobic 
exercises an average of 35.1 
(SD=12.8) days.  The mSF-
WOMAC (primary study 
outcome) decreased by about 7 
points following the program, 
which is a substantial improvement and a large effect size (Table 1). We also compared changes on the mSF 
WOMAC between participants with <4 years vs. ≥4 years of college education. This was of interest since VA 
health care users tend to have lower education levels than the general population. We found comparable 
changes; participants with <4 years of education reduced mean mSF WOMAC scores from 19.8 to 13.8 (a 
highly clinically relevant 30% change)43, and those with ≥4 years of college education reduced mean mSF 
WOMAC scores from 15.4 to 8.5.   There were also no substantial differences in study outcomes by gender.  
These data provide support for a positive response among VA healthcare users. The World Health 
Organization Quality of Life (WHOQOL) physical subscale and knee self-efficacy scale also improved 
significantly in this study (Table 1).  80% of study participants indicated experiencing “some” or “a lot” of 
improvement after using the website, and 43% reported a reduction in the use of pain medication. Patients also 
indicated a high degree of satisfaction with the program; on a scale of 18 items covering a broad range of 
aspects of the program and website (range 0-4), the mean score was 3.1 (SD=0.5). Also confirming patient 
satisfaction, 78% indicated that they would like to use the site in the future.   
Veteran User Testing of VET-KOA Program. We have met with five Veterans with knee OA at the Durham 
VAMC, who provided us with feedback about the VET-KOA features and usability.  These Veterans were very 
positive about the program, found it to be user-friendly, and stated that Veterans would be likely to use this.  
They particularly liked the animated exercises.  These Veterans also recommended minor changes, including: 
1.) Enhancing usability of several components so they are even simpler for veterans who have no computer 
experience (e.g. more instructions about website navigation), 2.) Adding a feature to track progress, 3.) Adding 
an option for more exercises. These changes will be incorporated into the website prior to beginning the trial. 
 
6.2 Studies Involving Telephone-Based Physical Activity Counseling for Knee OA:  Step 2 Intervention. Dr. 
Allen and colleagues have completed two HSR&D-funded clinical trials, Self-Management of OA in Veterans: A 
Telephone-Based Intervention (HSR&D IIR 04-016) and Patient and Provider Interventions for Managing OA in 
Primary Care (HSR&D IIR 10-126), which included telephone-based physical activity counseling 16,26. This 
experience forms the basis for our Step 2 intervention.   Both of these studies resulted in significant 
improvements in OA outcomes, and there were high rates of call completion.  
6.3 Physical Therapy Intervention for Knee OA:  Step 3 Intervention. Drs. Allen, Hoenig and Bongiorni recently 
conducted a clinical trial at the Durham VAMC to evaluate Group Physical Therapy for Veterans with Knee OA 
(HSR&D IIR 09-056)44. Group-based PT was compared with traditional individual PT, and our individual PT 
protocol forms the basis of Step 3 for the proposed work.  Among 161 participants assigned to the individual 
PT arm of this study, 97% at least one scheduled visit and 88% completed both planned visits.   
 
6.4 Other Exercise Studies at the Durham VAMC and Duke (Drs. Morey, Hall, and Huffman). Dr. Morey has 
directed physical activity trials and clinical exercise programs at the Durham VA for over 25 years.  She directs 
a longstanding and award-winning facility-based exercise program for older Veterans (Gerofit), a majority of 
whom have OA. In the last two years, she has received in excess of 2.1 million dollars to disseminate Gerofit to 
VA medical centers across the country. Her research focuses on examining modes of exercise delivery and 
Table 1.  Results of Pilot Study of Virtual Exercise Training System 
 
Baseline 
8-Week Follow-
up 
Test Statistics 
 
Mean 
SD 
Mean 
SD 
p-value 
pr 
mSF-WOMAC 
17.00 
7.67 
10.42 
7.94 
<0.001 
0.70 
     Pain Subscale 
5.67 
2.60 
3.60 
2.91 
<0.001 
0.66 
     Function Subscale 
8.10 
3.99 
4.87 
4.10 
<0.001 
0.67 
WHOQOL-Physical 
67.28 
15.87 
72.21 
14.44 
0.015 
0.33 
Self-efficacy 
16.94 
4.77 
19.59 
6.06 
<0.001 
0.54 
SD=standard deviation; pr = point-biserial partial regression coefficient as 
measure of effect size with .14 small, .36 medium, and .51 large effect   

 
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their impact on outcomes pertinent to older Veterans (HSRD-06-252, RR&D IIR E2756 and E3386).  45 Drs. 
Huffman and Hall have both collaborated closely with Dr. Morey on studies of home-based physical activity.  
Dr. Huffman conducted secondary analyses of these data and reported that physical activity levels were 
consistently lower among those with arthritis, but these participants still increased physical activity and 
reported improved outcomes as a result of a home-based program.46 These results support the potential for 
home-based and stepped care physical activity programs for Veterans with OA.  Dr. Hall has led several 
secondary analyses of trials led by Dr. Morey, focusing on predictors of adherence 47,48.  Lessons learned from 
these analyses have been incorporated into the proposed study, particularly related to goal-setting in the Step 
2 intervention.   
 
6.5 Summary of Preliminary Work.  In summary, this preliminary work shows: 
1. A well-developed internet-based exercise program for knee OA, including strong pilot data for feasibility, 
efficacy and patient satisfaction; this forms the basis for Step 1 of STEP-KOA. 
2. Established protocols for telephone-based physical activity counseling and in-person PT visits, within the 
context of randomized clinical trials, which form the basis of our Step 2 and 3 interventions (described in 
detail below). 
3. Successful processes for identifying, enrolling and retaining Veterans with OA into clinical trials of 
behavioral interventions, including physical activity and PT. 
 
B.  SIGNIFICANCE 
 
This study will have a significant impact for Veterans and VA healthcare system, for the following reasons:   
• Knee OA is one of the most common and disabling conditions among Veterans, and for many of these 
patients pain is not adequately controlled with pharmacotherapy and other typical clinical care. 
• Although exercise programs and PT improve outcomes among patients with OA, most of these individuals 
are sedentary and need support to increase physical activity 25.  Further, arthritis is a key barrier to activity in 
patients with other conditions such as cardiovascular disease, diabetes, and obesity 49-51; helping Veterans 
with OA to increase activity can therefore have an important impact managing many other health outcomes.   
• STEP-KOA combines different strategies for improving physical activity, with an increase in the intensiveness 
of the approach for patients who do not meet benchmarks for improvement.  This holds advantages over a 
“one-size-fits-all” approach, where individual patients may or may not achieve improvement with a given 
intervention.  STEP-KOA modulates intervention intensity to meet patients’ needs.   
• Step 1 can be administered widely at relatively low cost, and Step 2 is also a less costly approach to in-
person PT visits (Step 3).  Implementation of Steps 1 and 2 could therefore allow the VA to focus outpatient PT 
costs toward Veterans who fail to achieve clinically relevant improvement with lower cost exercise-related 
interventions.  In addition, the goal of Specific Aim #3 is to describe patient characteristics associated with 
success in a low-resource intervention (Steps 1 or 2) vs. a need for more intensive or in-person care.   This 
information has the potential to ultimately guide referrals to PT or other exercise-related care for knee OA.  For 
example, if we find that participants who are older or who have worse baseline pain, functional limitations or 
general self-rated health are highly likely to progress to Step 3, these individuals could be targeted by the VA 
for PT referrals, which are most likely to meet their needs; conversely, patients who are younger and have 
better health and fewer symptoms could be steered toward beginning with the Step 1 program.    
• If effective, STEP-KOA could serve as a model for other chronic conditions for which exercise and PT are 
key treatment components (e.g., low back pain).   
 
