Staying Positive: An Intervention to Reduce Osteoarthritis Pain Disparities
Phase: NA
Conditions: Arthritis
Sponsor: VA Office of Research and Development

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Title: Staying Positive with Arthritis: A Program to Improve Quality of Life
Funding Agency: Department of Veterans Affairs
Project ID: IIR 13-080
Leslie R.M. Hausmann, Ph.D.
Version 5 – 5/18/16

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Abstract
Background: Osteoarthritis (OA) is a prevalent and disabling source of chronic 
pain for which African Americans (AAs) bear a disproportionate burden. The 
purpose of this study is to test a patient-centered, non-invasive intervention to 
improve pain outcomes and reduce disparities in AA and White Veterans with 
knee OA. The intervention is designed to increase positive affect (PA), that is, 
enjoyable feelings such as happiness or contentment, the health benefits of 
which are well-documented.
Objectives: The primary aim of this study is to evaluate the impact of a PA 
intervention on pain and physical functioning in AA and white Veterans with knee
OA through a randomized, controlled, clinical trial. We hypothesize that patients 
randomized to a PA intervention will experience improved pain and functioning 
compared to patients randomized to an attention control (AC) program, and that 
these improvements will be larger for AAs than for whites. The secondary aim of 
this study is to identify variables that mediate the effects of the PA intervention on 
pain and functioning. We hypothesize that the effects of the PA intervention will 
be mediated by psychosocial variables known to be associated with OA 
outcomes or racial differences in OA outcomes (e.g., depression, self-efficacy, 
pain coping, perceived discrimination). 
Methods: A randomized, controlled, 2-arm design will be used to compare the 
effects of a 6-week PA intervention with that of an AC program on pain and 
functioning at 1, 3, and 6-months post-intervention among AA and white 
Veterans with knee OA. Approximately 180 AA and 180 white primary care 
patients with knee pain symptoms consistent with OA will be recruited from 
participating VA medical centers following the original protocol. After the original 
patients have been recruited, approximately 240 additional primary care patients 
with knee pain symptoms consistent with OA will be recruited from participating
VA medical centers using expanded inclusion criteria that take into account ICD-
10 codes. Eligible participants will complete an in-person baseline assessment of 
study outcomes, mediators, and control variables and be randomized to a 6-
week PA or AC program. The PA program consists of completing 6 at-home 
activities (1 per week) that have been shown to increase positivity. The AC 
program consists of 6 affectively neutral activities. Both groups will receive 
weekly telephone calls from trained interventionists to clarify instructions for the 
next week’s activity and assess completion of the previous week’s activity. 
Outcomes and proposed mediating variables will be assessed via telephone 
surveys at 1 month, 3 months, and 6 months post-intervention. Study outcomes 
include self-reported pain and physical functioning as measured by the Western 
Ontario MacMaster Index. Hypothesized mediators include depressive 
symptoms, positive/negative affect, satisfaction with life, arthritis self-efficacy, 
pain coping, pain catastrophizing, perceived discrimination, global stress, and 
social support. To assess intervention impact over time and by race (primary 
aim), we will fit linear mixed models that allow repeated measures on the 

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continuous outcomes for each participant and assess change in outcomes over 
time. To identify mediators (secondary aim), we will use a multiple mediator 
bootstrap approach to assess whether the effect of the intervention is mediated 
by the hypothesized mediators. 

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List of Abbreviations
Provide a list of all abbreviations used in the protocol and their associated meanings.
AA(s) – African American(s)
AC – Attention Control
CHERP – Center for Health Equity Research and Promotion
CIRB – Central Institutional Review Board
DSM-IV – Diagnostic and Statistical Manual of Mental Disorders, 4th edition
HSR&D – Health Services Research and Development
ICD-9 – International Classification of Diseases – 9th Revision
ICD-10 – International Classification of Diseases – 10th Revision
IRB – Institutional Review Board
LSI – Local Site Investigator
OA – Osteoarthritis
OARSI – OA Research Society International
PA – Positive Affect
PBRN – VA Women’s Health Practice-Based Research Network
PHI – Protected Health Information
PHQ – Patient Health Questionnaire
PI – Principal Investigator
PKI – Public Key Infrastructure
PVAMC – Philadelphia VA Medical Center 
TBN – To Be Named
TJR – Total Joint Replacement
US – United States
VHA – Veterans Health Administration
VA – Veterans Affairs
VAPHS – VA Pittsburgh Healthcare System
WH(s) – White(s)
WOMAC – Western Ontario MacMaster

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Contents
Protocol Title: .................................................................................................................. 6
1.0
Study Personnel.................................................................................................... 6
2.0
Introduction............................................................................................................ 9
3.0
Objectives............................................................................................................ 14
4.0
Resources and Personnel ................................................................................... 15
5.0
Study Procedures................................................................................................ 18
5.1 Study Design........................................................................................................ 18
5.2 Recruitment Methods........................................................................................... 22
5.3 Informed Consent Procedures ............................................................................. 25
5.4 Inclusion/Exclusion Criteria.................................................................................. 25
5.5 Study Evaluations ................................................................................................ 26
5.6 Data Analysis......................................................... Error! Bookmark not defined.
5.7 Withdrawal of Subjects......................................................................................... 31
6.0
Reporting............................................................................................................. 31
7.0
Privacy and Confidentiality .................................................................................. 32
8.0
Communication Plan ........................................................................................... 32
9.0
References.......................................................................................................... 34

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Staying Positive with Arthritis: A Program to Improve Quality of Life
1.0
Study Personnel
Principal Investigator:
Leslie R.M. Hausmann, Ph.D.
Core Investigator, Center for Health Equity Research and Promotion
VA Pittsburgh Healthcare System
University Drive (151C)
Pittsburgh, PA 15240-1001
Phone: (412) 360-2112
Fax: (412)360-2284
Email: leslie.hausmann@va.gov
Co-Investigators:
Said A. Ibrahim, M.D., MPH
Co-Director, Center for Health Equity Research and Promotion
Philadelphia VA Medical Center
3900 Woodland Ave.
Philadelphia, PA 19104-6162
Phone: (215) 823-4159
Fax: (215) 222-2592
Email: said.ibrahim2@va.gov
Rollin Gallagher, M.D., MPH
Deputy National Program Director for Pain Management 
Philadelphia VA Medical Center
3535 Market Street
Philadelphia, PA 19104-6162
Phone: (215) 746-6700 
Fax: (215) 823-6880
Email: rollin.gallagher@va.gov
C. Kent Kwoh, MD
Professor of Medicine and Medical Imaging
The Charles A. L. and Suzanne M. Stephens Chair of Rheumatology 
Chief, Division of Rheumatology
Director, University of Arizona Arthritis Center  
1501 N. Campbell Avenue, Room 8303
Tucson, AZ   85724-5093
Phone: (520) 626-3618
Fax: (520) 626-5018
Email: kwoh@arthritis.arizona.edu

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Acacia Parks, Ph.D.
Assistant Professor of Psychology
Hiram College
P.O. Box 67
Hiram, OH 44234
Phone: (330) 569-5229
Email: acacia.c.parks@gmail.com
Ernest R. Vina, MD
University of Arizona Arthritis Center
1501 N. Campbell Ave.
PO Box 245093
Tucson, AZ 85724
Phone: (520) 626-4206
Fax: (520) 626-2587
Email: evina@email.arizona.edu
Debra K. Weiner, M.D.
Core Investigator, Geriatric Research Education and Clinical Center
VA Pittsburgh Healthcare System
University Drive C
Pittsburgh, PA 15240
Phone: (412) 360-2920
Fax: (412) 360-2377
Email: debra.weiner@va.gov
Ada Youk, Ph.D.
Statistician, Center for Health Equity Research and Promotion
VA Pittsburgh Healthcare System
University Drive C
Pittsburgh, PA 15240
Phone: (412) 360-2124
Fax: (412) 360-2284
Email: ada.youk@va.gov
Collaborator:
Diane Carney, MA
Program Manager, VA Women’s Health Practice-Based Research Network 
VA Palo Alto Health Care System
795 Willow Road (152-MPD)
Menlo Park, CA 94025
Phone: (650) 493-5000 x22952

