Women Empowered to Live With Lupus Study
- Conditions
- Lupus Erythematosus, Systemic
- Interventions
- Behavioral: Chronic Disease Self-Management Program (CDSMP)
- Registration Number
- NCT02988661
- Lead Sponsor
- Emory University
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 699
- Currently participating in the GOAL study
- Participation in the Chronic Disease Self-Management Program (CDSMP) in the past five years
- Significant cognitive impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chronic Disease Self-management Program (CDSMP) 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.
- Primary Outcome Measures
Name Time Method 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.
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..
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.
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.
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.
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.
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.
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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10) Baseline, Months 6, 12, and 18 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.
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.
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.
Trial Locations
- Locations (1)
Emory University
🇺🇸Atlanta, Georgia, United States