C.  METHODS 
 

 
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1.0 Study Design. This will be a randomized 
controlled trial with participants assigned to two 
groups: STEP-KOA and Arthritis Education (AE) 
(Figure 2).  We chose AE as the control condition 
for two primary reasons.  First, this is an active 
condition, which will allow all participants to 
receive an OA-related intervention immediately.  
This may improve satisfaction and retention of 
participants, and it will help to account for any 
effects due to simply participating in an active 
intervention (e.g., attention effects). Second, AE 
has been utilized as an effective, feasible control 
condition in a number of other studies of 
behavioral interventions for OA 52-55.   We will use 
a 2:1 randomization ratio (STEP-KOA: AE 
Control); this design gives us ample sample size 
to characterize the STEP-KOA process and to 
explore characteristics of responders and non-
responders at each evaluation time point (Specific 
Aim #3).  Randomization will be stratified by 
gender and study site to ensure groups are 
balanced in these respects, since there is 
potential for treatment effects to differ based on 
these characteristics. Measurement time points 
are shown in Figure 2. Three and six-month 
assessments will be used to determine whether participants in STEP-KOA need to progress to more intensive 
steps.  The primary outcome point (Aim 1) will be at nine months.  In addition, Aim 2 will examine whether any 
effects are maintained in the STEP-KOA group in the six months following the intervention period (15 months 
post-randomization). A six-month follow-up period is meaningful for assessing maintenance in the context of 
physical activity trials among patients with OA 56,57, and it is feasible to complete within the study period.  
Following completion of 9-month assessments, participants assigned to the AE control group will receive 
access to the internet-based exercise training program, along with the Step 2 exercise counseling calls. 
(Therefore, the AE group will not complete 15-month assessments, as Aim 2 will now include the STEP-KOA 
group only.) We chose to provide treatment to the AE group after nine months because 15 months was 
deemed to be an overly long waiting period in the context of a symptomatic condition; this not only raises 
ethical concerns but scientific ones, since a long wait list period would increase the likelihood of participants 
seeking physical therapy outside the context of the study during that time frame.  We acknowledge that this 
strategy means that we will not be able to test between-group differences at a longer-term, 15-month follow-up 
period. However, we will still gain valuable information by assessing whether any changes observed within the 
STEP-KOA group are maintained over time (9-months to 15-months) and whether this may differ among 
participants exposed to the different Steps of the program.  All participants will continue other usual medical 
care for OA during the full study period, as recommended by their providers. 
 
2.0 Study Sites.  This study will be conducted in two sites in the VA Mid-Atlantic Health Care Network (VISN 
6), Durham, NC and Greenville, NC, to enhance generalizability. The Durham VAMC is more urban, and the 
Greenville VAMC (also known as the Greenville Health Care Center) is located in a more rural and coastal 
region. Participants will be able to select a different study site from the one originally assigned if their location 
is closer to the other site. 
 
3.0 Participant Eligibility Criteria.  This study will involve n=345 Veterans with symptomatic knee OA.  All 
participants must meet the following criteria: 1) Diagnosis of Knee OA (identified from VA electronic medical 
records and self-report) and 2) Current Joint Symptoms (based on self-report). In particular, participants must 
self-report having an average knee pain of 3 or greater (on a scale of 0-10) over that past two weeks. Patients 
meeting the following criteria will be excluded: Currently completing PT visits for knee OA; Gout (in knee), 

 
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rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease; Dementia; Psychosis; Active substance 
abuse disorder; meniscus or ACL tear in the past 6 months; total joint replacement, other major lower extremity 
surgery in the past 6 months or planned in the next 9 months (e.g., wait list or referred to non-VA care for 
Orthopedic surgery); Severe hearing or visual impairment; Serious / terminal illness; Other health problem that 
would prohibit participation in the study and/or warrant immediate PT; Current participation in another OA 
intervention study; Unstable angina;  History of ventricular tachycardia; Unstable chronic obstructive pulmonary 
disease (two hospitalizations within the previous 12 months and/or on oxygen); Uncontrolled hypertension 
(diastolic blood pressure >110 mm/Hg or systolic > 200mm/Hg, measured at the baseline visit); Stroke with 
moderate to severe aphasia, recent history of three or more falls (follow-up questions by a clinician will 
determine whether patient is likely at risk for continued falls and would therefore not be a good candidate for a 
new home exercise program), resident of a long-term care facility, hospitalization for a cardiovascular condition 
in the past 3 months.  
Based on patient populations at our planned VA sites and experience from our previous studies, there will 
be an ample number of patients eligible for the proposed study. In a recent data pull, there were 3,039 patients 
at the Durham VAMC and 882 patients at the Greenville VAMC who had ICD-9 codes indicating knee OA and 
no codes for our exclusion criteria. In our completed trial, Self-Management of OA in Veterans: A Telephone-
Based Intervention, 29% of patients who met initial eligibility criteria based on ICD-9 codes were ultimately 
eligible and consented to participate. Based on our recent data pull, this would result in approximately 1,137 
enrolled participants for the proposed study.  
 
4.0 Enrollment Procedures. 
We will recruit participants in three ways, which we have successfully employed in prior VA clinical trials: 1.) 
self-referral, 2.) provider referral, 3.) direct contact by the study team. Self-referral will involve placing posters 
and brochures in clinic waiting rooms and other common areas, as well as on the closed circuit television. VA 
clinicians may also give these brochures to patients who may be interested in the study.  To facilitate provider 
referral, we will meet with primary care providers to inform them about the study and give study information by 
email and paper forms.  We will set up a consult for referring patients to the study within the electronic medical 
record.  Methods for direct contact of patients by the study team will begin with a data pull of patients who have 
ICD codes for knee OA and no exclusionary diagnoses, followed by an introductory letter. For participants 
recruited via all three methods, the study team may review VA medical records to verify a diagnosis of knee 
OA and lack of exclusionary diagnoses. The study team will also administer a screening questionnaire via 
telephone to further assess eligibility.  If patients meet screening criteria and are interested in participating, 
they will be asked to come to their VA clinic for a baseline visit, which will consist of consent and baseline 
assessments.   Study exclusion criteria (described above) that may make it unsafe to participate in regular 
activity will be assessed at multiple time points during the enrollment process.  First, they will be identified from 
electronic medical records at the initial data pull (prior to sending out recruitment letters). Second, they will be 
included in the telephone-based screening questionnaire described above.  Third, research assistants will scan 
participants’ medical records prior to the baseline assessment to ensure these have health problems have not 
emerged since the phone screening.  Fourth, at the baseline visit research assistants will ask participants if 
they have had any health changes or new symptoms since the phone screener.  At the baseline visit, trained 
research assistants will measure participants Resting Blood Pressure using a digital sphygmomanometer after 
the consent process. Participants with diastolic blood pressure >110mm/Hg or systolic >200mm/Hg will be 
advised to be seen at the Emergency Department or Urgent Care immediately. Participant will not be able to 
continue until given a clearance. Elevated BP may be detected by trained research assistant at the baseline 
visit. Participants with signs of acute end-organ damage such as current chest pain, dyspnea (difficult or 
labored breathing) at rest, new onset of blurry vision, or new neurological deficits consistent with a stroke will 
be advised and assisted in seeking emergency medical care.  We note that our total sample size goal of n=345 
pertains to the number of participants who complete baseline assessments and are informed of their 
randomization assignment.  It is possible that some patients will be determined to be ineligible between the 
time of consent and randomization assignment; these patients will not count toward the sample size goal.  
Research assistants will also be trained to assess potential symptoms of acute inflammation (swelling, warmth, 
pain flare); these Veterans will be evaluated by Dr. Huffman or another health care provider prior to 
participation.   

 
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At the enrollment visit, participants who indicate they would need a tablet computer to participate in the 
Step 1 intervention will be oriented to basic use of an iPad.  This orientation will be given regardless of group 
assignment, since all participants will eventually participate in the Step 1 intervention.   
After the enrollment visit, at study team member will call participants to give them their randomization 
assignment.  Participants assigned to STEP-KOA will be given orientation to the website via phone and 
assistance with getting set up as a new user. This may occur during the same phone call as randomization or 
at a separate call.  Participants will be sent information on how to use the website, along with general 
information about physical activity and osteoarthritis. Also, participants who indicate they do not have regular 
internet access to participate in the study will be sent an Apple iPad Air 16GB (encrypted with FIPS 140-2) 
(Version 9.3.1 (13E238) with Mobile Broadband Access Calling Plan for use during the study period. We will 
follow procedures used by Dr. Hoenig and Mr. Caves in previous research to simplify use of these devices by 
patients and minimize risk of inappropriate use.  This will include a set of written instructions and an agreement 
regarding allowed use of the Apple iPad Air 16GB (encrypted with FIPS 140-2) (Version 9.3.1 (13E238) with 
Mobile Broadband Access Calling Plan as part of study participation, and monitoring of monthly data use by 
the research team. Following the telephone orientation to the exercise website, a team member will use brief 
motivational interviewing strategies to encourage adoption of physical activity and use of the exercise, and 
explore potential barriers 
 
5.0 STEP-KOA Intervention 
 
5.1 Overview. We have chosen intervention Steps that are evidence-based and focus on enhancing physical 
activity but differ in the amount, type and mode of care provided.  We have chosen three-month intervals for 
the Steps, based on prior research indicating this is an adequate time period to observe meaningful changes in 
pain and function 61. All participants in STEP-KOA will continue to have access to the Step 1 program for the 
full nine-month intervention period, regardless of whether they progress to Steps 2 and 3.  This is because 
VET-KOA may serve as a complementary resource to participants who go on to receive telephone counseling 
and in-person PT visits; this approach is similar to other stepped care interventions 33,35. Further, continued 
access to VET-KOA is of minimal cost and would be feasible for the VA to provide to Veterans on a longer 
term basis. Some participants who initially meet response criteria at the three-month assessment point (and 
therefore remain at Step 1) may regress by six months and no longer meet benchmarks when compared to 
baseline pain and function. Since these patients initially met response criteria after Step 1, one likely reason for 
regression is encountering barriers to maintaining activity.  These patients will be advanced to the Step 2 
intervention at the six-month time point, since the telephone counseling intervention is aimed at addressing 
multiple types of barriers (Figure 2); this approach is also similar to other stepped care interventions 33,35.  
 
