Optimization of Hyperlipidemia Management Among Patients With Rheumatoid Arthritis: A Patient-centered Intervention Development
Phase: NA
Conditions: Rheumatoid Arthritis, Cardiovascular Diseases, Hyperlipidemias
Sponsor: Weill Medical College of Cornell University

IRB Protocol Number: 1703018030 
CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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CArdiovascular Risk assEssment for patients with Rheumatoid Arthritis (CARE RA) Protocol 
 
NCT04488497 
 
Last Approved by IRB: February 6th, 2024 
 
 
 
 

IRB Protocol Number: 1703018030 
CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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CArdiovascular Risk assEssment for patients with Rheumatoid 
Arthritis (CARE RA) Protocol 
1. SUMMARY 
This is a 5-week, single-blinded, randomized trial to pilot test the efficacy of a behavioral 
intervention (CARE RA), a peer coach program, in increasing cardiovascular disease (CVD) risk 
assessment and self-efficacy in patients with rheumatoid arthritis (RA). Peer coaches are patients 
who themselves have the targeted condition (e.g., diabetes, RA) and have been trained to help 
others with the same condition in following treatment recommendations from their providers, 
social support, and improving self-efficacy, which translates into healthy behaviors. They are not 
physicians, nor other health professionals, and do not provide any medical advice to the patients 
they are coaching. We will explore their potential role to guide other patients with RA to obtain 
adequate CVD risk assessment, the most common cause of death in patients with RA. 
The study population will consist of individuals with RA between the ages of 40-75 who have no 
history of established CVD and are not receiving a statin. The study duration will be 18 weeks, 
including a 6-week intervention period, starting from baseline enrollment and ending with the 3- 
month follow-up contact. Eligible subjects will be randomized to either a self-administered online 
learning arm or to the CARE RA arm, also called the peer coach arm. The self-administered online 
learning arm will include a tutorial on how to use the Patient Activated Learning System (PALS) 
followed by self-driven completion of the CARE RA curriculum within the PALS. The peer coach 
arm will include the same tutorial on the use of the PALS but will also include contacts with a peer 
coach for 5 weeks to reinforce key points in the CARE RA curriculum within the PALS. Each week, 
the peer coaches will have a 30 to 45-minute call with their assigned participant(s) during which 
they will discuss concepts about RA, CVD and RA, the importance of cardiovascular risk 
assessment, how to better communicate with your doctors, and how to request cardiovascular 
risk assessment from your doctor. 
The primary objective is to increase the number of subjects who receive CVD risk assessment at 
their upcoming physician’s appointment at the end of the 5-week intervention. Since some 
subjects might not have this test done by their physician by the end of the intervention, but may 
have it later on, we will also examine this outcome 3 months after the intervention is completed. 
We will also examine at that point if they met criteria to initiate a statin medication. 
Secondary outcomes will be: 
1. Change in Routine Assessment of Patient Index Data (RAPID3) score from baseline to 
the end of the study between arms. 
2. Change in Social Support Survey Score from baseline to the end of the study between 
arms. 
3. Change in Patient Activation Measure (PAM) score from baseline to the end of the study 
between arms. In order to utilize this measure, subject data will be shared with the 
licensing agency to help continue to improve the measure. 
4. Change in Patient Health Questionnaire – 8 (PHQ-8) score from baseline to the end of the 
study between arms. Subjects who score a 10 or higher on the PHQ-8 at baseline data 
collection will be referred to mental health resources and counseling (websites, links, 

IRB Protocol Number: 1703018030 
CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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educational materials) by the study team. Peer coaches will be trained to direct subjects 
who express depressed thoughts and feelings during the course of the program to the 
mental health resources and counseling and will report such instances to the research 
team. 
5. Change in General Self-Efficacy (GSF) score from baseline to the end of the study 
between arms. 
6. Change in Medication Understanding and Use Self-Efficacy Scale (MUSE) score from 
baseline to the end of the study between arms. 
 
2. INTRODUCTION 
CVD is the most common cause of death among patients with RA. Several studies showed a 50- 
60% increased risk of death from myocardial infarction and stroke in patients with RA compared 
with the general population, with the standardized mortality ratio attributable to CVD ranging from 
1.13-5.15.1-6 Aggressive treatment of RA decreases CVD morbidity and mortality, but there is 
evidence that many patients do not benefit from the “treat to target” paradigm and do not in fact 
receive sufficiently aggressive RA treatment. Thus, CVD risk assessment through cholesterol 
testing among patients with RA remains an important CVD risk reduction strategy.7-11. 
Several studies have reported that the prevalence of hyperlipidemia in patients with RA is lower 
than in those without RA. However, the relationship between lipids, RA, and CVD risk is 
complicated by RA therapies that have been associated with increased lipid levels.12,13 We have 
reported previously that three different combination therapies were associated with increased lipid 
levels after 6 months of treatment.12 Nevertheless, the American Heart Association/American 
College of Cardiology recommend following their guidelines applicable to the general population 
for CVD risk assessment, including cholesterol testing. 
Although primary care physicians (PCPs) test RA patients’ lipids more frequently than 
rheumatologists, overall testing remains suboptimal, with only 44% or fewer patients with RA 
tested, compared with 79% of patients with diabetes mellitus (DM), another CVD risk factor that 
is more widely appreciated by PCPs. A significant knowledge gap has been reported among 
PCPs regarding RA as a CVD risk factor, with 68% of PCPs frequently failing to identify RA as a 
CVD risk factor,14 suggesting that specific interventions for these patients may be warranted. 
One such intervention may be peer coaching. Peer coaching interventions are gaining traction for 
chronic disease self-care. Peer coaches have been shown to improve medication adherence for 
human immunodeficiency virus (HIV), asthma, diabetes, and cancer screening.15-22 Peer coaches 
are lay individuals who themselves have the targeted chronic condition and who receive minimal 
training. They provide social and emotional support to the patient and could be used to help 
patients complete an educational program that includes decision support for CVD risk reduction 
strategies. However, peer coaches have not been used in RA, and have not been evaluated for 
CVD risk reduction in this population. Volunteer peer coaching programs are especially attractive 
in the context of patient communities, such as the online research community of >28,000 patients 
with arthritis enrolled in ArthritisPower. In preliminary discussions with my patients, several 
expressed interest in having contact with someone also living with arthritis to guide them through 
an educational program on CVD risk, ultimately helping them to discuss CVD risk reduction with 
their physician. 

