跳至主要内容
临床试验/NCT01837875
NCT01837875已完成不适用

Intervention to Improve Quality of Life for African-AmericaN Lupus Patients (IQAN)

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2013年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
153
试验地点
2
主要终点
Quality of Life

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • formal diagnosis of lupus
  • Black or African American

排除标准

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

研究组 & 干预措施

Control

No Intervention

Mailed informational literature

Set Menu

Active Comparator

Intervention: Enrollment in a local Chronic Disease Self-Management program (CDSMP) and monthly follow up calls to gauge progress and comfort

干预措施: Chronic Disease Self-Management Program (CDSMP) (Behavioral)

Intervention

Experimental

Intervention: Each individualized intervention plan (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).

干预措施: Support group (Behavioral)

Intervention

Experimental

Intervention: Each individualized intervention plan (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).

干预措施: Listserv (Behavioral)

Intervention

Experimental

Intervention: Each individualized intervention plan (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).

干预措施: Chronic Disease Self-Management Program (CDSMP) (Behavioral)

Intervention

Experimental

Intervention: Each individualized intervention plan (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).

干预措施: Mail-delivered arthritis kit (Behavioral)

结局指标

主要结局

Quality of Life

时间窗: Two years

次要结局

  • Disease Activity(Two years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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