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Efficacy of Chronic Disease Self-management Program in People With Schizophrenia

2021年11月8日 更新者:En-Chi Chiu、National Taipei University of Nursing and Health Sciences
This was a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of chronic disease self-management program in people on schizophrenia patients conditions of depression, activities of daily living, social function, work, and quality of life.

研究概览

详细说明

Subjects were randomized to intervention group and control group. The primary outcome included eight measures, Stanford Self-Management Questionnaire, the Beck Depression Inventory-II, the Activities of Daily Living Rating Scale III, the Instrumental Activities of Daily Living Scale, the Participation Measure-3 Domains, 4 Dimensions, the Work Behavior Inventory, and the Schizophrenia-Quality of Life questionnaire.

研究类型

介入性

注册 (实际的)

80

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

    • Wanhua Dist
      • Taipei、Wanhua Dist、台湾、108306
        • National Taipei University of Nursing and Health Sciences

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

20年 至 99年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Diagnosis of schizophrenia by DSM-5
  • age > 20 years
  • Stable mental symptoms
  • Willing to sign the subject's consent

Exclusion Criteria:

  • History of severe brain injury
  • Substance abuse
  • Diagnosis of intellectual developmental disorder
  • Unable to follow instructions

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:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Self-management group
Self-management group Chronic disease self-management program is conduct training skills, person how to live together with personal chronic disease to make life quality better.
The chronic disease self-management program is based on the self-efficacy theory for improving health behavior, by the solve health problem skill, health life style, emotion management skill, improve intention of health condition in people with chronic disease.
安慰剂比较:Control group
Control group will continue general psychiatric intervention.
General psychiatric intervention contains the activities in psychiatric center.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Stanford Self-Management Questionnaire
大体时间:6 week
The Stanford Self-Management Questionnaire is for Chronic Disease Self-management Program. A higher score indicates better self-management. Changes of the Canadian Occupational Performance Measure will be assessed at the 0 week, 6 weeks.
6 week
Beck Depression Inventory-II,
大体时间:6 week

Beck Depression Inventory-II assesses the person about depression. A higher score indicates more depression.

Changes of Beck Depression Inventory-II will be assessed at the 0 week, 6 weeks.

6 week
Activities of Daily Living Rating Scale III,
大体时间:6 week
Activities of Daily Living Rating Scale III assesses instrumental activities of daily living. A higher score indicates better activities of daily living. Changes of Activities of Daily Living Rating Scale III will be assessed at the 0 week, 6 weeks.
6 week
Instrumental Activities of Daily Living
大体时间:6 week

Instrumental Activities of Daily Living assesses instrumental activities of daily living.

A higher score indicates better instrumental activities of daily living. Changes of Instrumental Activities of Daily Living will be assessed at the 0 week, 6 weeks.

6 week
Participation Measure-3 Domains Domains, 4 Dimensions
大体时间:6 week
Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation. Changes of Participation Measure-3 Domains, 4 Dimensions will be assessed at the 0 week, 6 weeks.
6 week
Work Behavior Inventory
大体时间:6 week
Work Behavior Inventory assesses work behavior about chronic mental patients. A lower score indicates better work behavior. Changes of Work Behavior Inventory will be assessed at the 0 week, 6 weeks.
6 week
Schizophrenia-Quality of Life questionnaire
大体时间:6 week
Schizophrenia-Quality of Life questionnaire assesses schizophrenia quality of life. A higher score indicates better quality of life. Changes of Schizophrenia-Quality of Life questionnaire will be assessed at the 0 week, 6 weeks.
6 week
Mini Mental State Examination-2nd edition
大体时间:6 week

Mini Mental State Examination general cognitive function. A higher score indicates better general cognitive function.

Changes of Mini Mental State Examination will be assessed at the 0 week, 6 weeks.

6 week

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。

调查人员

  • 研究主任:En-Chi Chiu, PhD、National Taipei University of Nursing and Health Sciences

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 (实际的)

2020年9月7日

初级完成 (实际的)

2020年12月25日

研究完成 (实际的)

2020年12月25日

研究注册日期

首次提交

2020年8月5日

首先提交符合 QC 标准的

2020年8月5日

首次发布 (实际的)

2020年8月7日

研究记录更新

最后更新发布 (实际的)

2021年11月16日

上次提交的符合 QC 标准的更新

2021年11月8日

最后验证

2021年11月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

Chronic disease self-management program的临床试验

3
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