WELL: Women Empowered to Live With Lupus Study

• Sponsor: Emory University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02988661
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD) (NIH), Centers for Disease Control and Prevention (U.S. Fed)
• Enrollment: 699
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 70.4
• Patients Per Site Per Month: 9.9

Study Details

Study Description

Brief Summary

The purpose of this research is to examine whether the Chronic Disease Self-management Program (CDSMP) would improve health outcomes and reduce health care use in African American women with systemic lupus erythematosus (SLE). The CDSMP is a generic, evidence-based self-management education program that has been shown to help people with chronic conditions to take control of their health problems. This study focuses on African American women with SLE because the CDSMP has not been widely studied in this population.

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Systemic	Behavioral: Chronic Disease Self-Management Program (CDSMP)	N/A

Detailed Description

The CDSMP is an evidence-based, community-based, generic self-management program that consists of 6 weekly classes of two and a half hours each one, for six weeks. CDSMP classes are facilitated by certified peer leaders. 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 patient-reported outcomes and reduce health care utilization in African American women with lupus. Using a two-group longitudinal cohort design with participants sampled from a parent population-based SLE cohort in Georgia, investigators will examine behaviors, health and healthcare outcomes, and the extent to which individual characteristics modify the effectiveness of the CDSMP.

The Georgians Organized Against Lupus (GOAL), a longitudinal cohort of patients with a validated diagnosis of SLE, will be used to enroll participants into the intervention. A random sample of African American women with SLE selected from the parent GOAL cohort will be recruited 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. WELL participants will be asked to attend the CDSMP in the community and answer questionnaires at 4 select time periods before and after the program. Investigators will follow participant's progress for up to 18 months after they attend the CDSMP.

African American women from the GOAL cohort non-selected to be assigned to the intervention will comprise the usual care group. Participants will continue their longitudinal assessments as part of the GOAL cohort data collection efforts. Changes in outcomes for up to 18 months will be compared between WELL participants and the usual care group.

Study Design

• Study Type: Interventional
• Actual Enrollment: 699 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Widespread Self-management Education Program to Reduce Health Disparities in African American Women With Systemic Lupus Erythematosus
• Actual Study Start Date: Jan 19, 2017
• Actual Primary Completion Date: Feb 26, 2021
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Chronic Disease Self-management Program (CDSMP) A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort will be used to recruit participants into the CDSMP. This group will be identified as the WELL Cohort.	Behavioral: Chronic Disease Self-Management Program (CDSMP); The CDSMP consist of 6 weekly classes of two and a half hours each one, for six weeks. A group of 10-16 people with different chronic conditions attend the classes together. Classes are facilitated by two certified leaders, one or both of whom are non-health professionals with chronic diseases. The workshop covers topics such as: 1) how to deal with frustration, fatigue, pain and isolation, 2) exercise for maintaining and improving strength, flexibility, and endurance, 3) communicating effectively with family, friends, and health professionals, 4) nutrition, 5) decision making, 6) appropriate use of medications and how to evaluate new treatments. Participants receive a companion book, Living a Healthy Life with Chronic Conditions, and an audio relaxation CD, Relaxation for Mind and Body.; Other Names: Living Well with a Chronic Condition Workshop
No Intervention: Usual Care African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who have not been selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.

Outcome Measures

Primary Outcome Measures

1. Communication With Physician - Stanford 3Q Scale Score [Baseline, Months 6, 12, and 18]

   The Stanford 3Q Scale is a three-question measure that assesses communication between patients and physicians. The participant is asked to rank their responses using a 5-point Likert scale. Total scores range fro 0 to 5 and a higher score indicates better communication with physicians.

2. Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score [Baseline, Months 6, 12, and 18]

   Self-efficacy for managing medical care was assessed with the PROMIS Self-efficacy for Managing Medications and Treatments Short Form (SF) 8a instrument. This is an eight-item tool that quantifies the level of current confidence (from 1=not confident at all to 5=very confident) a person with a chronic condition has in taking and managing medication and other treatments in challenging situations (e.g., traveling, running out of medication, occurrence of side effects). Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher score indicates better self-efficacy for managing medications and treatments; scores higher than 50 indicate greater self-efficacy for managing medical care compared to the reference population.