IRB Protocol Number: 1703018030 
CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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This study will use Bandura’s Social Cognitive Theory to develop an online CVD risk reduction 
intervention for patients with RA. This theory proposed that experiential learning helps people to 
overcome their fears and impediments and can serve as a facilitator for behavioral change. Social 
support is also very important and can be achieved by interacting with others who have had similar 
experiences. 
 
 
3. STUDY OBJECTIVES AND OUTCOMES 
3.1 Primary Objective 
The primary objective is to test the difference in the proportion of subjects who receive 
cardiovascular risk assessment or learning from their healthcare provider that they already had 
one in the past year, between subjects randomized to the peer coaching condition and subjects 
randomized to the self-administered online learning condition. 
3.2 Secondary objectives: 
To determine whether the CARE RA program is effective in improving the following patient 
generated health data compared to subjects in the self-administered online learning arm. 
1. Change in Routine Assessment of Patient Index Data (RAPID3) score from baseline to 
the end of the study between arms. 
2. Change in Social Support Survey Score from baseline to the end of the study between 
arms. 
3. Change in Patient Activation Measure (PAM) score from baseline to the end of the study 
between arms. 
4. Change in Patient Health Questionnaire – 8 (PHQ-8) score from baseline to the end of the 
study between arms. Subjects who score a 10 or higher on the PHQ-8 at baseline data 
collection will be referred to mental health resources and counseling (websites, links, 
educational materials) by the study team. Peer coaches will be trained to direct subjects 
who express depressed thoughts and feelings during the course of the program to the 
mental health resources and counseling and will report such instances to the research 
team. 
5. Change in General Self-Efficacy (GSF) score from baseline to the end of the study 
between arms. 
6. Change in Medication Understanding and Use Self-Efficacy Scale (MUSE) score from 
baseline to the end of the study between arms. 
7. We will examine the feasibility of the intervention by having 80% or more of the subjects 
complete the intervention. 
 
4. STUDY DESIGN 
4.1 Study description 
This is a single-blinded randomized trial to pilot test the effectiveness of the CARE RA intervention 
with self-administered online learning. The CARE RA intervention consists of 3 components: peer 

IRB Protocol Number: 1703018030 
CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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Patient 
Activation 
(PALS & Peer 
coach) 
Education 
(PALS) 
Peer support 
(Peer coach) 
Patient with 
RA in need 
of CVD risk 
assessment 
support, patient activation, and online education via the PALS (Figure 1). It consists of weekly 
one-on-one telephonic sessions with a peer coach (a person with RA who has been trained on 
delivering the content of the CARE RA intervention to another person with RA) for five weeks. 
The intervention will begin at least 6 weeks before the subject’s next appointment with a 
rheumatologist or other physician on their care team. During the intervention, subjects will learn 
how RA can affect their heart and receive training on how to better communicate with their 
physician so that they can obtain appropriate CVD risk assessment. 
The peer coaches will be recruited and trained before deployment of the intervention. The 
recruitment and training of peer coaches for the CARE RA program is described below. 
 
 
Figure 1: Components of the CARE RA Intervention 
 
4.2 Peer Coaches 
Peer Coach Recruitment 
Peer coaches are individuals with RA who will be community member consultants in the study. 
Peer coaches are not health professionals but individuals who have RA. They will be trained in 
motivational interviewing, basics of communication, goal setting, and the PALS educational 
materials for the study. Peer coaches will complete a 7-week study protocol training led by Dr. Iris 
Navarro-Millán with support from the study research team. 
Peer coaches are recruited by 2 methods: 
1. ArthritisPower, our collaborator, will identify candidates who they believe would be good peer 
coaches based on their leadership and experience within the online arthritis community. 
2. Dr. Iris Navarro-Millán will also identify patients from her own rheumatology practice who would 
be suitable candidates. 
Peer Coach Screening 
After an individual is referred, a research assistant will assess if the candidate meets the following 
inclusion criteria: 
− Have RA 

IRB Protocol Number: 1703018030 
CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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o Patient should provide the RA medications (DMARDs) prescribed to them in order 
to meet criteria as having RA. 
− Speaks English 
− ≥ 40 and ≤75 years of age 
− Taking a statin OR had a cholesterol test within the last 2 years 
− Willing to have a cholesterol test if they have not yet been tested 
o This means that during training to become a peer coach, the potential peer coach 
would then need to have a cholesterol test done and a cardiovascular risk 
assessment done. This only applies to potential peer coaches who have not had 
a cholesterol test within the last 2 years or are not taking a statin. 
− Willing to become a peer coach and discuss with peers’ aspects about RA and CVD risk 
− Have internet access 
− Have a phone 
− Express interest in helping others with RA 
− Resides or lives in the US 
 
