Peer Approaches to Lupus Self-management
Phase: NA
Conditions: Systemic Lupus Erythematosus, Quality of Life, Behavior, Health
Sponsor: Medical University of South Carolina

 
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NCT number: 03734055 
Project title: Peer Approaches to Lupus Self-Management (PALS) 
Document date: December 31, 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Protocol 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table Of Contents 
Specific Aims…………………….. 1 
Background and Significance….. 2 
Preliminary Studies……………… 4 
Research Design and Methods.. .5 
Protection of Human Subjects…..14 
Targeted/Planned Enrollment…...15 
References………………………..20 
Systemic Lupus Erythematosus (SLE or lupus) is a chronic autoimmune disease that is associated with 
increased morbidity, mortality, health care costs and decreased quality of life.[1] In the United States, 
African Americans have three to four times greater prevalence of SLE, risk of developing SLE at an 
earlier age, and SLE-related disease activity, damage, and mortality compared with Caucasians, with the 
highest rates experienced by African American women.[2] There is strong evidence that patient-level 
factors are associated with outcomes,[3] which justifies targeting them with intervention. While evidence-
based self-management interventions that incorporate both social support and health education have 
reduced pain, improved function, and delayed disability among SLE patients,[4] African Americans and 
women are still disproportionately impacted by SLE.[5]  Peer mentoring interventions are effective in other 
chronic conditions that disproportionately affect minorities, such as diabetes, HIV, and kidney disease, but 
there is currently no empirically tested peer mentoring intervention developed for SLE patients. 
Preliminary data from our group suggest that peer mentoring improves self-management, reduces 
disease activity, and improves health related quality of life (HRQOL) in African American women with 
SLE.  
 
We propose to test an innovative, manualized peer mentorship program designed to provide modeling 
and reinforcement by peers (mentors) to other African American women with SLE (mentees) to 
encourage them to engage in activities that promote disease self-management. Through a randomized, 
“mentored” or “support group” controlled design, we will assess the efficacy and mechanism(s) of this 
intervention on self-management, disease activity, and HRQOL. This study is the first of its kind in this 
field to test peer mentorship as an alternative strategy to improve outcomes in African American women 
with SLE. This could result in a model for other programs that aim to improve disease self-management, 
disease activity, and HRQOL in African American women suffering from chronic illness. The immediate 
goal of proposed work is to determine the efficacy of the program in a randomized design. The long-term 
goal is to disseminate this potentially cost-effective intervention in diverse clinical and community settings 
in an effort to improve disease outcomes in African American women with SLE and reduce morbidity and 
mortality in this high risk group. The following aims will be addressed: 
 
AIM 1: Determine the efficacy of a peer mentorship intervention in African American women with SLE on 
disease self-management and HRQOL. Hypothesis 1: At 12 months post-randomization, mentees will 
report improved disease self-management and HRQOL, as measured by the Patient Activation Measure 
(PAM) and Lupus Quality of Life Questionnaire (LUP-QOL), compared with the social support control 
group. 
 
AIM 2: Determine the impact of a peer mentorship intervention in African American women with SLE on 
clinical indicators of disease activity and clinical profile that indicates success of the intervention. 
Hypothesis 2: At 12 months post-randomization, mentees will show clinical evidence of improved disease 
activity measured by the patient reported Systemic Lupus Activity Questionnaire (SLAQ) and physician-
collected clinical and laboratory SLE disease activity index (SLEDAI) data, compared with the social 
support control group. 
 
AIM 3: Determine the cost and cost-effectiveness of a peer mentorship intervention on disease self-
management, disease activity, and HRQOL, in African American women with SLE. Hypothesis 3: A peer 
mentorship intervention in African American women with SLE will be cost effective at improving disease 
self-management, disease activity, and HRQOL, as measured by quality adjusted life years (QALYS), 
compared with the social support control group.  
 

 
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An exploratory aim will be to determine the role of mediators and moderators of a peer mentorship 
intervention on outcomes in African American women with SLE, with the hypotheses that disease self-
management will act as a mediator and depression, trust, and social support will act as moderators of the 
relationship between the peer mentorship intervention and disease activity and HRQOL.  
 
The peer mentoring approach is uniquely fitted to African Americans, and this intervention has the 
potential to lead to health improvements for African American women with SLE that have not been 
attainable with other interventions. This would significantly reduce disparities and have considerable 
public health impact. 
B1. Scientific Premise 
Peer support provides a mechanism for creating a social network on a small scale that augments 
existing social supports and in which a person receives “support from a person who has 
experiential knowledge of a specific behavior or stressors and similar characteristics”.[1] In 
studies of predominantly low income and minority populations peer mentors have been shown to 
help support healthy behaviors including breast feeding, smoking cessation, increased physical 
activity, and maintenance of weight loss,[2-9] along with improved medication adherence and 
blood glucose monitoring in trials of people with diabetes.[10-16] Similarly, support group 
participation for women and patients with cancer and other chronic conditions has a positive 
impact in various areas, including quality of life, cognitive function, and fatigue.[17-32] These 
studies highlight the potential of peer support, and peer mentoring specifically, as a culturally 
sensitive means to improving health behaviors and outcomes in low income and minority groups 
in whom trust in the health care system may be lower than in the general population.[33-36] 
Previous results have shown that African American patients with SLE were more likely than white 
patients to have higher levels of unmet needs related to health care and information,[35,37,38] 
which may preclude adequate disease management[39] and contribute to persistent disparities. 
There is some evidence that peer mentoring has led to improvements in positive affect, sleep, 
social coping, and perception of bodily pain in rheumatic conditions, but there is no such peer 
mentoring intervention developed for SLE patients.[40,41] As a result, this study will bridge this 
gap in knowledge by testing a peer mentoring intervention for African American women with SLE 
wherein modeling and reinforcement of disease self-management skills by peers (mentors) to 
other African American women with SLE (mentees) will be achieved through a combination of 
educational and informal phone or video interactions with each other, along with the use of 
validated measures of patient reported outcomes and clinical indicators of disease activity to 
assess the efficacy of the program. 
 
B2. Significance 
This proposal addresses the mission of the National Institutes of Health (NIH) to promote and 
improve the health of individuals, families, and communities by proposing: 1) clinical research on 
health and illness that integrates the behavioral and biological sciences; 2) science to help people 
strengthen the quality of their lives; and 3) development of a personalized approach to maximize 
health and well-being for individuals. Specifically, this study will test a culturally tailored 
intervention that promotes better understanding and management of a chronic condition by 
engaging individuals as active participants in their own health, in an effort to prevent illness and 
promote health. This project is designed with the long term goal of improving disease self-
management and quality of life, and decreasing indicators of disease activity among African 
American SLE patients and African American women suffering from other chronic illnesses.  
Addressing the public health burden of SLE. SLE (or lupus) is a chronic autoimmune disease 
affecting over 250,000 individuals that is marked by acute periodic flare-ups of symptoms 
impacting any organ system and resulting in potentially life-threatening complications.[42-44] 
Additional annual costs associated with SLE are estimated to be $10,000-$50,000.[45-51] Health-
related quality of life (HRQOL) of patients with SLE is also significantly worse and affects all 
health domains at an earlier age compared to patients with other common chronic diseases and 
females in the general US population.[52-58]  
Acknowledging challenges in SLE disease self-management. Evidence-based self-management 
interventions designed to enhance social support and provide health education, among lupus 

 
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patients, have reduced pain, improved function, and delayed disability.[59,60] Specifically, 
arthritis self-management education delivered by small-group, home study, computer, and 
Internet modalities have demonstrated significant improvements in health distress, self-reported 
global health, and activity limitation,[17,61-65] but African Americans and women are still 
disproportionately impacted by SLE.[66-71] Persistent disparities may be due to the non-
responsiveness of existing programs to the unique needs of African Americans and/or women 
with SLE.[35,37,59,60,72] Studies that have explored adverse outcomes in SLE patients have 
acknowledged the role of understanding the medical regimen, trust in the provider, and 
communication with providers, which are impacted by patient subjective norms, cultural, social 
support networks, mental health, and education. Many patients lack the education, social support, 
self-efficacy, and trust necessary for effective disease self-management, and these trends are 
more pronounced in African-Americans than Caucasians.[73-76]  
Attending to unique needs within the African American community. Previous results have shown 
that African American patients with SLE were more likely than white patients to have higher levels 
of unmet needs related to health services and information.[35,37,77] These domains have 
included issues such as: 1) understanding the medical regimen, including considerations around 
depression, medication concerns (possible side effects and interactions), and physical symptoms 
(pain and fatigue), 2) trust in the provider, 3) communication with providers, 4) receiving adequate 
information from medical staff about treatment side effects, 5) having access to telephone support 
and advisory services, and 6) having assistance with knowing which symptoms should trigger a 
doctor visit.[35,37] Such deficits are compounded by findings that doctors may not be skilled in 
determining their needs and the barriers that lupus patients experience,[38] which may preclude 
adequate disease management[39] and contribute to persistent disparities.  
Targeting racial disparities in SLE. In the United States, the highest lupus morbidity and mortality 
rates are among African American women.[43,47,60] SLE affects approximately 1 in 250 African 
American women of childbearing age, and African Americans overall have three to four times 
greater prevalence of lupus, risk of developing lupus at an earlier age, and lupus-related disease 
activity, damage, and mortality compared with Caucasians.[66,70,78-80] Some have positioned 
elevated rates of SLE in African American women in the context of “immune cognition”, and 
suggest that the disease, for these women, is a physical manifestation of patterns of stress, 
discrimination, and social disadvantage.[68,71,81-85]  
Proposing peer mentoring as a solution to enhance self-management and improve outcomes. 
Peer mentors are usually individuals who have successfully coped with a similar condition as 
their mentees.[1] In formal interventions, mentors receive training focused on communication 
skills, including empathetic listening, helping mentees clarify life goals, and problem solving with 
the aim of having the mentor support the mentee.[86] In previous studies of predominantly low 
income and minority populations, and those focused on rheumatologic conditions, peer mentors 
have been shown to help support healthy behaviors[2-16] and improvements in quality of 
life.[40,41] In the Peer Approaches to Lupus Self-management (PALS) intervention pilot study, 
mentees showed a trend toward lower disease activity, higher quality of life, lower pain symptoms 
and higher social support (effect sizes >0.3) following participation in the intervention. In addition, 
both mentees and mentors gave very high scores for perceived treatment credibility and service 
delivery.[87,88]  
Recognizing the importance of cultural tailoring to the success of behavioral intervention. Since 
African American women are a highly marginalized population, it is imperative to explore disease 
self-management approaches that are culturally acceptable, effective, and inexpensive in order to 
have the potential to impact chronic disease outcomes on a large scale.[36] The proposed PALS 
intervention incorporates culturally-relevant components that are likely to mitigate the high 
burden of SLE and poor outcomes of the disease in African American women. Current data show 
that culture-specific or culturally enhanced programs for minorities are more effective in 
improving health outcomes than generic programs or other control conditions.[89-91] The 
proposed PALS intervention has adhered to the five accepted stages of cultural adaptation:[92] 
information gathering was achieved through extensive literature review and ascertainment of 
patient and participant feedback,[59,60,93-95] preliminary design built upon lessons learned from 
prior behavioral interventions in the same patient population,[93,96] preliminary testing was 
achieved by piloting the proposed intervention in a limited sample,[87] refinement involved 

 
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incorporating participant responses and lessons learned into the final design of the proposed 
intervention,[97,98] and the final trial is currently being proposed.  
 
B3. Innovation 
The project is innovative because it will be the first study to test peer mentorship as an alternative 
strategy to improve outcomes in a high risk population with SLE. Innovative aspects of the 
proposed study include: 1) Developing and testing a culturally relevant intervention in an 
understudied disease (lupus) and underrepresented population (minority women); 2) Recruiting 
from a community sample of peers, making it more grassroots and easier to deploy elsewhere; 3) 
Accounting for financial feasibility and long-term dissemination by using peers as mentors; and 4) 
Using a structured approach for matching mentors to mentees to ensure effective communication 
and adherence to study protocol. Given the success of the peer mentoring approach in other 
chronic conditions that disproportionately impact minorities, and its responsiveness to the needs 
of this unique population, this intervention is likely to result in health improvements that have not 
been attainable with other interventions and serve as a sustainable solution to persistent 
disparities in this population. Specifically, this study is innovative is that it is culturally tailored to 
the unique needs of African American women with SLE, will pair mentees with mentors who are 
race, gender, and SES concordant to facilitate bonding and social support, and will use peer 
mentors who are considered competent in the management of their condition in order to provide 
modeling and reinforcement to participants. To ensure that the PALS project is a true translational 
effort that addresses the context of African American women's lives (e.g., social determinants of 
health), we analyzed qualitative responses of mentees that were collected as part of weekly check-
ins over the course of the 12-week pilot and an end-of study semi-structured focus group to 
generate feedback. Qualitative inquiries and responses served as our participatory process in 
further refining and culturally adapting the intervention protocol.[97] 
Feasibility & Preliminary Data Relevant to the Proposed Work 
1. Investigative Team. This multidisciplinary team is well qualified to carry out the proposed study. 
Dr. Edith Williams is a new minority investigator who has recently completed her K01 award 
(Grant number 1K01AR060026). Her team of senior investigators complement her expertise and 
will provide complementary expertise. The team has worked together on both her K01 and the 
pilot study for this grant and this application represents a logical extension of the group’s 
program of research geared toward improving outcomes for African American women with SLE. 
2. The Balancing Lupus Experiences with Stress Strategies (BLESS) intervention 
(ClinicalTrials.gov Identifier: NCT01351662)Our team validated a stress management program and 
assessed its effectiveness in reducing perceived and biological indicators of stress in 30 African 
American lupus patients participating in the SLE Clinic Database Project at MUSC. The 
intervention included 6 weekly, group sessions (n=15) of the “Better Choices, Better Health” 
Chronic Disease Self-Management Program (CDSMP).  The patients randomly assigned to the 
control condition (n=15) received general disease information and relevant literature. Pre, post, 
and follow up (3-4 months post-intervention) measures were collected in all patients to assess the 
effectiveness of the program. Overall, we found that patients who received the intervention 
reported improved self-efficacy pertaining to coping with having lupus, less health distress, post 
intervention, and lower levels of depression, compared with controls, and concluded that the 
intervention workshops acted to reduce perceived stress and improve quality of life.[93,105,106]  
3. Intervention to Improve Quality of life for African-AmericaN lupus patients (IQAN) 
(ClinicalTrials.gov Identifier: NCT01837875) We conducted an RCT that assigned 50 subjects each 
to one of three treatments groups: 1)  a unique ‘a-la-carte’ self-management program with 
individualized intervention plan (IIP) including a mail-delivered arthritis kit, addition and access to 
a message board, participation in a support group, and enrollment in a local self-management 
program; 2) a ‘set menu’ that offered a standardized chronic disease self-management program 
only; and 3) a control group that  received usual care (UC).[96] At 6 months of follow up, the ‘a-la-
carte’ group had significant improvements in lupus disease activity, QOL, and stress/pain 
management compared to the control group. Based on feedback from subjects in the BLESS 

 
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study, the most valued aspect of the program was interaction with their peers, which informs the 
proposed intervention. 
4. The Peer Approaches to Lupus Self-Management (PALS) Pilot Study. The PALS intervention 
was piloted with African American women with lupus enrolled in the SLE database at MUSC. 
Seven mentors were trained and paired with 21 mentees to provide modeling and reinforcement to 
participants by telephone for at least 60 minutes every week for 12 weeks. Mentee outcomes of 
self-management, disease progression (including disease activity, damage, and cytokine balance) 
were obtained at baseline, mid-intervention (6 weeks from baseline), and immediately post-
intervention (12 weeks from baseline), using validated tools. Qualitative data were also collected 
over the course of the study in the form of weekly mentee check-ins, mentor logs, and an end-of 
study focus group. While the PALS pilot lacked a control group, it provided a sense of general 
effect size and was used to design the current study.[107,108] At post-intervention, we observed 
statistically significant decreases in patient-reported disease activity (significant change score of 
24.70 or 25% change in patient global assessment of overall lupus disease activity, p<0.001), 
incrementally improving trends in patient activation, and statistically significant decreases in 
depression (significant change score of 2.62 or 11% change in PHQ-8 score, p=0.05) and anxiety 
(significant change score of 3.52 or 15% change in GAD-8 score, p=0.018). Student t tests were 
also conducted to compare 2-month pre- and 2-month post-intervention hospitalization charges. 
Mean charges per person were $24289 prior to intervention and $872 post intervention, providing 
very strong evidence for the intervention’s potential to reduce inpatient charges post 
intervention.[109] In addition, both mentees and mentors gave very high scores for perceived 
treatment credibility and service delivery, providing preliminary support for the efficacy, 
acceptability, and perceived credibility of the PALS intervention.[87,88,97]  
In summary, our preliminary studies demonstrate that in African American women with SLE, self-
management education delivered in weekly sessions led to improvements in lupus self-efficacy, 
health distress, and depression, and that more culturally targeted information and increased 
social support could yield more significant improvements in quality of life. More importantly, 
results of BLESS and IQAN studies, feedback from patients, extensive review of the literature and 
preliminary data from the PALS pilot study suggest that a peer mentoring intervention is credible, 
acceptable and likely to be effective at improving self-management, decreasing disease activity 
and improving quality of life in African American women with SLE. Additionally, using the same 
outcome measures across investigations will allow comparison of the impact of the current 
culturally tailored approach to the untailored “Better Choices, Better Health” intervention used in 
the BLESS study with this patient population. 
B4. Approach   
B4a. Theoretical Basis for Peer Mentoring  
The Main Effect Model of Social Support posits that it is social relationships, and the support received 
from them, that are the primary drivers of improvements in both physical and mental health.99 The 
proposed peer mentoring intervention for African American women with SLE fits within a social support 
model that we hypothesize will influence this main effect by inducing downstream effects on health-
related quality of life, mental well-being, and immune function, as it relates to disease activity. Within this 
model, we expect peer mentoring to reduce feelings of isolation and loneliness; provide culturally tailored, 
experiential, and evidence based education and information about accessing available health services; 
and promote behaviors that positively improve disease self-management, health-related quality of life, 
and disease activity.[86,100,101]  
 
B4b. Study Overview. The Peer Approaches to Lupus Self-Management (PALS) study is a randomized 
controlled trial designed to examine whether a new, culturally tailored peer mentoring intervention 
improves disease self-management, indicators of disease activity, and health related quality of life 
(HRQOL) in African American women with systemic lupus erythematosus (SLE). African American 
women with active SLE will be recruited as mentees and peer mentors. We will recruit 300 mentees (150 
mentored and 150 support group) and up to 60 mentors. As part of each wave, mentors (n=20) will be 
trained to deliver intervention content, prior to being paired with up to three mentees (n=50). The peer 
mentoring intervention will occur by twelve 60-minute telephone or video sessions carried out across the 
course of 24 weeks. In each wave, social support controls (n=50) will participate in a lupus support group 

 
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created for this project, on the same schedule as peer mentoring sessions. Both conditions will be 
delivered via Webex, which has several advantages for this intervention: 1) Sessions are easily 
accessible via phone or computer, allowing participants to choose their preferred interaction style; 2) A 
study coordinator can host the support groups and drop in/out for monitoring purposes; 3) There are 
video- or voice-call options for up to 25 participants at a time; and 4) This application ensures concordant 
delivery methods across both arms of the study and the ability to document the frequency that voice and 
video options are used to adjust for participant choices in analyses. All participants (mentees, mentors, 
and social support controls) will be assessed using validated measures of patient reported outcomes and 
clinical indicators of disease activity at baseline, mid-intervention (3 months from baseline), immediately 
post-intervention (6 months from baseline), and 6 months post-intervention (12 months from baseline). 
For each wave, outcomes for mentees randomized to the mentored group will be compared with the 
outcomes of mentees randomized to the support group. A booster session will be incorporated for all 
participants (mentored and support group) at 3 months post-intervention to encourage retention.[102] 
 
B4c. Scientific Rigor: Assuming 3 post-randomization measurement time points, level of significance 
p=0.05, two-tailed comparison, correlation between pairs of measurements within participants (interclass 
correlation) no larger than p=0.7, AR(1) covariance structure, we estimate that 123 participants per group 
(total n=246) are needed to detect, with 80% power, a standardized effect size of 0.35sd with 20% 
inflation for attrition at 12 months. This study will apply strict principles of randomized clinical trials 
including randomization, blinding, careful tracking of all participants and intent-to-treat analyses to ensure 
robust and unbiased results.  
 
