Intervention Program for Patients With Mild Cognitive Impairment

NCT ID: NCT02670850

Last Updated: 2017-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-01
• Study Completion Date: 2016-07-31

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control group

Patients received only routine hospital care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

Patients received regular hospital routine care and model-based intervention program

Group Type: EXPERIMENTAL

Family Caregiver Intervention Program

Intervention Type: OTHER

Family Caregiver Intervention Program included three components: introduction of mild cognitive impairment, maintain and improve cognitive function, and health management.

Interventions

Family Caregiver Intervention Program

Family Caregiver Intervention Program included three components: introduction of mild cognitive impairment, maintain and improve cognitive function, and health management.

Intervention Type: OTHER

Eligibility Criteria

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

• Age 20 years or older
• Assuming primary responsibility for the care of the frail elderly person

Exclusion Criteria

• Terminally ill

• Terminally ill

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yea-Ing Lotus Shyu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yea-Ing L Shyu, PhD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

NSC102-2314-B-182-051-MY3

Identifier Type: -

Identifier Source: org_study_id