Intervention Program for Patients With Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Family Caregiver Intervention Program
Sponsored by

About this trial
This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring Mild Cognitive Impairment, Family caregiver, Intervention program, Elders
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
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Intervention group
Arm Description
Patients received only routine hospital care
Patients received regular hospital routine care and model-based intervention program
Outcomes
Primary Outcome Measures
Caregivers' preparedness was measured by the 10-item Caregiver Preparedness Scale.
Secondary Outcome Measures
Caregivers' competence was measured by the 17-item Competence Scale.
Caregivers' quality of life was measured by the The 36-Item Short Form Health Survey (SF-36).
Caregivers' depressive symptoms was measured by the the Center for Epidemiologic Studies Depression Scale.
Full Information
NCT ID
NCT02670850
First Posted
January 26, 2016
Last Updated
February 2, 2017
Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Science and Technology, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02670850
Brief Title
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
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 1, 2013 (Actual)
Primary Completion Date
July 31, 2016 (Actual)
Study Completion Date
July 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Science and Technology, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild Cognitive Impairment, Family caregiver, Intervention program, Elders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients received only routine hospital care
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Patients received regular hospital routine care and model-based intervention program
Intervention Type
Other
Intervention Name(s)
Family Caregiver Intervention Program
Intervention Description
Family Caregiver Intervention Program included three components: introduction of mild cognitive impairment, maintain and improve cognitive function, and health management.
Primary Outcome Measure Information:
Title
Caregivers' preparedness was measured by the 10-item Caregiver Preparedness Scale.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Caregivers' competence was measured by the 17-item Competence Scale.
Time Frame
6 months
Title
Caregivers' quality of life was measured by the The 36-Item Short Form Health Survey (SF-36).
Time Frame
6 months
Title
Caregivers' depressive symptoms was measured by the the Center for Epidemiologic Studies Depression Scale.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yea-Ing L Shyu, PhD
Organizational Affiliation
Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Intervention Program for Patients With Mild Cognitive Impairment
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