跳至主要内容
临床试验/NCT00000417
NCT00000417已完成2 期

A Randomized Controlled Trial of a Psychoeducational Intervention to Improve Outcomes in Systemic Lupus Erythematosus (SLE)

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 1997年4月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
150
试验地点
2

研究概览

简要总结

We will study the relationships among patient/partner communication, social support, and self-efficacy (a person's belief in the ability to manage his or her disease) as they affect the health of people with systemic lupus erythematosus (SLE, or lupus) over time. We are assigning 150 people with lupus and their partners to either (1) receive counseling to improve self-efficacy, partner support, and patient/partner problem solving or (2) see an informational film about lupus. We will follow study participants for 12 months to find out about their physical and mental health, disease activity, beliefs that they can take steps that help them feel better, coping, social support, and couples communication.

详细描述

Studies have shown that patient self-efficacy in disease management and social support predict physical and mental health and disease activity in lupus. We wished to study the relationships among patient/partner communication, social support, and self-efficacy as they influence patient health longitudinally. We are randomizing 150 lupus patients and their partners to either (1) participate in a counseling intervention to improve self-efficacy, partner support, and patient/partner problem-solving in lupus management or (2) see an informational film about lupus (control). The counseling intervention includes an initial in-person session followed by five monthly telephone calls to monitor and reinforce problem-solving. We will follow patients for 12 months for self-reported physical and mental health, disease activity, self-efficacy, coping, social support, and couples communication.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Has partner willing to participate in study

排除标准

  • Unable to read and write English questionnaires
  • Unable to be reached by phone
  • Rheumatologist considers patient unable to participate, generally due to patient cognitive problems or severe illness

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew H. Liang, MD

Professor of Medicine

Brigham and Women's Hospital

研究点 (2)

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