NCT02671630

Brief Summary

Little is known about the effects of computerized cognitive training programs on mild dementia patients' health. The purpose of this study was to examine the effects of a community-based computerized cognitive training program.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

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

June 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

January 23, 2016

Last Update Submit

January 29, 2016

Conditions

Keywords

Cognitive functionDepressionQuality of lifeCommunity-based computerized cognitive training programRandomized controlled trial

Outcome Measures

Primary Outcomes (3)

  • Cognitive Abilities as assessed by Cognitive Abilities Screening Instrument.

    3 months

  • Memory as assessed by Prospective and Retrospective Memory Questionnaire.

    3 months

  • Cognitive State as assessed by Mini-Mental State Examination

    3 months

Secondary Outcomes (2)

  • Depression as assessed by Geriatric Depression Scale.

    3 months

  • Quality of Life as assessed by Chinese Dementia Quality of Life, DQoL.

    3 months

Study Arms (2)

Control group

NO INTERVENTION

Patients receive only usual hospital care

Experimental group

EXPERIMENTAL

Patients receive only usual hospital care and community-based computerized cognitive training program

Other: A community-based computerized cognitive training program

Interventions

The computer training games included: 1) a phonological loop to train the participants to choose correct song from a list of different songs which can be categorized as people, nature, and musical instrument. The difficulty level progressed from choosing one from two to choosing one from three songs; 2) a visual-spatial sketchpad to train the participants to remember and find the same graphs including vegetable, fruits, daily necessity, and numbers. The difficulty level progressed from finding one pair to three pairs of similar graphs; 3) a central executive system to train the participants to execute dual tasks including conducting dual memory, calculating while listening to music, making phone calls, and matching medication at correct time.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • Aged 65 or older,
  • Being diagnosed as having mild dementia by a neurologist, and
  • Being able to communicate in Mandarin or Taiwanese.

You may not qualify if:

  • Vision or hearing impairment.
  • Living with the dementia patient,
  • The family member spending the most time on the patient's care, and
  • \>20 years old.
  • Terminally ill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DementiaDepression

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavioral SymptomsBehavior

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
MD

Study Record Dates

First Submitted

January 23, 2016

First Posted

February 2, 2016

Study Start

June 1, 2013

Primary Completion

October 1, 2013

Last Updated

February 2, 2016

Record last verified: 2016-01