Intervention to Improve Quality of Life in African American Lupus Patients
This trial is active, not recruiting.
|Conditions||depression, systemic lupus erythematosus|
|Treatments||chronic disease self-management program (cdsmp), mail-delivered arthritis kit, support group, listserv|
|Sponsor||Medical University of South Carolina|
|Collaborator||National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|
|Start date||April 2013|
|End date||August 2016|
|Trial size||150 participants|
|Trial identifier||NCT01837875, 1K01AR060026, IQAN|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
|Masking||single blind (caregiver)|
|Primary purpose||health services research|
Quality of Life
time frame: Two years
time frame: Two years
Male or female participants at least 18 years old.
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
|Official title||Intervention to Improve Quality of Life for African-AmericaN Lupus Patients (IQAN)|
|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.|
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