Lupus Erythematosus, SystemicWELLNCT02988661
Women Empowered to Live With Lupus Study
A study testing Chronic Disease Self-management Program (CDSMP) in people with Lupus Erythematosus, Systemic, run by Emory University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Chronic Disease Self-management Program (CDSMP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 699 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2017to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently participating in the GOAL study
Who cannot join
- Participation in the Chronic Disease Self-Management Program (CDSMP) in the past five years
- Significant cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Widespread Self-management Education Program to Reduce Health Disparities in African American Women With Systemic Lupus Erythematosus
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.
Read the 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.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Chronic Disease Self-management Program (CDSMP)
- Keywords
- Autoimmunity, Immune System Disorders
- Medical subject headings
- Lupus Erythematosus, Systemic, Autoimmune Diseases, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Disease Self-management Program (CDSMP)Behavioural
Also called Living Well with a Chronic Condition Workshop
The CDSMP consists 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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | Active comparator | 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. Receives: Behavioral: Chronic Disease Self-management Program (CDSMP) |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication With Physician - Stanford 3Q Scale Score
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.
Measured: Baseline, Months 6, 12, and 18
Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score
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.
Measured: Baseline, Months 6, 12, and 18
PROMIS Global Health Physical Health Domain Score
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..
Measured: Baseline, Months 6, 12, and 18
PROMIS Global Health Mental Health Domain Score
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.
Measured: Baseline, Months 6, 12, and 18
PROMIS Physical Function Score
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.
Measured: Baseline, Months 6, 12, 18
PROMIS Pain Interference Score
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.
Measured: Baseline, Months 6, 12, and 18
PROMIS Fatigue Score
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.
Measured: Baseline, Months 6, 12, and 18
PROMIS Sleep Disturbance Score
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.
Measured: Baseline, Months 6, 12, and 18
PROMIS Anxiety Score
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.
Measured: Baseline, Months 6, 12, and 18
PROMIS Ability to Participate in Social Roles and Activities Score
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.
Measured: Baseline, Months 6, 12, 18
Secondary outcomes (6)
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
The Patient Activation Measure (PAM-10) is a 10-item 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-10 survey measures individuals activation on a 0-100 scale, which are further grouped in 4 levels of activation along an empirically derived continuum. Activation Level 1 is "Disengaged \& Overwhelmed" where knowledge of and adherence to healthcare and is low. Activation Level 2 is "Becoming Aware But Still Struggling" where individuals can set simple goals but believe health is out of their control. Activation Level 3 is "Taking Action \& Gaining Control" where individuals are building self-management skills. Activation Level 4 is "Maintaining Behaviors \& Pushing Further" where individuals are maintaining newly adopted behaviors.
Measured: Baseline, Months 6, 12, and 18
PROMIS Adult Self-Efficacy Score
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.
Measured: Baseline, Months 6, 12, and 18
PROMIS Anger Score
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.
Measured: Baseline, Months 6, 12, and 18
Perceived Stress Scale 4 (PSS-4) Score
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.
Measured: Baseline, Months 6, 12, and 18
Hospitalization Rate
The number of hospitalizations were collected from the Georgia Department of Public Health (DPH) administrative data for the pre- and post-intervention period (up to two years). The hospitalization rate is the hospitalizations per 100 person years, adjusted for mortality and leaving the state of Georgia. For participants in the CDSMP group, data were collected for the period of one year before and one year after the date when the CDSMP workshop started. For participants receiving usual care, data were collected one year before and one year after the index date, which is when 50% of CDSMP participants started their first intervention class.
Measured: One year before and one year after the start of the study intervention (up to 2 years)
Emergency Department Visit Rate
The number of emergency department (ED) visits were collected from the Georgia DPH administrative data for the pre- and post-intervention period (up to two years). The emergency department visit rate is the emergency department visits per 100 person years, adjusted for mortality and leaving the state of Georgia. For participants in the CDSMP group, data were collected for the period of one year before and one year after the date when the CDSMP workshop started. For participants receiving usual care, data were collected one year before and one year after the index date, which is when 50% of CDSMP participants started their first intervention class.
Measured: One year before and one year after the start of the study intervention (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start19 Jan 2017
- Primary completion26 Feb 2021
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 699 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Cristina M Drenkard, Emory University
- Investigators
- Cristina M Drenkard, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988661
- Sponsor's protocol ID
- IRB00003656
- Other IDs
- R01MD010455
- Acronym
- WELL
- Status last verified
- Nov 2025
- First submitted
- 7 Dec 2016
- Last updated
- 15 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Drenkard C, Easley K, Bao G, Dunlop-Thomas C, Lim SS, Brady T. Overcoming barriers to recruitment and retention of African-American women with SLE in behavioural interventions: lessons learnt from the WELL study. Lupus Sci Med. 2020 Jun;7(1):e000391. doi: 10.1136/lupus-2020-000391.
PubMed 32532797Twumasi AA, Shao A, Dunlop-Thomas C, Drenkard C, Cooper HLF. Health service utilization among African American women living with systemic lupus erythematosus: perceived impacts of a self-management intervention. Arthritis Res Ther. 2019 Jun 25;21(1):155. doi: 10.1186/s13075-019-1942-7.
PubMed 31238992
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Widespread Self-management Education Program to Reduce Health Disparities in African American Women With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT02988661
- Acronym / sponsor ID
- WELL / IRB00003656
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Autoimmunity, Immune System Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 699 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Centers for Disease Control and Prevention
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Posted 22 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Disease Self-management Program (CDSMP) | Active comparator | Behavioral: 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Currently participating in the GOAL study
Key exclusion criteria (2 listed)
- Participation in the Chronic Disease Self-Management Program (CDSMP) in the past five years
- Significant cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic Disease Self-management Program (CDSMP)Also: Living Well with a Chronic Condition WorkshopThe CDSMP consists 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. | Behavioural | Chronic Disease Self-management Program (CDSMP) |
Primary outcome
Communication With Physician - Stanford 3Q Scale Score
Time frame: 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.
Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score
Time frame: 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.
PROMIS Global Health Physical Health Domain Score
Time frame: 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..
PROMIS Global Health Mental Health Domain Score
Time frame: 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.
PROMIS Physical Function Score
Time frame: 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.
PROMIS Pain Interference Score
Time frame: 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.
PROMIS Fatigue Score
Time frame: 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.
PROMIS Sleep Disturbance Score
Time frame: 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.
PROMIS Anxiety Score
Time frame: 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.
PROMIS Ability to Participate in Social Roles and Activities Score
Time frame: 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.
6 secondary outcomes
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Time frame: Baseline, Months 6, 12, and 18
PROMIS Adult Self-Efficacy Score
Time frame: Baseline, Months 6, 12, and 18
PROMIS Anger Score
Time frame: Baseline, Months 6, 12, and 18
Perceived Stress Scale 4 (PSS-4) Score
Time frame: Baseline, Months 6, 12, and 18
Hospitalization Rate
Time frame: One year before and one year after the start of the study intervention (up to 2 years)
Emergency Department Visit Rate
Time frame: One year before and one year after the start of the study intervention (up to 2 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32532797Drenkard C, Easley K, Bao G, Dunlop-Thomas C, Lim SS, Brady T. Overcoming barriers to recruitment and retention of African-American women with SLE in behavioural interventions: lessons learnt from the WELL study. Lupus Sci Med. 2020 Jun;7(1):e000391. doi: 10.1136/lupus-2020-000391.
- Derived from this study: PubMed 31238992Twumasi AA, Shao A, Dunlop-Thomas C, Drenkard C, Cooper HLF. Health service utilization among African American women living with systemic lupus erythematosus: perceived impacts of a self-management intervention. Arthritis Res Ther. 2019 Jun 25;21(1):155. doi: 10.1186/s13075-019-1942-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina M Drenkard, MD, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic Disease Self-management Program (CDSMP) in people with Lupus Erythematosus, Systemic, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication With Physician - Stanford 3Q Scale Score (time frame: Baseline, Months 6, 12, and 18). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02988661, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.