Evaluating Alternative Delivery Models for Arthritis Self-management Interventions
Phase: NA
Conditions: Arthritis, Gout, Fibromyalgia, Rheumatoid Arthritis, Osteoarthritis, Lupus Erythematosus, Systemic
Sponsor: University of South Carolina

University of South Carolina Protocol  v4 
 
Study Title: Evaluation of a Phone-Based Walk with Ease Program in Adults with Arthritis 
Principal Investigator Name: Christine Pellegrini, PhD 
NCT: NCT05289544 
Funding: Supported by Cooperative Agreement Number U48DP006401 from the Centers for 
Disease Control and Prevention 
Date: 6/12/2023 
 
 

University of South Carolina Protocol  v4 
 
A.SPECIFIC AIMS 
Aim 1: Identify and incorporate best practices for recruiting and retaining participants in 
behavioral interventions and programs, particularly among hard-to-reach populations (e.g., low 
socioeconomic status). A literature review will be conducted to identify best practices and 
recommendations for recruitment and retention strategies for hard-to-reach populations including those 
with low socioeconomic status. Results will be published and will help guide recruitment strategies for 
the proposed project. 
Aim 2: Evaluate the short-term (6 weeks and 6 months) and long-term (1 year) effects of a 
phone-based version of Walk with Ease (WWE-T) in adults with arthritis on primary (self-
reported pain and objectively measured physical function) and secondary (objectively 
measured physical activity, self-efficacy, depressive symptoms, weight, blood pressure, work 
loss, and health care utilization) outcomes as compared to a wait list control. We hypothesize 
that participants randomized to WWE-T will have greater improvements in outcomes at 6 weeks, 6 
months, and 1 year than those in the wait list control. 
Aim 3: Determine the effectiveness of recruitment and retention strategies in WWE-T. We will 
examine recruitment rates by recruitment avenue and site to determine which strategies led to greatest 
reach, and whether this differed by sociodemographic characteristics (e.g., age, race, income). We will 
also examine retention rates and reasons for attrition at program completion (6 weeks) and follow-up 
assessments (6 months, 1 year) by recruitment strategy among the total sample and by demographic 
(e.g., socioeconomic status) and clinical (e.g., pain) variables. 
 
B. BACKGROUND AND SIGNIFICANCE 
 
Walk with Ease (WWE) is a 6-week evidence-based physical activity program developed by the Arthritis 
Foundation for people with arthritis.1,2 WWE consists of 3 in-person group sessions each week (18 
sessions total) with each session lasting approximately 60 minutes. WWE has led to improvements in 
arthritis symptoms,1–4 physical activity levels,3 self-efficacy,1 depression symptoms,1,2 and function,1 and 
participants report high satisfaction,3,5 including minority participants.4 As a result of WWE’s success, it 
is one of the arthritis-appropriate evidence-based programs (AAEBI) recognized and recommended by 
the Centers for Disease Control and Prevention (CDC).6 WWE is currently being offered across the 
country, including by the South Carolina Department of Health and Environmental Control (DHEC).  
 
Although effective, many populations face barriers to attending in-person group WWE sessions. To 
overcome some of these barriers of a face-to-face program; a self-directed WWE program was 
developed. To date, the self-directed WWE has resulted in beneficial effects1,5 and participants report a 
high level of satisfaction;5 however, unlike the group-based WWE program, classified as a “recognized 
program,” the CDC classifies the self-directed adaptation as a “promising program.” While promising, 
the self-directed format may lack the provision of social support and accountability, both of which may 
be important for physical activity in populations with arthritis.7–9 
 
Having a variety of evidence-based formats to deliver WWE could maximize the reach of the program, 
allowing individuals with arthritis to participate in the WWE delivery format that is the most accessible 
based on their needs and preferences. Thus, we will develop and test a phone-based format of WWE, 
which has the ability to overcome the primary barriers of group, self-directed, online, and print-based 
formats of the program. A phone-based format of WWE may represent a translatable mode to deliver 
an arthritis-appropriate evidence-based physical activity program to increase the reach as well as better 
target those at the greatest need. 
 
C. RESEARCH DESIGN AND METHODS AND DATA ANALYSIS 

University of South Carolina Protocol  v4 
Study Design: To address Aims 2 and 3, we will use a randomized controlled trial. A total of 300 adults 
with arthritis, aged 18 and older, will be recruited throughout the community. Participants will be 
randomized to either Walk with Ease (WWE-T) or Wait list control. The WWE-T program will be 6 
weeks in duration, like the AAEBI version of WWE, and will include two phone calls each week: one 
group call and one individual call. Assessments will be conducted before randomization, immediately 
after the 6-week program, and at 6 months and 1 year. There will be no intervention-specific contact 
with participants following the 6-week program. Primary outcomes are pain and physical function. 
Secondary outcomes are weight, objectively measured physical activity, depressive symptoms, self-
efficacy, weight, blood pressure, work loss, and health care utilization. 
 
Procedures: 
 
Recruitment: Participants will be recruited using effective recruitment strategies used in the past as 
well as with the assistance of DHEC, the SC Department of Aging, and Lupus Foundation of America. 
All recruitment procedures are provided in more detail in section D.2.  
 
Screening: Participants will be screened by telephone or online to ensure they meet study criteria. 
Interested and eligible participants will be scheduled for a baseline appointment and mailed an 
informed consent form and study materials to review prior to their baseline visit.  
 
Informed Consent: At the baseline appointment, study staff will review the consent form with 
participants and answer any questions participants may have regarding their participation. To ensure 
the consent form is understandable to the study population, the consent form will be written using short 
sentences and non-technical terms, with a reading level at or below an eighth-grade level. Interested 
participants will sign the approved informed consent document and will be given a copy for their 
records.  
 
Randomization: After completing the baseline assessment, participants will be randomized in a 1:1 
ratio to either: (1) WWE-T or (2) Wait list control. Randomization, stratified by age (<65 years and ≥65 
years) and sex, will be done using randomly permuted blocks. The study team member conducting the 
randomization phone call will open the sealed envelope and reveal randomization to the participant. 
The study team member will describe the condition, provide the appropriate program materials via mail, 
and review study expectations. 
 
Randomized Conditions: 
 
1.) Walk with Ease by Telephone Program. Our Walk with Ease by Telephone (WWE-T) program 
is adapted from the original 6-week community-based group walking program developed by the 
Arthritis Foundation for adults with arthritis. After randomization, all participants in WWE-T will 
be given an Arthritis Foundation Walk with Ease Guidebook and a brief overview of the 
program. The program uses motivational strategies, which includes action planning, goal 
setting, and social support. Additionally, WWE provides participants with appropriate health 
education necessary to safely increase walking and exercise into their daily lives and assists in 
tailoring the program to fit individuals’ unique needs and goals. Examples of topics include 
exercise and arthritis, preparing to walk (e.g., identifying appropriate footwear, location, and 
walking pace), stretching, and overcoming barriers including pain and discomfort. Participants 
will work towards walking at least 30 minutes/day for 3 days/week, as this goal is consistent with 
the evidence-based WWE program.  
 
Phone Sessions for WWE-T. Participants in WWE-T will receive 2 phone calls each week for 6 
weeks. Each week, one phone call will be one-on-one with a WWE certified trained leader and 
the second call will be a group call led by the WWE leader and will include other WWE-T 
participants. During group phone sessions, the WWE-T leader will cover topics described above 
relating to exercise and arthritis. Group calls will include 12-16 participants, as recommended by 
previous studies. Group calls will last approximately 45 - 60 minutes in duration. During 

University of South Carolina Protocol  v4 
individual phone sessions, the WWE leader will focus on tailoring the WWE-T program for the 
individual and setting weekly walking goals. The WWE leader will also ensure that safety issues 
are assessed and addressed. Individual calls will be approximately 10 – 15  minutes in duration. 
WWE leaders will document attendance, topics discussed, any participant symptoms/adverse 
events, and call durations. 
 
2.) Wait List Control. Participants randomized to Wait List Control will receive the WWE-T 
program following the completion of the 1-year assessment. Besides scheduling for and sending 
reminders for each assessment, there will not be contact with participants in the Wait List 
Control.  
 
Measures: 
 
Assessments will be completed at baseline, 6 weeks, 6 months, and 1 year and will take place in the 
PHRC or Discovery I buildings at the University of South Carolina (Columbia, SC). Additionally, 
participants will be asked to report any injuries, illnesses, surgeries, or medication changes that occur 
between study assessments at each of the assessments. Staff completing assessments will be masked 
to randomization. Participants will receive $25 for completing the baseline and 6-week assessments, 
$40 for completing the 6-month assessment, and $50 for completing the 1-year assessment. 
 
1. 
Pain and Physical Function.  
Symptoms of arthritis: pain, fatigue, stiffness. A visual analog scale (VAS) will be used to assess 
the arthritis symptoms of pain, fatigue, and stiffness. VAS’s have been previously used to 
measure reduction in symptoms of arthritis in physical activity interventions.1,10,11 Participants 
will be asked to mark their experience with symptoms over the past 7 days on a 100-mm line. 
Each line is anchored with “no pain” and “severe pain.” Pain, fatigue, and stiffness will be 
assessed using this format. Participants responses for each arthritis symptom are measured in 
millimeters from the left anchor (no pain, 0) to their mark, with higher scores indicating higher 
levels of pain, fatigue, or stiffness. 
Physical function – 30 Second Chair Stand Test and Six-Minute Walk Test. The 30-second chair 
stand test evaluates sit-to-stand activity, lower body strength and dynamic balance. Participants 
are asked to complete as many chair stand repetitions as possible during a 30 second period. 
This test has been found to be a reliable and valid measure.12,13 The six-minute walk test 
assesses aerobic capacity and has been found to be a valid and reliable measure of functional 
ambulation in populations with arthritis.14,15 Participants will be asked to walk between two 
cones 50 feet apart for 6 minutes. The maximal distance in feet a participant can walk during the 
6-minute period will be calculated. Any use of assistive devices will be recorded and scores will 
be adapted accordingly.16 
2.) 
All-Cause Pain – PROMIS Pain Intensity and Pain Interference. General pain and pain 
interference will be assessed using the PROMIS pain intensity17 and interference.18,19 PROMIS20 
pain intensity and interference surveys utilize a non-computerized test  and generates a t-score, 
whereas 50 is the mean of the reference population and 10 is the standard deviation (SD). 
PROMIS pain and interference have demonstrated test-retest reliability and is sensitive to 
change in adults with arthritis.21,22 
3.) 
Physical Limitations - Health Assessment Questionnaire (HAQ). The Health Assessment 
Questionnaire (HAQ) was developed as a comprehensive measure of outcome in patients with 
a wide variety of rheumatic diseases, including rheumatoid arthritis, osteoarthritis, lupus, 
fibromyalgia, and psoriatic arthritis.23,24 It is widely used as an outcome in physical activity 
interventions for people with arthritis.25–27 The HAQ Disability Index assesses eight categories of 
activities of daily living (i.e., dressing, arising, eating, walking, hygiene, reach, grip, and common 
activities). There are 20 questions using a scale of 0 (without difficulty) to 3 (unable to do). 
These items will be averaged for a total score of 0-3, with a higher score indicating more 
impairment or disability. The HAQ is correlated with several clinical and laboratory 
measures23,28,29 and has also demonstrated test-retest reliability.30 

University of South Carolina Protocol  v4 
4.) 
Psychosocial Function - Arthritis Management Self-Efficacy. The Arthritis Self-Efficacy 
Scale (ASE) will be used to assess participants’ confidence to manage symptoms of arthritis.31 
We propose to use an 8-item version of the ASE as recommended by Lorig et al. given the 
overlap with the HAQ,32 with each item answered on a 1 (very uncertain) to 10 (very certain) 
point scale. The items are averaged to calculate a score. Higher scores indicate higher levels of 
self-efficacy for managing arthritis. The ASE is commonly used in arthritis intervention studies33 
and has been shown to have acceptable levels of construct and concurrent validity as well as 
reliability.31 Our previous work suggests the 8-item version is also a valid and reliable tool to 
measure arthritis self-efficacy.34 
5.) 
Physical Activity - Minutes of moderate-intensity physical activity will be assessed objectively 
using accelerometry. At each data collection visit, participants will be given an Actigraph GT3X 
link accelerometer to wear around the waist during waking hours for 7 days. Non-wear time will 
be defined as ≥90 minutes with zero activity counts, allowing for up to 2 minutes of <100 
counts/min.35 Physical activity will be categorized as sedentary (<100 counts/min), light (100-
2019 counts/min), and moderate-to-vigorous (MVPA) (≥2020 counts/min).36 Total MVPA/week 
will be calculated. Only those with ≥4 valid monitoring days (≥10 wear-hours/day), including one 
weekend day will be included in the analyses.36,37 Participants will also be asked to complete a 
log indicating times the accelerometer was worn and taken off over the 7-day assessment 
period. Using procedures successfully implemented in our previous studies, following the 7-day 
wear period, participants will return the accelerometer and log by mail using a pre-paid 
addressed padded envelope. 
6.) 
Body Weight. Height and weight will be measured by trained research staff using equipment 
that is regularly calibrated. The participant will be weighed wearing a light layer of clothing with 
shoes and belt removed and pockets emptied and the value to the nearest 0.1 lb. will be 
recorded. Height and weight will be used to calculate body mass index (BMI). 
7.) 
Mental Health Status - Center for Epidemiological Studies – Depression (CES-D). The 
Center for Epidemiological Studies-Depression (CES-D) index is a widely-used measure of 
depression symptoms38 and is frequently used in activity and arthritis studies.27,39,40 We will use 
a 10-item version of the CES-D41 in which participants rate the frequency of symptoms using a 
4-point Likert scale (0=rarely or none of the time to 3=most or all of the time). Responses are 
summed to yield a total score ranging from 0 to 30, with a higher score indicative of higher 
levels of depressive symptoms. The CES-D demonstrates high internal consistency, is 
correlated with other measures of depression, and can classify patients by level of 
depression.39,42 
8.) 
Work Loss – Work Productivity and Activity Impairment Questionnaire. The Work 
Productivity and Activity Impairment (WPAI) Questionnaire43,44 will be used to assess patient-
reported amount of absenteeism, presenteeism and daily activity impairment attributable to 
general health as well as specifically for arthritis. The WPAI includes 6-items that assess current 
employment status, number of hours missed due to a health problem or other reasons, hours 
actually worked, degree to which health affected productivity while working, and the degree to 
which health affected regular (nonwork) activities. Four outcome scores will be calculated: 
percent work time missed due to health, Q2/(Q2 + Q4) (percentage of absenteeism); percent 
impairment while working due to health, Q5/10 (percentage of presenteeism); percent overall 
work impairment due to health, Q2/(Q2 + Q4) + [(1 − Q2/(Q2+Q4)) × (Q5/10)]; percent activity 
impairment due to health, Q6/10. Higher scores for each outcome score (range 0–100%) 
suggest a greater impact of health. The WPAI has found to be a valid assessment of work-
related impairments in populations with arthritis45 and its use is recommended by the 
rheumatology community.46 
9.) 
Health-care utilization and Medical Expenditures. While access to medical records would 
provide a more accurate assessment of healthcare utilization and expenditures, it would not be 
feasible to obtain among our community-dwelling population due to the time and costs 
associated with obtaining and reviewing charts, healthcare visits may be with multiple providers 
and not all tracked, and due to privacy concerns.47 Self-report assessments of healthcare 
utilization have been found to be both valid and reliable among older adults48 and have a low 
likelihood of bias by demographic factors including socioeconomic status.47 Therefore, we 

University of South Carolina Protocol  v4 
propose to use the UCSD Healthcare Utilization Questionnaire49 to estimate health care 
utilization during the study. This survey consists of 12 questions that asks participants to report 
the number of times they used different healthcare services within a specific timeframe. 
Specifically, questions assess physician visits or telephone calls with health care providers, 
home-care visits, ambulance use, inpatient hospital days, surgeries, emergency room visits, and 
medication use. The costs associated with each health care utilization will be obtained from the 
Medical Expenditure Panel Survey (MEPS).50 
10.) 
Physiological outcomes – Blood Pressure. Systolic and diastolic blood pressure will be 
measured according to the American Heart Association guidelines in triplicate each visit using 
an osillometric blood pressure cuff (Omron, Tampa Bay, FL) on the left arm at each visit in the 
supine position after a 5-minute rest in a quiet room. The average of the all three measures in 
mmHg will be used in analyses.51,52 
11.) 
Demographic and Health Variables. At baseline, participants will be asked to complete 
general demographic and health history surveys. The demographic variables to be assessed 
include age, sex, race, ethnicity, education, income, and marital status. The health history 
survey will include an assessment of arthritis type, years since arthritis diagnosis, presence of 
comorbid chronic health conditions (e.g., hypertension, hyperlipidemia), prescription and over-
the-counter medications and doses, number of physician visits in the past 4 months, 
hospitalizations in the past month, and smoking status. 
12.) 
Process Measures & Program Evaluation. WWE-T leaders will track phone session 
attendance for both individual and group calls. The percentage of calls attended will be 
calculated for each participant (total calls attended/12 calls). Topics discussed and duration of 
each call will also be tracked. Following the completion of WWE-T, participants will complete the 
Walk with Ease Post-Program Evaluation.53 This evaluation asks participants to rate usefulness 
of tools and strategies provided, knowledge obtained, length of the program, and their overall 
satisfaction with the program using a Likert scale from 0 (not at all) to 3 (very well). Additional 
questions will be added specific to the phone-based program including satisfaction with group 
and individual calls, length of group and individual calls, and rapport with WWE-T leader. 
 
Data Analysis: After data collection and cleaning, baseline characteristics of the groups will be 
compared. Variables which differ between the groups at baseline will be used as covariates in the 
outcome models. For each of the Aim 2 primary and secondary outcomes, a generalized linear model 
will estimate group means at baseline, six weeks, six months and one year. Each model will include 
factors for group (2 levels), time (4 levels), group-by-time interactions and the required covariates. In 
the event of participants being lost to follow-up or otherwise missing data from the 6-week, 6-month 
and/or 1-year times, the models will provide estimates using Full Information Maximum Likelihood with 
robust standard errors, interpretable under an Intent to Treat principle.  
 
For each outcome at each follow-up time, a statistically significant (at the 0.05 level) group by time 
interaction in the hypothesized direction will be interpreted as supporting the research hypothesis. The 
magnitude of each intervention effect will be computed by a pre-defined contrast of baseline to follow-
up change in the group minus baseline to follow-up change in the Wait List Control, adjusted for 
covariates. All four time points for each outcome will be examined with a single model to best account 
for the full covariance structure over time. All analyses will be completed using SAS (SAS Institute Inc, 
Cary, NC).  
 
We will evaluate the recruitment and retention strategies used during the proposed study, focusing on 
successful strategies used to increase participation of adults with arthritis, particularly among those with 
low socioeconomic status. During the recruitment and screening of participants, participants will be 
asked to report how they heard of the program. We will also examine recruitment numbers over time in 
relation to recruitment activities. Following the completion of the program, we will categorize recruitment 
avenues (e.g., saw flyer, word of mouth) and sites (e.g., local rheumatologist site, lupus support group) 
and calculate the percentage of those screened, not interested, ineligible, and enrolled. Percentages 
will be calculated among the total sample recruited as well as specifically for those of low 

University of South Carolina Protocol  v4 
socioeconomic status (i.e., income <150% of poverty guidelines) and other demographic (e.g., race) or 
clinical variables (e.g., pain). We will compare enrollment yields by avenues and sites, using total 
sample and those with low socioeconomic status, using chi-square tests or Fisher’s exact test if cell 
frequencies are less than 5. Identifying the highest yielding recruitment sources, especially for those 
with low socioeconomic status, will help to inform recruitment strategies used in future programs.  
Retention of participants in WWE-T will be examined at program completion (6 weeks) and each follow-
up assessment (6 months and 1 year). Overall retention rates and percentages of specific reasons for 
attrition (e.g., loss to follow-up, no longer interested, medical issues) will be calculated among the total 
sample and by those with low socioeconomic status (i.e., income <150% of poverty guidelines), and 
other demographic (e.g., race) or clinical variables (e.g., baseline pain). We will also examine retention 
and specific reasons for attrition based on recruitment avenue and site. Independent samples t tests 
and chi-square tests (or Fisher’s exact test for those with cells less than 5) will be used to examine 
differential attrition.  
 
Data Management: All surveys will be administered via paper or online via REDCap (secure, web 
application for building and managing online surveys and database – managed by Health Sciences 
South Carolina). Any paper documents will be stored in a locked filing cabinet at the TecHealth Center 
at University of South Carolina. All computer files will be password protected. Only the study team will 
have access to the data. 
 
D. PROTECTION OF HUMAN SUBJECTS 
 
1.TARGET POPULATION 
 
Inclusion Criteria: The target population will include adults ≥18 years old who meet criteria for the 
CDC’s definition of self-reported arthritis.54,55 Specifically, participants who respond yes to the following 
question will be eligible: “Have you ever been told by a doctor or other health professional that you 
have some form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia?” Additionally, participants 
must be able to read and write in English, plan to live in the Columbia, SC region for the next year, 
complete all baseline measures, and be willing to be randomized to either study condition. 
 
Exclusion Criteria: Participants will only be excluded if they have any contraindications to exercise 
(besides arthritis) per the Physical Activity Readiness Questionnaires,56 are pregnant, breastfeeding, or 
planning to become pregnant in the next year, have a serious cognitive impairment, or are currently or 
have previously participated in a WWE program within the last 12 months.  
 