We have chosen the OMERACT-OARSI responder criteria to determine which patients progress to Step 2 
and Step 3 interventions 36. These criteria were established using a combined data-driven and expert opinion 
approach, and they have been used in over 30 clinical trials of behavioral, pharmacological and surgical 
interventions for OA (e.g. 2,62).  The validity and utility of these criteria have been supported in these trials, 
based on expected proportions of responders to various interventions, as well as the presence of expected 
associations between patient characteristics and response / non-response. We purposefully selected the 
OMERACT / OARSI criteria for stepping, rather than physical activity based criteria, for three reasons.  First, 
OMERACT / OARSI criteria cover domains of pain and function, which are treatment goals and outcomes of 
high importance to patients with OA, as well as their providers. The ultimate goal of the STEP-KOA 
intervention is to improve these outcomes, with physical activity enhancement being the mechanism.  Second, 
prior studies indicate that physical activity interventions can produce meaningful change in pain and functional 
outcomes in the context of OA, regardless of other concurrent treatments 20.  Third, it is possible that some 
patients could increase physical activity but not achieve meaningful improvement in pain and functional 
outcomes.  A likely reason for such a discrepancy is the need for more targeted physical activity to address 
specific deficits; this could be addressed by Step 1 and Step 2 interventions. Patients can meet OMERACT-
OARSI response criteria in two ways: 1) ≥ 50% improvement in pain OR function AND absolute change ≥ 20, 
2) Improvement in at least two of the following: pain ≥ 20% and absolute change ≥ 10; function pain ≥ 20% and 
absolute change ≥ 10; patient’s global assessment ≥ 20% and absolute change ≥ 10.  Based on prior research 
2,63,64, we estimate that about 1/3 of participants will meet OMERACT-OARSI response criteria after Step 1 and 
an additional 1/3 (2/3 of total) will meet response criteria after Step 2.  However, the success of this study is 

 
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not dependent on the responder rate; rather, this rate will provide important information for resource allocation 
if the STEP-KOA is implemented.  We note that the OMERACT-OARSI response criteria include two 
components of our primary outcome (WOMAC). However, we have purposefully chosen alternate pain and 
function scales to evaluate OMERACT-OARSI response criteria, so that the primary study outcome is distinct 
from the scales used to determine progression to more intensive Steps. The project coordinator, not blinded to 
study assignment, will inform patients via telephone about whether they progress to Step 2 and 3.       
 
5.2 Step 1: VET-KOA. Step 1 involves access to the VET-KOA program described above, with some 
modifications including no use of email messages.  We chose an internet-based program for Step 1 for several 
reasons.  First, there has been increasing and successful use of the internet to deliver physical activity and 
other behavioral programs,65 including recent studies among older adults66-68; this approach also aligns with the 
VA’s current movement toward mobile health behavioral interventions69.  Second, internet-based programs can 
be delivered widely at low cost.  Third, internet-based programs enhance access by removing transportation 
related barriers and offering flexibility in terms of the times in which patients can access the program.  Fourth, 
internet-based programs have the capability of tailoring activities to individuals’ preferences and abilities; this is 
important because research has supported the utility of a tailored approach to physical activity 70.  After minor 
changes, recommended by our Veteran “testers”, are made to the VET-KOA program, we will ask an additional 
10 Veterans with knee OA to use the website from home for about two weeks and provide feedback on 
usability.  Any additional recommended changes will be incorporated prior to beginning the trial. Prior to the 
beginning of recruitment, the Durham VAMC Information Security Officer will review the website to determine if 
it meets all VA information security requirements. 
 
 
Participants will be given an individualized code and instructions for accessing VET-KOA. They will also be 
given ankle weights and therapy bands (as in the pilot study), since these are utilized in some exercises.  
Participants will be given a telephone number to contact the project coordinator if they need technical support 
regarding the website. These telephone contacts will not involve advisement regarding physical activity and will 
not be handled by the exercise counselor. We will document the frequency and nature of these contacts, which 
will be useful in the overall evaluation of this internet-based resource. Participants will be encouraged to 
access the system as soon as they are randomized and throughout the study period. In accordance with 
guidelines for physical activity58, we will recommend that participants complete stretching and strengthening 
exercises, guided by the VET-KOA website, at least three times per week. Participants will be told that it is safe 
and appropriate to perform aerobic exercises daily, or as often as possible, guided by the VET-KOA website.  
An overall guiding principle is that participants will be encouraged to be as physically active as their abilities, 
health conditions, and pain allow, with an emphasis on reducing inactivity and sedentary behavior.   
 
When participants enter the VET-KOA website, they will be given information on principles of safe, effective 
physical activity, benefits for patients with knee OA (addressing Outcome Expectations), management of pain 
that may occur with physical activity (addressing Barriers Self-Efficacy), and dealing with general barriers to 
activity (addressing Barriers Self-Efficacy). Tailoring of the exercise program in VET-KOA is important for 
addressing Exercise Self-Efficacy; recommending exercises at appropriate levels will help to give participants 
confidence, especially early in the program, that they can complete these activities. If participants do not enter 
the website for two weeks, they will receive a telephone call from a study team member encouraging them to 
access the website, and most importantly to remain physically active. We may also contact the participants if 
we need to give them information about safety (e.g., if they are recording pain frequently in the website). 
Selected study team members will have access to a password-protected website that will include information 
on participants’ use of the VET-KOA website, along with any safety-related information.  There will be no PHI 
on this website; participants will be indicated by a unique ID only.   If a study participant cannot be reached by 
telephone, we will leave a voicemail message asking for the participant to call the study team member.  We will 
not leave any PHI on the voicemail message or with a family member. 
 
5.3 Step 2 Intervention: Telephone-Based Physical Activity Counseling. Participants who progress to Step 2 
will receive bi-weekly telephone calls from an exercise counselor for a three-month period. We have chosen 
this Step 2 intervention approach because studies indicate that personal support from an exercise counselor 
(or similar role) can improve physical activity 71.  Also, although this approach is more resource intensive than 

 
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an internet-based program, it is less costly than in-person PT visits and does not require Veterans to travel to a 
VA facility.  The overall goals of Step 2 calls are to address any OA or health-related difficulties participants are 
having with an exercise program, provide additional Social Support for Physical Activity, augment Barriers Self-
Efficacy by providing additional personalized counseling for the specific barriers, and reinforce information 
about the benefits of physical activity (Outcome Expectations).  During the first phone call the exercise 
counselor will query participants about whether OA symptoms or other health problems have presented 
challenges to their engagement in exercise. The counselor will have access to participants’ baseline study 
assessments, which include information on comorbid health conditions and other joints with arthritis; this will 
help the counselor to probe for potential barriers.  It is also common for individuals with OA to face challenges 
to exercise due to their pain and functional limitations.  Therefore, the counselor will work with participants to 
tailor the exercise types and intensity to accommodate any of these difficulties.  The exercise counselor will 
also ask participants about any other general barriers they encountered in completing their physical activity 
since the last call (e.g., time demands). The exercise counselor will guide participants in a process of problem-
solving any barriers, and this will be incorporated into the process of developing action plans for the following 
weeks.  Motivational interviewing strategies, including use of open-ended questions and reflective listening, will 
be employed to identify any ambivalence patients experience about engaging in physical activity 72.  We have 
used these strategies in our studies that include telephone-based physical activity counseling26.  During each 
telephone call, the exercise counselor will also engage participants in a process of goal-setting and action 
planning for their weekly physical activity, using “SMART” principles that emphasize that goals need to be 
Specific, Measurable, Action-oriented, and Time-Bound 39.  The exercise counselor will help participants to 
develop goals and action plans that are reasonable for them to achieve, facilitating Exercise Self-Efficacy.  
 
We expect most calls will take about 15-20 minutes and will document the duration of each call so that we 
can calculate the overall effort required to complete this intervention Step.  The first call will likely be longer 
since the counselor will take time for introductions and to explore current exercise and challenges.  The 
exercise counselor will encourage the participants to invite a friend or family member to be involved with calls if 
they would like. 
 