 
After screening, the principal investigator and research study team will meet to review and discuss 
each candidate. 
- 
If the candidate is not asked to move forward to be trained, the reason is documented. 
These individuals will be notified by the research assistant. 
- 
If the individual is considered to be a good candidate, but is unavailable for the scheduled 
training, permission is obtained from the individual to contact them for future programs. 
- 
Individuals who are considered a good candidate to be a peer coach will be scheduled for 
an upcoming training. 
Peer Coach Training 
Groups of 4-8 peer coaches will be scheduled for online training meetings. The peer coaches will 
be part of the research team that will be conducting this study and will be considered community 
member consultants. There will be a total of 7 group web conference training sessions via Zoom 
over 2 months. At the first meeting, peer coaches will be introduced to the CARE RA intervention 
schedule (Table 3). Over the course of training, the research team will review each chapter of the 
Peer Coaches’ manual to teach the activities that the peer coach will need to complete throughout 
the intervention. Frequently asked questions (FAQs) are included that will help peer coaches 
manage various situations that may arise with their client. 
During each online group training meeting, the following activities will occur: 
• 
Review of learning materials on PALS 
• 
Review of Peer Coach Manual (each week’s session calls will be scripted in these 
manuals) 
• 
Didactic training in motivational interviewing skills 
• 
Practice of motivational interviewing skills 
Group web conferences will be supplemented by 2 motivational interviewing (MI) training sessions 
on zoom with the PI and/or research assistant and only two coaches. During these smaller MI 

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CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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sessions, peer coaches will practice MI skills with reinforcement by the PI and/or research 
assistant. During each MI training session, the following activities will occur: 
- 
Practice of motivational interviewing skills by each peer coach, using role-play scripts and 
alternating roles between coach and subject under the supervision of the PI and/or the 
research assistants of the study 
- 
Reinforcement of skills in real-time with encouragement of peer coaches to critique each 
other’s skills 
Group training sessions will be accompanied by paired practice sessions. Each coach will be 
paired with another coach. They will be asked to listen to the PI and/or research assistant 
delivering each session to a mock subject on audio recordings. They will then each practice 
delivering the intervention session in turn to their partner. Each coach in training will be 
encouraged to critique their partner’s performance based on MI skills learned earlier in training. If 
coaches do not feel confident that they have mastered a session, they will be encouraged to 
continue to practice with their partner. Once each coach feels confident, they will schedule a 
separate one-on-one certification session with the PI and/or research assistant. At this session 
the PI and/or research assistant will play the role of the subject and the coach will deliver the 
session. The PI and/or research assistant will use a checklist to assess proficiency. Each coach 
will be certified on each session separately. If needed, additional training can be scheduled until 
each coach reaches the minimum level of proficiency. Only those that pass all the certification 
sessions will be allowed to work with subjects in the study. 
Peer Coach Retention 
Retention activities consist of the following: 
- 
Ensure timely payment for work 
- 
Provide ongoing support and continuing education/retraining with opportunities for 
practicing skills 
■ 
Weekly group conference calls to assess process measures and monitor progress 
of the intervention 
■ 
Provide group problem-solving for challenges encountered 
■ 
Provide emotional support 
■ 
Build group identity and pride 
- 
Allowing each coach to determine their workload, increasing or decreasing according to 
life demands 
- 
Be respectful of peer coaches’ time and schedules 
■ 
Keep mandatory conference calls and individual calls on time, short as possible, and 
reschedule only if necessary. 
■ 
Provide assistance as needed in scheduling sessions with subjects 
4.3 Patient Activated Learning System (PALS) 
The PALS is a publicly available educational and empowerment resource designed to provide 
engaging, easily understood, and well-researched facts for people who want to know more about 
health, medicines, and diseases. PALS was developed at Weill Cornell Medicine Division of 
General Internal Medicine where its content is developed and curated (www.palsforhealth.com). 
The content in the PALS is evidence-based and peer reviewed. This content is translated into 

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CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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patient-facing text in plain language, aiming for a sixth-grade reading level. Content is 
accompanied by visuals or short videos to reinforce the single learning objective for each module, 
known in the PALS parlance as a renewable knowledge object (RKO). Each RKO includes an 
assessment question about the information that they just reviewed. The PALS is based on Adult 
Learning Theory and Bandura’s Social Cognitive Theory, informed by Bartell’s Taxonomy of 
online interactions types. 
The educational material of CARE RA will be posted on the PALS platform and clients can access 
it as many times as they want. Each session of the CARE RA curriculum is tied to several PALS 
RKOs that clients are asked to view ahead of their discussion with the peer coach. Subjects in 
the self-administered learning arm of the study will be given the complete list of these same PALS 
RKOs to view on their own. 
4.4 Intervention Mapping 
CARE RA is a behavioral intervention with the goal of increasing activation and self-efficacy in 
individuals with RA to participate in their own care. A theoretical framework maps a causal 
relationship between a problem and the factors contributing to it, while identifying modifiable 
factors that can enable behavioral change. 
 
 
Table 1: Intervention Mapping to Social Cognitive Theory 
 
Theoretical 
Construct 
Targeted Barrier 
Intervention 
Activity 
Corresponding 
Session 
Self-Efficacy 
Feeling isolated 
Lack of understanding of CVD risk 
Lack of understanding of the effects of RA systemically 
Lack of understanding of the value of having a PCP 
Education (PALS), 
Coaching, 
Motivational 
Interviewing 
(MI), 
Empowerment 
Sessions 1, 2, 3 
Learn 
More 
modules 
Outcome 
Expectation 
Unrealistic expectations about the goals for RA disease 
control 
Unrealistic expectations about CVD risk 
Unrealistic expectations that because they ask for a 
cholesterol test, that the doctor will order it 
Fear of need to take another medication 
Education, 
Action planning, MI, 
Sessions 2, 3, 4, 
5 
Learn 
More 
modules 
Socio- 
Cultural 
Factors 
No resources to learn from about CVD 
No guidance of how to engage in healthy behaviors (e.g. 
healthy diet, regular exercise, take medications) 
Disruptive social support (e.g. family preference for 
unhealthy diet, preference for junk food over healthy food) 
Lack of understanding of CVD risk 
Supportive 
coaching, 
Action planning, 
Education (PALS) 
Session 2, 3, 4, 
5 
Learn 
More 
modules 
MI = motivational interviewing; CVD = Cardiovascular Disease; PCP= Primary Care Provider. 
 
