title: Intervention to Improve Quality of life for African-AmericaN lupus patients (IQAN): study protocol for a randomized controlled trial of a unique a la carte intervention approach to self-management of lupus in African Americans.
abstract: Systemic Lupus Erythematosus (lupus) is a chronic autoimmune disease that can impact any organ system and result in life-threatening complications. African-Americans are at increased risk for morbidity and mortality from lupus. Self-management programs have demonstrated significant improvements in health distress, self-reported global health, and activity limitation among people with lupus. Despite benefits, arthritis self-management education has reached only a limited number of people. Self-selection of program could improve such trends. The aim of the current study is to test a novel intervention to improve quality of life, decrease indicators of depression, and reduce perceived and biological indicators of stress in African-American lupus patients in South Carolina.
  
  
  
  In a three armed randomized, wait list controlled trial, we will evaluate the effectiveness of a patient-centered 'a-la-carte' approach that offers subjects a variety of modes of interaction from which they can choose as many or few as they wish, compared to a 'set menu' approach and usual care. This unique 'a-la-carte' self-management program will be offered to 50 African-American lupus patients participating in a longitudinal observational web-based SLE Database at the Medical University of South Carolina. Each individualized intervention plan will include 1-4 options, including a mail-delivered arthritis kit, addition and access to an online message board, participation in a support group, and enrollment in a local self-management program. A 'set menu' control group of 50 lupus patients will be offered a standardized chronic disease self-management program only, and a control group of 50 lupus patients will receive usual care. Outcomes will include changes in (a) health behaviors, (b) health status, (c) health care utilization, and (d) biological markers (urinary catecholamines).
  
  
  
  Such a culturally sensitive educational intervention which includes self-selection of program components has the potential to improve disparate trends in quality of life, disease activity, depression, and stress among African-American lupus patients, as better outcomes have been documented when participants are able to choose/dictate the content and/or pace of the respective treatment/intervention program. Since there is currently no "gold standard" self-management program specifically for lupus, this project may have a considerable impact on future research and policy decisions.
  
  
  
  NCT01837875 ; April 18, 2013.
authors.affiliation: Department of Public Health Sciences, Department of Medicine, Division of Rheumatology, Core Investigator, MUSC Center for Health Disparities Research, Medical University of South Carolina, 135 Cannon Street, Suite 303, MSC835, Charleston, SC, 29425, USA. wiled@musc.edu.
authors.forename: Edith M
authors.initials: EM
authors.lastname: Williams
authors.affiliation: Department of Medicine, Stanford University, 291 Campus Drive, Room LK3C02, Stanford, CA, 94305, USA.
authors.forename: Kate
authors.initials: K
authors.lastname: Lorig
authors.affiliation: Institute of Health Disparities, University of South Carolina, 220 Stoneridge Drive, Suite 103, Columbia, SC, 29210, USA.
authors.forename: Saundra
authors.initials: S
authors.lastname: Glover
authors.affiliation: Department of Rheumatology and Immunology, Medical University of South Carolina, 96 Jonathan Lucas Street, Suite 912, Charleston, SC, 29425, USA.
authors.forename: Diane
authors.initials: D
authors.lastname: Kamen
authors.affiliation: Department of Psychiatry/Behavioral Science, Division of Clinical Neuroscience, Medical University of South Carolina, 67 President Street, Charleston, SC, 29425, USA.
authors.forename: Sudie
authors.initials: S
authors.lastname: Back
authors.affiliation: Department of Epidemiology and Biostatistics, University of South Carolina, 800 Sumter Street, Room 211, Columbia, SC, 29208, USA.
authors.forename: Anwar
authors.initials: A
authors.lastname: Merchant
authors.affiliation: Department of Epidemiology and Biostatistics, University of South Carolina, 915 Greene Street, Columbia, SC, 29208, USA.
authors.forename: Jiajia
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Department of Medicine, Division of Rheumatology, Medical University of South Carolina, 114 Doughty Street, Room 425-C, Charleston, SC, 29414, USA.
authors.forename: James C
authors.initials: JC
authors.lastname: Oates
mesh_terms: D000328:Adult; D001741:Black or African American / Q000523:psychology*; D002908:Chronic Disease / Q000523:psychology / Q000628:therapy; D003695:Delivery of Health Care; D005260:Female; D015438:Health Behavior; D006304:Health Status; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000523:psychology* / Q000628:therapy*; D008297:Male; D011788:Quality of Life / Q000523:psychology*; D012648:Self Care / Q000379:methods*; D013022:South Carolina; D014481:United States
keywords: African-American; Lupus; Quality of life; Randomized trial; Self-management