Intervention Program for Patients With Mild Cognitive Impairment
- Conditions
- Mild Cognitive Impairment
- Interventions
- Other: Family Caregiver Intervention Program
- Registration Number
- NCT02670850
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Age 65 years or older
- Being diagnosed as having MCI by a neurologist or a psychiatris
- Being cared for in a home setting
Patients'
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Family Caregiver Intervention Program Patients received regular hospital routine care and model-based intervention program
- Primary Outcome Measures
Name Time Method Caregivers' preparedness was measured by the 10-item Caregiver Preparedness Scale. 6 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan