A Model of Family Caregiving and Model-based Intervention Program for Family Caregivers of Patients With Mild Cognitive Impairment
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
- 否
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
Yea-Ing Lotus Shyu
Professor
Chang Gung University