B4d. Consideration of Relevant Biological Variables: This study considers race/ethnicity, gender, age and 
comorbidity as relevant biological variables. Race/ethnicity, gender, age and comorbidity will be based on 
self-report. The primary population of interest is self-reported black or African American women. While the 
burden of SLE (e.g., prevalence, severity, prognosis) is higher across a number of ethnic/racial groups in 
addition to African Americans, compared to Whites,[43,103,104] we have chosen to establish the efficacy 
of the intervention in the highest risk group (African American women). Exploratory analyses will be 
performed, stratified by age (<25 years, 25-34 years, 35-44 years, 45-54 years, 55-64 years, and >65 
years) and number of comorbidities (0/1 vs. >2) to evaluate the differential effect of the intervention by 
age and number of comorbidities.  
 
Methods for AIM 1: Determine the efficacy of a peer mentorship intervention in African American women 
with SLE on disease self-management and HRQOL  
B4f. Study Population & Recruitment Plan 
Study Population/Feasibility of Recruitment. The study population are individuals with SLE at MUSC 
clinics. Preliminary review of electronic medical records show that there are 1000 African American 
female patients with SLE who have been seen in MUSC clincis in the last year. Of these, 501 patients are 
enrolled in a longitudinal SLE registry at MUSC. A total of 520 African American female SLE patients  
(283 MUSC-wide and 237 registry) have consented to be approached for research studies. While 113 of 
these potential participants have participated in our prior research (thus excluding them from the current 
study as mentees), approximately 30 new eligible patients are expected to be seen in MUSC lupus clinics 
each year, bringing our recruitment pool to N=557 for mentees. Prior participants will be eligible to 
participate as mentors. All patients have American College of Rheumatology (ACR) criteria and disease 
activity information available, as well as quality of life measures available in the database. All SLE 
patients meet at least four components of the 1997 ACR revised criteria for SLE.[110] Our team has a 
successful track record of recruiting minorities into clinical trials. For example, Dr. Egede has completed 5 
clinical trials with minimum of 12 months of follow up that enrolled only African Americans, the PI was 
able to successfully enroll 30 African American women with SLE for her BLESS study and 150 African 
American participants for her IQAN study within proposed recruitment periods, and for the PALS pilot, 
attrition was only 10%. We will use previously effective strategies for recruitment and retention including 
adequate patient incentives, use of minority study coordinators, token gifts at baseline visits, mailings to 
all participants in recognition of their personal life events, such as birthdays, births, graduations, and 
wedding anniversaries, certificate of completion, and a celebration at the end of each intervention wave 
that brings all participants together.[111,112] We are confident that these strategies will maximize 
recruitment and retention for the study. 

 
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Recruitment Strategy 
Recruitment of Mentees 
Mentees (n=300; 150 mentored, 150 support group) will be primarily recruited by a direct mailing to 
female African American lupus patients currently enrolled in the MUSC P30 Core Center for Clinical 
Research (CCCR) SLE database who have agreed to future contact as well as lupus patients from the 
MUSC clinics not in the registry. Flyers containing the same information contained in recruitment letters 
will be posted in MUSC lupus clinics and shared with local SLE support groups, other SC rheumatologists 
and arthritis health professionals, and local chapters of the Lupus and Arthritis Foundations for 
distribution to their patrons. If target recruitment is not achieved within the desired timeframe by self-
selection, patients will be approached individually during clinic encounters, by phone, and/or repeated 
mailed/emailed or patient health record portal invitation. Patients who have indicated that they are willing 
to be contacted for future research in their MCRC consent forms will serve as the base for these 
invitations. Recruitment letters and flyers will also be shared with other academic medical institutions with 
eligible patient populations. Patients outside of the MUSC system who express interest will still be able to 
participate. They will not be required to travel to MUSC as informed consent can be obtained and 
questionnaires completed via REDCap, study materials can be mailed, and all other study activities can 
be achieved by phone. 
 
Recruitment of Mentors 
Potential peer mentors will first be invited from PALS pilot participants (mentees and mentors) (n=30), 
with the intention of retaining mentors to mentor multiple groups of mentees over the course of the study. 
It is expected that everyone would benefit from the use of experienced mentors, and using experienced 
mentors over time is also consistent with future real-world implementation. As needed (up to n=60, but 
approximately n=30 expected to be needed based on past research participation and interest), potential 
peer mentors who are considered competent in the management of their conditions will be identified by 
MUSC rheumatologists and subsequently trained by the PI. As part of the ongoing MUSC SLE database, 
patients are regularly flagged who providers deem competent enough to speak with the media on behalf 
of the patient population. We will mail out recruitment letters that will explain the study and provide 
participants a number to call if they are interested in participating. Participants who indicate interest in the 
study will be contacted by telephone to conduct a pre-screening assessment. If eligibility criteria are met, 
the screening/enrollment visit will be scheduled. As part of the mentor screening interview with the PI, 
psychosocial status will be assessed using the psychological scales of the Arthritis Impact Measurement 
Scales (AIMS), the Arthritis Helplessness Index (AHI), Wallston General Perceived Competence Scale, 
University of California at Los Angeles (UCLA) Loneliness Scale, Rosenberg Self-Esteem, Campbell 
Personal Competence Index, Carkhuff Communication and Discrimination Skills Inventories, and the 
Applied Knowledge Assessment (AKA) scale.[113] The PI will make a determination of competence, 
maturity, emotional stability, and verbal communication skills after overall assessment during the 
screening interview and training. Additional recruitment strategies will include the identification of local 
SLE support group members who have emerged as natural helpers, referrals from other rheumatologists 
and arthritis health professionals, and outreach to the local chapters of the Lupus and Arthritis 
Foundations by letter and telephone. Others have used these approaches successfully in multiple 
studies.  
 
Study Eligibility criteria 
Inclusion criteria for mentees and mentors include: 1) African American race/ethnicity and female gender; 
2) clinical diagnosis of SLE from a physician, according to ACR revised criteria for SLE.[110]; and 3) 18 
years of age or older. Additional inclusion criteria for mentors include: 1) disease duration > 2 years; 2) 
able to attend scheduled training sessions; and 3) willing to provide one-on-one support to up to three 
African American women with SLE. Mentees who participated in the pilot will be ineligible to participate in 
this study as a mentee, but could participate as a mentor if they meet other eligibility criteria.  
 
B4g. Overview of the Peer Mentoring Intervention 
Peer Mentoring Intervention Elements  
Mentor Training: The principal roles of the peer mentors are to: 1) provide information about SLE, SLE-
related behaviors, thoughts, and feelings, and the nature of recommended treatments; 2) provide social 

 
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support to alleviate the mentee’s sense of social isolation; 3) enhance and reinforce the mentee’s sense 
of self-efficacy to manage their condition; and 4) encourage the mentee to participate actively in the 
recommended self-management skills building therapy. Mentors will be trained in conversational 
strategies to help them meet the objectives without being overly directive and will be instructed not to give 
clinical advice.[114] Upon enrollment, peer mentors will receive 12 hours of training, broken into two 6-
hour blocks, prior to working with mentees.[114] Mentors will be given a written manual presenting all the 
material in detail for their ongoing reference. The training manual was developed in collaboration  with 
social work leadership from  Hospital for Special Surgery’s LupusLine® Program. The program, led by the 
Department of Social Work Programs, is a free telephone counseling service staffed by trained volunteers 
who have SLE or are close family or friends of people living with lupus.[113,115] Training will will include 
the following:  
1) Review of slide presentation and rationale for learning self-management, as well as the contribution of 
biological, psychological, and social factors to the SLE experience;  
2) demonstration and practice of some basic skills to use in working with the mentee; 
3) review of the manual; outline of the format and required elements for each call;  
4) participation in role-playing exercises in pairs to learn ways of presenting didactic information, 
supporting positive statements, and responding to questions posed by the mentee; 
5) participation in question development and topic starter exercises;  
6) participation in troubleshooting exercises to suggest ways of addressing particular problems; and 
7) review of call formats, reporting requirements and detailed discussion of emergency situation 
procedures. 
 
Mentee pairing: After enrollment and completion of baseline assessments, mentees will be matched with 
peer mentors based on as many specific shared concerns of their experiences as possible. Potential 
matching areas include disease symptoms, parenting, work-related concerns, similarity of life stage 
(including age)]41] and demographics (including area of residence), similarity of personality 
characteristics, and peer mentor availability, and will be assessed as part of the screening process.  
 
