ClinicalTrials.Veeva

Menu

Intervention Program for Patients With Mild Cognitive Impairment

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Mild Cognitive Impairment

Treatments

Other: Family Caregiver Intervention Program

Study type

Interventional

Funder types

Other

Identifiers

NCT02670850
NSC102-2314-B-182-051-MY3

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Control group
No Intervention group
Description:
Patients received only routine hospital care
Intervention group
Experimental group
Description:
Patients received regular hospital routine care and model-based intervention program
Treatment:
Other: Family Caregiver Intervention Program

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems