Intervention Program for Patients With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670850
• Other study ID #: NSC102-2314-B-182-051-MY3
• Status: Completed
• Phase: N/A
• First received: January 26, 2016
• Last updated: February 2, 2017
• Start date: August 1, 2013
• Est. completion date: July 31, 2016

Study information

• Verified date: July 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 31, 2016
• Est. primary completion date: July 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregivers' preparedness was measured by the 10-item Caregiver Preparedness Scale.		6 months
Secondary	Caregivers' competence was measured by the 17-item Competence Scale.		6 months
Secondary	Caregivers' quality of life was measured by the The 36-Item Short Form Health Survey (SF-36).		6 months
Secondary	Caregivers' depressive symptoms was measured by the the Center for Epidemiologic Studies Depression Scale.		6 months