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Fax: (650 617-2690
Email: Diane.Carney@va.gov

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2.0
Introduction
2.1 Background and Study Rationale
2.1.1. Osteoarthritis causes substantial chronic pain and disability. 
Arthritis affects roughly 1 in 5 (46.4 million) adults in the United States (US) 
and half of US adults over age 65.1 Arthritis affects 16% of Veterans Affairs 
(VA) patients, making it one of the most prevalent chronic conditions among 
VA patients.2 Arthritis is the most common cause of disability and causes 
more functional limitations than heart disease or diabetes.1 Osteoarthritis 
(OA), the most common form of arthritis, is associated with disability, high 
health care costs, and reduced quality of life.3,4 People with OA are more 
likely to have physical and mental health comorbidities and receive more 
medications.5 OA accounts for $185.5 billion in annual medical expenses; 
$36.1 billion are patient out-of-pocket expenses.4 The current project focuses 
on improving OA-related pain and functioning to reduce the burden of this 
significant clinical condition.
2.1.2. There are racial disparities in the impact and management of OA.
Radiographic knee OA has been found in 52% of African Americans (AAs) 
compared to 36% of whites (WHs).6 Among people reporting physician-
diagnosed arthritis, AAs are more likely than WHs to experience severe joint 
pain, daily activity limitations, and work limitations.7 In Veteran patients with 
knee OA, AAs report more pain and functional impairment than WHs.8,9
Treatments used to manage OA also differ between AAs and WHs. 
Compared to WHs with OA, AAs are prescribed lower doses of drugs for OA 
and are less likely to adhere to OA drug regimens.10 Our research found that 
AAs, more so than WHs, prefer less invasive and non-traditional OA 
treatments over more aggressive treatments.11,12 AAs are more likely to use 
massage, prayer, creams, and over-the-counter medications to treat OA 
symptoms,13 whereas WHs are more willing to undergo total joint replacement 
(TJR), the only effective option for advanced OA.14 Our work suggests that 
treatment preferences are a major factor driving racial disparities in TJR 
utilization.12 The current project is designed to reduce racial disparities in OA 
using a novel intervention that is aligned with African American (AA) 
preferences for less invasive and non-traditional treatments and targets 
mechanisms that underlie racial disparities in OA pain and functioning.9,15

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2.1.3. More effective treatments for managing OA are needed. There is no 
known cure for OA and no drug is available to stop the progression of the 
disease. The goals of treatment are to alleviate symptoms, maintain and 
improve physical functioning, reduce disability, improve quality of life, and 
provide patient education.16 Over 50 treatments for OA exist, including non-
pharmacological (e.g., self-management, exercise, acupuncture), 
pharmacological (e.g., analgesics, intra-articular corticosteroids, topical 
creams), and surgical (e.g., arthroscopy, TJR) treatments.17 Existing 
treatments yield only small to moderate improvements in pain.17 A review 
found that the combined effect size (Cohen’s d) of all non-pharmacological 
treatments was 0.25, with self-management/patient education having the 
smallest effect on pain (Cohen’s d = 0.06).17 Pharmacological treatments 
were only slightly more effective (combined Cohen’s d = 0.39), and all were 
associated with major adverse side effects.17 There is clearly a need for more 
effective treatments for OA with minimal side effects or complications. 
2.1.4. OA treatments that can reduce racial disparities in OA pain and 
functioning are needed. A review of randomized, controlled trials of non-
pharmacological OA interventions found that only 3 of 25 studies included AA 
participants.18 Only 2 studies reported on racial differences and both found no 
racial difference in intervention efficacy.18 Two studies, including one by our 
research team, focused on improving the acceptability of TJR among AAs, 
with some success.19,20 Given that TJR is reserved for advanced cases of OA 
and that some AA patients with advanced OA still prefer non-surgical 
management, non-invasive interventions that can reduce disparities in pain 
and functioning across all disease stages are critical. A review of OA 
interventions targeting disadvantaged populations (e.g., AAs, low-literacy 
patients) found only 3 that focused on AAs with OA and only 1 included a 
white (WH) comparison group so that the effect of the intervention on 
disparities could be examined.21 Most interventions involved patient education 
using culturally tailored self-management programs. Overall, self-
management/education programs showed small and short-lived benefits.21
Given that existing interventions have done little to reduce OA racial 
disparities, we propose a new approach to improve pain and reduce pain 
disparities in patients with OA. 
2.1.5. Positive affect improves health through biological, psychological, 
and social pathways. The proposed intervention is from the field of 
psychology and is designed to increase positive affect (PA). PA is defined as 
feelings that are experienced when one is pleasurably engaged with the 
environment (e.g., joy, excitement, contentment).22 PA is associated with 
reduced mortality and other positive physical and mental health 

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outcomes.22,23 PA impacts health through biological processes, such as the 
release of endogenous opioids and stress hormones.22,24 PA also promotes 
health through psychosocial pathways by increasing creativity, curiosity, 
openness to new information, and the desire to connect with others.25 This 
can promote health by improving our ability to overcome barriers to positive 
health behaviors, increasing openness to health recommendations, and
strengthening social ties. 
2.1.6. Increasing PA can improve OA pain management and reduce OA
disparities through psychosocial mechanisms. The conceptual model in 
Figure 1 illustrates how PA can reduce racial disparities in OA outcomes. We 
developed this model by adapting biopsychosocial models of pain and 
arthritis26,27 to incorporate factors underlying racial differences in pain and 
functioning.15,28 The biopsychosocial model is featured in the VHA’s National 
Pain Management Strategy and in the Institute of Medicine’s call for a cultural 
transformation for pain treatment.29,30 According to the model, pain is 
determined by biological, psychological, and social factors.26,27 Because 
psychosocial factors can cause pain to be more or less extreme than one 
would expect based on biological indicators, targeting psychosocial factors 
may help reduce pain.
Our conceptual model highlights psychosocial factors that are associated 
with OA outcomes (Figure 1).15,27 Depression often co-occurs with OA and is 
associated with worse pain and functioning and worse outcomes following 
TJR.31-33 Pain-related cognitions, including self-efficacy, pain coping 
strategies, and pain catastrophizing (i.e., magnifying pain symptoms), are 
associated with OA pain severity and functional impairment.27 Social factors 
such as stress and the availability of social support are also associated with 
OA outcomes.27 Factors in bold contribute to racial disparities in pain related 

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to OA and other chronic conditions.15,28 Allen et al. found that negative affect, 
poor self-efficacy, and emotion-focused coping accounted for worse OA pain 
and functioning among AAs than WHs, with negative affect being the 
strongest mediator.15 Other studies show that perceived racial discrimination, 
a social stressor frequently encountered by AAs, is associated with greater 
bodily pain.28
2.1.7. Increasing PA may improve OA outcomes and reduce racial 
disparities in OA. Evidence indicates that PA has clinically meaningful 
positive effects on pain, OA outcomes, and several psychosocial factors in 
Figure 1. Our work shows that teaching people activities to increase PA is 
associated with a long-term reduction in self-reported bodily pain equivalent 
to a medium effect size.34 Research by others also demonstrates that, 
whether inherently present or induced experimentally, PA is associated with 
reduced pain and greater pain tolerance.22 Observational studies show that 
naturally occurring levels of PA predict less pain in subsequent weeks in 
women with OA or fibromyalgia35 and better functioning two years following a 
hip fracture (e.g., Cohen’s d effect sizes comparing those with high PA vs. 
those with depression at 2, 6, 12, 18, and 24 months following a hip fracture 
ranged from 0.29 to 0.44 for usual walking speed and 0.29 to 0.44 for chair 
stand speed).36 Among people with OA knee pain, those with high PA also 
walk an average of 8.5% more steps per day than those with low PA.37
Experimental studies show that inducing PA in a controlled setting has 
short-term effects on pain. For example, watching a funny movie was 
associated with decreased self-reported pain and decreased pain medication 
in adults with chronic pain in a long-term care facility.38 A study in an 
experimental setting also demonstrated that inducing optimism using a well-
established PA activity caused lower ratings of pain intensity in response to a 
pain induction task (mean pain intensity rating of 57.55 vs. 68.10 on a scale of 
0 to 100; Cohen’s d = 0.55).39 PA also affects psychosocial factors that 
contribute to OA outcomes and racial disparities in OA outcomes. For 
instance, it is well-established that PA interventions significantly reduce
depressive symptoms (medium effect size [Cohen’s d = 0.65, converted from 
r = 0.31], on average).40 In addition, PA increases creativity, curiosity, and 
openness to new information,25 which could improve OA through several of 
the psychosocial factors in Figure 1. For example, increasing PA may result in 
better coping strategies, more self-efficacy, and less pain catastrophizing. We 
will collect data in the proposed study to determine whether PA improves OA 
outcomes through these mechanisms.
Finally, a PA intervention is likely to be particularly beneficial to racial 
minority patients by guarding against the negative impact of race-based social 

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stress.41,42 Disproportionate exposure to social stress, especially in the form 
of discrimination, is believed to be at the heart of racial disparities in health.43
As part of her VHA HSR&D Career Development Award (RCD 06-287), Dr. 
Hausmann conducted several studies showing that perceived discrimination 
is associated with poorer health in a variety of patient populations.44-46 Her 
work showed that discrimination impacts health by taking a negative toll on 
emotional wellbeing and one’s overall outlook on life. In AA, Asian American, 
and Hispanic/Latino patients with hypertension, Dr. Hausmann and 
colleagues found that depression, anxiety, and cynical hostility mediated the 
negative effect of perceived discrimination on overall health.46 Dr. 
Hausmann’s work also shows that perceived discrimination among AA 
Veterans with OA is associated with less PA during encounters with 
orthopedic surgeons.47 These studies suggest that guarding against the 
psychological and emotional impact of perceived discrimination should reduce 
its negative effects on health. In fact, studies show that naturally-occurring PA 
reduces the association between perceived discrimination and depressive 
symptoms, and experimentally inducing PA using a self-affirmation activity 
reduces perceptions of discrimination.41,42 The proposed study tests an 
intervention that can potentially ameliorate the negative health effects of 
perceived discrimination by increasing PA, a natural buffer against 
psychosocial stressors like discrimination. 
2.1.8. PA can be increased using simple, evidence-based activities. 
Studies show that PA can be increased through a variety of simple, evidence-
based activities.23,40,48 The commonality across techniques is that they 
increase one or more of the three core components of subjective wellbeing: 
pleasure, engagement, and/or meaning in one’s life.23 Strategies shown to 
improve wellbeing through one of these routes include activities involving 
gratitude, kindness, optimism, mindfulness, self-affirmation, identifying and 
using personal strengths, reflecting on good things, forgiveness, or some 
combination thereof.40,48 PA interventions range in complexity from single-
episode events carried out independently to multi-faceted, 12-week programs 
administered by trained clinicians. A meta-analysis found that PA 
interventions increased wellbeing and reduced depressive symptoms, with 
interventions consisting of multiple PA activities and of longer durations 
producing the largest effects.40 We propose to test a 6-week PA intervention 
consisting of multiple evidence-based activities.
2.1.9. PA interventions have been translated for use in clinical patient 
populations. Most PA intervention studies focus on outcomes such as 
wellbeing or depressive symptoms and report improvements in these 

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outcomes in both depressed and non-depressed populations.40 Recent 
studies also examine PA interventions tailored for use in clinical 
populations.49-53 Randomized trials testing the effects of PA activities over 
and above disease-specific patient education and behavioral contracts found
that PA increased positive health behaviors.51,52 Compared to control groups 
that received educational materials and completed behavioral contracts, the 
addition of PA activities increased physical activity at 12 months in patients 
with coronary artery disease (PA group walked an average of 3.4 miles per 
week more)51 and improved medication adherence in AA patients with 
hypertension (42% in PA group vs. 36% in control group adhered).52 These 
studies demonstrate that PA can be used to increase desired health 
behaviors beyond the effects of standard approaches, such as patient 
education and behavioral contracts. PA interventions have also been 
developed for patients with acute cardiovascular disease, newly-diagnosed 
HIV, and schizophrenia.49,50,54 Feasibility trials show that PA activities are 
acceptable in these patient populations and show promising preliminary 
benefits for outcomes such as optimism, depressive symptoms, anxiety, 
subjective wellbeing, health-related quality of life, overall psychological 
wellbeing, and hope.49,50,54
2.1.10. Summary of Background. OA is a painful and disabling condition 
that disproportionately affects AAs. Existing OA treatments yield only small to 
moderate improvements in pain and are not effective at reducing racial 
disparities in OA pain. Novel interventions aligned with the biopsychosocial 
model of pain and that target psychosocial factors associated with OA 
outcomes and disparities in OA outcomes are needed. A PA intervention has 
the potential to improve pain and functioning and reduce racial disparities in 
patients with OA through multiple psychosocial mechanisms. PA interventions 
have been developed for clinical patient populations but have not yet been 
fully tested in patients with OA or in Veterans, nor have their effects on racial 
differences in clinical outcomes been examined. This study will address these 
gaps by testing the impact of an evidence-based PA intervention on pain and 
functioning in AA and WH Veterans with OA.
3.0
Objectives
Our team conducted extensive pilot work to design a psychosocial 
intervention for Veterans with OA that incorporates evidence-based strategies 
for producing meaningful and sustainable increases in PA. The short-term 
objective of the current study is to test the impact of this PA intervention on 
pain and functioning in AA and WH Veteran patients with knee OA. Veterans 

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will be assigned to a 6-week PA intervention consisting of weekly PA at-home 
activities (PA intervention) or a 6-week program consisting of affectively 
neutral activities previously used in the control groups of other PA intervention
studies (attention control). We hypothesize that the PA intervention will 
improve pain and functioning in Veterans with OA through its impact on 
psychosocial factors associated with OA outcomes (e.g., affective state, self-
efficacy).22,27 Given that psychosocial factors account for racial differences in 
OA, we further expect the benefits of the PA intervention to be larger for AAs 
than for WHs. This study therefore contributes to the long-term objective of 
reducing racial disparities in OA pain management among Veterans. The 
aims of this randomized, controlled trial are:
Primary Aim: To evaluate the impact of a PA intervention on pain and physical 
functioning in a sample of AA and WH Veterans with knee OA.
Hypothesis 1: Patients who are randomized to complete the PA intervention will 
experience improved pain and functioning compared to patients who are 
randomized to complete an attention control program.
Hypothesis 2: Improvements in pain and functioning associated with the PA 
intervention will be larger for AAs than for WHs.
Secondary Aim: To identify psychosocial variables that mediate the effects of the 
PA intervention on pain and functioning.
Hypothesis 3: The effects of the PA intervention on pain and functioning will be 
mediated by psychosocial variables known to be associated with OA outcomes 
or racial differences in OA outcomes (e.g., depression, self-efficacy, pain coping).
Exploratory Aim: Although there will not be adequate power to conduct formal tests 
to determine whether intervention effects are moderated by patient characteristics 
other than race, we will conduct exploratory analyses to examine sex as an 
additional moderator.
4.0
Resources and Personnel
This multi-site study will be led by Principal Investigator (PI) Leslie 
Hausmann, PhD. Dr. Hausmann is a core investigator at the Center for 
Health Equity Research and Promotion (CHERP), a national VA HSR&D 
Center of Innovation co-located at the VA Pittsburgh Healthcare System 
(VAPHS) and the Philadelphia VA Medical Center (PVAMC). As PI, Dr. 
Hausmann will oversee the conduct and execution of all phases of this project 