 
5. STUDY POPULATION 
5.1 Study population 
Inclusion Criteria 
• 
Have RA 
• 
Age between 40 and 75 years (inclusive) 

IRB Protocol Number: 1703018030 
CARE RA intervention: Aim 2 and 3 
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• 
Provide a date of their next appointment with their rheumatologist or other physician on 
their care team 
• 
Willing to work with a peer coach 
• 
Speaks English 
• 
Have a phone 
• 
Has access to the internet 
• 
Resides or lives in the US 
 
Exclusion criteria 
• 
Do not have RA 
• 
Younger than age 40 or older than age 75 
• 
Taking a statin 
• 
Known history of diabetes. 
• 
Known history of CVD defined by: 
o Open heart surgery 
o Coronary angioplasty 
o History of heart failure 
o History of heart attack or stroke 
Participants will be screened using a REDCap screening survey. If participants answer yes to any 
of the exclusion criteria questions, the survey skips to the end, and participants will be informed 
that they are not eligible. The age range for the inclusion criteria reflects the age range of the 
current AHA guidelines for risk assessment for CVD. The exclusion of established CVD reflects 
differences in national guidelines on the management of patients with established CVD vs. 
preventing CVD. The overall goal of this research is to discover effective strategies to prevent 
CVD, therefore we focus here on primary prevention. 
5.2 Study duration 
The study duration will be a maximum of 18 weeks from baseline enrollment to final follow up at 
3 months after enrollment. The duration of the intervention is 5 weeks (Figure 2 and Table 2). 
5.3 Planned number of subjects 
We plan to enroll 128 subjects into this study. We will recruit patients from the ArthritisPower 
Patient Powered Research Network (PPRN), the Bendcare patient network, Dr. Michael 
Malekan’s practice at New York Presbyterian – Brooklyn, and social media using Twitter. We will 
also be recruiting participants using flyers created by a company (BuildClinical). These flyers will 
be posted online and interested participants will be referred to us. The PPRN has over 28,000 
patients with arthritis throughout the United States and territories. In order to enroll this number 
of subjects, it is expected that approximately 180 subjects will be screened. This takes into 
account an estimate of at least a 20% screen failure rate between Screening and Baseline. We 
will monitor the actual screen failure rate to make estimates for the planned larger study to follow 
this one. 
• 
First subject’s first enrollment: Q1 2021 
• 
Last subject’s last encounter/call: Q2 2022 

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CARE RA intervention: Aim 2 and 3 
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5.4 Recruitment 
Figure 2 outlines the workflow of this study from recruitment to final data collection. 
Recruitment 
We will send out invitations to participate in CARE RA to members of the ArthritisPower registry 
and the Bendcare patient network via email messages in several waves. We will send out 200- 
400 invitations at a time and continue to send out invitations based on the response and on peer 
coach capacity. Bendcare will also reach out to their patients to determine their interest in this 
study. Bendcare will screen patients for eligibility. Eligible patients will be consented by Bendcare 
and transferred to the research team for randomization. Bendcare will provide access to this 
REDCap database used to screen and consent Bendcare patients to the WCM research team 
within their secure network. We will also be recruiting participants using flyers created by a 
company (BuildClinical). These flyers will be posted online and interested participants will be 
referred to us. If the patient clicks on the online flyer, they’ll be prompted to complete the 
BuildClinical screening survey based on our eligibility criteria. 
We will post a recruitment video on Twitter through the PI’s professional account. The recruitment 
video will briefly detail the CARE RA study and invite people to fill out an interest survey through 
REDCap if they would like to be contacted by the research team for more information. Once an 
individual completes the interest survey, the research team will reach out to them. 
We will further increase recruitment through the patient list of Dr. Michael Malekan, Dr. Yevgeniya 
Gartshteyn, Dr. Jon Giles, Dr. Teja Kapoor, Dr. Rabia Iqbal, and Dr. Ayat Abdelgadir. All 
physicians have provided our team with authorization to contact their patients whom our team will 
identify using EPIC. To help streamline the process of identifying patients, we will use the EHR 
Data and Reporting system TRAC to extrapolate patients that meet the eligibility criteria. We will 
not reach out to patients who marked in EPIC their wish not to be contacted for research. We will 
reach out to patients through doximity. 
Once a person consented to participate in the study, all data collected will follow those stipulated 
by the study. These recruitment processes will be in place until 128 subjects are recruited. 
Screening 
Individuals who are interested in participating will respond to the research assistant's contact 
information on the invitations for ArthritisPower, the survey that Bendcare is administering, and 
BuildClinical flyers and corresponding survey., An unblinded research assistant from WCM will 
respond to direct emails from interested individuals to schedule a screening telephone call. The 
WCM research assistant will also call patients that have indicated on the Bendcare survey, the 
Twitter REDCap survey, or patients of Dr. Michael Malekan, Dr. Yevgeniya Gartshteyn, Dr. Jon 
Giles, Dr. Teja Kapoor, Dr. Rabia Iqbal, and Dr. Ayat Abdelgadir who have not marked in EPIC 
their wish not to be contacted for research. Before the research assistant calls the participants, 
they will text them from a secure number through Doximity to let them know that they will be 
calling them shortly. During this phone call, the study will be explained in full. Prior to any study 
activities, subjects will be screened for eligibility and if eligible, they will review with the unblinded 
WCM research assistant the Informed Consent form approved by WCM Institutional Review 
Board (IRB) and which complies with regulatory requirements. Subjects will be given adequate 

