Clinical trial NCT02670850: Intervention Program for Patients With Mild Cognitive Impairment
Official title: A Model of Family Caregiving and Model-based Intervention Program for Family Caregivers of Patients With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Family caregiver
Intervention program
Elders
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2016-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Caregivers' preparedness was measured by the 10-item Caregiver Preparedness Scale.
timeFrame: 6 months
Secondary outcomes:
measure: Caregivers' competence was measured by the 17-item Competence Scale.
timeFrame: 6 months
measure: Caregivers' quality of life was measured by the The 36-Item Short Form Health Survey (SF-36).
timeFrame: 6 months
measure: Caregivers' depressive symptoms was measured by the the Center for Epidemiologic Studies Depression Scale.
timeFrame: 6 months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University
name: Yea-Ing L Shyu, PhD
role: PRINCIPAL_INVESTIGATOR
References: