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Intervention Program for Patients With Mild Cognitive Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670850
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 3, 2017
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Yea-Ing Lotus Shyu, Chang Gung University

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.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Other: Family Caregiver Intervention Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Model of Family Caregiving and Model-based Intervention Program for Family Caregivers of Patients With Mild Cognitive Impairment
Actual Study Start Date : August 1, 2013
Actual Primary Completion Date : July 31, 2016
Actual Study Completion Date : July 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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.




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670850


Locations
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Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Ministry of Science and Technology, Taiwan
Investigators
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Principal Investigator: Yea-Ing L Shyu, PhD Chang Gung University
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Responsible Party: Yea-Ing Lotus Shyu, Professor, Chang Gung University
ClinicalTrials.gov Identifier: NCT02670850    
Other Study ID Numbers: NSC102-2314-B-182-051-MY3
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yea-Ing Lotus Shyu, Chang Gung University:
Mild Cognitive Impairment
Family caregiver
Intervention program
Elders
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders