NCT02670850

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2016

Completed
Last Updated

February 3, 2017

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

January 26, 2016

Last Update Submit

February 2, 2017

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive ImpairmentFamily caregiverIntervention programElders

Outcome Measures

Primary Outcomes (1)

  • Caregivers' preparedness was measured by the 10-item Caregiver Preparedness Scale.

    6 months

Secondary Outcomes (3)

  • Caregivers' competence was measured by the 17-item Competence Scale.

    6 months

  • Caregivers' quality of life was measured by the The 36-Item Short Form Health Survey (SF-36).

    6 months

  • Caregivers' depressive symptoms was measured by the the Center for Epidemiologic Studies Depression Scale.

    6 months

Study Arms (2)

Control group

NO INTERVENTION

Patients received only routine hospital care

Intervention group

EXPERIMENTAL

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

Other: Family Caregiver Intervention Program

Interventions

Family Caregiver Intervention ProgramOTHER

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

Intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 years or older
  • Being diagnosed as having MCI by a neurologist or a psychiatris
  • Being cared for in a home setting

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Yea-Ing L Shyu, PhD

    Chang Gung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 2, 2016

Study Start

August 1, 2013

Primary Completion

July 31, 2016

Study Completion

July 31, 2016

Last Updated

February 3, 2017

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)