Sample Size: In order to assure sufficient statistical power to detect clinically meaningful effects, we 
relied on information from a previous study by Wilcox, et. al.11 for an estimate of variability in the VAS 
Pain scale and physical function tests including the 30-second chair stands and six-minute test. The 
Steps to Health study evaluated two 12-week self-directed multicomponent exercise programs for 
adults with arthritis.11 Clinically meaningful magnitude of changes were suggested by Bennell et al.57 as 
11 points for VAS pain, 1.3 repetitions for the chair stand test and 20-50 meters for the six-minute walk. 
Estimated power is based on a simplified analysis (t-tests) without covariate adjustments. A statistical 
significance level of 0.05 was used. 
 
A sample of 120 participants per group would provide 80% or greater power to detect a clinically 
meaningful difference in each primary outcome, with a minimum effect size of d=.37, assuming that the 
variability within our sample is comparable to that observed in the earlier study from a similar population 
(see Table 2). We anticipate that some participants may be lost to follow-up before the conclusion of 
the study. Therefore, we propose inflating the required sample size by 25% to account for potential 
attrition and recruiting 300 participants total, with 150 to be randomized into each treatment condition.  
 
2.RECRUITMENT PLANS: 
Participants will be recruited using effective recruitment strategies used in the past as well as with the 
assistance of DHEC, the SC Department of Aging, and Lupus Foundation of America across Richland, 

University of South Carolina Protocol  v4 
Lexington, and Fairfield Counties in South Carolina. Specifically, participants will be recruited from 
programs affiliated with the DHEC SNAP-Ed program (e.g., group dining programs, Text2bWell 
program). We will promote the study through local lupus support groups and the SC Lupus Events 
Facebook page, which has over 1,200 followers in SC. Additionally, participants will be recruited from 
community flyers (e.g., posted in the Drew Wellness Center in Columbia, SC, Fairfield County Parks & 
Recreation), University of South Carolina emails and flyers, local arthritis-related support groups, 
including the Arthritis Foundation website and Facebook pages, paid recruitment ads in newspapers 
and radio.. We will also share information with the UofSC PRC Community Advisory Board to share 
information with communities. All recruitment materials will include details about the study, eligibility 
criteria, and contact information. We will recruit at least 50% of participants who are between 18-64 
years old and have low socioeconomic status. Low socioeconomic status will be defined by an annual 
household income <150% of the US Department of Health & Human Services 2021 poverty 
guidelines.58 
 
3.EXISTING DATA/SAMPLES: 
 
N/A 
 
4. CONSENT/ASSENT: 
Eligible participants will be scheduled for a baseline visit where full details of the study will be reviewed, 
questions will be answered, and an equipoise induction reviewing the pros and cons of participating in 
the study will be conducted. Interested participants will sign an informed consent document approved 
by the Institutional Review Board.  Participants will be provided a copy of the signed consent form. 
 
5. POTENTIAL RISKS: 
 
1. Muscle soreness or pain from increasing physical activity. To minimize the risk, participants will 
regularly discuss activity with WWE certified leaders to ensure they are increasing their activities 
at a level appropriate.  
2. An injury or fall during the physical function tests at the in-person assessments. All physical 
function tests will follow OARSI recommended procedures and assessment staff will be trained 
to respond appropriately in the event of an injury or fall. In the event that a severe or 
unanticipated adverse event (AE) occurs, 9-1-1 or a physician (depending on the severity) will 
be called. To minimize risk, participants will be encouraged to go at a pace they feel comfortable 
with and to stop when necessary. In the event a participant currently uses an assistive device, 
the participant will be asked to use it for the test and will be noted on study records. Further, two 
chairs will be placed near the 6-minute walk test area, in the event a participant needs to sit 
down or rest. We will also have apple juice and snack bars available, if needed. 
3. An injury as a result of their physical activity. Participants are encouraged to stop exercising 
immediately if at any time they are injured or are encouraged to stop engaging in physical 
activity from a physician/medical professional. Since this is a telephone delivered intervention, 
WWE-T leaders will ask about symptoms or adverse events on individuals calls. Participants will 
also be encouraged to notify us of any injuries that occur in between calls or following the 6-
week program. Additionally, we will ask participants to report any injuries, illnesses, surgeries, 
or medication changes that occur between study assessments at each of the assessments. 
4. Some of the questions asked may be upsetting or may make participants feel uncomfortable 
answering them. Participants will have the option to skip any questions they do not feel 
comfortable answering. 
 
6. POTENTIAL BENEFITS: 
Participants may or may not directly benefit from participating in this study, however the risks of 
participating are considered minimal. If participants modify their activity, they may experience positive 
changes to their physical, psychological, or physiological health. Additionally, this research may be 
valuable in determining the effects of an alternatively delivered format of the Walk with Ease program.   

University of South Carolina Protocol  v4 
 
7.) CONFIDENTIALITY 
To ensure participants information is confidential, all participants will be assigned a study ID, which will 
be used on all paper or electronic forms. All study files will be stored in locked cabinets or on password-
protected computer data files or secure-websites that only authorized study personnel can access. All 
results will be presented in aggregate form and participants will not be identified personally in any 
scientific report or presentation. All study personnel will undergo or have completed the most up to date 
clinical training, human subjects, and confidentiality training prior to assisting with any aspect of the 
study. 
 
8. COMPENSATION 
Participants will receive $25 for completing the baseline and 6-week assessments, $40 for completing 
the 6-month assessment, and $50 for completing the 1-year assessment. Payment options will be in 
the form of a physical gift card or an e-gift card from Amazon, a retail store or grocery store. 
 
