Trial Outcomes & Findings for Women Empowered to Live With Lupus Study (NCT NCT02988661)
NCT ID: NCT02988661
Last Updated: 2025-12-15
Results Overview
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.
COMPLETED
NA
699 participants
Baseline, Months 6, 12, and 18
2025-12-15
Participant Flow
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.
Participant milestones
| Measure |
Chronic Disease Self-management Program (CDSMP)
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.
|
Usual Care
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.
|
|---|---|---|
|
Overall Study
STARTED
|
168
|
531
|
|
Overall Study
COMPLETED
|
165
|
447
|
|
Overall Study
NOT COMPLETED
|
3
|
84
|
Reasons for withdrawal
| Measure |
Chronic Disease Self-management Program (CDSMP)
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.
|
Usual Care
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.
|
|---|---|---|
|
Overall Study
Death
|
2
|
18
|
|
Overall Study
Lost to Follow-up
|
0
|
33
|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
|
Overall Study
Unable to complete the 18-month survey
|
1
|
27
|
Baseline Characteristics
Women Empowered to Live With Lupus Study
Baseline characteristics by cohort
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=168 Participants
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.
|
Usual Care
n=531 Participants
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
n=699 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
151 Participants
n=6009 Participants
|
473 Participants
n=42 Participants
|
624 Participants
n=77 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=6009 Participants
|
58 Participants
n=42 Participants
|
75 Participants
n=77 Participants
|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 12.3 • n=6009 Participants
|
47.3 years
STANDARD_DEVIATION 14.0 • n=42 Participants
|
47.9 years
STANDARD_DEVIATION 13.7 • n=77 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=6009 Participants
|
531 Participants
n=42 Participants
|
699 Participants
n=77 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=6009 Participants
|
531 Participants
n=42 Participants
|
699 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Black or African American
|
168 Participants
n=6009 Participants
|
531 Participants
n=42 Participants
|
699 Participants
n=77 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Region of Enrollment
United States
|
168 Participants
n=6009 Participants
|
531 Participants
n=42 Participants
|
699 Participants
n=77 Participants
|
PRIMARY outcome
Timeframe: Baseline, Months 6, 12, and 18Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
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.
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=168 Participants
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.
|
Usual Care
n=522 Participants
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.
|
|---|---|---|
|
Communication With Physician - Stanford 3Q Scale Score
Baseline
|
3.1 score on a scale
Standard Deviation 1.1
|
2.9 score on a scale
Standard Deviation 1.1
|
|
Communication With Physician - Stanford 3Q Scale Score
Month 6
|
3.3 score on a scale
Standard Deviation 1.2
|
3.0 score on a scale
Standard Deviation 1.1
|
|
Communication With Physician - Stanford 3Q Scale Score
Month 12
|
3.3 score on a scale
Standard Deviation 1.1
|
3.0 score on a scale
Standard Deviation 1.1
|
|
Communication With Physician - Stanford 3Q Scale Score
Month 18
|
3.3 score on a scale
Standard Deviation 1.1
|
3.0 score on a scale
Standard Deviation 1.1
|
PRIMARY outcome
Timeframe: Baseline, Months 6, 12, and 18Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
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.
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=168 Participants
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.
|
Usual Care
n=524 Participants
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.
|
|---|---|---|
|
Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score
Baseline
|
46.1 T-score
Standard Deviation 9.1
|
46.1 T-score
Standard Deviation 9.2
|
|
Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score
Month 6
|
47.0 T-score
Standard Deviation 9.0
|
47.5 T-score
Standard Deviation 8.5
|
|
Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score
Month 12
|
46.2 T-score
Standard Deviation 8.8
|
47.0 T-score
Standard Deviation 8.9
|
|
Patient-Reported Outcome Measurement Information System (PROMIS) Self-efficacy for Managing Medications and Treatments Score
Month 18
|
45.9 T-score
Standard Deviation 8.7
|
48.3 T-score
Standard Deviation 9.2
|
PRIMARY outcome
Timeframe: Baseline, Months 6, 12, and 18Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
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..
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=166 Participants
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.
|
Usual Care
n=530 Participants
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.
|
|---|---|---|
|
PROMIS Global Health Physical Health Domain Score
Baseline
|
38.3 T-score
Standard Deviation 7.5
|
40.6 T-score
Standard Deviation 8.8
|
|
PROMIS Global Health Physical Health Domain Score
Month 6
|
39.0 T-score
Standard Deviation 7.5
|
40.0 T-score
Standard Deviation 8.6
|
|
PROMIS Global Health Physical Health Domain Score
Month 12
|
38.9 T-score
Standard Deviation 7.6
|
40.3 T-score
Standard Deviation 8.7
|
|
PROMIS Global Health Physical Health Domain Score
Month 18
|
39.1 T-score
Standard Deviation 7.5
|
40.3 T-score
Standard Deviation 8.8
|
PRIMARY outcome
Timeframe: Baseline, Months 6, 12, and 18Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
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.
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=166 Participants
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.
|
Usual Care
n=530 Participants
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.
|
|---|---|---|
|
PROMIS Global Health Mental Health Domain Score
Baseline
|
41.5 T-score
Standard Deviation 8.9
|
43.5 T-score
Standard Deviation 9.3
|
|
PROMIS Global Health Mental Health Domain Score
Month 6
|
42.4 T-score
Standard Deviation 9.1
|
43.2 T-score
Standard Deviation 8.8
|
|
PROMIS Global Health Mental Health Domain Score
Month 12
|
42.4 T-score
Standard Deviation 8.6
|
43.4 T-score
Standard Deviation 9.1
|
|
PROMIS Global Health Mental Health Domain Score
Month 18
|
42.3 T-score
Standard Deviation 7.9
|
43.6 T-score
Standard Deviation 9.3
|
PRIMARY outcome
Timeframe: Baseline, Months 6, 12, 18Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
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.
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=168 Participants
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.
|
Usual Care
n=528 Participants
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.
|
|---|---|---|
|
PROMIS Physical Function Score
Baseline
|
38.4 T-score
Standard Deviation 7.6
|
40.5 T-score
Standard Deviation 10.0
|
|
PROMIS Physical Function Score
Month 6
|
38.4 T-score
Standard Deviation 7.6
|
40.8 T-score
Standard Deviation 9.8
|
|
PROMIS Physical Function Score
Month 12
|
39.0 T-score
Standard Deviation 8.4
|
40.1 T-score
Standard Deviation 9.9
|
|
PROMIS Physical Function Score
Month 18
|
38.4 T-score
Standard Deviation 7.5
|
40.4 T-score
Standard Deviation 9.8
|
PRIMARY outcome
Timeframe: Baseline, Months 6, 12, and 18Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
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.
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=167 Participants
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.
|
Usual Care
n=527 Participants
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.
|
|---|---|---|
|
PROMIS Pain Interference Score
Month 6
|
59.1 T-score
Standard Deviation 9.0
|
57.6 T-score
Standard Deviation 10.0
|
|
PROMIS Pain Interference Score
Baseline
|
59.0 T-score
Standard Deviation 9.2
|
57.7 T-score
Standard Deviation 10.1
|
|
PROMIS Pain Interference Score
Month 12
|
59.3 T-score
Standard Deviation 8.7
|
57.9 T-score
Standard Deviation 10.7
|
|
PROMIS Pain Interference Score
Month 18
|
59.3 T-score
Standard Deviation 8.6
|
58.1 T-score
Standard Deviation 10.1
|
PRIMARY outcome
Timeframe: Baseline, Months 6, 12, and 18Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
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.
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=168 Participants
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.
|
Usual Care
n=523 Participants
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.
|
|---|---|---|
|
PROMIS Fatigue Score
Baseline
|
58.6 T-score
Standard Deviation 10.5
|
57.6 T-score
Standard Deviation 11.2
|
|
PROMIS Fatigue Score
Month 6
|
59.5 T-score
Standard Deviation 9.7
|
57.5 T-score
Standard Deviation 11.3
|
|
PROMIS Fatigue Score
Month 12
|
58.7 T-score
Standard Deviation 10.0
|
57.8 T-score
Standard Deviation 11.0
|
|
PROMIS Fatigue Score
Month 18
|
58.2 T-score
Standard Deviation 10.5
|
57.4 T-score
Standard Deviation 11.3
|
PRIMARY outcome
Timeframe: Baseline, Months 6, 12, and 18Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
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.
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=168 Participants
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.
|
Usual Care
n=526 Participants
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.
|
|---|---|---|
|
PROMIS Sleep Disturbance Score
Baseline
|
57.3 T-score
Standard Deviation 10.8
|
56.6 T-score
Standard Deviation 10.8
|
|
PROMIS Sleep Disturbance Score
Month 6
|
57.8 T-score
Standard Deviation 10.0
|
55.8 T-score
Standard Deviation 10.1
|
|
PROMIS Sleep Disturbance Score
Month 12
|
57.3 T-score
Standard Deviation 10.3
|
56.5 T-score
Standard Deviation 10.1
|
|
PROMIS Sleep Disturbance Score
Month 18
|
57.7 T-score
Standard Deviation 9.8
|
55.0 T-score
Standard Deviation 9.0
|
PRIMARY outcome
Timeframe: Baseline, Months 6, 12, and 18Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
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.
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=168 Participants
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.
|
Usual Care
n=526 Participants
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.
|
|---|---|---|
|
PROMIS Anxiety Score
Baseline
|
53.8 T-score
Standard Deviation 10.5
|
52.0 T-score
Standard Deviation 11.5
|
|
PROMIS Anxiety Score
Month 6
|
54.6 T-score
Standard Deviation 10.4
|
50.5 T-score
Standard Deviation 11.1
|
|
PROMIS Anxiety Score
Month 12
|
54.3 T-score
Standard Deviation 10.6
|
52.0 T-score
Standard Deviation 11.2
|
|
PROMIS Anxiety Score
Month 18
|
53.2 T-score
Standard Deviation 10.7
|
51.6 T-score
Standard Deviation 11.3
|
PRIMARY outcome
Timeframe: Baseline, Months 6, 12, 18Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
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.
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=168 Participants
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.
|
Usual Care
n=520 Participants
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.
|
|---|---|---|
|
PROMIS Ability to Participate in Social Roles and Activities Score
Baseline
|
45.3 T-score
Standard Deviation 8.3
|
47.4 T-score
Standard Deviation 10.1
|
|
PROMIS Ability to Participate in Social Roles and Activities Score
Month 6
|
45.0 T-score
Standard Deviation 8.7
|
47.1 T-score
Standard Deviation 10.2
|
|
PROMIS Ability to Participate in Social Roles and Activities Score
Month 12
|
45.5 T-score
Standard Deviation 8.5
|
46.6 T-score
Standard Deviation 10.0
|
|
PROMIS Ability to Participate in Social Roles and Activities Score
Month 18
|
45.5 T-score
Standard Deviation 8.1
|
47.0 T-score
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Baseline, Months 6, 12, and 18Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
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.
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=165 Participants
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.
|
Usual Care
n=523 Participants
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.
|
|---|---|---|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Month 6 · Level 3: Taking Action & Gaining Control
|
56 Participants
|
101 Participants
|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Baseline · Level 1: Disengaged & Overwhelmed
|
12 Participants
|
40 Participants
|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Baseline · Level 2: Becoming Aware But Still Struggling
|
25 Participants
|
123 Participants
|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Baseline · Level 3: Taking Action & Gaining Control
|
72 Participants
|
206 Participants
|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Baseline · Level 4: Maintaining Behaviors & Pushing Further
|
56 Participants
|
154 Participants
|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Month 6 · Level 1: Disengaged & Overwhelmed
|
13 Participants
|
25 Participants
|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Month 6 · Level 2: Becoming Aware But Still Struggling
|
26 Participants
|
44 Participants
|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Month 6 · Level 4: Maintaining Behaviors & Pushing Further
|
59 Participants
|
90 Participants
|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Month 12 · Level 1: Disengaged & Overwhelmed
|
8 Participants
|
26 Participants
|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Month 12 · Level 2: Becoming Aware But Still Struggling
|
13 Participants
|
73 Participants
|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Month 12 · Level 3: Taking Action & Gaining Control
|
70 Participants
|
154 Participants
|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Month 12 · Level 4: Maintaining Behaviors & Pushing Further
|
63 Participants
|
113 Participants
|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Month 18 · Level 1: Disengaged & Overwhelmed
|
14 Participants
|
33 Participants
|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Month 18 · Level 2: Becoming Aware But Still Struggling
|
30 Participants
|
80 Participants
|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Month 18 · Level 3: Taking Action & Gaining Control
|
58 Participants
|
161 Participants
|
|
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)
Month 18 · Level 4: Maintaining Behaviors & Pushing Further
|
62 Participants
|
162 Participants
|
SECONDARY outcome
Timeframe: Baseline, Months 6, 12, and 18Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
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.