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and will serve as the Local Site Investigator (LSI) for the VAPHS site. She will 
supervise the hiring and training of research staff at VAPHS; monitor patient 
recruitment, administration of the intervention, and follow-up assessments at 
VAPHS; ensure quality of data management, analysis, and interpretation; 
prepare all project reports; manage the project budget; and lead efforts to 
disseminate study findings. She will also lead future implementation efforts to 
extend the benefits of PA activities to as many Veterans as possible.  
Dr. Ibrahim will serve as a Co-Investigator and LSI at PVAMC. He will 
oversee the hiring and the training of the PVAMC staff. He will work with Dr. 
Hausmann to assure successful conduct of all the study components at the 
PVAMC site. Dr. Ibrahim will participate in weekly or as-needed conference 
calls with Dr. Hausmann and the study staff from participating sites to review 
study progress and discuss issues of recruitment, enrollment, and data 
collection. He will also participate in bi-weekly or as-needed conference calls 
with the full investigative team to discuss study progress in meeting 
participant recruitment and other study goals and to review emerging data.
As a Co-Investigator, Dr. Rollin M. Gallagher will participate in regular 
investigative team meetings to advance the goals of the study and maximize 
the future impact of this work by situating it in the broader context of VHA pain 
management efforts.
As a Co-Investigator, Dr. C. Kent Kwoh will participate in regular 
conference calls with the investigative team to provide expertise on racial 
disparities in the treatment of OA and to assist with the interpretation and 
dissemination of findings.  
As a Co-Investigator, Dr. Acacia Parks will guide the content, format, and 
delivery of the study intervention; train research staff members to administer 
the intervention; and work with the team to ensure consistency in the delivery 
of the intervention throughout the recruitment period. She will participate in 
conference calls with the study team and will assist in interpreting results 
within the larger literature on positive psychology. She will also contribute to 
presentations, manuscripts, and the development of future projects.
As a Co-Investigator, Dr. Ernest Vina will provide input on the design and 
conduct of the project, participate in regular conference calls with the 
investigative team, and aid in the interpretation and dissemination of findings.
As a Co-Investigator, Dr. Debra Weiner will provide clinical expertise in pain 
management, assistance with patient recruitment through her affiliation with 
the VAPHS pain clinic, and methodological guidance regarding outcome 
measurement. Dr. Weiner will also participate in investigative team meetings 
to advance the goals of the study.
As a Co-Investigator and the senior biostatistician, Dr. Youk will design, 
direct, and supervise randomization procedures and all data analyses for the 
study. She will coordinate and supervise the activities of the Programmer 

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Analyst and ensure the integrity, verification, and documentation of all 
preliminary and final analyses. She will participate in regular meetings of the 
investigative team and assist in data interpretation and writing of manuscripts.
One or more Programmer Analysts will be responsible for the creation and 
maintenance of all project databases and tracking systems. S/he will 
coordinate data tracking, data entry, data verification, and data 
documentation across study sites and will train Research Assistants 
regarding data entry and tracking procedures. S/he will be responsible for 
extracting data from electronic medical records to identify potential 
participants. S/he will generate and distribute data and tracking reports as 
requested by the PI. S/he will perform data verification and quality assurance 
activities, prepare analytic datasets, and conduct preliminary study analyses
under the supervision of the lead biostatistician, Dr. Youk.
A Project Coordinator will assist with interviewing, hiring, training and
supervising VAPHS project staff. S/he will be involved in the daily 
management of the project activities and budget including coordination of 
communication with study investigators and research staff, preparation of 
Institutional Review Board (IRB) submissions, preparation of progress 
reports, materials for presentation at scientific meetings, and the final report, 
as well as manuscripts and correspondence related to the project. She will 
directly supervise the VAPHS Research Assistants. S/he will also serve as an
Interventionist at VAPHS. S/he will be responsible for recruitment and 
administering all aspects of the study intervention, including the delivery of 
the randomly assigned intervention or control activity booklets to participants 
at the baseline visit, orienting participants to their assigned booklet, reviewing 
instructions for the first activity at the baseline visit, and conducting weekly 
telephone calls with each patient to ask about their experience with the prior 
week’s activity, review the next week’s activity, and help participants trouble-
shoot anticipated barriers to completing activities. 
Additional Interventionists, Research Assistants, and Local Project 
Coordinators will be hired as needed at participating sites and will be
responsible for administering all aspects of the study intervention, including 
the delivery of the randomly assigned intervention or control activity booklets 
to participants at the baseline visit, orienting participants to their assigned 
booklet, reviewing instructions for the first activity at the baseline visit, and 
conducting weekly telephone calls with each patient to ask about their 
experience with the prior week’s activity, review the next week’s activity, and 
help participants trouble-shoot anticipated barriers to completing activities. 
Interventionists will not be directly involved in the collection of post-
intervention follow-up data. They may assist with identifying and screening 
patients, completing and documenting the informed consent process, 
scheduling patients for study appointments, administering in-person baseline 
patient surveys, abstracting clinical data from electronic medical records, and 
entering data into project databases. Research Assistants will assist with 
study recruitment, data collection, and data entry. They will assist with 

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identifying and screening patients, completing and documenting the informed 
consent process, and scheduling patients for study appointments. They will 
also be responsible for conducting all telephone post-intervention follow-up
surveys. Research Assistants responsible for collecting follow-up surveys will 
remain blind to whether participants have been randomization to the 
intervention or control arm of the study. 
As a Collaborator, Diane Carney, MA, will serve as an advisor to the PI and 
study team to ensure that approved recruitment strategies used by the study 
team are designed so that they effectively reach women Veterans. Ms. 
Carney is Program Manager for the VA Women’s Health Practice-Based 
Research Network (PBRN) at the VA Palo Alto Healthcare System. Ms.
Carney will provide the PI with general guidance regarding strategies for 
recruiting women Veterans and strategies for clinic-based research (e.g., how 
to build relationships with PBRN clinic staff, via the local PBRN Site Leads). 
She will also serve as a liaison between the PI and LSIs and the PBRN site 
leads at participating study sites to maximize enrollment of women in the 
study. 
PHI will be accessible to all personnel described in this section except for 
Diane Carney.
5.0
Study Procedures
5.1 Study Design
5.1.1. Experimental Design. 
A randomized 2-arm design will be used to compare the effects of a 6-week 
PA intervention with that of an Attention Control (AC) condition on pain and 
functioning at 1, 3, and 6-months post-intervention among AA and WH 
Veterans with knee OA. We will recruit from participating sites approximately 
180 AA and 180 WH primary care patients with symptomatic knee OA
following the original protocol. After the initial 360 patients have been 
recruited using the originally proposed criteria, up to approximately 240
additional patients (including some men and some women, as resources 
allow) will be recruited to increase power to detect sex differences. Eligible
participants will complete an in-person baseline assessment and be 
randomized to a 6-week PA or AC program. The PA program includes at-
home activities (1 per week) shown to increase PA. The AC program includes 
affectively neutral activities. Both groups will receive weekly telephone calls 
from study interventionists to assess adherence and review the next week’s
activity. Participants will be telephoned 1, 3, and 6 months post-intervention to 
complete follow-up assessments. Those who cannot complete study 

