A Widespread Self-management Education Program to Reduce Health Disparities in African American Women With Systemic Lupus Erythematosus
Phase: NA
Conditions: Lupus Erythematosus, Systemic
Sponsor: Emory University

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WOMEN EMPOWERED TO LIVE WITH LUPUS (WELL) STUDY 
[SUB-STUDY OF THE GEORGIANS ORGANIZED AGAINST LUPUS (GOAL) COHORT STUDY] 
 
 
 
 
Full Title: A widespread self-management education program to reduce 
health disparities in African American women with systemic lupus 
erythematosus 
 
Funding Source: NIH (NIMHD R01MD010455) 
 
Short Title: Women Empowered to Live with Lupus (WELL) Substudy 
 
Principal Investigator: Cristina Drenkard, MD, PhD 
 
NCT Number: NCT02988661 
 
 
 
 
 
Original Document Date:  August 26, 2016 
 
Revision Date: December 20, 2017 – Addition of the transcription services 
for the qualitative component 
 
 
Revision Date: April 4, 2019 – Increased enrollment number from 150 to 
168  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Lay Summary  
 
Systemic lupus erythematosus (SLE or lupus) is a chronic disease that 
predominantly strikes young African American women. Because SLE can potentially 
affect all organs and system, it has a substantial impact on the physical and 
psychological functioning of patients. Consequently, people living with lupus must 
engage in challenging self-management tasks to promote their wellbeing. For instance, 
patients are burdened with managing an array of medical symptoms and often 
expensive medications. Patients are also challenged with the emotional sequelae of a 
debilitating and painful condition, and are forced to make undesirable lifestyle changes.  
Successful self-management of SLE requires having the skills to engage in effective daily 
activities, which often comes from having access to up to date health education and self-
management support.  
 
Although self-management support is crucial to help patients to take control of their 
disease, no SLE-specific self-management program is widely available. The Chronic 
Disease Self-Management Program (CDSMP) or Living Well with a chronic condition 
Program is a nationwide accessible community-based self-management education 
program that contributes to improved health in people with a variety of chronic 
conditions.  Because the CDSMP is widely disseminated and available to the adult U.S. 
population through community centers, it may be a suitable and accessible option for 
African Americans with SLE, even though it is not specifically tailored to SLE or to 
African Americans. As the CDSMP has been primarily evaluated in predominantly white 
middle-class seniors with more common diseases (e.g. osteoarthritis, diabetes), the 
effectiveness of the CDSMP in helping African American women to self-manage SLE is 
unknown. This study will examine the effectiveness of the CDSMP to improve outcomes 
and reduce health care utilization in African American women with lupus. 
 
 
 
 
 
 
 
 

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BACKGROUND 
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease 
characterized by multi-system symptoms and an unpredictable course. SLE 
disproportionately strikes African American (AA) women of childbearing age. AA 
women with SLE at any age have significantly greater morbidly and mortality compared 
to Whites. Notably, AA women with SLE have been underrepresented in intervention 
research, which may be contributing to the existing health disparities and racial gaps in 
effective disease management. 
 
 
Because SLE impacts physical and psychological functioning, patients are 
burdened with managing an array of medical symptoms and often expensive 
medications, are challenged with the emotional sequelae of a debilitating and painful 
condition, and are forced to make undesirable lifestyle changes.  Successful self-
management of SLE requires having the skills to engage in effective daily activities, 
which often comes from having access to up to date health education and self-
management support.  
Self-management support is the provision of interventions to increase patients’ skills 
and confidence in managing their diseases, including assessment of problems, goal-
setting, action-planning, and problem-solving strategies. Although self-management 
support is crucial to help patients to take control of their disease, no SLE-specific self-
management program is widely available.  
 
The Chronic Disease Self-Management Program (CDSMP), also known as the 
Living Well Program, is an evidence-based nationwide accessible community-based self-
management education program that contributes to improved health in people with a 
variety of chronic conditions.  Because the CDSMP is widely disseminated and available 
to the adult U.S. population through community centers, it may be a suitable and 
accessible option for African Americans with SLE, even though it is not specifically 
tailored to SLE or to African Americans. As the CDSMP has been primarily evaluated in 
predominantly white middle-class seniors with more common diseases (e.g. 
osteoarthritis, diabetes), the effectiveness of the CDSMP in helping African American 
women to self-manage SLE is unknown. This study will examine the effectiveness of the 
CDSMP to improve outcomes and reduce health care utilization in African American 
women with lupus.  
 
Design Overview 
A random sample selected from our GOAL cohort will be used to recruit AA 
women with SLE into the WELL (Women Empowered to Live with Lupus) cohort. 
WELL participants will attend the CDSMP classes in the community, along with people 
with other chronic illnesses. Measures will be completed at baseline, 6, 12, and 18 
months. AA women from the GOAL cohort non-selected to be assigned to the 
intervention will comprise the usual care group. They will continue their routine annual 
assessments as part of the GOAL cohort efforts.  
 

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We will also conduct a longitudinal qualitative substudy to learn about African 
American women’s perspectives on (a) the processes through which the CDSMP affects 
self-management behaviors, health-related quality of life (HQRL), and healthcare 
service use; and (b) identify remaining challenges to successful SLE self-management 
after CDSMP participation. 
  
Recruitment and Informed Consent 
A random sample of SLE patients already recruited into the population-based 
GOAL study will be offered the opportunity to participate in the WELL Sub-study. 
Target enrollment will be 150 African American women who are resident of one of the 
metropolitan Atlanta counties where community-based CDSMP classes are provided. 
[Enrollment number increased to 168 to accommodate participants on a waiting list due 
to workshop cancellations and participants’ rescheduling needs (e.g., illness, 
hospitalizations, and family emergencies)]. Each woman will have the same probability 
of being chosen at any stage of the sampling process. Thus, we will ensure 
representation of the AA female 
population in the CDSMP. The only 
exclusion criteria will be participation in 
the CDSMP in the past 5 years. 
Women randomly selected will be 
mailed a flyer about the study and will 
receive a phone call by the Project 
Coordinator (PC) within the following 
week. During the phone call, the PC will 
assess the entry and exclusion criteria and 
will explain the study and level of 
participants’ commitment needed to 
ensure study integrity. Interested 
participants will receive a packet with the 
consent, information of the CDSMP 
workshops schedule and location, a list of 
measures and study staff contact 
information. The PC will follow up with a 
phone call within 1 week to answer any 
questions and finalize the recruitment and 
CDSMP registration. Since this study 
entails minimal risk, interested GOAL 
participants will be consented via mail, e-
mail, in person or telephone.  
The PC will coordinate CDSMP 
schedules and locations with CDSMP 
leaders, in order to facilitate the registration of WELL participants in CDSMP 
workshops at convenient locations and schedules. Participants of the WELL Substudy 
will receive monetary compensation for the research tasks (gift cards of $35 $40, $45 
and $50 for the baseline, 6-, 12- and 18-month assessments, respectively, and a round-
trip MARTA card,  $10.00 gas card, or shuttle/taxi services for transportation costs.  
 
Table 1.  Summary of Study Measures 
Category 
Measure 
Tool 
Self-management 
Behaviors 
Communication 
with Physicians 
3-item scale 
Medication 
Adherence  
MMAS-8 
Health-related 
Quality of Life 
Global Health  
PROMIS 
Physical Function PROMIS 
Pain Interference PROMIS 
Fatigue 
PROMIS 
Sleep  
PROMIS 
Anxiety 
PROMIS 
Social Function 
PROMIS 
Disease Severity Disease Activity 
SLAQ 
Organ Damage  
SA-BILD 
Multimorbidity 
CCHP 
Depression  
PROMIS 
Demographics Age 
Ad-hoc 
Education 
Ad-hoc 
Employment 
Ad-hoc 
Social Support 
Ad-hoc 
Health Service 
Utilization 
ED visits  
GA HDDB 
Hospitalizations 
GA HDDB 
MMAS; Morisky Medication Adherence Scale; 
PROMIS: Patient-Reported Outcome Measurement 
Information System; SLAQ: Systemic Lupus Activity 
Questionnaire; SA-BILD: Self-administered Brief 
Index Lupus Damage; ED: emergency department; 
GA HDDB: Georgia Hospital Discharge Database 

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Data Collection 
Self-reported data.  Baseline assessment for WELL participants will take place 
within the 4 weeks that precede the start of the CDSMP classes. Post-intervention 
assessments will be scheduled at 6-, 12- and 18-month after baseline. All patient-
reported measures will be collected online using the RedCap database. WELL 
participants will have a 2-week window to respond to the online surveys. Participants 
without computer access or those who do not complete the online survey within 2 weeks 
will be phone-interviewed.  
All self-reported measures collected for WELL participants are included in the 
GOAL survey and summarized in Table 1. The time needed to complete the self-reported 
data survey will be between 20 and 40 minutes.  
 
