Clinical Trial: Intervention Program for Patients With Mild Cognitive Impairment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 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.

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.


Sponsor: Chang Gung Memorial Hospital

Current Primary Outcome: Caregivers' preparedness was measured by the 10-item Caregiver Preparedness Scale. [ Time Frame: 6 months ]

Original Primary Outcome:

  • Caregivers' preparedness was measured by the 10-item Caregiver Preparedness Scale. [ Time Frame: 6 months ]
  • Caregivers' competence was measured by the 17-item Competence Scale. [ Time Frame: 6 months ]


Current Secondary Outcome:

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


Original Secondary Outcome:

  • Parients' self-care ability was measured by the Barthel Index and Instrumental activities of daily living. [ Time Frame: 6 months ]
  • Parients' cognitive function was measured by the Mini-Mental State Examination. [ Time Frame: 6 months ]
  • Caregivers' quality of life was measured by the The 36-Item Short Form Health Survey (SF-36). [ Time Frame: 6 months ]
  • Caregivers' depressive symptoms was measured by the the Center for Epidemiologic Studies Depression Scale. [ Time Frame: 6 months ]


Information By: Chang Gung Memorial Hospital

Dates:
Date Received: January 26, 2016
Date Started: August 1, 2013
Date Completion:
Last Updated: February 2, 2017
Last Verified: July 2016