Overview and Description of the PALS Intervention: 
Recruitment and enrollment: This will occur in 3 waves. Within each  wave, each mentor will be assigned 
all of their mentees at one time to ensure that intervention activities occur within the same 12-month 
period. As mentor:mentee quads (1 mentor, 3 mentees) are identified, they will attend an introductory 
session together, during which the mentoring process will be discussed, including time commitment, 
roles, responsibilities, benefits, and ground rules, and mentees and peer mentors will have the 
opportunity to ask questions and make informed decisions about their ability to fully participate in the 
intervention. If face-to-face meetings are not possible for all members of the quad, skype or another form 
of video meeting will be attempted. Mentees will be informed that she will be dropped from the study if 
she misses three consecutive or four of the 12 total educational sessions for non-emergency reasons; 
peer mentors will only be permitted to miss three educational sessions in total. Any missed educational 
content on the part of the mentee or mentor will be added to subsequent sessions and emphasized in 
booster sessions.  
Description of The PALS Program: The program will consist of 12 sessions of peer mentoring that will 
include one standard educational session by telephone or video for approximately 60 minutes every 2 
weeks. Additional interaction will be discouraged, but mentees and mentors will be asked to report any 
additional social interaction should it occur. The bi-weekly educational session will be generally structured 
in three parts: introduction, structured education, and problem solving. 60-minute calls are necessary for 
the delivery of educational content and mentors and mentees to be able to discuss their own experiences 
and potential solutions. Bi-eekly content has been adapted from the six modules of the Chronic Disease 
Self-Management Program (CDMP), Arthritis Self-Management Program (ASMP), and Systemic Lupus 
Erythematosus Self-Help (SLESH) Course,[61,116] and further tailored to African American women with 
six added sessions based on cultural issues reported as important to African Americans in earlier 
research conducted by the PI[93,117] and documented unmet needs in the African American SLE patient 
community.[94,95]  
Tailoring of the PALS intervention: To address unmet needs around understanding the medical regimen, 
including considerations around depression, medication concerns, and physical symptoms, culturally 
relevant sessions on ‘Complications’ and ‘Self-monitoring’ were developed. In response to unmet needs 

 
10
around trust in the provider, communication with providers, and receiving adequate information from 
medical staff about treatment side effects, sessions on ‘Coping’ and ‘Trust’ were developed. Lastly, unmet 
needs around having access to telephone support and advisory services and having assistance with 
knowing which symptoms should trigger a doctor visit[35,37,77] are addressed by the PALS study design 
(i.e., telephone/video delivery of intervention) and sessions devoted to less frequently discussed topics of 
‘Body image’ and ‘Sexuality/sexual health’. The PALS pilot was then used for initial refinement of the 
intervention protocol. We analyzed qualitative responses that were collected as part of weekly mentee 
check-ins, mentor logs, and the end-of study focus group. Themes that emerged included: a) 
interpersonal, familial and romantic relationships; b) individual experiences of living with SLE; and c) 
physician-patient relationships. Additional themes emphasized how the intervention worked bi-
directionally wherein both mentors and mentees were empowered toward greater disease self-efficacy. 
We found that: 1) empowerment was facilitated/achieved by mentors taking their mentorship 
responsibilities seriously and seeking several avenues for collaboratively developing success with their 
mentees; 2) mentors felt empowered through being able to discuss topics that they felt were often 
marginalized by healthcare professionals, such as sexuality; and 3) the intervention encouraged 
reciprocity. Such dynamic discussions served as a participative approach to determining which 
components of the intervention were most useful to participants. Based on observed themes, unique 
concerns of our study population have been built into the proposed intervention. Specifically, the 
importance of faith and spirituality in coping with their disease, the impact of chronic pain on their 
interpersonal, familial, and romantic relationships, the need for more sensitivity in interactions with 
medical staff, and the importance of support and relationship building in mentee-mentor interactions have 
been incorporated into session 4: effective communication, session 10: self-monitoring, and session 11: 
sexuality, of the PALS implementation plan and training protocols, to ensure that culture-bound myths 
and concerns about SLE are addressed in this cultural group.[97]  
 
Control Intervention (Support Group): Mentees randomized to the social support control group will be 
enrolled in a lupus support group designed specifically for this project. Unlike traditional support group 
meeting formats that are open to all lupus patients, family members, friends and supporters; advertised 
publicly; implemented by a trained facilitator; and generally include a specific discussion topic or an 
informative presentation, the PALS-specific support group will be limited to PALS control participants, be 
moderated by a PALS study coordinator who will not provide any information or discussion topics, and will 
simply provide a meeting session via WebEx for social support control participants to  interact on a bi-
weekly basis.  
 
Treatment Fidelity: At the onset of the study, peer mentors will receive extensive training. Dr. Oates will 
provide training in pathophysiology, clinical management, and effective strategies of lifestyle management 
in SLE. Ms. Rose will provide primary training on peer-mentoring and monitor counseling skills using audit 
and feedback. Dr. Williams will provide training on social support, telephone engagement and follow up 
and conflict resolution.[111,112] In addition, Dr. Williams will provide ongoing oversight of peer mentoring 
sessions. Training will consist of two full days of information and role-playing and then one day booster 
sessions in years 2-5 to minimize drift in peer mentoring skills.[102] After initial training, peer mentors will 
continue to meet with the PI bi-weekly to identify challenges and reinforce the guidelines for peer 
mentors.[114] Mentors will be required to submit logs of the number of calls made, number of hours spent 
with mentees, and content covered during that two-week period, in order to be compensated. To assess 
the frequency and duration of calls, other interactions with their mentor and whether specific content has 
been covered, mentees will receive a link to a brief REDCap survey by email and/or text message every 
two weeks. Additionally, a subset of sessions will be recorded to allow direct evaluation of the contents of 
interactions. Self-report assessments will be used to track the effectiveness of the intervention. Fidelity 
will be considered acceptable if: 1) a given participant completes at least 9 of 12 sessions (peer 
mentoring or support group) or receives corresponding content and achieves at least 9 hours of 
interaction; and 2) all assessments (baseline, mid-intervention, and post-intervention) are completed 
within 1 week of distribution.  
 
 
Data Collection Strategy 

 
11
Data Collection Process/Schedule: Fourteen trained peer mentors will deliver the intervention in each 
wave and one full-time study coordinator (SC) will conduct screening, consent, enrollment procedures, 
and support group moderation. The primary method of data collection will be face to face interview. 
Mentees will be assessed at baseline, mid-intervention (3 months from baseline), immediately post-
intervention (6 months from baseline), and 6 months post-intervention (12 months from baseline). 
Physical examination and laboratory evaluation will be achieved by in-person clinic visit when recent 
SLEDAI scores are not available in the database record of a given participant. Social support control 
participants will complete assessments on the same schedule as mentored participants. Given evidence 
that peer support may be just as beneficial to the supporters as it is to the person being 
supported,[118,119] mentors will be assessed on the same schedule as mentored and control 
participants, using the same tools. 
 
Primary Outcomes for Aim 1 will include: 
Quality of Life: The LUP-QOL incorporates the Medical Outcomes Study (MOS) Short Form 36 Health 
Survey (SF-36) and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), which are 
reliable and valid instruments that are frequently used in quality of life studies of persons with 
lupus.[120,121] Self-Management: The Patient Activation Measure (PAM)[122,123] assesses an 
individual’s knowledge, skill, and confidence for managing their health and healthcare. Individuals who 
measure high on this assessment typically understand the importance of taking a pro-active role in 
managing their health and have the skills and confidence to do so.  
 
Secondary Outcomes for Aim 1 will include:  
Treatment Credibility:  To assess for differences in outcome expectancy, a modified treatment credibility 
scale developed by Borkovec and Nau (1972) will be used.  Four of the questions will be used for this 
study, with 10-point Likert scales.  These include questions regarding how logical the treatment seems, 
how confident participants are about treatment, and their expectancy of success. Satisfaction with Care: 
Satisfaction with Care will be measured with a previously validated general scale to measure 
satisfaction/dissatisfaction with health care. The 2-item scale ranges from 1 (Strongly Agree) to 5 
(Strongly Disagree).  
 
Covariates for all three aims will include: 
Demographics: Previously validated items from the 2002 National Health Interview Survey [NCHS 2004] 
will be used to capture age, marital status, education, household income, and health insurance. The 28-
item Brief Index of Lupus Damage (BILD) was developed as a patient-reported measurement of lupus 
disease damage designed to quantify cumulative organ damage due to SLE regardless of attribution. The 
self-administered version of the BILD has been validated in a predominantly African American 
independent community-based cohort of SLE patients from the Southeastern US.[67] Coping: Coping will 
be assessed by the Arthritis Self-Efficacy Scale pain and other symptoms sub-scale,[124] which consists 
of 11 items designed to measure confidence in one’s ability to manage the pain, fatigue, frustration, and 
other aspects of disease.[64] Depression: The PHQ-9 is a brief questionnaire that scores each of the 9 
DSM-IV criteria for depression as "0" (not at all) to "3" (nearly every day). PHQ-9 score > or =10 have a 
sensitivity of 88% and a specificity of 88% for major depression.[125] We will use a modified version of 
the PHQ-9 that does not include the last question about suicidality, making it the PHQ-8. Anxiety: General 
Anxiety Disorder (GAD) will be assessed using the 8-item anxiety scale (GAD-8).  This is a valid and 
efficient tool for screening for GAD and assessing its severity in clinical practice and research.[126] 
Perceived Stress: The perceived stress scale (PSS) is a 4-item scale that assesses the degree to which 
the respondent finds situations stressful.[127] Responses range from “0” (never) to “4” (very often) and 
questions ask about the frequency of feelings related to events in the previous month. The Cronbach 
alpha value is 0.69 and scores are highly correlated with stress, depression and anxiety. Chew Health 
Literacy Screening:  The Chew Health Literacy Screening Survey[128] is a 3-item instrument designed to 
rapidly screen patients for potential health literacy problems. To test whether unique needs are better met 
in the group receiving the peer mentorship intervention compared to the group receiving social support, 
this instrument will be adapted to include questions about understanding the medical regimen, including 
considerations around depression, medication concerns (possible side effects and interactions), and 
physical symptoms (pain and fatigue), and knowing which symptoms should trigger a doctor 
visit.[35,37,77] Measures of Social Support, Trust, and Patient Centered Care will be administered to test 

 
12
whether unmet needs around trust in the provider, communication with providers, receiving adequate 
information from medical staff about treatment side effects, and having access to telephone support and 
advisory services are better met in the group receiving the peer mentorship intervention compared to the 
group receiving social support. Social Support: The Medical Outcomes Study (MOS) Social Support 
Survey[129] will be used to measure social support. The total scale (d=0.97) and subscales (d=0.91 to 
0.96) have high internal consistency, good criterion and discriminant validity, and one-year test-retest 
reliability (0.72 to 0.76). Trust: Trust will be measured using The 17-item Multidimensional Trust in Health 
Care Systems Scale (MTHCSS).[130] Items are scored on a 5-point Likert scale with scores ranging from 
5 (strongly agree) to 1 (strongly disagree). The higher scores represent greater trust in the healthcare 
systems. Patient Centered Care: Patient-Centered Care will be measured using the Modified Picker 
Survey. It is a 7-item scale that measures patients’ experience with the physician. Scores range from 1 
(Always) to 4 (Never).  
 
Methods for AIM 2: Determine the impact of a peer mentorship intervention in African American women 
with SLE on clinical indicators of disease activity and clinical profile that indicates success of the 
intervention 
Disease activity will be assessed using both physician assessment and patient-reported outcome 
measure. The Systemic Lupus Activity Questionnaire (SLAQ)[131] asks a single Patient Global 
Assessment (PGA) question about presence and severity of lupus activity over the past month, questions 
on 24 specific symptoms of disease activity and a single Numerical Rating Scale (NRS) asking the patient 
to rate disease activity on a scale of 0-10 over the past three months. Use of immunomodulatory drugs 
and prednisone (total dose and tapers) will also be assessed. For physician assessment of disease 
activity, the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) has been individually 
validated and found reliable in clinical trials.  SLEDAI scores are routinely collected as part of regular 
visits and clinical, demographic, genetic, disease activity/damage, genetic, and laboratory data are stored 
in the longitudinal web-based SLE database at MUSC as part of NIH-funded P60 and P30 grants (see 
Oates biosketch). All clinicians recording SLEDAI scores are trained in this assessment with annual 
refresher courses as part of their participation in industry-sponsored clinical trials. SLEDAI scores for 
each participant will be extracted from the database when available for dates within the same month as 
baseline, mid-intervention, and post-intervention data collection points. When scores are not available in 
the database, the participant will be scheduled for a clinic visit that will include vitals, blood collection, and 
labs to ascertain SLEDAI score. Clinic visits will take place within the South Carolina Clinical & 
Translational Research Institute (SCTR) Research Center (Research Nexus) at MUSC. The SC will 
coordinate questionnaire administration, clinic visits for SLEDAI ascertainment, and data entry. Physical 
examination and laboratory evaluation will be achieved by in-person clinic visit when recent SLEDAI 
scores are not available in the database record of a given participant. Social support control participants 
and mentors will complete assessments on the same schedule as mentored participants. The SLEDAI is 
a multicomponent, 24 question survey of clinical and laboratory signs and symptosm used as a 
representation of a phsyician’s assesment of a patient’s disease activity over the last 30 days (see 
Appendix). Items are weighted based on their severity ranging from a multiplier of 8 to no multiplier (i.e. 
1). The maximum ‘score’ for the test is 105.[132] Validated clinically meaningful changes in SLEDAI 
scores are -6 for improvements and +8 for worsening disease activity.[133] 
 
Methods for AIM 3: Determine the cost and cost-effectiveness of a peer mentorship intervention on 
disease self-management, disease activity, and HRQOL, in African American women with SLE 
Resource use and cost information will be collected to inform a well-designed economic study of the cost-
effectiveness of the use of peer mentors for SLE patients in the acute care setting. Cost of the 
intervention will include all personnel, equipment, supply and space cost associated with training and use 
of peer mentors, in real time dollar values. MUSC inpatient and outpatient costs of healthcare utilization of 
any MUSC services will be collected from MUSC administrative billing data based on ICD9/10 codes, 
Medicare Diagnosis Related Group (MSDRG), and CPT codes related to lupus to estimate distributions of 
cost for the medical care resources used. Resource use and cost data will be accessed through the 
Services, Pricing, and Application for Research System (SPARC Requests), which is available to MUSC-
based investigators under MUSC’s Clinical and Translational Science Award (CTSA). The system allows 
for easy access to pricing for services across the MUSC campus and its providers and focuses on billing 
compliance and budgetary analysis. In order to extract data from the MUSC record systems, services are 

 
13
requested through an online portal and data is then provided through direct consultation. Within the 
SPARC system, members of the study team will also be able to track service utilization and pricing 
throughout the duration of the study. Questionnaire responses will be used to ascertain care resources 
that patients use during the study period from other hospitals or entities who are not part of the MUSC 
record system.  
Healthcare Utilization: Stanford Patient Education Research Center Questionnaires[134,135] assessing 
medical outcomes such as hospital visits will be adapted to include questions related to use of other 
services, such as ER visits, other medical care resources of importance to patients, economic and 
financial barriers to use of care outside the hospital setting including loss of time at work/productivity, and 
any issues related to recidivism of patients once they no longer have mentor support.[136-138]   
 
Power and Sample Size Justification: The sample size calculation and power analyses are based on the 
primary outcome of change in HRQOL between baseline and 12 months post intervention. The minimum 
sample size was based on detecting a clinically meaningful difference of 0.35 standard deviation units 
(medium effect) based on prior studies.[87,93,139-143] Essentially, this is equivalent to testing the 
interaction between time and group. Assuming 3 measurement time points, level of significance p=0.05, 
two-tailed comparison, correlation between pairs of measurements within participants (interclass 
correlation) no larger than p=0.6, compound symmetry covariance structure, we estimate that 123 
participants per group (total n=246) are needed to detect, with 80% power, a standardized effect size of at 
least 0.35sd. This sample size includes a 20% inflation for attrition at 12 months. This effect size is robust 
enough to provide sufficient power for the outcomes listed under aims 1 and 2 and is consistent with data 
from our pilot study of 20 mentees and 7 mentors (see preliminary data). The pre-post differences in the 
outcomes (such as overall social support, positive social interaction, tangible support, vitality, emotional 
support, social functioning, general health, coping, etc), ranged from 0.35 to 0.88 standard deviation 
units. Although these calculations account for within patient clustering through the intera-class correlation 
mentioned above, clustering within mentors and mentees are assumed to have minimal intra-class 
correlation based on pilot data, especially since the cluster sizes would be at most 3 at a given wave. 
However, a multi-level model will be used in the analysis to verify this. Since the effect size planned is 
conservative, if the clustering leads to higher intra-class correlation, we would still be able to detect 
meaningful differences. We will also consider including mentor as a fixed effect in the model.  
 
Randomization Procedure: Participants recruited for the mentored or control (support group) portion of 
the study will be randomized using a block randomization procedure to assure equal sample sizes in the 
mentored and control groups. Using a block size of 3, participants will be assigned to the appropriate 
treatment condition as they enroll in the study until the block is completed. Then the following 3 
participants will be assigned based on the next block.[144] Once a patient is randomized and attends the 
first session, she will be entered into the study and included in the intent-to-treat analysis plan. Subjects 
will remain blinded to group allocation until after the completion of baseline assessment. The only 
members of the research team who will be aware of randomization assignment will be the Research 
Coordinator, and the statistical analyst in charge of randomization. Randomization will occur at the patient 
level. As such, we will take the following steps to minimize contamination between the two arms of the 
study: 1) patients in the intervention and control arms will be instructed not to share intervention materials 
with family members, friends, or other clinic patients; 2) patients will be given instructions not to disclose 
their treatment assignment to their assessment interviewers.  
 
Data Management: Data will be captured via REDCap (a free, secure, web-based application) and 
overseen by a data management and analysis team comprising statisticians at MUSC. Data will be 
collected electronically in password-encrypted files. A part-time masters-level statistician will be 
responsible for data management. Data will be reviewed on a bimonthly basis and issues will be 
communicated to the project coordinators. In particular, outlying and inconsistent data values, as well as 
missing data, will be the targets of the data quality review. 
 
Overview of Statistical Analysis Plan 
Univariate descriptive statistics and frequency distributions will be calculated as appropriate for all 
variables for the total sample. Descriptive analysis will be presented as percentages (with 95% 
confidence intervals [95% CI]) for categorical variables, and either means (±Standard deviation) with 95% 

 
14
CI or medians (with interquartile range) for continuous and ordinal variables on the biological indicators of 
disease activity, as appropriate, based on distributional assumptions. These analyses will provide 
descriptors of the respective parameters in the study population and will also be used to identify 
departures from distributional assumptions for proposed procedures.  If departures are identified, 
appropriate transformations of data will be applied, or alternative analysis procedures (e.g., semi-
parametric or nonparametric) will be used.  
 
AIM 1: Determine the efficacy of a peer mentorship intervention in African American women with SLE on 
disease self-management and HRQOL. Analyses for Aim 1 will focus on estimation of efficacy as 
determined by: (a) change in quality of life; and (b) change in self-management. Estimates of effect sizes 
for outcome variables will be reported as point estimates (mean differences between pre-post measures, 
as appropriate) and interval estimates (95% CI) with two-sided p-vales denoting statistical significance to 
provide an indication of the presence of a clinically important treatment effect.[145,146] A p-value of 0.05 
will be considered to be statistically significant. After studying the distributions of baseline characteristics, 
we will use a generalized linear mixed model regression model to determine if the intervention will 
produce a greater change in the main outcomes from baseline. This model will include time, treatment 
(along with their interaction), and covariates (including the amount of intervention received, demographic 
factors, medications, coping, depression, stress, anxiety, health literacy, trust, and social support) as 
fixed-effects. Using the amount of intervention, which is measured as an aggregate number of sessions 
completed or hours of interaction as a covariate would allow us to study the dose response.  In the 
generalized linear mixed model (GLMM), we will use different link functions depending on the assumed 
distribution of the response variable. For binary outcomes, we will use logit link and for count outcomes 
we will use log link under a poisson or negative binomial distribution.  For example, for the a given quality 
of life variable, HRQOL measured at baseline, month 3 and month 6, we will include intervention group, 
time, and time X intervention as the primary independent variables in the basic (unadjusted) model, and 
covariates that are not balanced at randomization (or a propensity score based on these covariates) will 
be added in the subsequent (adjusted) model to adjust for the possible confounding effect of these 
variables.  Unadjusted and covariate-adjusted least squares means for each outcome variable will be 
compared at the primary time point (month 12) and at intermediate secondary time point (month 6) using 
appropriate model contrasts and the Tukey-Kramer adjustment for multiple comparisons for the 
secondary time points. These contrast comparisons, along with corresponding 95% CI, will provide 
estimates of the difference in outcome means (effect sizes) for the hypothesized comparisons.      
 
AIM 2: Determine the impact of a peer mentorship intervention in African American women with SLE on 
clinical indicators of disease activity and clinical profile that indicates success of the intervention. 
Analyses for Aim 2 will focus on estimation of efficacy as determined by: change in disease activity of  
≥4 point reduction from baseline in SLEDAI score, in concordance with the accepted SLE Responder 
Index (SRI).[147] For comparative statistical assessments, the two groups will be compared using a 
generalized linear mixed models (GLMM) approach.[148]  This approach allows for measurement of 
participants at different time points, missing data under the assumption of missing at random (MAR), and 
can also account for the effect of correlated longitudinal measurements within participants. In addition, 
GLMM accommodates a wide range of distributional assumptions such as dichotomous (e.g. binomial), 
count (e.g. Poisson), continuous (e.g. Gaussian), and categorical or ordinal outcomes. Additionally, 
outcomes that are measured longitudinally (at 6 and 12 months) will have intervention group, time, and 
time-by-intervention group as primary independent variables in the model. Additional adjustment co-
variables will be added to the model in a second set of analyses, when indicated. The magnitude of 
between intervention differences in outcome variables (effect sizes) at each time point will be estimated 
using appropriate contrasts in the corresponding GLMM models. We will then perform a responder 
analysis to develop a profile of the clinical and laboratory characteristics that predict success of the 
intervention. For this, a multivariate regression logistic regression model where the outcome is success 
(/failure) and the difference in the clinical (SLEDAI components) levels over time are independent 
variables. We will use model selection approaches such as the all subsets selection, to identify the 
important clinical and laboratory features in the presence of others. As much as the data allows, we will 
also consider interactions of the SLEDAI components. As an alternative to logistic regression, we will also 
consider other approaches such as the CART, or logic forest to efficiently identify the clinical and 
laboratory characteristics that predict intervention success. 

 
15
 
Secondary analyses of process measures: Important process measures will include recruitment, session 
attendance/dropout proportions and participant satisfaction.  We will use 95% confidence intervals (CI) for 
proportions to estimate the proportion of participants who agree to participate out of the number who are 
initially approached, the proportion who are compliant with the treatment protocol, and the proportion who 
exit the study prematurely (drop out). In addition, frequency distributions describing the participants' 
reasons for noncompliance and discontinuation of study participation will be developed. We will also 
evaluate patient satisfaction with the peer mentoring intervention using a likert-type satisfaction scale and 
will determine the proportions (along with CI) within the categories. For continuous process measures 
(e.g. treatment credibility, treatment adherence, peer mentoring phone sessions and attrition), frequency 
distributions and the median and mean responses (with 95% CIs) will be obtained. 
 
Exploratory analyses to determine the role of mediators and moderators on outcomes and obtain 
estimates of the effect of the intervention on mentors: Analysis for exploratory aims will focus on change 
scores over time for potential mediator and moderator variables related to identified unmet needs unique 
to African American women with SLE, including: (a) Anxiety; (b) Depression; (c) Stress; (d) Coping; (e) 
Health Literacy; (f) Trust; (g) Social Support; and (h) Patient centered care. Differences between baseline 
and post-baseline measurements will be tested with the Wald test in the GLMM model. As described for 
Aim 1, estimates of effect sizes for the outcome variables will be obtained via 95% confidence intervals 
(CI) to provide an indication of the presence of a clinically important treatment effect.  Individual treatment 
change scores (pre-post) will be estimated via 95% CI (adjusting for clustering).[145,146] Since the 
intervention is designed to improve outcomes in mentees, we will not have power to test the efficacy of 
the intervention in the mentors, but will explore the effect of the intervention on the mentors using the 
same analytical methods. 
 
Missing data: We will handle missing data using several techniques including multiple imputation and 
maximum likelihood,[149] and latent class based multiple imputation.[150]  Missing data mechanisms will 
be examined using both univariate and multivariate methods. We will check for missing at random (MAR) 
by creating a missing indicator for each missing variable and study the predictors of missingness using 
logistic regression. If any of the fully observed covariates or outcomes become significant in the missing 
data model then we will use methods for MAR if we do not have any reason to believe that the missing 
data mechanism is not at random.  
 
Mid-point Analyses for the protection of participants: In an effort to protect both mentors and mentees 
from potential deleterious effects of mentoring, a mid-point (interim) analysis will be undertaken to assess 
safety using 3-month post-intervention data.  If mentored participants have worsened beyond a threshold, 
we will stop the trial for ethical concerns. For instance, if the lower confidence limits based on 95% 
confidence interval at the midpoint, for any one of the variables, namely depression, anxiety, and/or 
disease activity, is larger than 50% compared with their baseline measure, the trial will be terminated.  
Similarly, mentors will be monitored for depression, anxiety, and disease activity and if a worsening 
trajectory is observed at mid-point analyses, they will be removed from the study. 
 
AIM 3: Determine the cost and cost-effectiveness of a peer mentorship intervention on disease self-
management, disease activity, and HRQOL, in African American women with SLE. 
The cost of the intervention will be compared to the outcomes of the intervention 12 months post 
baseline. In order to compare with previous lupus studies,[151,152] Quality adjusted life years (QALYS) 
will be calculated for intervention and control groups based on the SF36 outcome which will be measured 
12 months post baseline. The calculation will be based on an established peer reviewed method.[153] 
Measuring QALYS gained relative to cost of the intervention is the preferred outcome method for the 
American College of Physicians (ACP).[154]  
 
Using QALYs, the incremental cost-effectiveness ratio (ICR) can be calculated as: 
(QALYintervention-QALYcontrol)/(Costintervention-CostControl). The ICR can then be compared with the 
ICRs for previous lupus interventions. We will take the perspective of the provider, insurer and patient. All 
three are affected in the hospitalization charges since insurers pay part and patients will pay part of the 
charges. In addition to the main cost-effectiveness outcome of QALY and the ICR, costs of the 

 
16
intervention can be compared with any changes in MUSC health services utilization costs for emergency 
department, inpatient and outpatient care for the intervention relative to the control group. In addition to a 
comparison of intervention cost with average difference between MUSC costs for intervention and control 
group 12 months post baseline, generalized linear cost models can be estimated to examine the 
association of the treatment with MUSC health services costs while adjusting for patient demographics 
(age, gender, race/ethnicity, co-morbidities) and clinical outcomes. MUSC does not provide cost 
information, only charges. In addition we will estimate the impact on work loss and income by estimating 
the changes in days lost to illness and income based on values provided by participants. We will use the 
year for which the hospital charge and income data is reported and adjust for inflation as appropriate 
using the US Department of Labor Consumer Price Index. Inpatient and outpatient MUSC costs will be 
compared separately and together between the control and intervention groups. Bootstrapping methods 
will be used to conduct sensitivity analyses for all cost models. Sensitivity analysis will be performed by 
estimating a separate MUSC health services cost model while adjusting for each clinical outcome to 
insure robust results regarding the marginal effect of the treatment on MUSC health services costs. Park 
tests will be conducted to determine the best fit for the cost data in specifying the generalized linear 
model. In the event of many zero values, a two-part model will be used to first examine the association of 
the treatment with the likelihood of any MUSC costs and then the conditional generalized linear cost 
model, conditional on having non zero MUSC cost value for the patient. The ICR will be reported as a 
single ratio with no uncertainty attached to it. Therefore, standard statistical characteristics such as 
confidence intervals or hypothesis test to compare it to an a priori ICR from another study are not 
applicable.  We will calculate the ICR and a clinically relevant interpretation of the outcome will be p 
Human Subjects Involvement and Characteristics. The Peer Approaches to Lupus Self-Management 
(PALS) study is a randomized controlled trial designed to examine whether a new, culturally tailored peer 
mentoring intervention improves disease self-management, indicators of disease activity, and health 
related quality of life (HRQOL) in African American women with systemic lupus erythematosus (SLE). 
African American women with active SLE will be recruited as mentees and peer mentors who are 
considered competent in the management of their condition will be identified and recruited to provide 
modeling and reinforcement to participants. We will recruit mentees for 300 observations (150 mentored 
and 150 support group) and up to 60 mentors. Mentees and mentors will be primarily recruited from the 
longitudinal web-based SLE database at the Medical University of South Carolina (MUSC) in three 
cohorts. As part of each cohort, mentors (n=20) will be trained to deliver intervention content, prior to 
being paired with up to three mentees (n=50). The peer mentoring intervention will occur by twelve 60-
minute telephone or video sessions carried out across the course of 24 weeks. In each cohort, social 
support controls (n=50) will participate in a lupus support group created for this project, on the same 
schedule as peer mentoring sessions. All participants (mentees, mentors, and social support controls) will 
be assessed using validated measures of patient reported outcomes and biological indicators of disease 
activity at baseline, mid-intervention (3 months from baseline), immediately post-intervention (6 months 
from baseline), and 6 months post-intervention (12 months from baseline). For each cohort, outcomes for 
mentees randomized to the mentored group will be compared with the outcomes of mentees randomized 
to the social support control group. A booster session will be incorporated for mentored participants at 3 
months post-intervention to encourage retention. 
 
Inclusion criteria FOR MENTEES include: 1) African American race/ethnicity and female gender; 2) 
clinical diagnosis of systemic lupus erythematosus (SLE) from a physician; 3) 18 years of age or older; 4) 
able to provide informed consent and take part in ongoing assessment/evaluation activities (self-reported 
questionnaires, interviews); 5) able to commit to duration of study (12 months); and 6) able to 
communicate in English. Exclusion criteria FOR MENTEES include: 1) cognitive impairment; 2) active 
alcohol or drug abuse/dependency; 3) acute decompensation of chronic conditions precluding 
participation; 4) conditions that preclude participation in assessments (e.g. blindness or deafness); 5) 
terminal illness or life expectancy less than 18 months as evaluated by physician; and 6) current 
enrollment in an interventional study or trial that could affect quality of life outcomes and/or participation in 
one of the PI’s prior behavioral trials.  
 
Inclusion criteria FOR MENTORS include: 1) African American race/ethnicity and female gender; 2) 
clinical diagnosis of systemic lupus erythematosus (SLE) from a physician; 3) 18 years of age or older; 4) 
able to provide informed consent and take part in ongoing assessment/evaluation activities (self-reported 

 
17
questionnaires, interviews, observation, activity logs); 5) able to commit to duration of study (12 months); 
6) able to communicate in English; 7) disease duration > 2 years; 8) able to attend scheduled training 
sessions; 9) willing to provide one-on-one support to up to three African American women with SLE; and 
10) PI determination of competence, maturity, emotional stability, and verbal communication skills after 
overall assessment during screening interview and training. Exclusion criteria FOR MENTORS include: 1) 
cognitive impairment; 2) active alcohol or drug abuse/dependency; 3) acute decompensation of chronic 
conditions precluding participation; 4) conditions that preclude participation in assessments (e.g. 
blindness or deafness); and 5) terminal illness or life expectancy less than 18 months as evaluated by 
physician. rovided similarly to other studies in the literature.[155,156] 
African Americans display the highest rates of lupus. Due to the exposure of African Americans to a 
unique trajectory of stressors throughout the life course, it may be critical to test peer mentorship as an 
alternative strategy to improve outcomes in this population. Given the success of the peer mentoring 
approach in other chronic conditions that disproportionately impact minorities, and its responsiveness to 
the needs of this unique population, this intervention could result in health improvements that have not 
been attainable with other interventions. This would significantly reduce disparities and have considerable 
public health impact. 
  