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assessments over the phone will be permitted to complete them in person if 
necessary.
5.1.2. Randomization and intervention procedures.
5.1.2.1. Randomization of participants. We will randomize enrolled 
participants to one of two study arms (PA intervention or AC) using permuted 
block randomization at the patient level, stratified by study site and patient 
race. The study statistician will develop the randomization schedule using
standard randomization procedures. Once a patient has enrolled and 
completed the baseline assessment, a study interventionist will open a sealed 
envelope containing the patient’s random assignment. Randomized patients
will be included in intent-to-treat analyses.
5.1.2.2. Masking. Participants will not be told whether they have been 
assigned to the PA or AC arm. Interventionists who deliver the PA and AC 
programs cannot be blinded to assignment. However, research assistants 
responsible for all post-intervention assessments will be blinded to treatment 
assignments. 
5.1.2.3. PA intervention program. The PA intervention is based on empirical 
research regarding how to implement PA interventions to provide maximum 
and sustained benefits.55 PA interventions that are administered individually 
(vs. in a group), are of longer duration (e.g., over multiple weeks vs. 1-time 
events), and combine multiple activities yield the largest effects.40 For our PA 
intervention, we selected the following PA activities, all of which have 
sustained benefits for wellbeing and had the greatest potential for use in 
Veterans with OA. 
Three Good Things: Participants write down three positive events that 
happen each day, completing the exercise at the end of each day for 1 week. 
This activity focuses attention on positive events to overcome our natural 
predisposition to remember negative events.56 It has been shown to increase 
subjective wellbeing and reduce depressive symptoms, with effects lasting for 
6 months.23
Expressing Thanks: Participants write a thank-you letter to someone 
who has been kind to them but was never thanked.23 Writing a letter of thanks 
provides an immediate and intense increase in gratitude.57 Reading  thank-
you letters to the intended recipient produces increases in subjective 
wellbeing and decreases in depressive symptoms  of greater magnitude than 
the Three Good Things activity.23
Making Good Moments Last: Participants practice prolonging the 
experience of 1 positive moment each day for a week. This cultivates 
mindfulness, which leads to more frequent positive emotion and enhanced 

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self-regulation.58 Research on Mindfulness-Based Stress Reduction 
demonstrates that mindfulness has numerous physical and psychological 
benefits.59 While a full mindfulness meditation practice can be time-
consuming to learn and difficult to maintain, this activity is a brief and easy 
way to enhance mindfulness in everyday life.
Acts of Kindness: Practicing kindness is associated with increased 
subjective wellbeing.60 Based on evidence that completing 5 acts of kindness 
in a single day produces larger improvements in wellbeing than distributing 5 
kind acts over a week,60 participants complete 5 kind acts in 1 day for this 
activity.
Increasing Pleasant Activity: Participants identify from a list of pleasant 
activities those that give them a sense of enjoyment or achievement, or bring 
them closer to others. They then engage in at least 4 pleasant activities per 
day for a week and record them in an activity diary. Increasing pleasant 
activities is one of the most well-researched intervention strategies for 
reducing depression.48 We include it in our PA intervention based on its 
effectiveness across different populations and its ease of administration.
Practicing Your Favorite(s): For the first 5 weeks, participants will 
complete one new activity each week. In week 6, participants will select an 
activity from previous weeks to complete again. Repeating an activity serves 
to engage participants in identifying PA activities that appeal to them, and to 
give them additional practice building PA activities into their daily lives.
5.1.2.4. AC program. The only difference between the PA and AC programs 
is that patients randomized to the AC arm will receive an activities booklet 
that contains affectively neutral activities used in control conditions in 
previous studies testing the impact of PA activities (Appendix A).23,57,61,62
Using AC activities established as structurally similar, yet affectively neutral in 
previous PA studies assures that any increases in PA or improvement in 
other variables among participants in the AC arm would be due to placebo 
effects. This provides the strongest possible comparison condition to achieve 
our primary study aim, which is to evaluate the impact of a PA intervention on 
pain and physical functioning. It is important to show that improvements in the 
PA intervention arm are not simply due to expectations and/or motivation, 
given that patients who are particularly motivated to be positive may self-
select into the study. 
5.1.2.5. PA and AC program delivery. PA and AC activities will be delivered 
using a combination of activity booklets and oral instructions provided during 
weekly telephone calls from trained interventionists. Interventionist will orient 

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participants to the booklets and review the first activity at the end of the 
baseline visit. The booklet contains all instructions patients need to complete 
the full program. However, the interventionist will conduct weekly telephone 
calls to provide any additional support patients may need. During these calls, 
the interventionist will assess whether participants completed the previous 
week’s activity, review instructions for the next week’s activity, and help 
participants trouble-shoot anticipated barriers to completing the next activity. 
At the conclusion of week 6, the interventionist will encourage participants to 
continue using activities in the booklet. Introducing a single new activity each 
week, trouble-shooting barriers to completing each activity, and providing the 
opportunity to identify and practice activities they find most beneficial are 
features of efficacious PA interventions.56 Those who cannot complete study 
assessments over the phone will be permitted to complete them in person if 
necessary.
5.1.2.6. Program fidelity. Prior to the start of enrollment, interventionists, 
research assistants, and LSIs from participating sites will be trained on how to 
deliver the PA and AC programs in a consistent manor. Those attending the 
training will learn how to describe each activity accurately and systematically, 
anticipate and respond to resistance or barriers to completing activities, and 
provide encouragement when necessary. Once enrollment begins, 
conference calls will be held from those administering the intervention at 
participating sites to discuss delivery of the intervention and address 
questions as they arise. Once frequent conference calls are no longer 
needed, refresher training sessions via telephone or video-conferencing will
be held as needed to maintain treatment integrity for the remainder of 
enrollment. 
5.1.3. Follow up procedures.
Research staff will telephone Veterans to assess outcomes and proposed 
mediating variables at 1- month (+ or - 1 week), at 3 months (+ or - 1 week), 
and at 6 months (+ or - 1 week) post-intervention. To maximize study 
retention, Veterans will receive a card at the baseline visit to help them keep 
track of upcoming appointments and will be mailed reminder letters prior to 
the 1, 3, and 6-month follow-up calls. A blank survey will be mailed with the 
reminder letters for Veterans to refer to during the telephone call. Veterans 
who cannot complete the follow-up surveys by telephone will also be 
permitted to complete the surveys in person, if that is more feasible for them. 
To maintain blinding of staff to randomization assignment, a study staff 
member at one site may make follow-up calls for participants recruited at 
another site.

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5.1.4. Study population. The target population will be AA and WH Veterans 
who have symptomatic knee OA.  Vulnerable populations will not be recruited 
in this study.  Biological specimens are not a part of this study.
5.1.5. Risks and benefits. There is a possible risk that some participants will
experience psychological discomfort while disclosing information about 
themselves during the surveys. To protect against this risk, study participants
will be assured that participation is completely voluntary, that they can refuse 
to answer any of the study questions, and that they have the right to withdraw 
from the study at any time without penalty. There is also a risk of breach of 
confidentiality. To protect against this risk, all data collected from participants 
will be maintained separately from identifiable information and will be stored 
in locked filing cabinets and in databases on secure servers located behind 
the VA firewall to which only the study investigators and designated research 
staff will have access through the use of VA login and password permissions.
Participants may directly benefit from participating in this study. Research has 
shown that doing activities such as the ones in the PA intervention in this 
study reduces pain and increases overall well-being for some people. While it 
is hopeful that participation in this study will reduce pain and increase well-
being of participants assigned to the PA intervention arm, this outcome 
cannot be guaranteed.
This study will lead to knowledge that will help others and society in general 
by adding to the scientific knowledge available regarding methods to reduce 
pain and increase well-being. 
Given the minimal nature of the study risks and the potential benefits to be 
gained from this research, the benefits outweigh the risks for this study.
5.2 Recruitment Methods
5.2.1. Identification and recruitment of participants. We have requested a 
waiver or alteration of the informed consent process for screening purposes 
only (CIRB Form 112a). We will use data from the Corporate Data
Warehouse (CDW), accessed through the VA Informatics and Computing 
Infrastructure (VINCI), to identify potential participants meeting eligibility 
criteria that can be ascertained from administrative data. Specifically, a VINCI 
programmer will be assigned to the study to help identify Veterans who are 
non-deceased; are non-Hispanic WH or AA; are 50 years or older; have had a 
primary care appointment at a participating site in the past 12 months; have 