Data on Health Service Utilization (HSU). These data will be obtained by a well-
established linkage procedure that links the GOAL cohort data with the GA Hospital 
Discharge Database (IRB#55041). This database contains claims data on emergency 
department (ED) visits and hospital admissions, including causes of admissions and ED 
visits. 
 
CDSMP Implementation  
The CDSMP consists of six weekly sessions, each lasting 2.5 hours, led by two 
peer leaders and conducted in a small group workshop format with 10 -16 participants. 
CDSMP clients are community adult men and women of all races and ages with a variety 
of chronic conditions (e.g., diabetes, heart disease, arthritis) who all are interested in 
learning self-management skills.  WELL participants will be referred to CDSMP at 
community centers in Atlanta. Participants will have the flexibility to register for 
workshops based on the convenience of the location and CDSMP schedule. The 
importance of attending all CDSMP classes will be emphasized during recruitment. 
Attendance at 4 or more classes will be considered “program completion” for purposes 
of analyses. The PC will check in with each participant about the last week’s class 
attendance at the reminder phone call for the next class. Reasons for missing classes will 
be collected.  
CDSMP Certified Leaders: CDSMP lay leaders are trained and certified according to the 
Stanford Patient Education Center Protocol, updated in 2012. Leaders will be selected 
and overseen by the community organizations offering the classes and will not receive 
any specific training from the research team on SLE.  
 
Analytic Methods 
Data will be organized and cleaned following quality control procedures after each 
wave, involving identifying outliers and inappropriate patterns of missing data. 
Psychometric properties of known measures will be compared with reported properties. 
For multi-item scales and indices, we will use methods such as reliability and factor 
analyses for data reduction and formation of composite summary variables. 
Confirmatory factor analyses will be conducted to evaluate the consistency and fit of 
individual items to a combined construct. We will make every attempt to avoid missing 
data by discouraging omissions, e.g., by ensuring confidentiality of responses in the 

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study description and encouraging participants to respond to each question.  
For patient-reported and health services utilization outcomes, analysis of repeated 
measures data is needed that properly accounts for the correlation between multiple 
observations from the same participant. Two commonly used models to analyze such 
data will be employed: the mixed-effects model and the generalized estimating 
equations (GEE) approach.60 Both approaches allow for covariate adjustment. The 
results will be summarized with adjusted means and 95% confidence intervals for 
continuous outcomes. GEE can also be used to analyze count data (e.g., ED visits), 
ordinal data, and to perform a logistic regression of repeated binary responses within 
participants. Low classes attendance may attenuate outcome change and have a negative 
impact on study integrity. Longitudinal analyses will allow us to estimate the effect of 
CDSMP attendance (# of classes attended) on outcome change.  
 
Qualitative component 
A longitudinal qualitative substudy will be conducted to learn about WELL 
participants’ perspectives on (a) the processes through which the CDSMP affects self-
management behaviors, HQRL, and healthcare service use; and (b) identify remaining 
challenges to successful SLE self-management after CDSMP participation. 
       a) Recruitment.  We will use a form of purposive sampling to generate a subsample 
of 25 women from the WELL Substudy that is varied with respect to 4 characteristics 
that are relevant to the research question: depression, disease activity, age and 
educational attainment. Participants will be randomly drawn from the WELL Substudy 
prior to beginning the CDSMP. Responses from the most recent GOAL survey will be 
used to stratify the WELL Substudy at enrollment by pre-intervention measures of 
depression, disease activity, age, and education. Eligible women from each of these 
strata will be called and recruited for the interview.  
      b) Interviews. Wave 1 interview will be conducted after the baseline survey and 
before the start of the CDSMP. Wave 2 interview will be conducted one month after 
completion of the CDSMP.  Each in-person interview will be conducted by a graduate 
research assistant (GRA) student, and will take 60-90 minutes. With participant’s 
permission, interviews will be audiotaped and transcribed verbatim, which strengthen 
the validity of the qualitative analysis. Participants will be able to choose among several 
interview locations at the Rollins School of Public Health or Emory School of Medicine 
Grady campus, located in downtown Atlanta.  Each participant will receive a round-trip 
MARTA card (or $10 gas card) for transportation, and $35 and $40 for taking part in 
the two interviews, respectively. Providing slightly increasing amounts for data 
collection has been used in other studies as a successful retention strategy.  
       c) Outcomes. We will develop a semi-structured interview guide to explore women’s 
definitions of “successful SLE self-management,” “HRQL,” and “successful health 
services utilization,” and their efforts and challenges in managing SLE and improving 
their HRQL and health services utilization. After the intervention, domains will include 
their current definitions of “successful SLE self-management,” “HRQL,” and “successful 
health services utilization.” As is common in qualitative research, we will analyze data as 
we gather it. Ongoing analyses allow altering the guide in response to emerging findings.  
 
d) Analytic Methods. We will use a longitudinal qualitative design to learn about 

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women’ perspectives of the challenges to successful SLE self-management; women’s 
efforts and remaining challenges after participating in the CDSMP; and women’s views 
of the processes through which participating in CDSMP affected women’s self-
management behaviors, HRQL and healthcare service use. We will use thematic 
methods to analyze interviews’ transcripts.  
We plan to work with an independent transcription service, Transcript Divas, to 
transcribe qualitative interviews. The transcribers who work for this company will sign a 
confidentiality agreement to assure the privacy of interview respondents and any 
identifying information. Each participant's audiofile  will be uploaded to a secure 
encrypted website owned by Transcript Divas.  Audiofiles will be transcribed, transcripts 
will be returned to the researchers via this same encrypted website, and audiofiles (both 
at transcript divas and at Emory) will be destroyed after transcription.  
 
Qualitative findings will generate a deeper understanding of how AA women with 
SLE define successful “SLE self-management”, “health-related quality of life” and 
“health service utilization” before taking part in CDSMP; and of how these definitions 
change after participating in CDSMP. It will also help identify challenges that AA 
women perceived to successful self-management of SLE before and after participating in 
CDSMP. This aim will also explore variations of women’s definitions and experiences 
across participants’ characteristics.    
 
 
RISKS TO PARTICIPATION 
Potential risks to participants are considered minimal. This study involves 
primarily attending an evidence-based community-based education program to learn 
about chronic disease self-management, and answering questions.  Some people find 
answering questions frustrating.  We will choose questions carefully to be sure that we 
will collect only necessary information.  Demands on participants will be minimized; 
time required to fill out surveys will not exceed 45 minutes.  Letters and written 
information will be at the 8th-grade level.  Additionally, participants will have the option 
to complete the surveys by telephone, mail, face-to-face, or web according to their needs 
and/or preferences.   
 
SOURCES OF MATERIALS  
  
Involvement of human subjects for this study includes the completion of surveys, 
participation in the Chronic Disease Self-Management Program (CDSMP) and optional 
semi-structured interviews among those participants enrolled into the WELL cohort. 
Surveys will be done at four intervals (baseline, 6-month, 12-month, and 18-month post 
baseline) by computer or by telephone. WELL participants will attend the CDSMP 
workshop at a convenient location. Through quota-sampling, a purposive sample of 25 
CDSMP participants will be enrolled in a qualitative substudy to participate in semi-
structured interviews. Interviews will be conducted in-person at two intervals (pre- and 
post- CDSMP workshop completion).  
As previously discussed, the types of data that will be obtained from WELL 
(CDSMP) participants are self-reported data from questionnaires and semi-structured 
interviews. Validated instruments will be used to examine self-management behaviors 
and health-related quality of life. NIH-PROMIS measures will be used to assess the 
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through online surveys using the Research Electronic Data Capture (REDCap), which is 
a mature, HIPPA compliant secure web application for building and managing online 
surveys and databases. Participants may also request to have the questionnaire 
interviewer-administered via telephone.  
Qualitative semi-structured interviews will be designed to explore personal 
definitions of successful self-management, health-related quality of life, health service 
utilization and challenges to the successful management of SLE. Interviews will be audio 
recorded and transcribed verbatim. Audio recordings and transcripts will be stored on 
an encrypted password-protected computer. Any printed transcripts will be stored in 
locked cabinets. 
De-identified data routinely collected from those GOAL participants receiving 
usual care, who meet the same inclusion and exclusion criteria than WELL participants 
(CDSMP group), will be used to enable the comparison of study outcomes between the 
CDSMP group and the usual care group.  
Health services utilization data will be obtained under the auspices of the Georgia 
Department of Public through a well-established procedure that links the GOAL cohort 
data with the GA Hospital Discharge Database. Thus, for both the CDSMP and usual 
care groups, administrative claims data regarding emergency department visits and 
hospitalizations will be captured from the GA Hospital Discharge Database. This 
includes the number and characteristics of visits to the emergency department and the 
number and characteristics of hospital admissions. These data will be stored on an 
encrypted password-protected computer.  Emory University and GA Department of 
Public Health have provided the IRB approval needed to conduct the databases linkage 
necessary to obtain health services utilization data for the GOAL population-based 
cohort. 
 
POTENTIAL BENEFITS 
Participants may benefit from having direct access to an education program that 
may help them self-manage their SLE. They may gain an increased knowledge of their 
behaviors and their health, and enhance the skills they use to manage their disease. 
Results from this study may provide another option for SLE patients to improve health 
education and the skills needed to better self-manage the symptoms of their disease. 
Results from this study may also be relevant to efforts to improve health outcomes and 
health care utilization among African American women with SLE, by potentially 
disseminating the findings on the effectiveness of the CDSMP in the lupus community, 
including patients, providers, payers and policymakers. Findings may also inform 
broader public health policies by drawing attention to SLE in African American 
communities, for which there is a paucity of existing research; and may also highlight 
self-management activities in this population. Accordingly, findings from this study 
have the potential to benefit the broader population of African American women with 
SLE, and may generate results that can be used to design strategies to manage SLE. 
Participants will be kept informed about the study progress through annual newsletters 
 
TRAINING 
The Research Coordinator and Graduate Research Assistants will be trained in all 
components of this study:  Consenting, Data Collection, Data Entry.  They will be 
trained to address participants’ questions/concerns and explain study purpose and 

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importance. They will also be training on the importance of appropriate telephone 
etiquette and prompt replies.  
PROTECTIONS AGAINST RISKS 
 
Surveys and workshop settings are designed to minimize risks. Demands on 
participants will be minimized; time required to fill out quantitative measures will not 
exceed 40 minutes. Moreover, we have developed safeguards for protecting against the 
loss of confidential data. Personal identification information used for contacting 
participants and tracking their participation in the CDSMP will be stored in a separate 
secure database that is encrypted and password protected. This data will only be 
accessible to the investigators and project coordinators in order to contact participants 
for recruitment, scheduling, and data collection reminders. Participants will be assigned 
a unique identification number that will be linked to analytical data. Participants who 
opt to complete a web-based questionnaire must have access to a stable Internet 
connection. Participants will be given a unique identifier to login to the web page. Once 
authenticated, the participant will be prompted to complete the survey.  The web-based 
system will be firewall protected and SSL certified. For those who request to complete 
annual surveys via telephone, upon verifying the identity of the participant, the 
Research Coordinator will be trained to enter responses directly into the computer via 
the web-based system. 
In order to minimize the potential that some subjects may feel coerced to 
participate and to protect the rights and welfare of all subjects, study staff will take 
precautions: (1) during the informed consent process, subjects will be informed that 
participation is voluntary and that they may withdraw at any time without penalty and 
(2) subjects will be given printed copies of the informed consent form including contact 
information for the principal investigator and the IRB. 
 