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time to consider any information concerning the study given to them by the Investigator or 
designee. As part of the Informed Consent process, subjects will be given the opportunity to ask 
the Investigator any questions regarding potential risks and benefits of participation in the study. 
This informed consent process will be voice recorded during the screening telephone call in the 
secure HIPAA protected server of WCM Division of General Internal Medicine. 
Enrollment and Randomization 
We will randomize subjects by a computer-generated random allocation list. The unblinded 
research assistant will call the subject to complete the enrollment and randomization in the study. 
The call will consist of the following activities: 
- 
The subject will need to provide the date of their next appointment with their 
rheumatologist or other physician on their care team . 
- 
The intervention will begin at least 6 weeks before their next appointment and the first data 
collection point will be at that time. 
- 
Once a subject is enrolled and randomized, the unblinded research assistant will inform 
the subject the arm they have been assigned to (CARE RA vs self-administered online 
learning) by phone. 
- 
During the call, the unblinded research assistant will instruct the subject on how to 
complete the baseline data form on the WCM REDCap that they will receive by email 
before initiating the intervention or at least 6 weeks before their appointment with their 
rheumatologist or other physician on their care team . 
- 
During this call, all subjects regardless of arm assignment will go through a PALS tutorial 
with the unblinded research assistant. This training will be over the phone/Zoom by the 
unblinded research assistant on how to access and navigate the PALS (e.g. finding the 
website, searching for articles, viewing the patient-facing text, watching the videos, 
completing the self-assessment question for each PALS RKO). We will make available 
also a video tutorial on the PALS to all participants. 
- 
All participants will receive a phone call from a blinded research assistant to make sure 
that they have completed all the items in the data collection form at the timepoints 
established for the study. 
- 
If assigned to the CARE RA arm of the study, the unblinded research assistant will provide 
the subject with information about how to they will be matched with their peer coach. After 
the subject is matched with a peer coach, the subject will be notified that their name and 
phone number has been shared with their peer coach and their peer coach will be in 
contact with them to schedule their first call. The first call between peer coaches and 
subjects should occur around 5-6 weeks before their next physician appointment. 
Subjects will receive a copy of the CARE RA Activity Book, the Intervention Schedule, and 
PALS tutorial by email. A hard copy of the CARE RA Activity Book will be available upon 
request by the subject. The unblinded research assistant will also ensure that the subjects 
have received all intervention materials. 
- 
If assigned to the self-administered online learning arm, the unblinded research assistant 
will provide the PALS training as described above, the curriculum of the CARE RA 
program in the PALS and schedule the first data collection call around 5-6 weeks before 
their next physician visit. 
Figure 2: Diagram of the workflow of the study 

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CARE RA intervention: Aim 2 and 3 
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Recruitment 
Screening 
Informed Consent 
 
 
 
 
 
Randomization 
 
 
 
 
 
 
 
 
 
 
1-week after visit data collection 
1-week post intervention data 
collection 
 
 
 
3-month post-rheumatology 
visit data collection 
 
 
 
 
 
 
 
 
 
 
 
 
5.5 Schedule of study assessments 
Table 2: Schedule of study assessments 
3-month post intervention data 
collection 
 
Baseline 
1 week after Intervention 
completed/1 week after 
doctor’s appointment 
3 months after 
intervention 
completed 
Lost to Follow- 
Up/Dropouts 
Demographics 
X 
Medications and comorbidities 
X 
Surveys 
RAPID3 
X 
X 
X 
Social Support Survey 
X 
X 
X 
Patient Activation Measure (PAM) 
X 
X 
X 
Patient Health Questionnaire – 8 (PHQ- 8) 
X 
X 
X 
Self-administered learning5 
N = 64 
weeks 
CARE RA Intervention 
N = 64 

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Medication Understanding and Use Self- 
Efficacy Scale (MUSE) 
X 
X 
X 
The General Self-Efficacy Scale (GSF) 
X 
X 
X 
Outcomes 
Cholesterol test 
X 
X 
Initiating lipid lowering therapy 
X 
X 
Program Evaluation 
Evaluation Survey 
X 
X 
Focus Group/Interview 
X 
X 
 
6. STUDY TREATMENTS 
6.1 CARE RA arm 
• 
Subjects in the CARE RA arm will have a Zoom call with the unblinded research assistant 
to review the study procedures relevant to the study arm one week before their Session 1 
call with the peer coach. The subject will have an opportunity to ask any questions that 
they might have before initiating the program. 
• 
The unblinded research assistant will remind the subject about the call with their assigned 
peer coach for Session 1. 
• 
The unblinded research assistant will call the subject twice over the 5-week intervention 
period to check on them and to remind the subject of the second data collection point one 
week after the intervention has ended. These calls will also serve as intervention fidelity 
checks to assure that the sessions are occurring as scheduled and that the peer coach is 
interacting with the subject in a manner concordant with training. We will also remind 
subjects that they can call the study telephone number or contact the research team by 
email with questions. 
6.2 Self-administered online learning arm 
• 
Subjects will receive the same tutorial on the PALS by an unblinded research assistant 
(via phone/Zoom) on how to access and navigate the PALS (e.g. searching for articles, 
viewing the evidence summary, watching the videos, completing the self-assessment 
question after each PALS module). 
• 
They will receive the list of PALS RKOs that correspond to the CARE RA curriculum by 
email. The mailing will include reminders of how to access the PALS and find the CARE 
RA PALS RKOs. 
• 
The unblinded research assistant will call the subject twice over the next 5 weeks to remind 
them that they are in the study, give an opportunity to ask any questions, and remind them 
of the upcoming assessment points. The research assistant will avoid discussing the 
PALS unless the subject has specific questions to assure that these retention calls are not 
interventions. 
7. STUDY PROCEDURES AND SCHEDULE 
7.1 Intervention fidelity measures 

IRB Protocol Number: 1703018030 
CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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A careful assessment of intervention implementation can provide insights into which aspects of 
the intervention were particularly effective. We will use several strategies to monitor intervention 
fidelity. 
First, we will ask peer coaches to use Zoom teleconference calls for intervention delivery and 
record the weekly sessions between peer coaches and subjects. The goal of these recordings is 
to monitor fidelity of the intervention and monitor duration of the calls. These secure calls will be 
recorded and stored in the secure and HIPAA compliant server of the WCM Division of GIM. Study 
staff will review each session and use a checklist to assess intervention fidelity for each session. 
Second, the peer coaches will have a checklist that they will have to complete as they go through 
the call of all the activities and topics that they have to cover in each session, which will ensure 
that these are completed by the end of each call. We will collect these checklists and compare 
the self-assessment of the coach to those of the study team based on their review of the Zoom 
call recordings. In the future larger trial, we will use these comparisons to plan for how to monitor 
intervention fidelity. 
Third, we will monitor intervention implementation on an ongoing basis through weekly 
teleconferences with peer coaches, and weekly outreach to each peer coach individually 
throughout the intervention period. We will provide updates on the progress of the study, 
collaboratively troubleshoot problems, and provide ongoing advice, which often stems from other 
peers. At these calls, coaches will be asked to report on their clients and progress, giving the 
opportunity to reinforce the study protocol and MI skills. 
Fourth, the research team will contact each subject twice over the 5-week intervention period to 
check on how the intervention is unfolding from the subject perspective. 
7.2 Data collection: 
All subjects will receive a baseline telephone call, the post-intervention follow up call, and the 3- 
month/final follow up call from the study team (Table 2). Subjects who are lost to follow-up or drop 
out of the study before completion will be contacted to complete the program evaluation portions 
of the intervention. 
We will use REDCap to collect the data at baseline, post-intervention, and final follow up. The 
subject will receive a REDCap link via email that they will click to access the surveys at each data 
collection point. A blinded research assistant from WCM will follow up by phone with those 
subjects that have not completed or partially completed the surveys to minimize missing data. 

IRB Protocol Number: 1703018030 
CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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Session 
Objectives 
Activity/Assignment 
PALS - Renewable Knowledge Objects (RKOs) 
1. “Introduction to the 
CARE RA Program” 
1. Get to know each other 
2. Introduce the 
CArdiovascular Risk assEssment 
Program for Rheumatoid Arthritis 
(CARE RA) program 
3. Introduce the client to the Patient 
Activated Learning System (PALS) 
A. Verify contact information and receipt of Activity 
Book 
B. Get to know each other 
C. Introduce the CARE RA program 
D. Introduce the PALS 
E. Rules and Responsibilities 
F. Sign contract 
G. PALS assignments (RKOs) for Session 2 
H. Schedule Session 2 call 
None for Session 1 
2. “RA and My Heart” 
1. Learn how RA affects your heart 
2. Learn why a cholesterol test is 
needed to assess risk for heart 
attack and stroke 
A. 
Greetings between coaches and clients 
B. 
Verify the client has reviewed the RKOs and introduction 
to Session 2 
C. 
Review of PALS assignments for Session 2 
D. 
CARE RA Highlights of Session 2 
E. 
Plans for Session 3 
F. 
PALS assignments for Session 3 
G. 
Schedule Session 3 call 
Required: 
- How can rheumatoid arthritis (RA) affect my body 
and my health? 
- What does atherosclerotic cardiovascular disease 
(ASCVD) risk mean? 
- How does rheumatoid arthritis (RA) affect my 
heart? 
- How can I lower my risk of heart disease if I have 
rheumatoid arthritis (RA)? 
- What is cholesterol? 
- Do I need a cholesterol test if I have rheumatoid 
arthritis (RA)? 
Learn more: 
- What is rheumatoid arthritis (RA)? 
- How is rheumatoid arthritis (RA) treated? 
- What medicines are used to treat rheumatoid 
arthritis (RA)? 
3. “The Different Doctors 
Caring for People Living 
with Rheumatoid Arthritis 
(RA)” 
1. Learn 
the 
difference 
between 
a 
rheumatologist 
and 
a 
primary 
care 
provider. 
2. Learn how important is to have a primary 
care 
provider 
in 
addition 
to 
a 
rheumatologist if you have rheumatoid 
arthritis (RA) 
A. 
Greetings between coaches and clients 
B. 
Verify that client has reviewed the RKOs and introduction 
to Session 3 
C. 
Review of PALS assignments for Session 3 
D. 
CARE RA Highlights of Session 3 
E. 
Making a plan 
F. 
Plans for Session 4 
G. 
PALS assignments for Session 4 
H. 
Schedule Session 4 call 
Required: 
- What is a rheumatologist? 
- What is a primary care provider (PCP)? 
- Do I need to see a primary care provider (PCP) if I 
already see a rheumatologist for my rheumatoid 
arthritis (RA)? 
- What can a primary care provider (PCP) do for me? 
- Which doctor should check my cholesterol levels if I 
have rheumatoid arthritis (RA)? 
Learn more: 
- What is a specialist or specialty doctor? 
- True or False: A primary care provider performs sick 
visit, injury, routine wellness care, and chronic 
disease management. A specialist focuses on treating 
specific conditions or organs. 