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ICD-9 codes indicating a diagnosis of OA; and do not have ICD-9 codes
indicating a diagnosis of inflammatory arthritis (rheumatoid arthritis, lupus, 
psoriatic arthritis, or ankylosing spondylitis), Alzheimer’s disease, or 
dementia. [Note: Diagnoses based on ICD-10 codes will be incorporated after
the original study sample size has been met.] The VINCI programmer will 
create data views that study staff will use to determine potential participants. 
Staff will then request information about patients meeting the above criteria:
names, addresses, telephone numbers, site of care, patientICN, gender, race, 
ethnicity, age, and date and location of most recent outpatient visit. We will 
request this data at the beginning of study recruitment and may request
updates of potential participants as needed until recruitment targets have 
been met. A research staff member will download the data provided by VINCI
into designated subfolders accessible only to authorized study personnel 
through the use of VA login and password permissions. Data transfers 
between CDW and VINCI, and between VINCI and approved study staff, take 
place entirely behind the VA firewall, so data will remain behind the VA 
firewall at all times.
Study staff will inform patients in the files provided by VINCI about the study 
by mail. Mailings will be made in batches throughout the recruitment period 
until recruitment goals have been met. Mailings to potential participants will 
include a letter describing the study, a study brochure, and reply card (see 
Appendix B). The study brochure will provide potential participants with a 
number they can call to verify the validity of the study. Potential participants 
will be asked to contact the research team via telephone or postage-paid 
reply card to express interest in the study or to indicate that they are not 
interested in participating. 
Potential participants who do not opt-out of future contact about the study 
within 2 weeks following the mailing will be telephoned by research staff to 
complete a more in-depth screening. In the event that patient contact 
information provided by VINCI is incomplete or incorrect (e.g., telephone 
number no longer in service), research staff may access electronic medical 
records through CPRS to update the contact information obtained from 
VINCI. For potential participants who cannot be reached after 2 messages 
have been left at their available telephone numbers, no additional call 
attempts will be made unless they contact the study staff to indicate that they 
are interested in being contacted further. In the event that recruitment goals 
are unable to be met using this calling plan, potential participants who were 
unable to be reached after the first mailing may be mailed a second time, 
followed by up to 2 additional telephone messages. 

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We will supplement this recruitment strategy by placing study brochures in 
waiting areas of clinics at participating sites. When possible and with 
permission of the clinic staff, study staff may also be stationed in clinic 
reception areas so that interested patients may approach our staff to learn 
about the study and be screened. Depending on the physical layout of 
reception areas, research staff may set up a table or booth that patients may 
approach for information about the study. 
5.2.2. Participant payments. Enrolled participants will be reimbursed up to 
$110. Participants will receive $20 after completing the in-person visit 
baseline visit and each of the 1-month, 3-month, and 6-month follow-up
telephone surveys. Participants will also receive $5 after the completion of 
each of the weekly assessments during the 6-week program. Payments will 
be delivered in the form of cash, mailed checks, or direct deposit, per local 
payment policies at participating sites.

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5.3 Informed Consent Procedures
Patients who meet the study’s eligibility criteria will meet in person with a 
research team member, who will explain the details of the study and obtain 
written informed consent. Participants will be advised that they are free to 
withdraw from the study at any time, and that the information provided by 
them will be kept strictly confidential.
Eligible patients will be considered to be enrolled in the study after they 
provide written documentation of informed consent but prior to initiation of the 
baseline interview or randomization to the PA or AC study arm. 
The PI, LSIs, and the project coordinators, Interventionists, and Research 
Assistants at participating sites will be authorized to obtain informed consent.
All study personnel will have current VA Human Subjects Protections and 
Good Clinical Practices CITI training and will be trained by the PI or LSIs on 
the elements of informed consent and the correct process for obtaining 
informed consent for this study.
5.4 Inclusion/Exclusion Criteria
Inclusion criteria
The target population will be AA and WH Veterans with symptomatic knee
OA. Specific inclusion criteria include:
-
Age 50 years or older
-
Receive primary care at a participating site
-
Self-report as non-Hispanic black/AA or non-Hispanic WH 
-
Frequent, symptomatic knee pain identified using questions from the OA 
Initiative63
-
Pain level of 4 or higher on a 0-10 numeric rating scale
-
Can speak, read, and write in English
Exclusion criteria
Patients will be excluded if they:
-
Report serious problems with hearing, eyesight, or memory
-
Report having been diagnosed any type of arthritis other than osteoarthritis or 
degenerative arthritis
-
Report that they are currently being treated or followed for recent cancer
-
Report having had a steroid injection into one or both knees in the past 3 
months

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-
Report having had a knee replacement into one or both knees in the past 3 
months
-
Report having plans to have a knee replacement in one or both knees in the 
next 6 months
-
Report that there is a reason they cannot complete the study procedures, 
which include telephone calls and program activities that involve reading and 
writing
-
Do not have a telephone number where they can receive telephone calls from 
research staff
-
Screen positive for cognitive impairment on the Six-Item Screener to Identify 
Cognitive Impairment64
5.5 Study Evaluations
5.5.1. Data collection. Outcomes, mediating variables, and covariates will be 
assessed using validated instruments with strong psychometric properties 
(refer to cited references below for psychometric information; see Appendix 
C for model study questionnaires). 
5.5.1.1. Study outcomes: OA pain and functioning (baseline, 1 month, 3 
months, and 6 months post-intervention). The OA Research Society 
International (OARSI) Standing Committee for Clinical Trials Response 
Criteria Initiative and the Outcome Measures in Rheumatology Committee 
recommend a core set of three outcomes to be used in clinical trials of OA 
treatments: pain, physical function, and patient global assessment.65 We will 
measure all three in this study, with the study being powered to detect race 
differences in the effect of the intervention on pain. We will assess pain and 
physical functioning using the pain and functioning subscales of the Western 
Ontario MacMaster (WOMAC) Index.66 Designed to assess lower extremity
pain and function in patients with OA, the WOMAC consists of pain, stiffness, 
and physical function subscales and can be used to compute an overall 
measure of OA severity. Although we will focus on the pain and functioning 
subscales, we will administer the full WOMAC so we can also compute an 
overall score.  We will measure Patient Global Assessment of pain in the last 
week using an 11-point numeric rating scale.65
Although the main study outcomes are OA pain and functioning, 
increasing PA may also make patients more open to considering TJR as a 
treatment option. We will assess willingness to undergo TJR at each time 
point for exploratory purposes using the willingness to consider TJR item 
used in prior studies.12
5.5.1.2. Hypothesized mediators (baseline, 1 month, 3 months, and 6 
months post-intervention). Depressive symptoms will be assessed by the 
8-item Patient Health Questionnaire (PHQ-8), which assesses the 9 DSM-IV 