5.4 Step 3 Intervention:  PT Visits. We have chosen this Step 3 intervention approach because physical 
therapists have specialized training to evaluate functional impairments and biomechanical issues and can 
assist patients with tailoring exercises to address these deficits. Physical therapists can also evaluate patients’ 
needs for knee braces, shoe lifts, or other assistive devices.  We posit that patients who do not experience 
meaningful improvement after remotely delivered physical activity interventions may have greater functional 
impairments or other underlying clinical issues that will benefit from in-person attention by a physical therapist.  
We have based this intervention on usual PT care for knee OA within the VA healthcare system, as well as 
processes we have utilized in a clinical trial at the Durham VAMC 44. Core components of PT for knee OA 
include: instruction in a tailored exercise program, instruction in activity pacing and joint protection, and 
evaluation of:  mobility, stability, function, knee alignment, limb length inequalities, specific areas of weakness 
or inflexibility, and need for mobility aids, knee braces, and shoe orthotics.  Participants will receive 
approximately 3-7 PT visits; the first will be about hour and the remaining visits will be about 30 minutes. 
Participants will be paid $10 for each physical therapy visit, plus an additional amount that varies by distance 
traveled (as specified in the consent form).   The number of visits will be based on participants’ progression 
and need for additional follow-up.  Components of the physical therapy sessions will include:  
1. Standard assessments including range of motion, strength, knee alignment, limb length equality, balance, 
and gait. 
2. Review the participant’s current exercise and provide recommendations for tailoring 
3. Examine participants’ affected knee(s) for edema and provide appropriate recommendations for the use of 
heat, cold, elevation, and / or self-massage, particularly to be used before or after exercises. 
 
4. Observation of participants as they perform strengthening and stretching exercises to ensure proper 
technique. 
5.  Provision of recommendations for referrals to: 
a. Prosthetics for assistive device (if participants experience balance or instability with walking) 
b. Prosthetics for knee brace (if participants experience knee instability or significant malalignment) 

 
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c. Podiatry for shoe orthotics / lifts (if participants have a limb length inequality) 
6. Instruction in activity pacing and joint protection. 
 
PT visits can impact multiple factors associated with physical activity as outlined in the Social Cognitive 
Model. Specifically, these visits provide more intensive and personalized instruction in a home exercise 
program, which can bolster both Exercise Self-Efficacy and Barriers Self-Efficacy.  Physical therapists also 
provide additional Social Support for Physical Activity and help participants to have an understanding of long-
term benefits of physical activity for knee OA (Outcome Expectations).  Finally, these visits provide additional 
instruction on managing pain that can occur with physical activity, addressing Somatic Sensations.   
 
As of February 14, 2018, we are no longer able to provide study-specific PT at the Greenville VA Healthcare 
Center due to lack of an available study physical therapist.  Participants may come to the Durham VA for 
study-provided PT, and we will compensate them additionally to account for the travel (based on mileage rates 
already specified in our consent form). If a participant opts not to come to the Durham VA for study PT, a 
clinical member of the study team may contact the participant’s PCP to notify them about the participants’ 
inability to receive physical therapy as part of study-related procedures.  The PCP will also be notified that it is 
up to their discretion regarding whether to refer the patient to PT, as clinically appropriate.   (Study-provided PT 
was designed to mirror routine PT for knee osteoarthritis, so the type of care that patients would receive should 
not differ substantially if it is provided through a typical clinical route at the VA.)  If participants do not want to 
participate in either option, they can still remain in the study if they choose, and we will inform them that this 
will not have any impact on their usual care at the VA.  Because some patients will not move on to Step 3 of 
the intervention (PT), we will inform participants of these options at the 6-month follow-up point, via phone 
(using a script), if the information is relevant for them.   
 
6.0 Arthritis Education Intervention 
Participants in the AE control group will receive low 
literacy educational materials via mail every two weeks.  
Because STEP-KOA is a multi-component intervention, with 
participants receiving different numbers of Steps, it is not 
possible to implement a control condition that will mirror the 
exact intervention “dose” received by all participants in the 
STEP-KOA group. However, AE will achieve the goal of 
providing an active, OA-related control condition.  We 
selected a mail format because it mirrors the “remote” aspect 
of the Step 1 intervention that will be received by all study 
participants in the STEP-KOA group. We selected the two 
week interval for mailings because it mirrors aspects of each 
of the STEP-KOA interventions: Step 1 includes feedback 
regarding potential changes in exercise level on a two-week 
basis, Step 2 involves biweekly phone calls, and Step 3 
involves PT visits spaced approximately 2 weeks apart. The 
AE intervention will include a comprehensive set of topics 
related to OA and its management, based on established 
treatment guidelines (Box 1) 17,73. These materials will be 
based on those we have already developed and successfully 
utilized in prior HSR&D funded clinical trials among Veterans 
with OA16,26.  
 
 
7.0 Measures 
Study assessments will be conducted in person at baseline and 9-months (primary outcome point); interim 
assessments (3-months, 6-months) and longer-term follow-up (15-months) will be conducted via telephone. 
Assessments will be conducted by a research assistant blinded to group assignment. Participants will be paid 
$40 for in-person and $20 for telephone-based assessments. This measurement battery is shorter in length 
than those from our recent clinical trials among veterans with knee OA26,44, and the time burden has been 
Box 1.  Topics for AE Intervention 
• What is OA? 
• Diagnosis of OA 
• Risk Factors for OA 
• Health Care Providers And OA 
• Pain Medications (Oral) 
• Topical Pain Medications 
• Joint Injections 
• Knee Braces 
• Shoes and Orthotics 
• Physical Activity 
• Weight Management 
• Joint Protection 
• Pain Coping Skills 
• Surgery 
• Complementary and Alternative Therapies 
• OA and Sleep 
• OA and Mental Health 
• OA and Fatigue 

 
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acceptable to participants, with little missing data.  Prior to each assessment point (either on the phone at the 
time of scheduling, on the phone just before assessments begin, or in-person at the time of assessment), a 
study team member will ask participants whether they have had any new health problems since their last 
assessment point.  If there are new health problems, the study team will ask the nature of these problems.  If 
these problems are related to exclusion criteria, the study team member will either:  1) Let the participant know 
they need to be withdrawn from the study OR 2) If it is unclear whether withdrawal is appropriate, let the 
participant know they will contact a clinical co-investigator and follow-up to let them know if they are eligible to 
continue in the study; assessments will not proceed until this is resolved.  At in-person follow-up visits, 
research assistants will measure the participants Resting Blood Pressure; if diastolic blood pressure 
>110mm/Hg or systolic >200mm/Hg will be advised to be seen at the Emergency Department or Urgent Care 
immediately.  Assessments will not proceed until these issues are resolved. 
 
7.1 Primary Outcome: WOMAC. The primary outcome measure is the WOMAC, a measure of lower extremity 
pain (5 items), stiffness (2 items), and function (17 items), with items rated on a Likert scale of 0 (no 
symptoms) to 4 (extreme symptoms). The reliability and validity of the WOMAC total score and subscales have 
been confirmed 74.  The WOMAC has been widely used in trials behavioral interventions for knee OA, 
confirming its sensitivity to change. The WOMAC has also been validated for use via telephone 75.  To 
supplement the WOMAC, we will add additional measures that are part of the widely used Knee Osteoarthritis 
Outcome Survey (KOOS). 
 
7.2 Secondary Outcome: Objective Physical Function.  We will assess physical function using measures 
recommended by OARSI for clinical trials of knee OA 76.  These tests have been previously validated, with 
strong measurement properties and sensitivity to change in clinical trials among patients with OA.  These tests 
will include a 30 second stair stand test, a 40m fast-paced walk, a timed get up and go test, stair climbing test, 
and a 6-minute walk test, following previously established procedures for each. The 30 second stair stand asks 
participants to rise and sit back down in a chair as many times as they can during that time period, without 
using hands or arms for support 77.  The 40m fast-paced walk is a timed test of walking twice back and forth 
(as fast as participants are able) over a 10m distance 78.The timed get up-and-go  test requires the participants 
to stand from a standard arm chair, walk 3 meters and then return to sitting in the same chair (as quickly and 
safely as possible). The stair climbing test measures the time it takes to ascend and descend a flight of 12 
steps (each step 18 cm high and 28 cm deep). Participants will be asked to complete the test as quickly as 
they felt safe and comfortable. The use of one handrail will be allowed if necessary, but patients will be 
encouraged to minimize their use of the handrail. The 6-minute walk test will require participants to walk as far 
as they can during a 6-minute periods.  Walking aids are permitted as needed. Participants will be asked to 
walk the amount of time they are able to walk.  Following these tests, we will ask participants to indicate the 
maximum pain they experienced, on a scale of 0-10, during the test.   
 
7.3 Self-Efficacy for Exercise Scale.  The Self-Efficacy for Exercise scale assesses individuals’ confidence in  
engaging in exercise in nine different situations that could present barriers (including having pain when 
exercising) 75.  For each situation, individuals are asked to rate their confidence in being able to exercise three 
times a week for 20 minutes each time, on a scale of 0 (not confident) to 10 (very confident).  Validity of this 
measure was confirmed by expected associations with actual exercise, as well as physical and mental health. 
 
7.4 Social Support for Exercise Scale. This scale includes 13 items that assess the frequency with which 
friends and family members (separately) engage in behaviors that may either support exercise (e.g., “Gave me 
encouragement to stick with my exercise program”) or discourage exercise (e.g., “Complained about the time I 
spend exercising”).  All items are measured on a scale of 1 (none) to 5 (very often).  The scale has shown 
acceptable test-retest reliability and internal consistency reliability. In addition, the scale was correlated with 
exercise habits, providing evidence of concurrent criterion-related validity.   
 
7.5 Hopkins Rehabilitation Engagement Rating Scale (HRERS), a 5-item, clinician-rated measure developed to 
quantify engagement in acute rehabilitation services.  This will be completed by the telephone counselor at the 
end of the Step 2 and by physical therapists at the end of Step 3, for participants involve in those steps only.    
 

 
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7.6 Physical Activity, Adherence and Related Measures 
Physical Activity Scale for the Elderly (PASE).  The PASE is a self-report, 12-item scale that measures 
occupational, household, and leisure activity during a one-week period.79  This scale was developed for use 
among older adults and is appropriate for patients with knee OA who typically have more limited physical 
activity than the general population.  The PASE has been validated for use via telephone.  
Additional Self-Report Physical Activity Items.  We are also specifically interested in purposeful exercise 
behaviors. We will ask participants to report the number of times and minutes per week, on average, they are 
completing strengthening, stretching, and aerobic exercises 
Adherence to Intervention Step Components.  As described above, participants’ use of the VET-KOA 
website will be logged within the site.  For participants who advance to Step 2, we will collect information on 
the number of scheduled phone calls completed, and for participants who advance to Step 3, we will collect 
information on the number of scheduled PT visits attended.  
 
7.7 OMERACT-OARSI Responder Criteria (for determining progression to intervention Steps)36. We will use 
single item numeric rating scales to assess average pain and function during the prior two weeks (0=no pain / 
no difficulties with function to 100 = pain / difficulties with function as bad as you can imagine). Similar to prior 
research62, we will use the Patient Global Impression of Improvement scale for the third domain, with 
improvement defined as “better” or “much better.” We have chosen not to use WOMAC scores in the 
construction of these criteria, since this is the primary study outcome.  Prior clinical trials have also utilized both 
OMERACT-OARSI responder criteria and WOMAC scores as separate, distinct outcomes 2,63,64. Whereas the 
OMERACT-OARSI criteria simply designate individuals as responders vs. non-responders, WOMAC scores 
describe the degree of response or change in pain and function.   
 
7.8 Participant Characteristics Associated with Treatment Response. Specific Aim 3 will evaluate participant 
characteristics associated with treatment response and the need for intensification to Steps 2 and / or 3 (See 
Section C.8.3).  We will focus on four a priori characteristics we believe have strong potential for predicting the 
need of intervention intensification: age, baseline self-reported pain and function (single items described above 
for the Responder Criteria), and baseline self-rated general health (excellent, very good, or good vs. fair or 
poor). We have selected these measures because they are single items that could be quickly and easily 
administered in a clinical setting to guide referral to a specific treatment most likely to meet patients’ needs.  
 
7.9 Additional Participant Characteristics.  We will assess the following to describe the study sample: age, race 
/ ethnicity, gender, household financial state, education level, work status marital status, body mass index, 
questions about internet and technology use, the Patient Activation Measure, , comorbid illnesses (Self-
Administered Comorbidity Questionnaire)81, joints with OA (including designation of unilateral vs. bilateral knee 
OA), duration of OA symptoms, and documentation of variables to verify an OA diagnosis based on American 
College of Rheumatology Clinical Criteria (duration of morning stiffness, presence of bony tenderness and 
bony enlargement, crepitus). 
 
7.10 Knee OA and Related Care During Study Period. We will assess use of treatments for knee OA at 
baseline and follow-up assessments, including pain medications, topical creams, knee braces, joint injections, 
and assistive devices.  We will assess this via self-report, as well as using VA medical records to identify 
receipt of physical therapy for knee OA, participation in MOVE!, and prescription pain medication use.  We may 
also examine Fee Basis files to more comprehensively assess care received outside the VA.   We will not 
exclude participants who have new OA treatments during the study period.  However, it is important to 
evaluate whether there are differences in these treatments across study groups.  If differences are observed, 
we will conduct two types of sensitivity analyses: a.) participants who received specific treatments will be 
excluded from analyses, b.) the specific treatment (e.g., new MOVE! participation) will be included as a 
covariate in statistical models.  In addition, if we find that ≥20% of participants have a change in any given type 
of treatment, we will conduct a sensitivity analysis that removes these participants. Because of the drastic 
improvements typically associated with joint replacement surgery, participants having this surgery during the 
study period will not be included in analyses of WOMAC scores.  However, since receipt of total joint 
replacement is also an important OA outcome, we will compare the proportions of participants in each study 
group who receive this surgery during the study period.   

 
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7.11 Measures for Cost-Effectiveness Analysis 
Intervention Costs. We will use a micro-costing approach to derive labor and equipment costs for the STEP-
KOA intervention. Labor costs for Step 1 will include programmer time to maintain the website and phone calls 
for technical support. Labor costs for the Step 2 intervention will include the time needed to train the exercise 
counselor and to conduct the telephone calls; this time will include any required pre-call preparation, post-call 
activities, partial call completions, call attempts and callbacks.  Labor costs for Step 3 will involve the 
therapist’s time to complete in-person visits.  Hourly wage + fringe benefit rates for personnel will be applied to 
the labor time to derive total labor costs. The equipment costs for Step 1 include ankle weight and therapy 
bands, as well as the Apple iPad Air 16GB (encrypted with FIPS 140-2) (Version 9.3.1 (13E238) with Mobile 
Broadband Access Calling Plan costs for a subset of participants. Equipment costs for Step 3 include any 
devices recommended by the physical therapist.  Adaptations to the existing VET-KOA website for this project 
will be one-time study-related costs and not included in the intervention cost estimate.  Total labor and 
equipment costs will be divided by the number of patients in the STEP-KOA arm to derive per-patient 
intervention cost. We note that costs will vary across participants, participants will not all receive the same 
Steps. We will report this variability but are primarily interested in the average cost per participant.  
 
 
Patient Resource Utilization and Costs.  The intervention may affect primary care and specialist outpatient 
visits for OA and outpatient pain medication use.  To assess VA outpatient visits and VA prescribed pain 
medication use and costs we will utilize the outpatient extract and pharmacy data extracts from the DSS 
Outpatient National Data Extract (NDE), and the DSS NDE SAS Pharmacy Dataset.  Outpatient encounters 
will be categorized using clinic stop codes of interest, as well as a count of total encounters and total costs of 
OA-related outpatient care. We will also include fee basis OA-related outpatient care and costs of the same 
categories because these are of increasing importance to VAMCs.  
Effectiveness Measures.  We will use two effectiveness measures to calculate cost effectiveness ratios:  
WOMAC units (described above) and the EuroQoL EQ-5D-5L questionnaire. The EuroQol health outcome 
measure (EQ-5D-5L and EQ-VAS) allows us to calculate quality-adjusted life years (QALYs), and it has been 
used successfully in previous research among patients with arthritis 82.   
 
7.12   Participant Feedback on STEP-KOA.   We will ask open-ended questions regarding the intervention 
components.  For example, we will ask participants about usability of the VET-KOA website, appropriateness 
of the number and length of telephone sessions with the exercise counselor, content of PT visits, and ways we 
can improve the interventions.  
 
8.0 Data Analyses 
 
8.1. General Considerations. Primary study analyses will be conducted on an intent-to-treat basis, with 
participants analyzed in the group to which they were assigned.  Additional exploratory analyses focusing on 
more restrictive analytic cohorts (e.g., per protocol analysis) will be considered, to provide additional 
information about the impact of magnitude of exposure to the intervention.  The main conclusions drawn from 
this trial will be based on the pre-specified primary and secondary hypotheses outlined below and will be tested 
with two-sided p-values at the standard 0.05 level unless noted otherwise.  Statistical analyses will be 
performed using SAS for Windows (Version 9.2: SAS Institute, Cary, NC) and R (http://www.R-project.org/). 
 
8.2. Primary Analysis (Specific Aim 1). The main study outcome, WOMAC, is a continuous measure collected 
at baseline, 3, 6, 9 and 15 months (STEP-KOA group only).  For the primary hypothesis we will examine 
STEP-KOA effects at the 9-month assessment. We will use a linear mixed model (LMM) that accounts for the 
correlation between a participant’s repeated outcome measurements over time. We will apply an unstructured 
covariance matrix to take into account the within-patient correlation between repeated measures. The fixed-
effect portion of the model will have the form: Yit = β0 + β13month+ β26month+ β39month+ β4STEP-
KOA*3month + β5STEP-KOA*6month+ β6STEP-KOA*9month, where Yit is the WOMAC score for subject i at 
t=0, 3, 6, and 9months. We will estimate the parameters in the model and set up contrasts for tests of 
hypotheses using the SAS procedure MIXED (Cary, NC).  Specifically, for Hypothesis 1, we will test for a 
difference in mean WOMAC scores between the STEP-KOA and AE groups at 9-months by testing that  β6=0. 

 
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Time is coded in the model to fit a constrained longitudinal data model (cLDA), in which baseline WOMAC 
score is modeled as a dependent variable in conjunction with the constraint of a common baseline mean 
across treatment arms83. For improvement in precision, the model will be adjusted for stratification variables84.   
 
8.3. Secondary Analyses.  Since the secondary outcomes, 30 second chair stand and 40 meter fast-paced 
walk, are continuous, longitudinally collected measures, we will use similar modeling procedures as those 
described above for WOMAC scores to assess between-group differences at 9-month follow-up.  We will also 
examine Poisson or negative-binomial mixed models as a sensitivity analysis as these outcomes (particularly 
chair stands) can be skewed and assumption of a normal distribution may not be reasonable.  
For Specific Aim 2, to examine the maintenance effects of STEP-KOA at the15-month follow-up, we will 
add the 15-month outcomes and the 15-month time-point to the fixed effect portion of the model.  As we will 
only be estimating the maintenance effects for participants randomized to the STEP-KOA arm, we will drop the 
treatment by time variables from the fixed effects.  We will set up contrasts of model parameters to estimate 
the difference and associated 95% confidence intervals in outcomes between the 9-month and 15-month time 
points.  Models will also be fit to estimate these differences for subgroups defined by the combination of steps 
received during the STEP-KOA program by adding variables to the fixed effects indicative of the steps received 
as well as their interactions with time.    
For Specific Aim 3, we are interested in understanding the flow of responders and non-responders through 
the STEP-KOA intervention.  Our goal is to determine whether there are patient-level factors, already known or 
easily determined in routine clinic visits, which could be used by providers (individually or in combination), to 
guide referral of patients to a Step that is most likely to meet their needs.  We will first calculate proportions of 
responders and non-responders at each time point and describe responder patterns longitudinally We will also 
calculate proportions of individuals who meet response criteria in the two-different way described in Section 
C.5.1. We will then examine characteristics associated with responder status at each time point, using 
multivariable logistic regression models.   In these models, we will first focus on the four a priori patient 
characteristics:  age, baseline pain and function, and baseline self-rated health, to avoid spurious statistical 
findings 85. Based on clinical experience, we believe these variables have potential to predict response, and 
they can be assessed easily and quickly, making them practical screening tools.    
 
8.4. Missing Data. Because the main predictors of interest, intervention arm and patient characteristics, are 
collected at baseline, we do not anticipate much missing data in these variables.  There may be missing values 
in the follow-up outcome measures due to dropout, death, a missed interim assessment, or item non-response. 
Our main analysis technique for the primary outcomes, general linear mixed models via maximum likelihood 
estimation, implicitly accommodates missingness when missingness is due either to treatment, to prior 
outcome, or to other baseline covariates included in the model, defined as missing at random 86,87. If the 
missing values are related to other measured patient factors, , then multiple imputation (MI) provides a 
framework for incorporating information from these variables, while still preserving a parsimonious main 
treatment effect model 88,89. Depending on the type and scope of missing data, MI will be conducted via the 
SAS procedure PROC MI or the SAS macro IVEware (http://www.isr.umich.edu/src/smp/ive/).   
 
8.5. Sample Size. The sample size estimate of n=345 patients is based on a 2:1 randomization and the 
comparison of the primary outcome between the STEP-KOA and AE control arms at 9 and 15 months.  Since 
AIM 3 is to describe the responder patterns for the Step progression in STEP-KOA we are using a 2:1 
randomization to facilitate our ability to evaluate these patterns90.  For sample size calculations we used 
methods appropriate for ANCOVA type analyses 91, which are equivalent in terms of efficiency to our linear 
model in randomized trials 83.  This method is based on performing a two-sample t-test sample size calculation 
for the between group difference, multiplied by a factor 1-(rho)^2, where rho represents the Pearson correlation 
between baseline and follow-up time point outcome measures.  This sample size is then inflated to 
compensate for potential missing observations due to attrition. We estimate a 20% attrition rate at the 9-month 
time point, which is conservative based on our other clinical trials among Veterans with OA, all of which have 
had attrition rates <20%, including one that required two or more in-person visits from participants 16,26,44.  Also, 
based on our previous data, we assume a correlation of 0.4 between baseline and follow-up WOMAC scores, 
and an SD of 17.5. With 80% power, alpha=0.05, SD= 17.5, rho=.4, and approximately 20% attrition rate by 
15-months, 230 and 115 participants are needed in the STEP-KOA and AE groups, respectively, for an effect 

 
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size of 0.33. This corresponds to a 5.8 point difference in mean total WOMAC scores at 9-months between 
STEP-KOA and AE, which is a clinically relevant improvement 43. We will also be powered to detect medium 
effect size differences in secondary study outcomes.  For Aim 3, based on an assumption of 1/3 responders 
after Step 1, we would have about 154 participants that progress to Step 2; additional participants who initially 
meet response criteria at three months may regress at six-months and enter Step 2 at that time point.  We also 
expect that about 1/3 of the total STEP-KOA group (about n=76) will progress to Step 3.   
 
9.0 Economic Evaluation. The overall goal of Specific Aim #4 is to provide the VA with information about the 
value of the STEP-KOA program, from a cost effectiveness perspective.  In addition to informing the VA 
regarding the overall average cost of STEP-KOA per patient, this evaluation will provide information on how 
much improvement in outcomes can be achieved for that cost.  This information is important for evaluating the 
potential for downstream implementation of STEP-KOA under various assumptions about scale and scope. We 
will not evaluate differences in costs or cost effectiveness according to the number of Steps each participant 
received; rather this will be a simple approach that is consistent with using the VHA perspective and comparing 
total aggregated costs across the two study arms (STEP-KOA vs. AE) at the 9-month follow-up point. The 
analysis will begin with descriptive statistics of the cost and effectiveness (utility) data.  We will examine each 
measure of effectiveness, WOMAC and mean QALY (and the scores on the different EQ-5D-5L attributes, 
such as pain/discomfort), using the general analytic procedures and time points described above for primary 
and secondary outcomes.  We will calculate the incremental cost effectiveness ratio (ICER) of STEP-KOA 
compared to the AE control group, separately for WOMAC and QALYs. The ICER will be calculated as the 
difference in the average total cost per participant STEP-KOA and AE, divided by the difference in the average 
effectiveness per participant between STEP-KOA and AE.  Bootstrapping of estimates, multiple imputation for 
missing EuroQoL values, and sensitivity analyses will all be conducted to ensure robustness of our results. 
 
10.0 Data Management and Quality Control.  Study tracking and randomization functions will be 
completed with a database previously created in our Center with Microsoft .NET.  Screening and outcome 
measures, as well as content and results of Step 2 physical activity counseling calls, will be recorded using 
DatStat Illume™, a web-based survey tool. The VET-KOA website is hosted by Visual Health Information.  The 
study team will give each participant a unique code. They will use this code to initially log in.  The link between 
participants’ unique codes to access the website and other participant information will be kept on a computer 
server at the Durham VA, accessible only to IRB-approved study team members. So when the website vendor 
sends information to the VA team at the end of the study (e.g. on participants' website usage), the VA study 
team will be able to link this to each participant.  When this information on website usage is conveyed to VA at 
the end of the study, it will be done so using a VA approved method (e.g., encrypted CD). The information that 
the vendor will supply to VA by the end of the study includes:  self-reported pain, physical function, and 
physical activity, as well as whether they reported an increase in pain after completing their exercises. 
 
11.0 Privacy, Confidentiality, and Information Security 
 
11.1 Lists of Data Reviewed and/or Collected for Screening/Recruitment and Conduction of Study:  
 
The Personal Health Information that will be used and/or shared for this study includes: 
Identifier(s) 
Source(s) of Health Information 
 Names 
 Medical history & physical exam information 
 All geographic subdivisions smaller than a 
State, including street address, city, county, 
precinct, and zip code  
 Photographs, videotapes, audiotapes, or 
digital or other images 
 All elements of dates (except year) for dates 
directly related to an individual, including birth date, 
admission date, discharge date, visit or treatment 
dates, etc.; and all ages over 89  
 Biologic specimens (e.g., blood, tissue, 
urine, saliva) 
 Telephone numbers 
 Progress notes 
 Fax numbers 
 Diagnostic / Laboratory test results 
 Electronic mail addresses 
 Operative reports 

 
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Identifier(s) 
Source(s) of Health Information 
 Social Security Numbers 
 Imaging (x-ray, CT, MRI, etc.) 
 Medical record numbers 
 Discharge summaries 
 Health plan beneficiary numbers 
 Survey / Questionnaire responses as 
described in section 7 above 
 Account numbers 
 Billing records 
 Certificate and/or license numbers  
 HIV testing or infection records 
 Vehicle identifiers and serial numbers, including 
license plate numbers  
 Sickle cell anemia information 
 Device identifiers and serial numbers 
 Alcoholism or alcohol use information 
 Web Universal Resource Locators (URLs) 
 Drug abuse information 
 Internet Protocol (IP) address numbers 
 Mental health (not psychotherapy) notes 
 Biometric identifiers, including finger & voice 
prints 
 Psychological test results 
 Full-face photographic images and any 
comparable images 
 Genetic testing 
 Any other unique identifying number, 
characteristic, or code, describe:  unique Study ID 
number 
 Other, describe:   
 
11.2 Data and/or Specimen Acquisition:  Data for this study will be collected through (check all that apply): 
 
  Prospective data and/or specimen collection obtained from participants.  Provide description of processes:  
No specimens will be obtained during the study period.  Prospective data will be collected as follows: 
• 
The study requires use of some individually identifiable data, including participant names, street 
address, city, county, zip code, telephone number, and Social Security number to complete telephone 
screening, send recruitment letters, and appointment reminder letters. We will collect the minimum 
amount of study data required to complete study aims involving recruitment, outcome assessment and 
reimbursement. These data will we stored in the study tracking.  This database will also be used to 
keep track of study related telephone calls to participants, opt-out calls, study payment dates, and study 
appointments. 
• 
Some data will be collected prior to consent, as outlined in our HIPAA waiver request, and on page 7 
“Enrollment Procedures” above.  We will collect the minimum amount of data to be able to identify 
potentially eligible patients and contact them about the study.  These data will come from VA medical 
records (see sections above on “Participant Eligibility Criteria” and “Enrollment Procedures”), as well as 
a brief telephone-based screening questionnaire to capture information not reliably included in the 
medical record.   
• 
For patients who enroll in the study, other data will be collected via questionnaires (and results of 
functional tests), completed in person at the VA.  
• 
Screening and outcome measures will be recorded using DatStat Illume™, provided per VA enterprise 
license and funded by HSR&D.  Illume is a web-based survey tool.  Data will be stored on a secure VA 
server.  However, we will have consent forms and a form on which we will record results of functional 
assessments. All hard copies of data will be stored in a locked filing cabinet in the office of a study team 
member located in suite 600 of the NC Mutual Building or at the Greenville Health Care Center room 
1C214.  All electronic data will be stored on a secure VA server managed by Durham VA HSR&D 
personnel, in a folder (\\vhadurshrdfile1\$projects\STEP_KOA) accessible only to study team members 
on the IRB approved staff listing. 
• 
No -data will be transported outside the VA.  Consent forms with patient names will be transported from 
the VA interview rooms to the study team’s offices in Legacy Tower by an approved study team 
member; these documents will remain in direct possession of the study team member in a courier bag 
throughout transport.  VA clinicians may refer patients to the study team, with patients’ permission; this 
will be via a consult option within the medical record.   
• 
Apple iPad Air 16GB (Version 9.3.1 (13E238) with Mobile Broadband Access Calling Plan issued to 
participants will be encrypted and FIPS 140-2 validated. 

 
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  Retrospective data collection and/or specimens obtained from medical chart review/data access.  Describe 
how data will be obtained (e.g., fileman, CDW, etc.):  We will use a data pull as one recruitment method, as 
described in sections 3 and 4 above.  The study programmer will comply with instructions in the VINCI File 
Transfer Guide for electronic download of data from the project VINCI workspace to our local file server, 
and the VINCI Database User guide for export of CDW data to the local study tracking database hosted on 
SQL server instance in the Durham VAMC Data Center. Data will be pulled for patients who have ICD-9 
codes for knee OA and no exclusionary diagnoses 
  Retrospective data collection and/or specimens obtained from an IRB-approved data and/or specimen 
repository.  Indicate the repository source including name, VA location, and IRB number     . 
 
11.3 Level of Data:  the following level(s) of data will be acquired/maintained for this study (check all that 
apply): 
 
  Identified (e.g., names, addresses or other identifiers included)  
  Coded (direct and/or all identifiers removed, study code/ID included)  
  De-Identified (all HIPAA 18 and study ID/code removed): 
  Verified Statistically  
 
OR 
  Verified by Absence or Removal of HIPAA 18 and study ID  
  Limited Data Set 
  Other: Describe      
 
11.4 Location of Data and/or Specimens, and Data Retention Plan: 
   
• 
A. Data and/or Specimen Location:  Data will be stored electronically in the study tracking database 
(\\vhadurhsrdfile1\$research\Distributed Apps\HSRDTrackingApp) and in a folder accessible only to 
study team members on the IRB approved staff listing (\\vhadurshrdfile1\$projects\STEP_KOA), 
managed by Durham VA HSR&D personnel.  Data that will be stored electronically include identifiers 
such as participant names, street address, city, county, zip code, telephone number, and social security 
number, and may include data noted above in section 11.1.  We will also keep track of study related 
telephone calls to participants, opt-out calls, study payment dates, and study appointments. 
• 
Paper records of data include informed consent forms, HIPAA forms, and data collection forms and will 
be stored in locked cabinets either at the Durham VAMC, Legacy Towers, Suite 600 or in room 1C214 
at the Greenville Health Center.   
 
  Data will be also be placed at the VA Informatics and Computing Interface (VINCI; 
http://vaww.vinci.med.va.gov/vincicentral/VINCIWorkspace.aspx).  The VA Informatics and Computing 
Infrastructure is a partnership between the VA Office of Information Technology and the Veterans’ Health 
Administration Office of Research and Development.  Researchers and operations staff can use VINCI to 
access data and statistical analysis tools in a virtual working environment through a certified VHA network 
computer using the VA Intranet or Virtual Private Network (VPN).   
 
B. Data Retention Plan 
 
  Research records will be maintained and destroyed according to the National Archives and Records 
Administration, Records Schedule Number:  DAA-0015-2015-0004.  Records destruction, when authorized, will 
be accomplished using the then current requirements for the secure disposal of paper and electronic records.  
Currently, destruction of research records (see DAA-0015-2015-0004, section 7.6 “Research Investigator Files” 
for materials included in research records) is scheduled for 6 years after the cut-off (the cut-off is the 
completion of the research project) and may be retained longer if required by other federal agencies.  Records 
will not be destroyed without pre-notification to the facility records manager.     
  Other data retention plan, describe:        
 

 
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11.5 Data Access and Data Recipients:  Only study team members who are listed on the study staff listing will 
have access to identifiable data. This will be stored behind the VA firewall.    
All VA research personnel who have access to VHA records are instructed, in accordance with VA policy, on 
the requirements of Federal privacy and information laws and regulations, VA regulations and policies, and 
VHA policy. All study personnel who are VA employees working within the VA system have fulfilled all required 
HIPAA and other VA security and privacy policy training requirements and have agreed to follow guidelines 
pertaining to the protection of patient data. All research staff sign VA Rules of Behavior, and all study staff are 
up-to-date with VHA Privacy Policy Training and the VA Office of Cyber and Information Security Awareness 
Training Course. The data security and privacy procedures summarized in that course include logging off or 
locking the computer when walking away from it; no sharing of access codes, verify codes or passwords; not 
allowing anyone else to use the computer under one’s password; and disposing of sensitive information using 
VA-approved methods (e.g., shredder bins).  Access to study data will be removed for all study personnel 
when they are no longer part of the research team.  
 
11.6 Data and/or Specimen Transportation and/or Transmission for all data and/or specimens involved in the 
study:   
  
I. 
  Data and/or specimens will not be transported or transmitted outside of Durham VAMC 
environment with the exception of the subject’s e-mail address as noted above. 
 
II. 
   Data and/or specimens will be transmitted to other VA sites using the following method(s): 
 
A. 
Data 
  Data are de-identified and thus will be sent via unencrypted e-mail or unencrypted disk 
(encryption is optional). 
  Data are coded or contain identifiers and thus will be sent <chose method of transfer such as:  
PKI or RMS encrypted e-mail, FIPS 140-2 encrypted disk (with VA-authorized carrier and 
tracking), or FIPS 140-2 encrypted external drive (with VA-authorized carrier and tracking). You 
may identify a primary and secondary method>. 
  Other, describe:   
 
B. Specimens (N/A) 
  Specimens are de-identified and thus will be sent via standard carrier (tracking is optional). 
  Specimens are coded or contain identifiers and thus will be sent via VA-authorized carrier with 
tracking.   
  Other, describe      
 
III. 
  Data and/or specimens will be transported to non-VA/VHA sites (e.g., academic affiliates, 
laboratories, etc.) using the following method(s): 
 
A. Data 
  Data are de-identified and thus will be sent via unencrypted e-mail or unencrypted CD. 
  Data are coded or contain identifiers and thus will be sent via <chose method of transfer such as 
FIPS 140-2 encrypted CD or FIPS 140-2 encrypted hard drive/flash drive> using VA—approved 
carrier with tracking.   
  Data are coded or identified and will be uploaded to sponsor website using electronic case report 
form (eCRF) <the VET-KOA program website http://va.helpmyknees.com will be used to access 
the exercise program.   
 Other, describe:  
 
B. Specimens (N/A) 
  Specimens are de-identified and thus will be sent via standard carrier (tracking is optional) or will 
be hand-delivered by research study personnel.  Specify method of delivery:        

 
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  Specimens are coded and thus will be sent via VA-approved carrier with tracking or will be hand-
delivered by research study personnel.  Specify method of delivery:        
 
In accordance with the HIPAA and the Privacy Act, for any coded or identifiable data or specimens released 
from the Durham VAMC (with the exception of Limited Data Sets), an Accounting of Disclosure (AOD) will be 
maintained (e.g., in a database or spreadsheet) that includes the participant’s name, date of the disclosure, 
description of the nature of the Individually Identifiable Information (III) disclosed, purpose of each disclosure, 
and the name and address of the person/agency to whom the disclosure was made. 
 
11.7 Risk Mitigation Strategies:   
  Data are fully de-identified (stripped of HIPAA 18 and study ID/code) before being shared outside of 
Durham VAMC. 
  Specimens are fully de-identified (stripped of HIPAA 18 and study ID/code before being shared outside of 
Durham VAMC. 
  Direct identifiers will be maintained separately from data and or specimens by using a code to “identify” 
subjects.  In a separate database (i.e., a “linking” or “cross-walk” database) this code will be linked to 
identifying subject information.   
  Other, specify:  Information will be accounted for by regular checks and reports generated from the tracking 
database (e.g., information on participant stages within the study); this will be approximately biweekly. In 
addition the study team will maintain a check sheet associated with tasks and data collected for the baseline 
and follow up assessments; this will help to that all required tasks are completed (e.g., providing participant 
with copy of the signed consent form) and that all data collected and stored will be in accordance with the VA 
records control schedule.  The entire study team will work collectively to oversee the privacy and security of the 
data. 
 
VHI Risk Mitigation Strategies: 
1. Browser Encryption - All site content, whether participant specific or generic in nature, is served using 
HTTPS.  TLS is required, SSLv2 and SSLv3 have been disabled. 
  
2. Firewalls - The web server is protected by both hardware and software firewalls as well as using 
SELinux. 
  
3. Limited Access – Only those employees who need to maintain the server are given the server security 
credentials. 
  
4. Cookies – Cookies are transmitted using encryption and protected against tampering. 
  
5. Password Security – No clear text passwords are stored, only salted hashes of passwords.  Salted 
passwords are SHA1 hashed.  A minimum password length of 6 is enforced but there are no other 
requirements on the password. 
  
6. Forgotten Passwords – Since raw passwords are not stored, we cannot provide the user with their 
current password.  Instead, the user can reset their password by calling a study team member. 
  
7. URLs – There is no user or session information in URLs. 
  
8. Backups – Database backups are made nightly and are stored on durable, encrypted storage. 
  
9. Database Segregation – The study database will run on its own web and database server.  It will not be 
shared by other sites. 
 
11.8 Suspected Loss of VA Information:  Should any incident such as theft or loss of data, loss or theft of the 
VA study issued iPad, unauthorized access of sensitive data or non-compliance with security controls occur, it 
will be immediately reported according to VA policy. All incidents regarding information security/privacy 

 
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incidents will be reported to the ISO and PO within 1 hour of acknowledgement of issue and done so using the 
VHADUR Research Events Report e-mail group (VHADURResearchEventReport@va.gov). 
 
11.9 Reporting of Results:   
  Reporting of results, such as in scientific papers and presentations, will never identify individual subjects.  
Data will be presented in aggregate and individual-level data will not be published. 
  Other results reporting plan, describe:       
 
12.0 Study Limitations and Challenges.  One limitation is that within the time permitted, we will not be able 
to fully evaluate long-term adherence after completion of STEP-KOA.  However, we have included a 15-month 
assessment point that will evaluate use of the program six months after the initial intervention period.  If this 
trial supports the effectiveness of STEP-KOA, an important next step will be evaluation of longer-term 
adherence. We acknowledge that all VA healthcare users have regular internet access. However about 85% of 
U.S. adults report being internet users, including 80% of adults of who live in rural areas 92, and these numbers 
are steadily rising.  Therefore we believe the VET-KOA program will be accessible to a large number of 
Veterans, and as internet access becomes more ubiquitous, this barrier will be lessened. As the VA continues 
to push forward to engage Veterans in MyHealtheVet, VET-KOA is the type of program that could be 
integrated within that platform. Additionally, VET-KOA is currently being developed for a mobile platform and 
could also be converted to an App format; this would further increase the reach of the program 93.   
 
13.0 Dissemination and Implementation Activities & Roles of Clinical / Operations Partners. We will 
disseminate findings to the scientific community via publications in professional journals and conference 
presentations.  We will also work with the Durham VA Press Office and colleagues at the Arthritis Foundation 
and Centers for Disease Control and Prevention to further disseminate these findings.  If the STEP-KOA 
program is found to be effective, there are several VA organizations whose missions relate to the potential 
implementation of this program. Therefore, during development of this proposal, we have been consulting with 
partners in each of these areas, including the National Center for Health Promotion and Disease Prevention, 
and the Office of Connected Health.  These partners have enthusiastically supported the project, contributed to 
our study design decisions, and will continue to provide input throughout the study.  We plan for monthly calls 
with partners during the study start-up period, then at least quarterly calls and progress reports afterward.  
These partners will help the study team ensure that results are of high relevance to the VA, assist with 
dissemination of results to relevant VA partners and leadership, and provide advisement about implementation 
strategies.  
 
14.0 Project Management Plan 
  
14.1 Timeline for Study Activity Completion. We propose a 3-year study. During the first four months we will 
finalize study materials, databases, and processes, train personnel and work with VHI to make minor changes 
to the VET-KOA program. Website changes will be completed in the first four weeks, after which we will ask 
n=10 veterans to test the usability of the program.  There will be 14 months of participant enrollment (Year 1, 
Month 5 - Year 2, Month 6).  This will require us to enroll about 24-25 participants per month, which is very 
feasible based on our prior clinical for Veterans with OA 16,26,44.  Three-month follow-up assessments will be 
completed by Year 2 Month 9, and 15-month follow-up assessments by Year 3, Month 9. We will devote the 
final three months of the grant to final data cleaning, analyses, preparing manuscripts, and completing the 
other dissemination and implementation activities.  
 
14.2. Training and Supervision of Study Team.  Dr. Allen will train and oversee the project coordinator and 
research assistant. Dr.’s Allen, Morey and Hall will all contribute to training the exercise counselor regarding 
delivery of the telephone-based intervention. In addition, Dr. Huffman will provide the exercise counselor with 
training regarding clinical issues surrounding OA, particularly related to exercise prescription and response.  
Before starting to deliver the intervention to study participants, the exercise counselor will perform multiple 
practice sessions with the study team.  We will also audio tape intervention calls for approximately the first 10 
participants.  Dr.’s Allen and Morey will listen to each of these interview sessions and provide feedback to the 
exercise counselor.  For the remainder of the study, approximately 5% of telephone conversations will also be 

 
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reviewed by the same study team members.  Drs. Allen, Bongiorni and Hodges will provide training to the 
physical therapists who deliver the Step 3 intervention and will attend the first 10 visits for each therapist, 
followed by 5% thereafter to assure fidelity to the intervention protocol.  
 
14.3.  Website Maintenance Plan. The exercise program website has been in operation by VHI, including the 
pilot study, for two years without problems.  Planned modifications will be tested by VHI programmers, as well 
as veterans in our initial feasibility study.  We have allocated funds for VHI for this testing, as well as 
programmer support for routine maintenance or unforeseen problems encountered with the website.   
 
References 
1. 
Murphy L, Schwartz TA, Helmick CG, et al. Lifetime risk of symptomatic knee osteoarthritis. Arthritis & 
Rheumatism. 2008;59(9):1207-1213. 
2. 
Knoop J, Dekker J, van der Leeden M, et al. Is the severity of knee osteoarthritis on magnetic resonance 
imaging associated with outcome of exercise therapy? Arthritis care & research. Jan 2014;66(1):63-68. 
3. 
Centers for Disease Control and Prevention. Projected state-specific increases in self-reported doctor-
diagnosed arthritis and arthritis-attributable activity limitations--United States, 2005-2030. Morbidity and 
Mortality Weekly Report. 2007;56(17):423-425. 
4. 
Dominick KL, Ahern FM, Gold CH, Heller DA. Health-related quality of life among older adults with 
arthritis. Health and Quality of Life Outcomes. 2004;2(1):5. 
5. 
Hootman JM, Helmick CG, Brady TJ. A public health approach to addressing arthritis in older adults: the 
most common cause of disability. Am J Public Health. Mar 2012;102(3):426-433. 
6. 
Guccione AA, Felson DT, Anderson JJ, et al. The effects of specific medical conditions on the functional 
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