9.  WITHDRAWAL: 
Participants will be informed they can leave the research at any time without penalty. If a participant 
decides to withdraw, no more information will be collected. The participants will be made aware of this 
during the consent process. 
 
Any data collected during their participation may be used by the investigators for the purposes 
described above. Choosing not to be in the study will not result in any penalty or loss of benefit to which 
participants are entitled. Specifically, the choice not to be in this study will not negatively affect a 
participant’s right to any present or future medical treatment or his/her present or future employment. 
 
 
 

University of South Carolina Protocol  v4 
E. REFERENCES/LITERATURE CITATIONS 
 
1. Callahan LF, Shreffler JH, Altpeter M, et al. Evaluation of group and self-directed formats of the Arthritis 
Foundation’s Walk With Ease Program. Arthritis Care Res. 2011;63(8):1098-1107. 
doi:https://doi.org/10.1002/acr.20490 
2. Bruno M, Cummins S, Gaudiano L, Stoos J, Blanpied P. Effectiveness of two Arthritis Foundation programs: 
Walk With Ease, and YOU Can Break the Pain Cycle. Clin Interv Aging. 2006;1(3):295-306. 
3. Conte KP, Odden MC, Linton NM, Harvey SM. Effectiveness of a Scaled-Up Arthritis Self-Management 
Program in Oregon: Walk With Ease. Am J Public Health. 2016;106(12):2227-2230. 
doi:10.2105/AJPH.2016.303478 
4. Wyatt B. Impact of the Arthritis Foundation’s Walk With Ease Program on Arthritis Symptoms in African 
Americans. Prev Chronic Dis. 2014;11. doi:10.5888/pcd11.140147 
5. Nyrop KA, Cleveland R, Callahan LF. Achievement of Exercise Objectives and Satisfaction with the Walk with 
Ease Program—Group and Self-Directed Participants. Am J Health Promot. 2014;28(4):228-230. 
doi:10.4278/ajhp.120920-ARB-453 
6. Centers for Disease Control and Prevention. Lifestyle Management Programs for Arthritis. Accessed January 
18, 2021. https://www.cdc.gov/arthritis/interventions/index.htm 
7. Kanavaki AM, Rushton A, Efstathiou N, et al. Barriers and facilitators of physical activity in knee and hip 
osteoarthritis: a systematic review of qualitative evidence. BMJ Open. 2017;7(12):e017042. 
doi:10.1136/bmjopen-2017-017042 
8. Willett M, Duda J, Fenton S, Gautrey C, Greig C, Rushton A. Effectiveness of behaviour change techniques in 
physiotherapy interventions to promote physical activity adherence in lower limb osteoarthritis patients: A 
systematic review. PLOS ONE. 2019;14(7):e0219482. doi:10.1371/journal.pone.0219482 
9. Larsson A, Feldthusen C, Mannerkorpi K. Factors promoting physical activity in women with fibromyalgia: a 
qualitative interview study. BMJ Open. 2020;10(8):e031693. doi:10.1136/bmjopen-2019-031693 
10. Conn VS, Hafdahl AR, Minor MA, Nielsen PJ. Physical Activity Interventions Among Adults with Arthritis: 
Meta-Analysis of Outcomes. Semin Arthritis Rheum. 2008;37(5):307-316. 
doi:10.1016/j.semarthrit.2007.07.006 
11. Wilcox S, McClenaghan B, Sharpe PA, et al. The Steps to Health Randomized Trial for Arthritis: A Self-
Directed Exercise Versus Nutrition Control Program. Am J Prev Med. 2015;48(1):1-12. 
doi:10.1016/j.amepre.2014.08.006 
12. Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-
residing older adults. Res Q Exerc Sport. 1999;70(2):113-119. doi:10.1080/02701367.1999.10608028 
13. Gill S, McBurney H. Reliability of performance-based measures in people awaiting joint replacement surgery 
of the hip or knee. Physiother Res Int. 2008;13(3):141-152. doi:10.1002/pri.411 
14. Pankoff BA, Overend TJ, Lucy SD, White KP. Reliability of the six-minute walk test in people with 
fibromyalgia. Arthritis Care Res. 2000;13(5):291-295. doi:https://doi.org/10.1002/1529-
0131(200010)13:5<291::AID-ANR8>3.0.CO;2-X 