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criteria for the diagnosis of depressive disorders, with the exception of 
suicidality.67 PHQ-8 has psychometric properties comparable to the PHQ-9
and is recommended for studies such as ours where a) there is low risk of 
suicidality among participants, b) depression is not an inclusion criterion or a 
primary outcome, and c) research staff are unable to provide adequate 
intervention if suicidal thoughts are reported by participants (e.g., because 
staff are communicating with participants by telephone).67 Positive and 
negative affect will be assessed using the positive and negative affect 
subscales of the International Positive and Negative Affect Schedule Short 
Form.68 Satisfaction with life will be assessed by the Satisfaction With Life 
Scale.69 Arthritis self-efficacy will be measured using the 20-item Arthritis 
Self-Efficacy Scale, which assesses patients' perceived ability to cope with 
consequences of chronic arthritis.70 Pain coping will be assessed by the 
Daily Coping Inventory adapted for pain coping, which assesses patients’ use 
of emotion-focused (e.g., sought or found spiritual support or comfort) or 
problem-focused (e.g., did something to help you relax) pain coping 
strategies.71 Pain catastrophizing will be assessed by the Pain 
Catastrophizing Scale, which measures the degree to which patients magnify 
the unpleasantness of pain experiences, ruminate on pain-related thoughts, 
and feel helpless in response to pain.72 Perceived discrimination will be 
assessed by the Everyday Discrimination measure, which assesses how 
often one has encountered day-to-day unfair treatment (e.g., treated with less 
respect than other people) and the attributed reason for the treatment (e.g., 
one’s race or sex).73 Global stress will be measured using the Perceived 
Stress Scale, which assesses the extent to which people appraise their life as 
stressful.74 Social support will be assessed by an abbreviated version of the 
Medical Outcomes Study Social Support Survey.75
5.5.1.3. Demographic and clinical covariates (baseline only, except for 
OA treatments): OA treatments participants are using will be assessed at all 
time points (baseline, 1 month, 3 months, and 6 months post-intervention) by 
a comprehensive list of treatment options based on those assessed in the OA 
Initiative.63 All other demographic and clinical covariates will be assessed only 
at baseline. A demographic survey will be used to assess participants’ sex, 
age, income, education, employment, marital status, and general health 
status. Health literacy will be assessed by the item, “How confident are you 
filling out medical forms by yourself?” This was the best single-item measure 
for detecting inadequate literacy in a study of VA outpatients, demonstrating 
high specificity and sensitivity.76 Physical comorbid medical conditions will 
be assessed using an interviewer-administered version of the Charlson 
Comorbidity Index.77 Mental comorbidity will be assessed using items from 

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the 2010 Behavioral Risk Factor Surveillance System Questionnaire to 
assess diagnoses and treatment of depression or anxiety.78
Comorbidity will be further assessed by having research staff conduct chart 
reviews to extract medical diagnoses that are recorded in enrolled 
participants’ electronic medical records. Obesity will also be determined 
through chart reviews by extracting the most recent height and weight 
measurements available in patients’ electronic medical records at baseline,
which will be used to calculate body mass index. For participants who have a 
knee x-ray or MRI available in their medical record, we will assess biologic 
disease severity by looking at the x-ray and MRI reports for signs of OA.
Reports documenting osteophytes with joint space narrowing, bony sclerosis, 
or possible deformity of bone ends or simply osteoarthritis will be considered 
radiographic confirmation of OA.
5.5.1.4. Intervention adherence and engagement (6 weekly surveys after 
baseline). Adherence to and engagement with PA and AC activities will be 
assessed during weekly surveys. Participants will be asked if they completed 
the previous week’s activity.79 In addition, participants will rate how much they 
felt they benefited, how much they enjoyed, and how difficult they found each 
exercise using a 7-point Likert-type scale.79
5.6 Data Analysis
5.6.1. General approach. Analyses will be performed using SAS or Stata.
We will check the outcomes for normality and use transformations if
necessary. We will compute descriptive statistics to determine central 
tendency, data sparseness, and the existence of outliers for all other 
continuous variables. For categorical variables, we will generate frequency 
and percentage distributions to identify data sparseness, and categories with 
small frequencies will be merged when appropriate. Differences in baseline 
variables by study arm and by race will be tested using chi-square statistics
for categorical variables and t-tests for continuous variables. We will test 
study hypotheses using linear mixed models that account for repeated 
measures, assess change over time (baseline, 1 month, 3 months, and 6 
months), and allow for missing data if data are missing at random. 
Demographic and clinical variables (see 5.5.1.3) with a univariate association 
with the outcome (p<0.10) will be considered for inclusion as covariates.
Covariates will be retained in final multivariable models if significant at p<0.05
and all models will be adjusted for study site. All tests will be two-sided. 
We will conduct intent-to-treat analyses80 that include all patients in the 
groups to which they were randomized, regardless of adherence and/or 

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subsequent withdrawal. We will also perform exploratory analyses to examine 
whether there is a dose-response effect of the intervention.
5.6.2. Missing data. While we will attempt to minimize missing data, it is 
likely that there will be some incomplete data from missing assessments, lost-
to-follow-up, or withdrawal. We will attempt to assess the missing data 
mechanism for data missing due to lost-to-follow-up or withdrawal. If there are 
significant differences in baseline variables between participants that have 
complete outcome data and those that do not, we will adjust for those 
covariates in the models.81 If no systematic differences are found or if the 
missing data is intermittent, the missingness will be handled as part of the 
regression modeling. Using linear mixed linear models allows the use of all 
available data, including data from those who are missing one or more of the 
assessments. We will also assess sensitivity to the missingness by 
performing completers-only analyses.
5.6.3. Analyses for primary aim, hypothesis 1: Patients who are 
randomized to complete the PA intervention will experience improved 
pain and functioning compared to patients who are randomized to 
complete an attention control program. Intervention effects will be 
assessed using separate models for pain and functioning that include fixed 
effects for study arm (PA intervention vs. control), time, and the interaction 
between study arm and time.
5.6.4. Analyses for primary aim, hypothesis 2: Improvements in pain and 
functioning associated with the PA intervention will be larger for AAs 
than for WHs. Whether intervention effects differ by race will be assessed by 
adding to the Hypothesis 1 model fixed effects for race, the study arm and 
race interaction, the time and race interaction, and the 3-way interaction 
between study arm, race, and time. 
5.6.5. Analyses for secondary aim, hypothesis 3: The effects of the PA 
intervention on pain and functioning will be mediated by psychosocial 
variables known to be associated with OA outcomes or racial 
differences in OA outcomes (e.g., depression, self-efficacy, pain 
coping). We will assess whether intervention effects are mediated by 
proposed mediators (see 5.5.1.2.) using a multiple mediation bootstrap 
approach that allows indirect effects of each potential mediating variable to be 
examined while controlling for the effects of other mediators.82 We will fit race-
specific mediation models to assess whether mediating effects are different 
among WH and AA patients.
5.6.6. Analyses for exploratory aim. Although there will not be adequate 
power to conduct formal tests to determine whether intervention effects are 
moderated by patient characteristics other than race, we will conduct 
exploratory analyses to examine sex as an additional moderator. We will plot 
each outcome separately for men and women to evaluate whether response 
to the intervention varies by patient sex. We will also run models testing the 