 
Participants may also experience psychological discomfort from sensitive items 
on the questionnaire. However, the majority of questions are from standard instruments 
that have been previously used in the target population of the study. Participants will 
also be told that they may refuse to answer any question.  
Hard copies of informed consent forms in addition to all personal identifying 
information will be stored in a locked file cabinet in a locked office, which will be 
attached to a unique identifier to connect the different types of data that are being 
collected. Hard copy interest reply cards that ask for participants’ contact information 
will be destroyed within one year of receipt. Personally identifying information that will 
be used for tracking and locating participants, including names and addresses, will be 
held in a separate, secure file that is encrypted and password protected. This 
information will only be accessible to the principal investigators and project coordinator 
in order to contact participants for recruitment and scheduling. All analytic data will be 
de-identified. Individually identifiable information will not be linked to survey data. 
Rather, we will use unique participant identifiers to link types data within study wave 
components and across data waves.  
Computers storing data will be password protected. The anonymity of all study 
data will be assured by the appearance of their identity linked to their Study ID only on 
a single log to be maintained and stored in locked files.  Accounts and passwords will be 
issued only to staff involved with the direct processing of the data, and only these 
individuals will have access to any of the files.  

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Research Electronic Data Capture (REDCap) is the program that will be used to collect 
survey data via the computer and Internet. This is a secure and web-based program that 
is HIPAA compliant. Security is based on Emory Net IDs and there are many levels of 
user rights that enable the investigators to control who has access to identifiable data. 
All data are stored at Emory in a secure, HIPAA compliant zone and are backed up by 
University Technology Services (UTS) regularly.  
 
CONFIDENTIALITY 
All facts about participants will be kept private.  Participants’ identifiers will be used 
for contact purposes and to track CDSMP workshops attendance. Identifiers will not be 
linked to the research database. All surveys will display record numbers instead of 
personal identifiers. All research data will be stored on a HIPPA compliant server. Only 
team members based on assigned role limitations will be able to access the data. 
 
RECRUITMENT AND INFORMED CONSENT  
The randomized sample will be mailed a packet including detailed instructions 
regarding the requirements for this study and a copy of the consent form. This provides 
potential participants with an opportunity to closely review documents and ask 
questions before determining their interest and availability. If interested, a research 
coordinator will discuss the study further and start the telephone consent process. 
Potential study participants will be enrolled after a full understanding of the purpose, 
rationale and procedures of the study is reached. Informed consent will be obtained 
during this telephone discussion. In some circumstances, informed consents may be 
also obtained by written, or online-based methods (RedCap).  Written consent will occur 
during face-to-face visits of selected participants to their clinic appointments. During 
telephone recruitment process, participants will also be given the opportunity to finalize 
the consent process through the RedCap online system, once all questions are answered 
and concerns addressed by the RC. All informed consent conversations will be 
documented and stored with consent. 
The information in the consent form will be reviewed in detail and a verbal 
agreement to participate in this study will be obtained. Similarly, the graduate research 
assistant (GRA) will call participants randomly selected for the qualitative substudy. 
During a face-to-face interview with the GRA, potential qualitative substudy 
participants will be enrolled after a full understanding of the purpose, rationale, and 
procedures of the study is reached.  
 
NEW FINDINGS 
This study will add to knowledge, on multiple system levels including patient, 
health care system and public health. This knowledge will contribute to filling a 
longstanding void in self-management needs for SLE patients. By addressing this unmet 
need, this knowledge could lead to a reduction in the overall disease burden and health 
disparities in SLE.  
 
DATA SAFETY AND MONITORING PLAN 
The PI will be responsible for the oversight and monitoring of the study activities 
to ensure the safety of participants and validity and integrity of the data.  
 
Monitoring the Progress of Research and Participants’ Safety  

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Study staff will receive extensive training on data collection protocols, including 
methods for presenting the study and responding to questions. All study staff will be 
certified to conduct research on human beings and will sign a confidentiality agreement. 
The Project Coordinator will be trained not to deviate from any standardized techniques 
when completing surveys by telephone. He/her will receive training about research 
ethics with a focus on the importance of confidentiality and safety. The Project 
Coordinator and graduate research assistant staff will also be trained to recognize and 
document any unusual circumstances that they observe while collecting data. 
Observations will be recorded on comment cards that the Project Coordinator reviews.  
Should a major, sensitive issue be arising in the process of data collection (e.g., suicidal 
thoughts), research personnel collecting the information will: 1) Provide the participant 
with referral to the Georgia Crisis and Access Line [GCAL]; phone number: 1-800-715-
4225), if the participant is capable of calling on her own. The GCAL is a resource 
provided by the Georgia Department of Behavioral Health and Developmental 
Disabilities. GCAL is staffed with professional social workers and counselors 24 hours, 7 
days per week and will ensure that the participant receives a mental health referral that 
is local for the participant. 2) In the case of immediate emergency (e.g. imminent danger 
to self or others), research personnel will directly contact GCAL or local authorities on 
behalf of the participant.  
 