In the United States, the highest lupus morbidity and mortality rates are among African American women. 
SLE affects approximately 1 in 250 African American women of childbearing age. Very few men are 
affected by the disease with a general ratio of 10 females to every 1 male with SLE. 
 
Research Material & Data: Sources of research material include medical records, research 
questionnaires, and blood specimens. The data will be obtained for research purposes. 
2. 
Linkages to Subjects: Participants will provide identifying information in addition to research data. 
Paper documents pertaining to this study will be stored in locked file cabinets in both the clinical center 
and the data management center, and data will be entered into secure, password-protected web 
databases developed for this study. A database of name, contact address, telephone number, and other 
research identification numbers will be stored separate from the study database, for purposes of audit by 
the MUSC IRB, if necessary. Access to study data will be limited to research personnel.  
3. 
Collection of Data and Specimens:  
A. 
Personnel: A full-time research coordinator (RC) and part-time data coordinator (DC) will be 
responsible for consent, enrollment and data collection.  
B. 
Data Collection Schedule: At the baseline visit, the RC will give detailed explanation of the study, 
the reimbursement schedule, and obtain consent. Participants will provide a blood sample, if necessary, 
and complete a questionnaire that captures demographics, health literacy, coping, disease activity, 
disease self-management, anxiety, depression, perceived stress, social support, trust, patient centered 
care, perceived control, perceived discrimination, spirituality, and quality of life. The RC will review study 
goals, establish the schedule of study sessions, obtain contact information (primary and alternate 
telephone numbers), and receive study materials. After the baseline assessment, follow-up assessments 
will be conducted at 6 months (questionnaire only) and 12 months (questionnaire and blood collection). 
As much as possible, research visits will be scheduled on the same day as their clinic visit. Mentors and 
mentees will be on the same schedule of data collection, regardless of whether a mentor has assigned 
mentees after their enrollment. 
 
Potential risks to mentees and mentors include: 1) discomfort, bruising, or scarring from venipuncture, 2) 
possible violation of the patient’s privacy, 3) discomfort with questions on the research questionnaire, and 
4) psychological distress. Additional risks to mentors specifically include: 1) discomfort with interactions 
with mentees and 2) feeling overwhelmed. Details on how these risks will be minimized are discussed 
under adequacy of protection against risks below. 
Confidentiality:  This will be maintained by keeping participant folders in locked file cabinets in the 
research center.  Only participants’ unique identification numbers will be recorded in folders and on data 
forms.  The database will remain on the MUSC computer system that use unique ID numbers, rather than 
names, and will be password-protected. To further ensure confidentiality, participants will be provided 

 
18
with a basic phone and calling/texting plan for the duration of the study for mentoring interactions so that 
personal phones are not used. 
Recruitment and Informed Consent. All African American lupus patients who indicate willingness to 
participate and meet the inclusion criteria of the study will be invited to participate in data collection. 
Informed consent will be sought from each participant for participation in intervention and data collection 
activities. Participants will be encouraged to ask any questions they have regarding the procedures. 
There will be no coercion to participate or prejudice against those who choose not to take part in the 
study. We will submit an application to the Medical University of South Carolina Institutional Review Board 
for approval of study procedures and the informed consent protocol. Study activities will not take place 
prior to IRB approval.  
 
After obtaining approval from the IRB, we will obtain a list of potential mentors from MUSC 
rheumatologists and the full list of female African American SLE patients enrolled in the web-based SLE 
database who have consented to future contact to be contacted as mentees. We will mail out recruitment 
letters that will explain the study and provide participants a number to call if they are interested in 
participating. Participants who call and indicate interest in the study will be contacted by telephone to 
conduct a pre-screening assessment. If eligibility criteria are met the screening/enrollment visit will be 
scheduled. Additional recruitment strategies will include invitations to other academic medical centers 
with eligible patient populations, the identification of local SLE support group members who have 
emerged as natural helpers, referrals from other rheumatologists and arthritis health professionals, and 
outreach to the local chapters of the Lupus and Arthritis Foundations by letter and telephone. 
Written informed consent to obtain and use clinical data and specimens will be requested by the research 
staff, using paper or electronic (eConsent via REDCap survey format on computer or tablet) consents. If 
the participant is seen in person, the default will be paper consents. The participant will be given the 
opportunity to read the consent before the study coordinator goes over it with them. The study coordinator 
will introduce him or herself to the potential participant during the course of a normal outpatient clinic visit, 
describe the study in further detail including the possible discomforts of the procedure(s), the purposes for 
which the samples are being taken, and that s/he will not personally benefit from the results. Any 
questions that the patient might have will be answered by the study staff as appropriate. This process will 
be conducted in a closed room within the clinic to ensure a proper, private environment. If they agree to 
participate, the study coordinator will ask the patient to sign the standard participation consent and a 
HIPAA form.  
 
Once the participant has the informed consent open on a computer or tablet, they are able to scroll 
through (using mouse or finger) and read the document in its entirety, just as they would an article on a 
website. The study coordinator will guide the participant through the consent, asking open-ended 
questions to assess their comprehension of the study procedures. As the participant finishes reading 
sections of the document that require initialing or signature to provide consent for specific procedures, 
they are given the ability to do so by clicking on a link stating “add signature.” Each of these links provides 
verbiage identical to the paper consent form indicating the procedures for which they are being 
consented. These initials and signatures are completed by using their finger (tablet) or the mouse 
(computer) and accepting the changes by clicking “save signature.” Only the portions of the document 
that require the initials or signature of the participant will be provided to the participant, ensuring that they 
will not sign, initial, or date the improper portion of the document (e.g. – signing on the line for the person 
obtaining consent). The study coordinator will then be allowed to print their name, sign and date the form 
independent of the participant. The “submit” button is then pressed at the bottom of the screen by the 
study coordinator which then automatically opens the HIPAA document for the same review and 
signature/initialing process as above. Just as for paper copy consenting above, the eConsent process will 
be conducted in a closed room within the clinic to ensure a proper, private environment, and the study 
coordinator will conduct the eConsent process over the phone with the participant. In this event, the 
participant will be sent an electronic copy via email before the consent call, so that they can read the 
documents before the researcher goes over it. All participants will receive copies of the appropriate 
consent forms and HIPAA notice.  
 

 
19
Given the complexity of SLE and the overall study goal to provide modeling and reinforcement by peers 
to other African American women with lupus (mentees) to encourage mentees to engage in activities that 
promote the learning of disease self-management skills and support the mentees’ practice of these 
learned skills, every attempt will be made to ensure that the study/mentorship does not negatively impact 
the mentee. To address this potential concern the following approach will be implemented: 
 
1. 
Upon enrollment, peer mentors will receive training, prior to working with mentees.  
2. 
Mentors will be given a written manual presenting all the material in detail for their ongoing 
reference. 
3. 
Mentors will be given parameters for their roles and instructed on how to handle potential issues 
that may arise (e.g. not providing clinical advice) along with role-playing.  
4. 
After the initial training, peer mentors will continue to meet with the PI weekly to identify 
challenges and reinforce the guidelines for peer mentors. During these meetings, the PI will also monitor 
mentors' comfort with interactions and their mentee load. If mentors express discomfort and/or feeling 
overwhelmed, mentees will be reassigned and/or redistributed. 
5. 
Bi-weekly surveys to mentees and PI meetings with mentors will be used to track participant 
satisfaction with the peer mentoring process.  
 
Additional protections against potential risks include the following: 
 
1. 
Psychological Distress: Because we will be administering a questionnaire that measures the 
presence of depression, we will take several steps to ensure the safety of research participants. RAs will 
be trained by the PI to identify patients who meet criteria for depression on the PHQ-9. Participants who 
screen positive for depression will be assessed by a clinician before leaving their study visit to ensure 
their well-being and verbally instructed to seek care from their PCP. If deemed appropriate, they will also 
be given the Suicide Prevention National Hotline, 1-800-SUICIDE (784-2433), and told to call if they 
experience acute worsening of symptoms before they can be seen by their PCP. 
2. 
Administration of Research Questionnaires: Some participants might be offended by detailed 
questions about emotional or physical health status and impairment. All participants will be informed at 
the outset that they may terminate participation at any point. Past research suggests that data collection 
using these measures can be conducted without undue psychological distress or exacerbation of 
symptoms among study participants. 
3. 
Unknown risks: Participation in research may have other unknown risks. The researchers will 
advise participants if they learn of emerging information that might alter participants’ decisions to 
participate. 
 
In an effort to manage any high-risk aspects of the proposed work, potential mentees will be screened for 
depression and anxiety prior to pairing and mentors will be provided with summary sheets for each of 
their assigned mentees, to ensure that we are not putting mentors in a situation where they have to 
counsel those with serious mental health concerns (i.e., not expecting them to manage clinical 
depression, suicidality, etc.). Additionally, having a rheumatologist on the study team provides someone 
mentors can reach out to for rapid clinical feedback. When we encounter serious psychosocial (abuse, 
neglect, suicidal thoughts) or medical issues that need to be referred, Dr. Williams will be the primary 
contact for less urgent issues and responsible for linking participants to appropriate services. Dr. Oates 
will ensure that more urgent referrals are addressed within the MUSC hospital system. Participants 
requiring medical or other professional intervention for study-related events will be provided with 
appropriate and timely medical guidance by the PI. If adverse events occur during the conduct of this 
study, they will be reported to the MUSC IRB in accordance with Section 4.7 - Unanticipated Problems 
and Adverse Events Policy and Procedures.  
 
To protect against the potential risk of loss of confidentiality and/or breach of privacy, data will be 
compiled using codes in lieu of personal identifiers. Access to study data will be limited to research 
personnel. Development of and security oversight for the electronic database for this study will be 
performed by the PI and study statistician. Paper documents pertaining to this study will be stored in 
locked file cabinets and electronic data will be entered into secure, password-protected databases 
developed for this study by the research assistants. The PI will perform periodic review of the data entry 

 
20
process to ensure accuracy of recording. When study results are published or presented, only aggregate 
reports of the results will be used and participants’ identity will not be revealed. A file of name, contact 
address, telephone number, and other research identification numbers will be stored separately on paper 
and on computer, for purposes of audit by the MUSC IRB, if necessary. To further ensure confidentiality, 
participants will be provided with a web-enabled phone and calling/texting/data plan for the duration of the 
study for mentoring and support group interactions so that personal phones are not used.  
 
In the event of negative interactions between mentor and mentee, the following steps will be taken: 
 
1. 
The PI will communicate with mentees and mentors on a bi-weekly basis to assess calling 
patterns, content of calls, any other interactions between mentor and mentee, and any concerns either 
may have. 
2. 
Mentees and mentors will be encouraged to contact the PI at any time if they run into a difficult 
situation with a mentee. If during such communication, mentee or mentor reports that they believe that 
their mentee/mentor may be depressed, homeless/displaced, suicidal, has broken confidentiality, is 
repeatedly asking for medical advice, prying too much into their personal life, or that they are simply not 
connecting with who they have been paired with, the PI will meet with each party individually to discuss, 
troubleshoot, and develop solutions or direct to services, when applicable. 
3. 
If the mentor/mentee does not resolve the issue successfully on their own (with the exception of 
issues of suicidality, depression, and homelessness, which they are instructed to turn over to the PI to 
handle/address), the PI will meet with the pair together to discuss, troubleshoot, and develop solutions. 
4. 
If the mentor and mentee agree to continue, but report that issues can/have not been resolved, 
the PI will reassign to a different mentee/mentor, making every effort to match as closely as they were 
originally paired. 
5. 
If complaints persist about a specific mentor or mentee that contradict study procedures (e.g., 
breaking confidentiality, not adhering to intervention format), that participant could be asked to leave the 
study. 
 
Mid-point Analyses for the protection of participants: In an effort to protect both mentors and mentees 
from potential deleterious effects of mentoring, a mid-point (interim) analysis will be undertaken to assess 
safety using 3-month post-intervention data.  If mentored participants have worsened beyond a threshold, 
we will stop the trial for ethical concerns. For instance, if the lower confidence limits based on 95% 
confidence interval at the midpoint, for any one of the variables, namely depression, anxiety, and/or 
disease activity, is larger than 50% compared with their baseline measure, the trial will be terminated.  
Similarly, mentors will be monitored for depression, anxiety, and disease activity and if a worsening 
trajectory is observed at mid-point analyses, they will be removed from the study. 
The overarching aims of this pilot project is to test the efficacy of a peer mentoring intervention in three 
hundred (300) African American women with systemic lupus erythematosus (SLE) (60 mentors and 300 
mentees). Our rationale is that peers who have experience in managing their lupus may be in a better 
position to share knowledge and experience with which others may often not be able to relate. This can 
establish trust and in turn decrease disparities in health care outcomes. The proposed study if successful 
will lead to mentees’ improved health-related quality of life, self-management, and disease activity. The 
project is innovative because it will be the first study of its kind in this field to test peer mentorship as an 
alternative strategy to improve outcomes in this population. Given the success of the peer mentoring 
approach in other chronic conditions that disproportionately impact minorities, and its responsiveness to 
the needs of this unique population, this intervention could result in health improvements that have not 
been attainable with other interventions. This would significantly reduce disparities and have considerable 
public health impact.  
With assistance from appropriate staff, the Principal Investigator (PI) will serve as the safety monitor for 
the study. The functions of the SM/PI will include: 1) provide scientific oversight; 2) review all adverse 
effects or complications related to the study; 3) monitor accrual; 4) generate summary reports relating to 
compliance with protocol requirements; and 5) guide resource allocation. The PI will review and 

 
21
recommend appropriate action regarding adverse events and other safety issues. The PI will also be 
responsible for submitting all reports to NINR.  
 
Study procedures and participants will be monitored throughout the course of the project to ensure patient 
safety and minimal risk. Study coordinators will monitor study participants at consent, all data collection 
encounters, and during intervention activities for any discomfort, satisfaction with study participation, and 
for any questions or concerns participants may have. Frequency will be determined by the rate of 
recruitment and enrollment. It is the study coordinator’s responsibility to ensure that all returned forms are 
complete, intact, and transmitted to the PI and Biostatistician, as appropriate. The PI will maintain at least 
weekly communication with coordinators and other study team members for progress, updates, and any 
concerns. If a concern is raised, it will be addressed immediately. The PI will coordinate communication 
and/or meet with necessary parties to resolve the matter and take appropriate action (e.g., notify IRB 
and/or NINR, notify participant(s), amend approved IRB protocol, etc.). 
 
On a daily basis, the PI and Biostatistician will ensure the security of all data files. At critical data 
collection junctures (baseline, mid-intervention, immediately post-intervention and 6 months post-
intervention), the PI will review the data set to ensure de-identification prior to analysis. It is the 
Biostatistician’s responsibility to enter, manage and analyze data, and transmit outputs and summarized 
results to the PI, as appropriate. On a bi-weekly basis (according to the schedule of intervention and 
support group sessions), the PI will monitor mentor and mentee reports of their activities and 
communications to ensure that they are safe and to detect any unexpected adverse events and report 
any concerns to the institutional IRB. Summaries of adverse events reports or patient safety concerns 
reported to the IRB will be made to NINR in the annual progress report unless the nature of a particular 
event is such that it warrants immediate reporting. If any adverse events or serious adverse events occur 
during the conduct of this study, they will be reported to the MUSC IRB in accordance with Section 4.7 - 
Unanticipated Problems and Adverse Events Policy and Procedures. The timeframe for collecting 
adverse events will be from the time of enrollment to last follow-up. Adverse events will be collected 
during each follow-up phone call or meeting by prompting participants to let the study coordinator or other 
research team member know if they have experienced any adverse events. In addition, should events be 
reported in-between follow-up calls, those will be recorded immediately. The study coordinator will inform 
the principal investigator of SAE and AEs by phone or secure email communication. The principal 
investigator will, in turn, inform the IRB immediately by updating the study record in the Health Sciences 
South Carolina (HSSC) eIRB system. As the PI receives notification of any study-associated adverse 
event, that information will be immediately shared with the overseeing IRB. Notification of an adverse or 
serious adverse event may be provided by the participant, MUSC study coordinator, etc. All Serious 
Adverse Events (SAE’s) will be reported to NINR within 48 hours of the Principal Investigator becoming 
aware of the event.   
 
In an effort to protect both mentors and mentees from potential deleterious effects of mentoring, a mid-
point (interim) analysis will be undertaken to assess safety using 3-month post-intervention data.  If 
mentored participants have worsened beyond a threshold, we will stop the trial for ethical concerns. For 
instance, if the lower confidence limits based on 95% confidence interval at the midpoint, for any one of 
the variables, namely depression, anxiety, and/or disease activity, is larger than 50% compared with their 
baseline measure, the trial will be terminated.  Similarly, mentors will be monitored for depression, 
anxiety, and disease activity and if a worsening trajectory is observed at mid-point analyses, they will be 
removed from the study. 
 
The PI will document all study activities and communications and generate formal quarterly, annual and 
final reports that will be disseminated to the study team and NINR program officer. At least quarterly 
meetings will be held with the entire study team, for regular review of research progress and for general 
project oversight and guidance. 
 
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22
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31
The Research Nexus and Department of Rheumatology and Immunology at the Medical University of 
South Carolina. 
Laboratory.  The laboratory consists of approximately 1700 sq feet of space in the Strom Thurmond 
Research Building.  A tissue culture room is included in the laboratory space.  Additional core space is in 
the Strom Thurmond building including a cold room, a warm room and a large equipment room.  An 
additional 700sq ft of lab space is in the MUSC Children’s Research Institute including a tissue culture 
room and core space. 
            Clinical. Patients at MUSC are seen in the Rutledge Tower Ambulatory Care Center.  Phlebotomy 
services are available there and serum samples on all lupus patients seen at MUSC are currently 
obtained using the laboratory phlebotomy services.  Patients that are part of the MUSC cohort will be 
seen in the outpatient clinic space of the GCRC in the Clinical Research Building. 
            Animal.  Animals are housed in the Ralph H. Johnson animal facility that is in the Strom Thurmond 
Biomedical Research Building.  It is an AALAC approved facility and animals are maintained under 
pathogen free conditions. 
            Computer.  The laboratory has three G3/4 Macintosh computers and an additional four Dell 
Pentium computers.  Appropriate software is installed on the computers including MacVector.  Access to 
the GenBank is available through a server at MUSC.  Each computer is connected via ethernet to the 
main server at MUSC for email and internet access. 
            Offices.  Departmental heads have 125 ft2 offices adjacent to the laboratory space for personal 
use. One has an iMac and a G4 Powerbook computer for portable use and e other has a Dell PC and 
IBM laptop.  An outer office suite is available for administrative personnel along with three additional 
offices for laboratory personnel. 
Other.  Administrative support for this project is provided by the Division of Rheumatology.  A full time 
secretary is also on staff for other projects. 
Major Equipment.  The laboratory contains three dual block thermocyclers, two real time PCR machines, 
Amaxa Nucleofector device, three tissue culture hoods, three CO2 incubators, a spectrophotometer, an 
ELISA plate reader and plate washer, four power supplies, an electroporator, an HPLC apparatuses, a 
gel dryer, two table top centrifuges, water baths, various horizontal gel apparatuses, liquid nitrogen 
storage, a -80 freezer, two refrigerators and   -20 freezers.  Light, inverted, and fluoroscopic microscopes 
with digital camera setup are in the laboratory.  A Sievers 280 nitric oxide analyzer along with analysis 
equipment are in the laboratory.  A Molecular Dynamics Storm Phosphoimager is located in the 
laboratory.  Both large and small screens are available as well as a Macintosh G4 computer with 
appropriate soft- ware.  Core equipment includes an Excalibar flow cytometry machine, an Olympus 
confocal microscope, and an electron paramagnetic resonance imager.