Intervention to Improve Quality of Life in African American Lupus Patients
| Status: | Completed |
|---|---|
| Conditions: | Depression, Lupus |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/17/2018 |
| Start Date: | April 2013 |
| End Date: | August 31, 2016 |
Intervention to Improve Quality of Life for African-AmericaN Lupus Patients (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.
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.
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.
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.
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
We found this trial at
1
site
Columbia, South Carolina 29210
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