跳至主要内容
临床试验/NCT00222755
NCT00222755已完成不适用

Improving Care for Veterans With Bipolar Disorder

University of Michigan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年1月1日最近更新:
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
60
试验地点
1
主要终点
Health-related quality of life (SF-12)

研究概览

简要总结

The purpose of this research study is to learn whether or not a coordinated medical and psychiatric care program can improve outcomes of care for patients with bipolar disorder. We hypothesize that coordinated care via a Care Manager will improve physical and mental health-related quality of life, improve functioning, and reduce symptoms.

详细描述

Bipolar disorder is a chronic illness associated with significant personal and societal costs. Patients with bipolar disorder also experience more general medical comorbidities than the general population. Potential disparities exist in the receipt of medical and preventive care for individuals with serious mental illness compared to those without serious mental illness. The goal of this study is to pilot test an adapted version of the Wagner Chronic Care Model (CCM). Our target population will be all adult patients with a diagnosis of bipolar disorder (bipolar I, II, NOS) receiving care in the VA Pittsburgh Healthcare System. We plan on consenting and enrolling 60 patients, in which 30 will be randomized to receive the intervention, and 30 will receive usual care. Key components of the intervention include: 1) access to a Care Manager who will help patients make and keep appointments for general medical care by contacting patients on a regular basis; 2) a self-management program, which is education on adherence and self-management for patients by the Care Manager, including information on side-effects, bipolar disorder illness, and tips on communicating with general medical providers that will be provided during group sessions during the first 3 months of the study, and; 3) a registry that tracks patient progress maintained by the Care Manager. Both groups will receive practice guidelines for the treatment of medical conditions tailored to the needs of patients with bipolar disorder. Patients in the intervention arm will meet with the Care Manager after the baseline assessment, who will initially set up regular visits or contacts with the patients and work with them to connect with a primary care clinician. A Survey Coordinator will have patients complete a baseline assessment, and then a follow up assessment at 3 and 6 months later. Our primary outcome is changes in physical and mental health related quality of life. Secondary outcomes include changes in symptoms and functioning. Findings from this study will inform our long-term goal of implementing a larger scale version of the adapted CCM for veterans with bipolar disorder.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •>=18 years old
  • •active diagnosis of bipolar disorder
  • •have an assigned primary care provider in the VA, and
  • •have been seen by a provider in the Beta Team Mood Disorders clinic.

排除标准

  • •actively using substances (alcohol or drugs) at the time of enrollment
  • •already enrolled in a mental health program with a mobile outreach component in which clinical caregivers deliver services to the patient in the community (e.g., Assertive Community Treatment or Intensive Case Management)
  • •have a terminal medical illness with <3 years expected longevity, or
  • •unable to provide informed consent for this study. (Ineligibility to be confirmed based on registry review and Survey Coordinator's assessment)

研究组 & 干预措施

1

Experimental

Behavioral Care Management

干预措施: Disease Management (Behavioral)

2

No Intervention

Usual Care

结局指标

主要结局

Health-related quality of life (SF-12)

时间窗: 3 and 6 months

次要结局

  • Bipolar Disorder symptoms (Internal State Scale)(3 and 6 months)
  • Functioning (WHO-DAS)(3 and 6 months)

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验