NCT02462135

Brief Summary

This study sought to investigate the changes in objective memory performance (including immediate recall and delayed recall), subjective memory complaints and degree of depression in older adults with mild cognitive impairment after Virtual interactive memory training (VIMT).

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 Mar 2014

Longer than P75 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

March 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 15, 2017

Status Verified

December 1, 2017

Enrollment Period

3.8 years

First QC Date

May 28, 2015

Last Update Submit

December 13, 2017

Conditions

Keywords

Mild cognitive impairmentMemory trainingRandomized controlled study

Outcome Measures

Primary Outcomes (1)

  • Change in objective memory performance as measured by the Chinese version of the Wechsler Memory Scale-III (WMS-III).

    Change from baseline in objective memory performance at Immediate post-test, 3 months, 6 months and one year after intervention.

Secondary Outcomes (1)

  • Change in subjective memory complaints as measured by the Multifactorial Memory Questionnaire (MMQ).

    Change from baseline in subjective memory complaints at Immediate post-test, 3 months, 6 months and one year after intervention.

Study Arms (2)

Virtual interactive memory training

EXPERIMENTAL

Training sessions of the VIMT group are divided into initial training and booster training. Each training session is 45 minutes/day, 3 sessions/week, for 12 weeks for both initial training and booster training (36 sessions each).

Behavioral: Virtual interactive memory training

Passive information activities

ACTIVE COMPARATOR

The training of active control group is the same as VIMT group (45 min/day, 3 days/week, for 12 weeks, for a total of 36 sessions). The active control group receives only the initial training.

Behavioral: Passive information activities

Interventions

Training sessions of the VIMT group are divided into initial training and booster training. Each training session is 45 minutes/day, 3 sessions/week, for 12 weeks for both initial training and booster training (36 sessions each). The training content of the four memory training include: (1) spatial encoding memory training task, (2) updating-spatial memory training task, (3) updating-visual memory training task, and (4) rehearsal-visuospatial memory training task.

Also known as: Memory training
Virtual interactive memory training

The active control group (Passive information activities) only accepts the initial training phase, which training content of the two types to include: (1) listening to audio books, and (2) reading online newspaper.

Also known as: Active control group
Passive information activities

Eligibility Criteria

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

You may qualify if:

  • Participants must endorse at least two items from a list of frequent subjective memory complaints by patient and/or an informant
  • Objective memory impairment on neuropsychological tests of memory 1.5 SD or more below age/education norms
  • Clinical neurologic examination by the Mini-Mental State Examination (MMSE) score of 24 or higher, and cut-off score of 23/24 on the Montreal Cognitive Assessment (MoCA)
  • No impairment in personal activities of daily living (P-ADL) as determined by clinical interview with participant and family

You may not qualify if:

  • The clinical diagnosis of dementia was based on the DSM-IV-TR
  • Active in another cognitive or memory-related training in the past year
  • Comorbid medical conditions that would predispose them to imminent functional decline or cognitive impairment
  • A diagnosis of major neurological or psychiatric illness history and/or behavioral problems that would sufficiently impair performance to make participation impossible
  • Severe losses in vision, hearing, or communicative ability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Residential care facilities

Taipei, 22176, Taiwan

Location

Related Publications (1)

  • Yang HL, Chu H, Kao CC, Chiu HL, Tseng IJ, Tseng P, Chou KR. Development and effectiveness of virtual interactive working memory training for older people with mild cognitive impairment: a single-blind randomised controlled trial. Age Ageing. 2019 Jul 1;48(4):519-525. doi: 10.1093/ageing/afz029.

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Hui-Ling Yang, PhD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR
  • Kuei-Ru Chou, Professor

    Taipei Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. candidate

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 3, 2015

Study Start

March 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 15, 2017

Record last verified: 2017-12

Locations