Women Empowered to Live With Lupus Study

NCT02988661 | Completed Results

• 2 other identifiers: IRB00003656R01MD010455
• Study Type: interventional
• Target: 699
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus Erythematosus, Systemic

Keywords

Autoimmunity; Immune System Disorders

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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..

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline, Months 6, 12, 18

Secondary Outcomes (6)

• Number of Participants at Each Activation Level of the Patient Activation Measure (PAM-10)

  Baseline, Months 6, 12, and 18

• PROMIS Adult Self-Efficacy Score

  Baseline, Months 6, 12, and 18

• PROMIS Anger Score

  Baseline, Months 6, 12, and 18

• Perceived Stress Scale 4 (PSS-4) Score

  Baseline, Months 6, 12, and 18

• Hospitalization Rate

  One year before and one year after the start of the study intervention (up to 2 years)

Study Arms (2)

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.

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.

Interventions

Chronic Disease Self-management Program (CDSMP) BEHAVIORAL

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.

Also known as: Living Well with a Chronic Condition Workshop

Chronic Disease Self-management Program (CDSMP)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently participating in the GOAL study

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

• 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.

  PMID: 32532797 DERIVED

• Twumasi 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.

  PMID: 31238992 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Autoimmune Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Cristina Drenkard, MD, PhD
• Organization: Emory University

cdrenka@emory.edu

404-251-8901

Study Officials

• Cristina M Drenkard, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 9, 2016
• Study Start: January 19, 2017
• Primary Completion: February 26, 2021
• Study Completion: January 31, 2025
• Last Updated: December 15, 2025
• Results First Posted: March 22, 2022

Record last verified: 2025-11

Locations

US (1)