Reporting adverse events 
The proposed research will examine the CDSMP, an evidence-based self-
management education program that has been implemented for over 20 years in the 
community across the country, in a population with SLE. Participating in the proposed 
research does not involve more than minimal risk. Adverse events are not anticipated, 
but should an unanticipated adverse event occur, the principal investigator will report 
the event immediately to the Emory University Institutional Review Board. Should the 
unanticipated adverse event be research related, it will be reported to the Office of 
Human Research Protections and the NIH project officer, along with a description of the 
event. The NIH project officer will be informed of any IRB action taken concerning 
unanticipated adverse events. All project personnel will adhere to state laws regarding 
the reporting of these events. Limitations of confidentiality are discussed during the 
informed consent process.   
Cumulative adverse events and study progress summary will be communicated to 
the IRBs at the time of continuing review. 
 
Data accuracy and protocol compliance 
The principal investigator will be responsible for reviewing protocol compliance, 
data collection and verification. Protocols for data collection (Case Report Form 
Design), data back-up, routine data management, and data quality audits will be in 
place before the enrollment of the first participant into the study and through the data 
collection. Monthly data summary reports and data tracking reports will be 
generated by the data analyst to assure data quality and procedural adherence.  
Reports will include data on screening and recruitment, the status of case report form 
completion, queries regarding data edit checks for data accuracy, baseline 
demographic and covariate data, CDSMP workshop attendance, a longitudinal 

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summary of patient-reported outcomes and missing data, and cohort retention. 
Quality control will be applied to each stage of data handling to ensure that all data 
are reliable and have been processed correctly.  
 
NIH DATA AND SAFETY MONITORING BOARD  
The proposed study is exempted from the NIH Data and Safety Monitoring Board 
requirement because the research will be conducted in community delivered, commonly 
accepted educational settings, involving an evidence-based self-management 
educational program for people with chronic conditions. Participating in the proposed 
research does not involve more than minimal risk. 
 
CLINICALTRIALS.GOV REQUIREMENTS  
This research will examine the effectiveness of the CDSMP, an evidence-based 
community-based self-management education program, on patient reported outcomes 
and health care utilization among African American (AA) women with SLE. A random 
sample selected from our parent GOAL cohort will be used to recruit AA women with 
SLE into the WELL (Women Empowered to Live with Lupus) cohort. WELL 
participants will attend the CDSMP classes in the community, along with people with 
other chronic illnesses. Measures will be completed at baseline, 6, 12, and 18 months. 
AA women from the GOAL cohort non-selected to be assigned to the intervention will 
comprise the usual care group. They will continue their routine annual assessments as 
part of the GOAL cohort efforts.  
This research meets the NIH definition of a clinical trial because it entails the 
prospective assignment of SLE patients to the CDSMP to evaluate the effect of the 
intervention on health-related outcomes. Our research will be conducted in commonly 
accepted educational settings, involving an evidence-based self-managing educational 
program to gather information on the effect of the intervention in a population of SLE 
patients.   
This study is exempted from the Public Law 110-85 for mandate 
registration and results reporting of “applicable clinical trials” in 
ClinicalTrials.gov because the study does not include 1) Trials of Drugs or 
Biologics; or 2) Trials of Devices. However, following NIH recommendations for all 
clinical trials, the PI will register the research at the ClinicalTrials.gov Protocol 
Registration System Information Website (http://prsinfo.clinicaltrials.gov/) before 
starting the recruitment of the first participant. Upon the receipt of the NCT 
ClinicalTrials.gov registry number, we will submit results under the voluntary 
submission provision.    
 
 
 
 
 
 
 
 
 
 
 

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