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effect of the intervention over time (Primary Aim, Hypothesis 1) separately for 
men and women. 
5.6.7. Power calculations. This study uses a repeated measures design with 
2 intervention groups (PA, AC), 2 race groups 
(WH, AA), and 4 time periods (baseline, 1 month, 3 
months, and 6 months post-intervention). We 
computed sample size estimates that were 
powered to detect a racial difference in WOMAC 
pain subscale scores for the intervention effect 
over time (80% power). Interaction effects between 
study arm, race, and time were taken into account 
in the sample size computations. A 30% change in 
baseline pain scores is widely accepted as a clinically meaningful 
improvement, although changes on the WOMAC as small as 12% are also
meaningful.83,84 We therefore estimated the sample sizes needed to detect 
race differences in response to the intervention, assuming the intervention will 
produce a 12% to 30% improvement for our target population. As seen in 
Table 1, 360 Veterans (180 in each study arm split equally for each race), 
would be needed to detect a 20% change in baseline WOMAC pain subscale 
scores (effect size = 0.26) for 80% power. We therefore set the initial target 
sample size at 360, which ensures adequate statistical power to detect a 
clinically meaningful effect of 20-30% change from baseline. The initial target 
sample size of 360 also allows for possible attrition over the course of the 
study, as a 25% change from baseline would still be detectable with as few as 
232 participants.
After the initial target sample at each participating site is reached for the study 
using the original protocol, we will continue recruitment as resources allow to 
support analyses of the exploratory aim examining sex as a potential 
moderator. Specifically, we will attempt to enroll up to approximately 240 
additional Veterans (including some men and some women, as resources 
allow) using expanded criteria that includes individuals with OA codes using 
ICD-10, which was not in use at the time the study was initiated. All other 
inclusion criteria and recruitment procedures will remain the same. Taking 
ICD-10 codes into account is necessary to identify patients who have been 
diagnosed with relevant diagnoses since October of 2015, when the ICD-10
system began being used in the VA. It is essential to enroll both men and 
women using the expanded criteria because there may be systematic 
differences between patients who are more recently diagnosed and those 
who were identified using ICD-9 codes. If we only enroll women using the 
expanded criteria, then we will not be able to determine whether sex 
differences in outcomes are due to more women participants being more 
recently diagnosed with arthritis. Therefore, we will attempt to recruit both 
men and women using the expanded criteria. To maximize the inclusion of 
women, however, we will plan to invite all women who meet the expanded 
inclusion criteria to participate; we expect this will be approximately 5% of the 

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overall number of patients identified, based on the proportion of women who 
met the original study criteria based on ICD9 codes.
The expanded cohort will potentially allow comparison by sex. Using the 
same logic that was used to generate the power calculations for the number 
of participants needed to detect meaningful Race X Intervention X Time 
interactions (Table 1), we need an overall sample size ranging from 164 to 
360 (approximately half white and half black) to detect 30% to 20% changes 
in baseline. To have the same power to detect Sex X Intervention X Time 
interactions, we would need 82 to 180 women in the final sample. Thus we 
will attempt to increase our overall target sample size, as resources allow, by 
240 participants.
5.7 Withdrawal of Subjects
Study participants will be assured that participation is completely voluntary, 
that they can refuse to answer any of the study questions, and that they have 
the right to withdraw from the study at any time. There will be no penalty or 
consequences should a participant choose to withdraw from this research 
study. To withdraw from the study, participants may tell the PI, LSI, or study 
personnel that they no longer wish to participate. If participants express 
interest in withdrawing during the intervention phase of the study, they will be 
given the option of discontinuing the intervention but still completing the follow 
up surveys. There will be no penalty if participants choose not to complete 
these surveys and withdraw completely from the study.
The PI can withdraw participants from the study without their consent for
reasons, such as it is in their best interest to discontinue the study protocol,
they do not follow the study plan, or they experience a study-related injury.
Withdrawal of participants will be documented using a study withdrawal form 
(Appendix D) that indicates the participant study id number, the date the 
participant was withdrawn, whether the participant withdrew or was withdrawn 
by the PI, and the reason for the withdrawal (when available).
6.0
Reporting
All current applicable federal and state laws and CIRB procedures for 
reporting unanticipated problems, serious adverse events, and protocol 
deviations will be followed.
A data and safety monitoring plan will be implemented to ensure that there 
are no changes in the risk/benefit ratio during the study and that 
confidentiality of research data is maintained. LSIs and study personnel at 
each participating site will meet regularly to discuss issues like study 
progress, modifications, documentation, recruitment, retention, data analysis, 
and confidentiality and to address any local issues or concerns as they 
emerge. These meetings will be overseen by the LSI, who will be responsible 

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for assuring that activities at their site are conducted according to the IRB-
approved protocol. LSIs will report to the CIRB and the study PI all instances 
of adverse events, protocol deviations, or other problems identified during the 
meetings within the required reporting timeframes using the standard forms 
and/or procedures set forth by the CIRB (i.e., Unanticipated Serious Adverse 
Events, Unanticipated Problems and Deviations that meet certain reporting 
criteria will be reported to the VA Central IRB within 5 business days, and all
other events will be reported at time of continuing review). The PI will also 
communicate with LSIs through regular conference calls and by email to 
inform engaged sites of changes to the study or any serious adverse events 
or unanticipated problems that may impact the conduct of the study. 
7.0
Privacy and Confidentiality
The study requires use of subjects’ Protected Health Information (PHI).
Privacy of participants will be protected by allowing patients to opt out of 
future contact about the study, conducting in-person interviews in private 
settings, and allowing participants to refuse to answer any questions they do 
not wish to answer.  
Data management policies described in the VA Information Resource Center 
Data Security Statement will be used to maximize data security and minimize 
risk of breach of confidentiality. Electronic data will be stored on computer 
systems within the VA computing network that is protected by a VA firewall
and accessible only to authorized study personnel through the use of VA login 
and password permissions. Paper files will be locked in filing cabinets. Only 
project staff will have access to electronic and paper data. Data from 
screening forms will be entered into a database so that information may be 
summarized on patients who do not meet eligibility criteria or decline to enroll. 
Enrolled participants will be assigned a unique study identifier and included in 
a study cohort tracking system. Survey responses will be recorded in writing 
by research staff and double-entered by hand into study databases. 
All staff will undergo training modules on maintaining patient privacy and 
confidentiality that are required for all VHA employees. All staff will also have 
current PKI email encryption.
8.0
Communication Plan
Prior to starting study activities at participating sites, the PI will review all LSI 
applications to assure they are aligned with the model procedures and study 
materials approved by the CIRB. LSIs will notify the study PI, as well as all others 
who need to be notified at their site, when local site approval has been granted.

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As the study is conducted, LSIs and study personnel at each participating site will 
meet regularly to discuss issues like study progress, modifications, documentation, 
recruitment, retention, data analysis, and confidentiality and to address any local 
issues or concerns as they emerge. These meetings will be overseen by the LSI, 
who will be responsible for assuring that activities at their site are conducted 
according to the IRB-approved protocol. LSIs will report to the CIRB and the study PI 
all instances of adverse events, protocol deviations, or other problems identified 
during the meetings within the required reporting timeframes using the standard 
forms and/or procedures set forth by the CIRB. The PI will also communicate with 
LSIs through regular conference calls and/or by email to inform engaged sites of 
changes to the study or any serious adverse events or unanticipated problems that 
may impact the conduct of the study. 
The PI will notify the LSIs when the study reaches the point that it no longer 
requires engagement of the local facility. LSIs will be responsible for completing all 
locally-required notifications that the site is no longer engaged in the study.

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List of Amendments to Staying Positive with Arthritis Study Protocol 
Amendment 01 – October 17, 2014, approved December 23, 2014 
x
Change in the study team staff 
x
Revised the protocol, waiver of informed consent, and waiver of HIPAA authorization to reflect a 
change in the source data for sending recruitment mailings to potential participants 
Amendment 02 – June 8, 2015, approved July 29, 2015 
x
Changed recruitment materials to correct typos and grammatical errors and added a study 
brochure and flier 
x
Modified the surveys and correct answer options 
x
Modified phone screening instruments to make it easier for interviewers to clearly see eligibility 
criteria, make answer options consistent on the whole instrument, and make questions clearer. 
 Amendment 03 – June 26, 2015, approved July 2, 2015 
x
Changed the format of the mailing postcard 
Amendment 04 – August 20, 2015, approved September 14, 2015 
x
Changed the protocol to include exclusion criteria and to give Veterans the option to complete 
assessments over the phone or in person 
x
Modified the phone screening instrument to include skip patterns and to include additional 
exclusion questions 
x
Modified surveys to include checkboxes for the manner in which the survey was completed 
x
Modified telephone scripts to include clarifying language for the study 
Amendment 06 – June 15, 2016, approved June 21, 2016 
x
Changed the protocol, informed consent form, waiver of HIPAA authorization, and waiver of 
informed consent to increase the number of participants enrolled in the study, as allowed by the 
existing study budget and timeline