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. 2018 Jul 19;2018(7):CD006732. doi: 10.1002/14651858.CD006732.pub4

NCT02988661.

Trial name or title Women Empowered to Live With Lupus Study (WELL)
Methods NRCT
Participants Inclusion criteria
  • Currently participating in the GOAL study


Exclusion criteria
  • Participation in the Chronic Disease Self‐Management Program (CDSMP) in the past five years

  • Significant cognitive impairment

Interventions Active comparator: Chronic Disease Self‐management Program (CDSMP)
A random sample of African American women with SLE selected from the Georgians Organized Against Lupus (GOAL) parent cohort will be used to recruit participants into the CDSMP. This group will be identified as the WELL Cohort.
No intervention: usual care
African American women consented into the parent Georgians Organized Against Lupus (GOAL) cohort who have not been selected to be enrolled in the intervention will comprise the usual care group. This group will continue their longitudinal assessments as part or the GOAL cohort data collection efforts.
Outcomes Primary outcomes:
  • Change in Communication with Physicians assessed by the Stanford 3Q Scale

  • Change in Self‐efficacy for Managing Medications assessed by the PROMIS SF8a score

  • Change in Global Health assessed by the PROMIS Global Health score

  • Change in Physical Function assessed by the PROMIS SF10b score

  • Change in Pain Interference assessed by the PROMIS SF8a score

  • Change in Fatigue assessed by the PROMIS SF8a score

  • Change in Sleep Disturbance assessed by the PROMIS SF8a score

  • Change in Anxiety Level assessed by the PROMIS SF8a score

  • Change in Ability to Participate in Social Roles and Activities assessed by the PROMIS SF8a score


Secondary outcomes:
  • Change in the Patient Activation Measure (PAM SF 10) score

  • Change in Self‐Efficacy assessed by the PROMIS SF4a score

  • Change in Angry Mood assessed by the PROMIS SF5 score

  • Change in Perceived Stress Scale (PSS) Score

  • Hospitalization Rate

  • Emergency Department Visit Rate

Starting date January 2017
Contact information Charmayne M Dunlop‐Thomas, MS, MPH, 404‐251‐8898, cmdunlo@emory.edu
Notes