IRB Protocol Number: 1703018030 
CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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4. 
“Requesting 
a 
Cholesterol Test” 
1. To describe the importance of having a 
cholesterol test in order to learn what your 
risk is for heart attacks and strokes 
2. To learn about how to communicate with 
your doctor about getting your cholesterol 
checked 
3. To provide an overview of the medications 
used to lower your risk for heart attacks and 
strokes 
A. 
Greetings between coaches and clients 
B. 
Verify that client has reviewed the RKOs and introduction 
to Session 4 
C. 
Review of PALS assignments for Session 4 
D. 
CARE RA Highlights of Session 4 
E. 
Making a plan: 
A. Getting cholesterol test 
- Rheumatologist? 
- Primary Care Physician? 
B. Doing something with the results 
- Who will assess the CVD risk? 
- Who will manage cholesterol if CVD is high? 
C. Once you find out you have a test (feasibility): 
- Make a plan for determining 10-year CVD risk 
- Make decision for initiation of statins 
F. 
Rehearse script to request a cholesterol test 
G. 
Plans for Session 5 
H. 
PALS assignments for Session 5 
I. 
Schedule Session 5 call 
Required: 
- How can I talk with my doctor if they are in a rush? 
- What medications are used to treat high 
cholesterol? 
- Do statins lower my chances of blood pressure 
related problems like heart disease and stroke? 
- When do I have to start taking medicine to treat 
high cholesterol? 
- Can rheumatoid arthritis (RA) medications lower my 
risk for heart attacks and stroke? 
- Do I need to prepare for a cholesterol test? 
Learn more: 
- Can I take my rheumatoid arthritis (RA) medication 
with statins? 
- What are some common side effects of statins? 
5. “How Did it Go?” 
1. To discuss how the encounter with the 
rheumatologist or other physician on their 
care team was regarding having a 
cholesterol test done 
2. To learn more about how exercise and diet 
can help people with RA lower their 
cholesterol. 
3. To establish plans for follow up with a 
primary 
care 
physician 
for 
possible 
initiation of statins 
A. Greetings between coaches and clients 
B. Verify that client has reviewed the RKOs and introduction 
to Session 5 
C. Review of PALS assignments for Session 5 
D. CARE RA Highlights of Session 5 
E. Discussion about the visit with the doctor 
F. Emphasize importance of following up with PCP 
G. Final questions and closure 
Note: Client should have completed the form with all the 
information for the 10-year pooled cohort risk equation. 
Required: 
- What foods can help lower my cholesterol? 
- What is a healthy diet or eating pattern? 
- Can exercise help my rheumatoid arthritis (RA)? 
- Does exercise lower my risk for heart attacks and 
stroke if I have rheumatoid arthritis (RA)? 
- How can I exercise when I am in pain? 
- What should I expect when I receive the results of a 
cholesterol test? 
Learn more: 
- Can exercise make my rheumatoid arthritis (RA) 
symptoms worse? 
- What foods can help improve my rheumatoid 
arthritis (RA)? 
- What are the benefits of exercise? 

IRB Protocol Number: 1703018030 
CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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7.3 Baseline telephone call (All subjects in the study) 
The blinded research assistant will perform this call. Assessments at this phone call will include: 
• 
Verify that subjects have completed the baseline data collection forms sent via email through 
REDCap: 
o Demographic data including gender, and race and ethnicity 
o RA history 
o General medical history 
o Surgical history 
o Surveys 
■ 
RAPID3 
■ 
Social Support Survey 
■ 
Patient Activation Measure (PAM) 
■ 
Patient Health Questionnaire – 8 (PHQ- 8) 
■ 
The General Self-Efficacy Scale (GSF) 
■ 
Medication Understanding and Use Self-Efficacy Scale (MUSE) 
7.4 Post-intervention completion data collection point (All subjects in the study) 
This call will take place around a week after completing the intervention by the blinded research 
assistant. This is a data collection call for all subjects in the study. 
• 
Surveys 
o RAPID3 
o Social Support Survey 
o Patient Activation Measure (PAM) 
o Patient Health Questionnaire – 8 (PHQ- 8) 
o The General Self-Efficacy Scale (GSF) 
o Medication Understanding and Use Self-Efficacy Scale (MUSE) 
• 
Outcomes 
o 
Cholesterol test 
o 
Initiating lipid lowering therapy 
• 
Program Evaluation 
o Evaluation Survey 
o Focus Group/Interview 
7.10 3-month post-intervention completion data collection point (All subjects in the study) 
This call will take place around 3 months from completing the intervention by the blinded research 
assistant. This is a data collection call for all subjects in the study. 
• 
Complete patient generated health data (PGHD) 
o RAPID3 
o Social Support Survey 
o Patient Activation Measure (PAM) 
o Patient Health Questionnaire – 8 (PHQ- 8) 
o The General Self-Efficacy Scale (GSF) 
o Medication Understanding and Use Self-Efficacy Scale (MUSE) Outcomes 

IRB Protocol Number: 1703018030 
CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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• 
Outcomes 
o 
Cholesterol test 
o 
Initiating lipid lowering therapy 
8. ANALYSIS AND STATISTICS 
8.1 Power Calculations and Sample Size 
The primary outcome measure is the percentage of patients in each arm that had a lipid panel 
checked or initiated LLT. Assuming 80% of the subjects in the intervention group have their lipids 
checked within the 3 months of the study, and 60% of the subjects in the control group have their 
lipid checked N=64 subjects per group would have at least 80% power to detect a margin 
difference of 20%, for a one-sided test and significance level of 0.05. We recognize that the 
sample of 128 subjects is modest, which reflects the pilot nature of the study in the context of a 
training grant. We will use data from this pilot study to design a more definitive trial powered to 
detect smaller differences in the primary outcome, and to compare usual care with the 
intervention. 
8.2 Data Analysis 
To analyze the data, descriptive analyses (means, medians, standard deviations, proportions, 
and frequency distributions) and correlation analyses (Spearman/Pearson rank correlations) will 
be conducted to assess and describe the cohort. Baseline comparability between study arms will 
be assessed with parametric and nonparametric analyses including two sample t-tests, Wilcoxon 
Rank Sum, and Chi-Square tests of proportions. Every effort will be made to keep subjects in the 
study for the entire follow-up. Analysis will be based on intention-to-treat, regardless of whether 
the subject completed the intervention program. The primary outcome is the percentage of 
patients with lipids checked (available now through national laboratory chain) or that reported 
having their lipids checked. Secondary outcomes include the percentage of subjects that reported 
initiating LLT, self-efficacy, and patient activation as described above. We will determine these 
outcomes in each group (self-administered online learning program and the CARE RA arm) as 
well as differences in these outcomes between the groups. Two-sided t-tests will be used to 
calculate differences and P values ≤ 0.05 will be considered statistically significant. We will 
examine differences in socio-demographics, disease severity, and depressive symptoms. These 
characteristics will be included in a multivariable logistic regression model to determine their 
association with the outcome (lipids being checked) and potentially increase the statistical power 
of the test of group differences. 
9. PROGRAM EVALUATION 
We will use the RE-AIM Framework for the evaluation of the program. The investigators of CARE 
RA will use these set of questions within Table 4 to evaluate the CARE RA program with the 
participants of the program and to guide the approach that investigators will follow to evaluate the 
reach, effectiveness, adoption, implementation, and maintenance of the program. This will help 
in the expansion of the program for a larger clinical trial. 
Table 4: RE-AIM Evaluation Dimensions for the Cardiovascular Risk Reduction Program for 
Patients with Rheumatoid Arthritis. 

IRB Protocol Number: 1703018030 
CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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REACH 
Individual Level 
 
-What percentage of potentially eligible subjects decided not to participate? 
-What percentage of potentially eligible subjects were excluded? 
-What percentage of potentially eligible subjects were enrolled in the program? 
-How representative of the target population were the subjects that were enrolled? 
-What proportion of subjects agreed to participate out of the total number of those that were 
invited and met criteria? 
-What factors contributed to the participation/non-participation of the subjects? 
-What might have been done to get more of the target population to participate? 
 
REACH will be assessed using our REDCap enrollment data, surveys, and focus groups or 
interviews. Through REDCap, we will be able to determine how many subjects were 
contacted through ArthrisPower, screened, and enrolled, compared to the overall number 
of subjects that completed the program. Surveys, focus groups, and interviews will allow us 
to determine factors that contributed to the use of the program. Through the surveys, focus 
groups, and interviews, we will conduct a qualitative analysis with subjects in the program 
so that we can obtain feedback on the reason’s subjects chose to participate initially in the 
program, barriers they faced in enrolling in the program, and reasons why they chose to join 
or not to join the program. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ADOPTION 
Organization Level 
 
-What factors contributed to ArthritisPower and its members, and the Bendcare network, to 
taking up the intervention? 
-What barriers interacted with the intervention to prevent adoption within ArthritisPower and 
the Bendcare patient network? 
 
ADOPTION will be assessed upon completion of the trial through talking with members of 
the ArthritisPower community and the Bendcare patient network. 
Dimension* 
Level 
EFFECTIVENESS 
Individual Level 
-How many subjects in the CARE RA arm received a cholesterol test during the program 
compared to the control arm? 
-How many subjects in the CARE RA arm received a cholesterol test by 1-week post intervention 
follow up compared to the control arm? 
-How many subjects in the CARE RA arm received a cholesterol test by 3-months post 
intervention follow up compared to the control arm? 
-How many subjects in the CARE RA arm initiated a statin, if indicated, after completion of the 
program in each arm? - See statistical analysis section for details. 
-How many subjects saw an improvement in their secondary outcomes (RAPID3, SSS, PHQ-8, 
PAM, MUSE, and GSE) from baseline to 1-week and 3-month post intervention data collection 
between arms? 
-Were you able to understand the program information? 
-Do you believe the program information is valuable to living a healthy life? 

IRB Protocol Number: 1703018030 
CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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MAINTENANCE 
Organizational and Individual Level 
 
- What was the attrition rate; were drop-outs representative of the target population? 
- How did attrition impact conclusions about effectiveness? 
- Is this intervention being implemented (and adapted) after the pilot study is completed? 
- What elements of the program are sustained for continuation of the program and why? 
- What elements of the program are discontinued for continuation of the program and why? 
- What elements of the program are modified for continuation of the program and why? 
- How do certain elements, such as using peer coaches instead of licensed professions and 
internet delivery, impact program continuation? 
 
This dimension will be assessed through surveys and focus groups/interviews with the subjects. 
IMPLEMENTATION 
Individual Level 
-To what extent were the intervention components delivered as intended in the protocol? 
-How was the intervention implemented? By whom and when? 
-How was the program adapted or modified over time? 
-What was it like to deliver this program to individuals with rheumatoid arthritis? 
-What do you think was most successful? What were the major barriers in implementing this 
program? 
-What was it like to conduct the weekly sessions? 
-Would you do anything to revise the program? 
-Does the program improve my ability to deal with life’s challenges to my health. 
-Does using the program makes it easier to live a healthier life? 
-Is the program useful in my life? 
-How satisfied are you with the program? 
-Was participating in the program difficult for you? 
-Would you recommend the program to people you know? 
This dimension will be assessed through surveys and focus groups/interviews with the 
subjects. 

IRB Protocol Number: 1703018030 
CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
21 of 22 
 
 
 
 
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CARE RA intervention: Aim 2 and 3 
PI: Navarro-Millán 
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