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=168 Participants
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.
|
Usual Care
n=522 Participants
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.
|
|---|---|---|
|
PROMIS Adult Self-Efficacy Score
Baseline
|
47.1 T-score
Standard Deviation 7.8
|
48.4 T-score
Standard Deviation 8.7
|
|
PROMIS Adult Self-Efficacy Score
Month 12
|
48.2 T-score
Standard Deviation 8.5
|
48.7 T-score
Standard Deviation 8.6
|
|
PROMIS Adult Self-Efficacy Score
Month 18
|
48.2 T-score
Standard Deviation 7.8
|
49.3 T-score
Standard Deviation 8.8
|
|
PROMIS Adult Self-Efficacy Score
Month 6
|
47.5 T-score
Standard Deviation 7.8
|
49.1 T-score
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline, Months 6, 12, and 18Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
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.
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=168 Participants
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.
|
Usual Care
n=522 Participants
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.
|
|---|---|---|
|
PROMIS Anger Score
Baseline
|
53.2 T-score
Standard Deviation 11.6
|
51.0 T-score
Standard Deviation 12.4
|
|
PROMIS Anger Score
Month 6
|
53.5 T-score
Standard Deviation 13.0
|
50.3 T-score
Standard Deviation 12.5
|
|
PROMIS Anger Score
Month 12
|
52.7 T-score
Standard Deviation 11.8
|
50.8 T-score
Standard Deviation 12.3
|
|
PROMIS Anger Score
Month 18
|
52.3 T-score
Standard Deviation 12.3
|
50.9 T-score
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Baseline, Months 6, 12, and 18Population: This analysis includes participants who completed the assessment at the indicated time points. Not all participants responded to all surveys.
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.
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=168 Participants
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.
|
Usual Care
n=526 Participants
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.
|
|---|---|---|
|
Perceived Stress Scale 4 (PSS-4) Score
Month 18
|
6.1 score on a scale
Standard Deviation 3.2
|
6.1 score on a scale
Standard Deviation 3.1
|
|
Perceived Stress Scale 4 (PSS-4) Score
Baseline
|
6.2 score on a scale
Standard Deviation 3.2
|
6.3 score on a scale
Standard Deviation 3.2
|
|
Perceived Stress Scale 4 (PSS-4) Score
Month 6
|
6.2 score on a scale
Standard Deviation 3.3
|
6.1 score on a scale
Standard Deviation 3.2
|
|
Perceived Stress Scale 4 (PSS-4) Score
Month 12
|
6.0 score on a scale
Standard Deviation 3.3
|
6.4 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: One year before and one year after the start of the study intervention (up to 2 years)Population: This analysis includes participants with data available with the Georgia Department of Public Health.
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.
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=168 Participants
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.
|
Usual Care
n=531 Participants
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.
|
|---|---|---|
|
Hospitalization Rate
During the year before the start of the study intervention
|
42.3 hospitalizations per 100 person years
|
45.5 hospitalizations per 100 person years
|
|
Hospitalization Rate
During the year after the start of the study intervention
|
49.6 hospitalizations per 100 person years
|
47.8 hospitalizations per 100 person years
|
SECONDARY outcome
Timeframe: One year before and one year after the start of the study intervention (up to 2 years)Population: This analysis includes participants with data available with the Georgia Department of Public Health.
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.
Outcome measures
| Measure |
Chronic Disease Self-management Program (CDSMP)
n=168 Participants
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.
|
Usual Care
n=531 Participants
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.
|
|---|---|---|
|
Emergency Department Visit Rate
During the year before the start of the study intervention
|
126.2 ED visits per 100 person years
|
121.3 ED visits per 100 person years
|
|
Emergency Department Visit Rate
During the year after the start of the study intervention
|
103.9 ED visits per 100 person years
|
111.5 ED visits per 100 person years
|
Adverse Events
Chronic Disease Self-management Program (CDSMP)
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place