3. PROMIS Global Health Physical Health Domain Score [Baseline, Months 6, 12, and 18]

   The PROMIS for Global Health short form is a 10-item instrument representing multiple domains such as general health, quality of life, and mental health. Participants will be asked to respond to questions on a scale from 1 to 5, where 1 represents poor health, and 5 represents excellent health. Total raw scores are calculated for two domains: Physical Health and Mental Health. Raw scores are further converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better physical health; scores higher than 50 indicate greater physical health compared to the reference population..

4. PROMIS Global Health Mental Health Domain Score [Baseline, Months 6, 12, and 18]

   The PROMIS for Global Health short form is a 10-item instrument representing multiple domains such as general health, quality of life, and mental health. Participants will be asked to respond to questions on a scale from 1 to 5, where 1 represents poor health, and 5 represents excellent health. Total raw scores are calculated for two domains: Physical Health and Mental Health. Raw scores are further converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better mental health; scores higher than 50 indicate better mental health compared to the reference population.

5. PROMIS Physical Function Score [Baseline, Months 6, 12, 18]

   The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function SF 10b is a self-administered instrument that assesses self-reported capability rather than actual performance of physical activities. Participants are asked to respond to questions regarding the extent of their physical function. Responses range from 1 to 5, where 1 represents "unable to do" and 5 represents "without any difficulty". Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better physical function capabilities; scores higher than 50 indicate greater physical function compared to the reference population.

6. PROMIS Pain Interference Score [Baseline, Months 6, 12, and 18]

   The PROMIS Pain Interference SF 8a is a self-administered instrument that assesses the interference of pain on daily activities. Participants are asked to respond to questions regarding the extent of their pain. Responses range from 1 to 5, where 1 represents "not at all" and 5 represents "very much". Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A lower score indicates the least amount of pain interference; scores higher than 50 indicate greater pain interference compared to the reference population.

7. PROMIS Fatigue Score [Baseline, Months 6, 12, and 18]

   The PROMIS Fatigue SF 8a is a self-administered instrument that assesses fatigue level within the past seven days. Participants are asked to respond to questions regarding fatigue frequency. Responses range from 1 to 5, where 1 represents "never" and five represents "always". Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10; scores higher than 50 indicate greater fatigue compared to the reference population.

8. PROMIS Sleep Disturbance Score [Baseline, Months 6, 12, and 18]

   The PROMIS Sleep Disturbance SF 8a is a self-administered instrument to assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. It assesses sleep disturbance over the past seven days. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates more sleep disturbance; scores higher than 50 indicate greater sleep disturbance compared to the reference population.

9. PROMIS Anxiety Score [Baseline, Months 6, 12, and 18]

   The PROMIS Anxiety SF 8a is a self-administered instrument to assess emotional distress within the past seven days. Participants are asked to rate their anxiety level for various items ranked from 1 to 5, where 1 represents "never" and 5 represents "always". Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates high anxiety; scores higher than 50 indicate greater anxiety compared to the reference population.

10. PROMIS Ability to Participate in Social Roles and Activities Score [Baseline, Months 6, 12, 18]

    The PROMIS Ability to Participate in Social Roles and Activities SF 8a is a self-administered instrument to assess perceived ability to perform one's usual social roles and activities. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better perceived abilities; scores higher than 50 indicate better perceived abilities to participate in social activities and roles compared to the reference population.

Secondary Outcome Measures

1. Patient Activation Measure (PAM-10) Score [Baseline, Months 6, 12, and 18]

   The Patient Activation Measure (PAM) is a tool to assess an individual's knowledge, skill, and confidence for managing one's 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. The PAM survey measures patients on a 0-100 scale and can segment patients into one of four activation levels along an empirically derived continuum. Data on PAM-10 scale values are pending receiving the scores from Insignia, which is the organization that owns the license.

2. PROMIS Adult Self-Efficacy Score [Baseline, Months 6, 12, and 18]

   The PROMIS Adult Self-Efficacy SF 4a is a self-administered instrument to assess current level of confidence in managing symptoms of chronic conditions. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates higher self-efficacy; scores higher than 50 indicate greater self-efficacy compared to the reference population.

3. PROMIS Anger Score [Baseline, Months 6, 12, and 18]

   The PROMIS Anger SF 5a is a self-administered instrument to measure angry mood (irritability, frustration), negative social cognitions (interpersonal sensitivity, envy, disagreeableness), and efforts to control anger. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates more anger; scores higher than 50 indicate greater anger compared to the reference population.

4. Perceived Stress Scale 4 (PSS-4) Score [Baseline, Months 6, 12, and 18]

   The Perceived Stress Scale 4 (PSS-4) is the most widely used psychological instrument for measuring the perception of stress. Participants are asked to rank responses to each of the four items on a scale from 0 to 4, where zero means never and four means very often. Total scores range from 0 to 16 and a higher score indicates higher perceived stress.

5. Hospitalization Rate [Up to 2 years]

   The number of hospitalizations will be collected from the Georgia Department of Public Health (DPH) administrative data for the pre- and post-intervention period (up to two years). The Georgia DPH has been focused on the Coronavirus Disease 2019 (COVID-19) pandemic which has caused delays in obtaining the information for this outcome measure.

6. Emergency Department Visit Rate [Up to 2 years]

   The number of emergency department visits will be collected from the Georgia DPH administrative data for the pre- and post-intervention period (up to two years). The Georgia DPH has been focused on the COVID-19 pandemic and obtaining information for this outcome measure has been delayed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Currently participating in the GOAL study

Exclusion Criteria:

• Participation in the Chronic Disease Self-Management Program (CDSMP) in the past five years

• Significant cognitive impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Emory University
• National Institute on Minority Health and Health Disparities (NIMHD)
• Centers for Disease Control and Prevention

Investigators

• Principal Investigator: Cristina M Drenkard, MD, PhD, Emory University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 4, 2019
• Informed Consent Form - Aug 15, 2018

More Information

Publications

None provided.

• Responsible Party: Cristina M Drenkard, Associate Professor, Emory University
• ClinicalTrials.gov Identifier: NCT02988661
• Other Study ID Numbers: IRB00003656; R01MD010455
• First Posted: Dec 9, 2016
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cristina M Drenkard, Associate Professor, Emory University: Autoimmunity; Immune System Disorders
• Additional relevant MeSH terms: Lupus Erythematosus, Systemic

Study Results

Participant Flow

Recruitment Details	Participants were recruited through Emory University in Atlanta, Georgia, USA. Participant enrollment began January 19, 2017 and the 18-month follow-up assessments were completed by February 26, 2021.

Arm/Group Title	Chronic Disease Self-management Program (CDSMP)	Usual Care
Arm/Group Description	A random sample of African American women with systemic lupus erythematosus (SLE) selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the chronic disease self-management program (CDSMP). This group is identified as the Women Empowered to Live with Lupus (WELL) Cohort.	African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
Period Title: Overall Study
STARTED	168	531
COMPLETED	165	447
NOT COMPLETED	3	84

Baseline Characteristics

Arm/Group Title	Chronic Disease Self-management Program (CDSMP)	Usual Care	Total
Arm/Group Description	A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.	African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.	Total of all reporting groups
Overall Participants	168	531	699
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	151 89.9%	473 89.1%	624 89.3%
>=65 years	17 10.1%	58 10.9%	75 10.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.8 (12.3)	47.3 (14.0)	47.9 (13.7)
Sex: Female, Male (Count of Participants)
Female	168 100%	531 100%	699 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	168 100%	531 100%	699 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	168 100%	531 100%	699 100%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	168 100%	531 100%	699 100%

Outcome Measures

1. Primary Outcome

Title	Communication With Physician - Stanford 3Q Scale Score
Description	The Stanford 3Q Scale is a three-question measure that assesses communication between patients and physicians. The participant is asked to rank their responses using a 5-point Likert scale. Total scores range fro 0 to 5 and a higher score indicates better communication with physicians.
Time Frame	Baseline, Months 6, 12, and 18

Outcome Measure Data

Analysis Population Description

This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.

Arm/Group Title	Chronic Disease Self-management Program (CDSMP)	Usual Care
Arm/Group Description	A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.	African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
Measure Participants	168	522
Baseline	3.1 (1.1)	2.9 (1.1)
Month 6	3.3 (1.2)	3.0 (1.1)
Month 12	3.3 (1.1)	3.0 (1.1)
Month 18	3.3 (1.1)	3.0 (1.1)

2. Primary Outcome

Title	Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score
Description	Self-efficacy for managing medical care was assessed with the PROMIS Self-efficacy for Managing Medications and Treatments Short Form (SF) 8a instrument. This is an eight-item tool that quantifies the level of current confidence (from 1=not confident at all to 5=very confident) a person with a chronic condition has in taking and managing medication and other treatments in challenging situations (e.g., traveling, running out of medication, occurrence of side effects). Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher score indicates better self-efficacy for managing medications and treatments; scores higher than 50 indicate greater self-efficacy for managing medical care compared to the reference population.
Time Frame	Baseline, Months 6, 12, and 18

Outcome Measure Data

Analysis Population Description

This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.

Arm/Group Title	Chronic Disease Self-management Program (CDSMP)	Usual Care
Arm/Group Description	A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.	African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
Measure Participants	168	524
Baseline	46.1 (9.1)	46.1 (9.2)
Month 6	47.0 (9.0)	47.5 (8.5)
Month 12	46.2 (8.8)	47.0 (8.9)
Month 18	45.9 (8.7)	48.3 (9.2)

3. Primary Outcome

Title	PROMIS Global Health Physical Health Domain Score
Description	The PROMIS for Global Health short form is a 10-item instrument representing multiple domains such as general health, quality of life, and mental health. Participants will be asked to respond to questions on a scale from 1 to 5, where 1 represents poor health, and 5 represents excellent health. Total raw scores are calculated for two domains: Physical Health and Mental Health. Raw scores are further converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better physical health; scores higher than 50 indicate greater physical health compared to the reference population..
Time Frame	Baseline, Months 6, 12, and 18

Outcome Measure Data

Analysis Population Description

This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.

Arm/Group Title	Chronic Disease Self-management Program (CDSMP)	Usual Care
Arm/Group Description	A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.	African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
Measure Participants	166	530
Baseline	38.3 (7.5)	40.6 (8.8)
Month 6	39.0 (7.5)	40.0 (8.6)
Month 12	38.9 (7.6)	40.3 (8.7)
Month 18	39.1 (7.5)	40.3 (8.8)

4. Primary Outcome

Title	PROMIS Global Health Mental Health Domain Score
Description	The PROMIS for Global Health short form is a 10-item instrument representing multiple domains such as general health, quality of life, and mental health. Participants will be asked to respond to questions on a scale from 1 to 5, where 1 represents poor health, and 5 represents excellent health. Total raw scores are calculated for two domains: Physical Health and Mental Health. Raw scores are further converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better mental health; scores higher than 50 indicate better mental health compared to the reference population.
Time Frame	Baseline, Months 6, 12, and 18

Outcome Measure Data

Analysis Population Description

This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.

Arm/Group Title	Chronic Disease Self-management Program (CDSMP)	Usual Care
Arm/Group Description	A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.	African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
Measure Participants	166	530
Baseline	41.5 (8.9)	43.5 (9.3)
Month 6	42.4 (9.1)	43.2 (8.8)
Month 12	42.4 (8.6)	43.4 (9.1)
Month 18	42.3 (7.9)	43.6 (9.3)

5. Primary Outcome

Title	PROMIS Physical Function Score
Description	The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function SF 10b is a self-administered instrument that assesses self-reported capability rather than actual performance of physical activities. Participants are asked to respond to questions regarding the extent of their physical function. Responses range from 1 to 5, where 1 represents "unable to do" and 5 represents "without any difficulty". Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better physical function capabilities; scores higher than 50 indicate greater physical function compared to the reference population.
Time Frame	Baseline, Months 6, 12, 18

Outcome Measure Data

Analysis Population Description

This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.

Arm/Group Title	Chronic Disease Self-management Program (CDSMP)	Usual Care
Arm/Group Description	A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.	African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
Measure Participants	168	528
Baseline	38.4 (7.6)	40.5 (10.0)
Month 6	38.4 (7.6)	40.8 (9.8)
Month 12	39.0 (8.4)	40.1 (9.9)
Month 18	38.4 (7.5)	40.4 (9.8)

6. Primary Outcome

Title	PROMIS Pain Interference Score
Description	The PROMIS Pain Interference SF 8a is a self-administered instrument that assesses the interference of pain on daily activities. Participants are asked to respond to questions regarding the extent of their pain. Responses range from 1 to 5, where 1 represents "not at all" and 5 represents "very much". Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A lower score indicates the least amount of pain interference; scores higher than 50 indicate greater pain interference compared to the reference population.
Time Frame	Baseline, Months 6, 12, and 18

Outcome Measure Data

Analysis Population Description

This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.

Arm/Group Title	Chronic Disease Self-management Program (CDSMP)	Usual Care
Arm/Group Description	A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.	African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
Measure Participants	167	527
Baseline	59.0 (9.2)	57.7 (10.1)
Month 6	59.1 (9.0)	57.6 (10.0)
Month 12	59.3 (8.7)	57.9 (10.7)
Month 18	59.3 (8.6)	58.1 (10.1)

7. Primary Outcome

Title	PROMIS Fatigue Score
Description	The PROMIS Fatigue SF 8a is a self-administered instrument that assesses fatigue level within the past seven days. Participants are asked to respond to questions regarding fatigue frequency. Responses range from 1 to 5, where 1 represents "never" and five represents "always". Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10; scores higher than 50 indicate greater fatigue compared to the reference population.
Time Frame	Baseline, Months 6, 12, and 18

Outcome Measure Data

Analysis Population Description

This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.

Arm/Group Title	Chronic Disease Self-management Program (CDSMP)	Usual Care
Arm/Group Description	A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.	African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
Measure Participants	168	523
Baseline	58.6 (10.5)	57.6 (11.2)
Month 6	59.5 (9.7)	57.5 (11.3)
Month 12	58.7 (10.0)	57.8 (11.0)
Month 18	58.2 (10.5)	57.4 (11.3)

8. Primary Outcome

Title	PROMIS Sleep Disturbance Score
Description	The PROMIS Sleep Disturbance SF 8a is a self-administered instrument to assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. It assesses sleep disturbance over the past seven days. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates more sleep disturbance; scores higher than 50 indicate greater sleep disturbance compared to the reference population.
Time Frame	Baseline, Months 6, 12, and 18

Outcome Measure Data

Analysis Population Description

This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.

Arm/Group Title	Chronic Disease Self-management Program (CDSMP)	Usual Care
Arm/Group Description	A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.	African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
Measure Participants	168	526
Baseline	57.3 (10.8)	56.6 (10.8)
Month 6	57.8 (10.0)	55.8 (10.1)
Month 12	57.3 (10.3)	56.5 (10.1)
Month 18	57.7 (9.8)	55.0 (9.0)

9. Primary Outcome

Title	PROMIS Anxiety Score
Description	The PROMIS Anxiety SF 8a is a self-administered instrument to assess emotional distress within the past seven days. Participants are asked to rate their anxiety level for various items ranked from 1 to 5, where 1 represents "never" and 5 represents "always". Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates high anxiety; scores higher than 50 indicate greater anxiety compared to the reference population.
Time Frame	Baseline, Months 6, 12, and 18

Outcome Measure Data

Analysis Population Description

This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.

Arm/Group Title	Chronic Disease Self-management Program (CDSMP)	Usual Care
Arm/Group Description	A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.	African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
Measure Participants	168	526
Baseline	53.8 (10.5)	52.0 (11.5)
Month 6	54.6 (10.4)	50.5 (11.1)
Month 12	54.3 (10.6)	52.0 (11.2)
Month 18	53.2 (10.7)	51.6 (11.3)

10. Primary Outcome

Title	PROMIS Ability to Participate in Social Roles and Activities Score
Description	The PROMIS Ability to Participate in Social Roles and Activities SF 8a is a self-administered instrument to assess perceived ability to perform one's usual social roles and activities. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates better perceived abilities; scores higher than 50 indicate better perceived abilities to participate in social activities and roles compared to the reference population.
Time Frame	Baseline, Months 6, 12, 18

Outcome Measure Data

Analysis Population Description

This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.

Arm/Group Title	Chronic Disease Self-management Program (CDSMP)	Usual Care
Arm/Group Description	A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.	African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
Measure Participants	168	520
Baseline	45.3 (8.3)	47.4 (10.1)
Month 6	45.0 (8.7)	47.1 (10.2)
Month 12	45.5 (8.5)	46.6 (10.0)
Month 18	45.5 (8.1)	47.0 (9.6)

11. Secondary Outcome

Title	Patient Activation Measure (PAM-10) Score
Description	The Patient Activation Measure (PAM) is a tool to assess an individual's knowledge, skill, and confidence for managing one's 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. The PAM survey measures patients on a 0-100 scale and can segment patients into one of four activation levels along an empirically derived continuum. Data on PAM-10 scale values are pending receiving the scores from Insignia, which is the organization that owns the license.
Time Frame	Baseline, Months 6, 12, and 18

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	PROMIS Adult Self-Efficacy Score
Description	The PROMIS Adult Self-Efficacy SF 4a is a self-administered instrument to assess current level of confidence in managing symptoms of chronic conditions. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates higher self-efficacy; scores higher than 50 indicate greater self-efficacy compared to the reference population.
Time Frame	Baseline, Months 6, 12, and 18

Outcome Measure Data

Analysis Population Description

This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.

Arm/Group Title	Chronic Disease Self-management Program (CDSMP)	Usual Care
Arm/Group Description	A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.	African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
Measure Participants	168	522
Baseline	47.1 (7.8)	48.4 (8.7)
Month 6	47.5 (7.8)	49.1 (9.0)
Month 12	48.2 (8.5)	48.7 (8.6)
Month 18	48.2 (7.8)	49.3 (8.8)

13. Secondary Outcome

Title	PROMIS Anger Score
Description	The PROMIS Anger SF 5a is a self-administered instrument to measure angry mood (irritability, frustration), negative social cognitions (interpersonal sensitivity, envy, disagreeableness), and efforts to control anger. Total raw scores are converted to T-scores by the Health Measures Scoring Service. The T-score rescales the raw score into a standardized score with a mean of 50 and an SD of 10. A higher score indicates more anger; scores higher than 50 indicate greater anger compared to the reference population.
Time Frame	Baseline, Months 6, 12, and 18

Outcome Measure Data

Analysis Population Description

This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.

Arm/Group Title	Chronic Disease Self-management Program (CDSMP)	Usual Care
Arm/Group Description	A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.	African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
Measure Participants	168	522
Baseline	53.2 (11.6)	51.0 (12.4)
Month 6	53.5 (13.0)	50.3 (12.5)
Month 12	52.7 (11.8)	50.8 (12.3)
Month 18	52.3 (12.3)	50.9 (12.6)

14. Secondary Outcome

Title	Perceived Stress Scale 4 (PSS-4) Score
Description	The Perceived Stress Scale 4 (PSS-4) is the most widely used psychological instrument for measuring the perception of stress. Participants are asked to rank responses to each of the four items on a scale from 0 to 4, where zero means never and four means very often. Total scores range from 0 to 16 and a higher score indicates higher perceived stress.
Time Frame	Baseline, Months 6, 12, and 18

Outcome Measure Data

Analysis Population Description

This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.

Arm/Group Title	Chronic Disease Self-management Program (CDSMP)	Usual Care
Arm/Group Description	A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.	African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
Measure Participants	168	526
Baseline	6.2 (3.2)	6.3 (3.2)
Month 6	6.2 (3.3)	6.1 (3.2)
Month 12	6.0 (3.3)	6.4 (3.1)
Month 18	6.1 (3.2)	6.1 (3.1)

15. Secondary Outcome

Title	Hospitalization Rate
Description	The number of hospitalizations will be collected from the Georgia Department of Public Health (DPH) administrative data for the pre- and post-intervention period (up to two years). The Georgia DPH has been focused on the Coronavirus Disease 2019 (COVID-19) pandemic which has caused delays in obtaining the information for this outcome measure.
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

16. Secondary Outcome

Title	Emergency Department Visit Rate
Description	The number of emergency department visits will be collected from the Georgia DPH administrative data for the pre- and post-intervention period (up to two years). The Georgia DPH has been focused on the COVID-19 pandemic and obtaining information for this outcome measure has been delayed.
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Information concerning mortality was collected beginning at the baseline assessment and continued through the 18-month assessment.
Adverse Event Reporting Description	The intervention is a well-established education self-management program, consequently, adverse events were not expected to occur from participating in the study and were not collected. Nevertheless, information on all-cause mortality was collected beginning at the baseline assessment and continued through the 18-month assessment.
Arm/Group Title	Chronic Disease Self-management Program (CDSMP)		Usual Care
Arm/Group Description	A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort was used to recruit participants into the CDSMP. This group is identified as the WELL Cohort.		African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who were not selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
All Cause Mortality
	Chronic Disease Self-management Program (CDSMP)		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/168 (1.2%)		18/531 (3.4%)
Serious Adverse Events
	Chronic Disease Self-management Program (CDSMP)		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Chronic Disease Self-management Program (CDSMP)		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.