University of South Carolina Protocol  v4 
15. Dobson F, Hinman RS, Hall M, et al. Reliability and measurement error of the Osteoarthritis Research Society 
International (OARSI) recommended performance-based tests of physical function in people with hip and 
knee osteoarthritis. Osteoarthritis Cartilage. 2017;25(11):1792-1796. doi:10.1016/j.joca.2017.06.006 
16. Dobson F, Hinman RS, Roos EM, et al. OARSI recommended performance-based tests to assess physical 
function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013;21(8):1042-
1052. doi:10.1016/j.joca.2013.05.002 
17. Revicki DA, Chen WH, Harnam N, et al. Development and psychometric analysis of the PROMIS pain 
behavior item bank. PAIN. 2009;146(1):158-169. doi:10.1016/j.pain.2009.07.029 
18. Amtmann D, Cook KF, Jensen MP, et al. Development of a PROMIS item bank to measure pain interference. 
PAIN. 2010;150(1):173-182. doi:10.1016/j.pain.2010.04.025 
19. Askew RL, Cook KF, Revicki DA, Cella D, Amtmann D. Evidence from diverse clinical populations supported 
clinical validity of PROMIS pain interference and pain behavior. J Clin Epidemiol. 2016;73:103-111. 
doi:10.1016/j.jclinepi.2015.08.035 
20. Cella D, Yount S, Rothrock N, et al. The Patient-Reported Outcomes Measurement Information System 
(PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007;45(5 
Suppl 1):S3-S11. doi:10.1097/01.mlr.0000258615.42478.55 
21. Broderick JE, Schneider S, Junghaenel DU, Schwartz JE, Stone AA. Validity and Reliability of Patient-Reported 
Outcomes Measurement Information System Instruments in Osteoarthritis. Arthritis Care Res. 
2013;65(10):1625-1633. doi:10.1002/acr.22025 
22. Driban JB, Morgan N, Price LL, Cook KF, Wang C. Patient-Reported Outcomes Measurement Information 
System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-sectional 
study of floor/ceiling effects and construct validity. BMC Musculoskelet Disord. 2015;16(1):253. 
doi:10.1186/s12891-015-0715-y 
23. Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 
1980;23(2):137-145. doi:10.1002/art.1780230202 
24. Maska L, Anderson J, Michaud K. Measures of functional status and quality of life in rheumatoid arthritis: 
Health Assessment Questionnaire Disability Index (HAQ), Modified Health Assessment Questionnaire 
(MHAQ), Multidimensional Health Assessment Questionnaire (MDHAQ), Health Assessment Questionnaire II 
(HAQ-II), Improved Health Assessment Questionnaire (Improved HAQ), and Rheumatoid Arthritis Quality of 
Life (RAQoL). Arthritis Care Res. 2011;63(S11):S4-S13. doi:https://doi.org/10.1002/acr.20620 
25. Gilbert AL, Lee J, Ehrlich-Jones L, et al. A randomized trial of a motivational interviewing intervention to 
increase lifestyle physical activity and improve self-reported function in adults with arthritis. Semin Arthritis 
Rheum. 2018;47(5):732-740. doi:10.1016/j.semarthrit.2017.10.003 
26. Häkkinen A, Sokka T, Kotaniemi A, Hannonen P. A randomized two-year study of the effects of dynamic 
strength training on muscle strength, disease activity, functional capacity, and bone mineral density in early 
rheumatoid arthritis. Arthritis Rheum. 2001;44(3):515-522. doi:https://doi.org/10.1002/1529-
0131(200103)44:3<515::AID-ANR98>3.0.CO;2-5 
27. Callahan LF, Mielenz T, Freburger J, et al. A randomized controlled trial of the people with arthritis can 
exercise program: Symptoms, function, physical activity, and psychosocial outcomes. Arthritis Care Res. 
2008;59(1):92-101. doi:https://doi.org/10.1002/art.23239 

University of South Carolina Protocol  v4 
28. Bruce B, Fries JF. The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, 
and documentation. J Rheumatol. 2003;30(1):167-178. 
29. Daltroy LH, Larson MG, Eaton HM, Phillips CB, Liang MH. Discrepancies between self-reported and observed 
physical function in the elderly: the influence of response shift and other factors. Soc Sci Med. 
1999;48(11):1549-1561. doi:10.1016/S0277-9536(99)00048-9 
30. Linde L, Sørensen J, Østergaard M, Hørslev-Petersen K, Hetland ML. Health-Related Quality of Life: Validity, 
Reliability, and Responsiveness of SF-36, EQ-15D, EQ-5D, RAQoL, and HAQ in Patients with Rheumatoid 
Arthritis. J Rheumatol. 2008;35(8):1528-1537. 
31. Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure 
perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989;32(1):37-44. 
doi:https://doi.org/10.1002/anr.1780320107 
32. Stanford Patient Education Research Center. Arthritis Self Efficacy. Accessed February 1, 2021. 
https://www.selfmanagementresource.com/docs/pdfs/English_-_self-efficacy_arthritis.pdf 
33. Brady TJ. Measures of self-efficacy: Arthritis Self-Efficacy Scale (ASES), Arthritis Self-Efficacy Scale-8 Item 
(ASES-8), Children’s Arthritis Self-Efficacy Scale (CASE), Chronic Disease Self-Efficacy Scale (CDSES), Parent’s 
Arthritis Self-Efficacy Scale (PASE), and Rheumatoid Arthritis Self-Efficacy Scale (RASE). Arthritis Care Res. 
2011;63(S11):S473-S485. doi:10.1002/acr.20567 
34. Wilcox S, Schoffman DE, Dowda M, Sharpe PA. Psychometric Properties of the 8-Item English Arthritis Self-
Efficacy Scale in a Diverse Sample. Arthritis. doi:https://doi.org/10.1155/2014/385256 
35. Choi L, Liu Z, Matthews CE, Buchowski MS. Validation of Accelerometer Wear and Nonwear Time 
Classification Algorithm. Med Sci Sports Exerc. 2011;43(2):357-364. doi:10.1249/MSS.0b013e3181ed61a3 
36. Troiano RP, Berrigan D, Dodd KW, Masse LC, Tilert T, McDowell M. Physical activity in the United States 
measured by accelerometer. Med Sci Sports Exerc. 2008;40(1):181-188. 
doi:10.1249/mss.0b013e31815a51b3 
37. Matthews CE, Ainsworth BE, Thompson RW, Bassett DR. Sources of variance in daily physical activity levels 
as measured by an accelerometer. Med Sci Sports Exerc. 2002;34(8):1376-1381. doi:10.1097/00005768-
200208000-00021 
38. Kohout FJ, Berkman LF, Evans DA, Cornoni-Huntley J. Two shorter forms of the CES-D (Center for 
Epidemiological Studies Depression) depression symptoms index. J Aging Health. 1993;5(2):179-193. 
doi:10.1177/089826439300500202 
39. Smarr KL, Keefer AL. Measures of depression and depressive symptoms: Beck Depression Inventory-II (BDI-
II), Center for Epidemiologic Studies Depression Scale (CES-D), Geriatric Depression Scale (GDS), Hospital 
Anxiety and Depression Scale (HADS), and Patient Health Questionnaire-9 (PHQ-9). Arthritis Care Res. 
2011;63(S11):S454-S466. doi:https://doi.org/10.1002/acr.20556 
40. Kerr J, Rosenberg D, Millstein RA, et al. Cluster randomized controlled trial of a multilevel physical activity 
intervention for older adults. Int J Behav Nutr Phys Act. 2018;15(1):32. doi:10.1186/s12966-018-0658-4 
41. Irwin M, Artin KH, Oxman MN. Screening for depression in the older adult: criterion validity of the 10-item 
Center for Epidemiological Studies Depression Scale (CES-D). Arch Intern Med. 1999;159(15):1701-1704. 
doi:10.1001/archinte.159.15.1701 

