此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

A Self-Management Program for Adults With Both Schizophrenia and a Co-occurring Medical Condition

2019年8月23日 更新者：Richard Goldberg、University of Maryland, Baltimore

Optimizing Chronic Illness Self-Management for Individuals With Schizophrenia

This study will develop and evaluate the effectiveness of a self-management program for adults living with both schizophrenia and a co-occurring medical condition.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, and believe that others are controlling their thoughts. People with schizophrenia also experience increased rates of concurrent medical conditions, such as diabetes, respiratory illness, and heart disease. This can make holding a job or even caring for oneself very difficult. The purpose of this study is to develop and evaluate a self-management program for adults living with both schizophrenia and a concurrent medical condition.

Participants in this open-label study will attend 10 to 16 group sessions led by two group leaders. Group sessions will meet each week for an hour during which participants will learn new skills to help them take responsibility for the daily management of chronic medical conditions. In addition to learning how to communicate more effectively with medical providers, participants will learn about healthy eating, the importance of physical activity, addictive behaviors that can worsen health conditions, and proper use of medications. Homework will be assigned weekly for participants to review skills learned in each session. After each session, participants will complete a survey to evaluate the session's effectiveness. At the end of the study, participants will attend one additional group meeting and an individual interview to discuss the overall effectiveness of the intervention and their experiences in the group sessions. The results of this study will be used to evaluate and improve the self-management program for future use.

研究类型

介入性

注册 (实际的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Maryland
      • Baltimore、Maryland、美国、21201
        • Fayette Street Clinics

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 64年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
  • Current documented chart diagnosis of at least one chronic medical condition
  • Received clinic services for a minimum of 3 months prior to study entry
  • English-speaking
  • Willing to use an effective form of birth control throughout the study if sexually active

Exclusion Criteria:

  • History of a serious neurological disorder or head trauma with loss of consciousness
  • Diagnosed with mental retardation or dementia
  • Diagnosed with end stage organ disease
  • Currently receiving chemotherapy and/or radiation treatment for cancer
  • Received psychiatric hospitalization less than 3 months prior to study entry date
  • Blind and/or deaf
  • Pregnant
  • Infected with HIV with a CD4 count under 350
  • Diagnosis of AIDS
  • Diagnosis of anorexia
  • Problematic substance use, as defined by a mental health provider
  • Psychiatric instability, as defined by a mental health provider

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：1
Participants will receive a self-management program for chronic illness
行为的：Self-management program for chronic illness
Self-management program for chronic illness will include between 10 and 16 psychoeducational and supportive group sessions.
无干预：Usaual Care
Usual Care; no additional intervention

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Health-related self-efficacy and recovery orientation
大体时间：Measured at pre- and post-intervention
Measured at pre- and post-intervention
Medical illness self-management skills
大体时间：Measured at pre- and post-intervention
Measured at pre- and post-intervention
Social and communication skills during interactions with health care providers
大体时间：Measured at pre- and post-intervention
Measured at pre- and post-intervention
Physical and mental health status
大体时间：Measured at pre- and post-intervention
Measured at pre- and post-intervention
Medical service use patterns
大体时间：Measured at pre- and post-intervention
Measured at pre- and post-intervention

次要结果测量

结果测量
大体时间
Medication use
大体时间：Measured throughout the study
Measured throughout the study
Neurocognition
大体时间：Measured at baseline
Measured at baseline
Substance abuse
大体时间：Measured at pre- and post-intervention
Measured at pre- and post-intervention
Psychiatric symptoms
大体时间：Measured at pre- and post-intervention
Measured at pre- and post-intervention
Amount and seriousness of related comorbidities
大体时间：Measured at pre- and post-intervention
Measured at pre- and post-intervention
Quantitative and qualitative survey ratings
大体时间：Measured throughout the study
Measured throughout the study

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Maryland, Baltimore

合作者

National Institute of Mental Health (NIMH)

调查人员

  • 首席研究员：Richard W. Goldberg, PhD、University of Maryland, College Park

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年9月1日

初级完成 (实际的)

2015年5月1日

研究完成 (实际的)

2015年5月1日

研究注册日期

首次提交

2007年9月4日

首先提交符合 QC 标准的

2007年9月4日

首次发布 (估计)

2007年9月5日

研究记录更新

最后更新发布 (实际的)

2019年8月28日

上次提交的符合 QC 标准的更新

2019年8月23日

最后验证

2019年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HP-00040526
  • DAHBR 96-BHB
  • R34MH078168 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