Intervention Program for Patients With Mild Cognitive Impairment

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

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Other: Family Caregiver Intervention Program

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Patients received only routine hospital care
Experimental: Intervention group; Patients received regular hospital routine care and model-based intervention program	Other: Family Caregiver Intervention Program; Family Caregiver Intervention Program included three components: introduction of mild cognitive impairment, maintain and improve cognitive function, and health management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Caregivers' preparedness was measured by the 10-item Caregiver Preparedness Scale.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: Yea-Ing L Shyu, PhD, Chang Gung University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): July 31, 2016
• Study Completion (Actual): July 31, 2016

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): February 2, 2016

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Family caregiver; Mild Cognitive Impairment; Intervention program; Elders
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: NSC102-2314-B-182-051-MY3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO