Clinical trial NCT01837875: Intervention to Improve Quality of Life in African American Lupus Patients
Official title: Intervention to Improve Quality of Life for African-AmericaN Lupus Patients (IQAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Systemic Lupus Erythematosus
Keywords: Intervention
Quality of life
African American
Stress
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: University of South Carolina
First posted: 2013-04-23
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of the proposed project is to enhance the Principal Investigator's research ability to conduct behavioral interventions for people with lupus. This includes intervention design, implementation, data collection and data analysis. The Intervention to Improve Quality of life for African-AmericaN lupus patients (IQAN) Project is designed to examine whether a uniquely tailored intervention program can improve quality of life, decrease indicators of depression, and reduce perceived and biological indicators of stress in African American lupus patients. This study builds on three decades of work conducted in the field of arthritis self-management but differs in that the intervention mode, the disease (lupus), and the study population (African-Americans) are unstudied or understudied. The IQAN Project will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model as its theoretical framework. This program has three specific aims. The first aim seeks to design a three armed randomized, wait list controlled trial that employs a patient-centered 'a-la-carte' approach that offers subjects a variety of modes of interaction, allowing them to choose as many or few as they wish. The second aim is to assess the intervention, using the RE-AIM model framework. The third aim, to be achieved before the first aim, is to use previously collected data to characterize patient-centric barriers to care in African-American lupus patients, in order to identify trends in patient needs and desires, as well as correlates of non-response and non-compliance that can be used in the development and refinement of the intervention.

Detailed description: The intervention will be coordinated by an Intervention Coordinator, with assistance from local/MUSC Study Coordinators. A unique 'a-la-carte' self-management program will be offered to 50 African-American lupus patients participating in an ongoing SLE Clinic Database Project at MUSC. The Intervention Coordinator will work with each participant in the intervention arm to create an individualized intervention plan (IIP). Each IIP will include 1-4 options, including a mail-delivered arthritis kit, addition and access to a listserv, participation in a support group, and enrollment in local self-management program(s). Due to the nature of the IIP, the proposed intervention will inherently vary by participant. 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 (UC), void of intervention components. Validated measures of stress, depression, and quality of life will be collected in all patients in each condition before and after intervention activities. To ensure intervention integrity, discrete components will follow written protocols and peer leaders will complete a standardized checklist for each session/encounter.

Eligibility criteria: Inclusion Criteria:

* formal diagnosis of lupus
* Black or African American

Exclusion Criteria:

* Younger than 18 years
* CNS/neuropsychiatric lupus and/or dementia
* participation in a chronic disease self management program in the last 12 months

Primary outcomes:
measure: Quality of Life
timeFrame: Two years
Secondary outcomes:
measure: Disease Activity
timeFrame: Two years
Other outcomes:
measure: Stress
timeFrame: Two years
Locations:
city: Columbia
country: United States
facility: Institute for Partnerships to Eliminate Health Disparities, University of South Carolina
state: South Carolina
Study officials:
References:
citation: Williams EM, Lorig K, Glover S, Kamen D, Back S, Merchant A, Zhang J, Oates JC. 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. BMC Health Serv Res. 2016 Aug 2;16(a):339. doi: 10.1186/s12913-016-1580-6.