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Intervention Program for Patients With Mild Cognitive Impairment

2017年2月2日 更新者:Yea-Ing Lotus Shyu、Chang Gung Memorial Hospital

A Model of Family Caregiving and Model-based Intervention Program for Family Caregivers of Patients With Mild Cognitive Impairment

Mild Cognitive Impairment (MCI) is a syndrome defined as a cognitive decline that is more severe than can be explained by an individual's age and education. One study in the United States found that MCI caregivers have experienced distress in association with caregiver burden. The prevalence of MCI for people age 65 and older ranges from 3% to 19%. Understanding the process of family caregiving provides a knowledge base for the health professionals when developing effective interventions. However, little is known about the phenomenon of family caregiving to patients with MCI in Taiwan.

Therefore, the purpose of the proposed study is to develop a theoretical model and a model-based intervention program for family caregivers of patients with MCI in Taiwan, and pilot test it in a clinical trial.

研究概览

详细说明

Mild Cognitive Impairment (MCI) is a syndrome defined as a cognitive decline that is more severe than can be explained by an individual's age and education. One study in the United States found that MCI caregivers have experienced distress in association with caregiver burden. The prevalence of MCI for people age 65 and older ranges from 3% to 19%. Understanding the process of family caregiving provides a knowledge base for the health professionals when developing effective interventions. However, little is known about the phenomenon of family caregiving to patients with MCI in Taiwan.

Therefore, the purpose of the proposed study is to develop a theoretical model and a model-based intervention program for family caregivers of patients with MCI in Taiwan, and pilot test it in a clinical trial.

To conduct a small scale pilot randomized control trial (total N = 60; 30 in each group) to pilot test the intervention program. The intervention group will receive the caregiver training program, and the control group received printed sheets with general information on MCI and dementia such as the causes, courses and symptoms. At 1 month, 3 months, and 6 months after the intervention group will complete the two-session training program, both groups will receive a follow-up assessment for preparedness, HRQoL and depressive symptoms. To minimize attrition, caregivers in both groups will receive monthly follow-up phone calls from the first to the sixth month. Changes in outcome variables will be analyzed using hierarchical linear models, in order to provide a reference for further formal clinical trial.

研究类型

介入性

注册 (实际的)

60

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

      • Taoyuan、台湾
        • Chang Gung Memorial Hospital

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

65年 及以上 (年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Patients' Inclusion Criteria:

  • Age 65 years or older
  • Being diagnosed as having MCI by a neurologist or a psychiatris
  • Being cared for in a home setting

Patients' Exclusion Criteria:

  • Terminally ill

Caregivers' Inclusion Criteria:

  • Age 20 years or older
  • Assuming primary responsibility for the care of the frail elderly person

Caregivers' Exclusion Criteria:

  • Terminally ill

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:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:Control group
Patients received only routine hospital care
实验性的:Intervention group
Patients received regular hospital routine care and model-based intervention program
Family Caregiver Intervention Program included three components: introduction of mild cognitive impairment, maintain and improve cognitive function, and health management.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Caregivers' preparedness was measured by the 10-item Caregiver Preparedness Scale.
大体时间:6 months
6 months

次要结果测量

结果测量
大体时间
Caregivers' competence was measured by the 17-item Competence Scale.
大体时间:6 months
6 months
Caregivers' quality of life was measured by the The 36-Item Short Form Health Survey (SF-36).
大体时间:6 months
6 months
Caregivers' depressive symptoms was measured by the the Center for Epidemiologic Studies Depression Scale.
大体时间:6 months
6 months

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

  • 首席研究员:Yea-Ing L Shyu, PhD、Chang Gung University

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)

2013年8月1日

初级完成 (实际的)

2016年7月31日

研究完成 (实际的)

2016年7月31日

研究注册日期

首次提交

2016年1月26日

首先提交符合 QC 标准的

2016年1月28日

首次发布 (估计)

2016年2月2日

研究记录更新

最后更新发布 (估计)

2017年2月3日

上次提交的符合 QC 标准的更新

2017年2月2日

最后验证

2016年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • NSC102-2314-B-182-051-MY3

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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.

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