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临床试验/NCT02670850
NCT02670850已完成不适用

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

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Caregivers' preparedness was measured by the 10-item Caregiver Preparedness Scale.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

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

入选标准

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

排除标准

  • 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

结局指标

主要结局

Caregivers' preparedness was measured by the 10-item Caregiver Preparedness Scale.

时间窗: 6 months

次要结局

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

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yea-Ing Lotus Shyu

Professor

Chang Gung University

研究点 (1)

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