University of South Carolina Protocol  v4 
42. Zauszniewski JA, Bekhet AK. Depressive symptoms in elderly women with chronic conditions: Measurement 
issues. Aging Ment Health. 2009;13(1):64-72. doi:10.1080/13607860802154481 
43. Reilly Associates. WPAI General Information. 2019. Accessed October 13, 2020. 
http://www.reillyassociates.net/WPAI_General.html 
44. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity 
impairment instrument. PharmacoEconomics. 1993;4(5):353-365. doi:10.2165/00019053-199304050-00006 
45. Zhang W, Gignac M a. M, Beaton D, Tang K, Anis AH. Productivity Loss Due to Presenteeism Among Patients 
with Arthritis: Estimates from 4 Instruments. J Rheumatol. 2010;37(9):1805-1814. 
doi:10.3899/jrheum.100123 
46. Tang K, Beaton DE, Boonen A, Gignac MAM, Bombardier C. Measures of work disability and productivity: 
Rheumatoid Arthritis Specific Work Productivity Survey (WPS-RA), Workplace Activity Limitations Scale 
(WALS), Work Instability Scale for Rheumatoid Arthritis (RA-WIS), Work Limitations Questionnaire (WLQ), 
and Work Productivity and Activity Impairment Questionnaire (WPAI). Arthritis Care Res. 
2011;63(S11):S337-S349. doi:https://doi.org/10.1002/acr.20633 
47. Ritter PL, Stewart AL, Kaymaz H, Sobel DS, Block DA, Lorig KR. Self-reports of health care utilization 
compared to provider records. J Clin Epidemiol. 2001;54(2):136-141. doi:10.1016/S0895-4356(00)00261-4 
48. Lubeck DP, Hubert HB. Self-report was a viable method for obtaining health care utilization data in 
community-dwelling seniors. J Clin Epidemiol. 2005;58(3):286-290. doi:10.1016/j.jclinepi.2004.06.011 
49. Singh JA, Bharat A, Khanna D, et al. Health care utilization in patients with gout: a prospective multicenter 
cohort study. BMC Musculoskelet Disord. 2017;18(1):233. doi:10.1186/s12891-017-1573-6 
50. AHRQ. Mean expenditure per person by event type, United States, 2017-2018. Medical Expenditure Panel 
Survey. Accessed February 5, 2021. https://meps.ahrq.gov/mepstrends/hc_use/ 
51. Padwal R, Campbell NRC, Schutte AE, et al. Optimizing observer performance of clinic blood pressure 
measurement: a position statement from the Lancet Commission on Hypertension Group. J Hypertens. 
2019;37(9):1737-1745. doi:10.1097/HJH.0000000000002112 
52. Muntner Paul, Shimbo Daichi, Carey Robert M., et al. Measurement of Blood Pressure in Humans: A 
Scientific Statement From the American Heart Association. Hypertension. 2019;73(5):e35-e66. 
doi:10.1161/HYP.0000000000000087 
53. Osteoarthritis Action Alliance. Walk with Ease Post-Program Evaluation Form. Published online 2018. 
Accessed February 5, 2021. https://oaaction.unc.edu/wp-content/uploads/sites/623/2018/08/WWE-Post-
Program-Survey-2.7.18.pdf 
54. 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. 2012;102(3):426-433. doi:10.2105/AJPH.2011.300423 
55. Murphy LB, Cisternas MG, Greenlund KJ, Giles W, Hannan C, Helmick CG. Defining Arthritis for Public Health 
Surveillance: Methods and Estimates in Four US Population Health Surveys. Arthritis Care Res. 
2017;69(3):356-367. doi:https://doi.org/10.1002/acr.22943 
56. Adams R. Revised Physical Activity Readiness Questionnaire. Can Fam Physician. 1999;45:992-1005. 

University of South Carolina Protocol  v4 
57. Bennell K, Dobson F, Hinman R. Measures of physical performance assessments: Self-Paced Walk Test 
(SPWT), Stair Climb Test (SCT), Six-Minute Walk Test (6MWT), Chair Stand Test (CST), Timed Up & Go (TUG), 
Sock Test, Lift and Carry Test (LCT), and Car Task. Arthritis Care Res. 2011;63(S11):S350-S370. 
doi:https://doi.org/10.1002/acr.20538 
58. US Dept of Health & Human Services. Poverty Guidelines. HHS Povery Guidelines for 2021. 2021. Accessed 
February 1, 2021. https://aspe.hhs.gov/poverty-guidelines