CClinicalTrials.gg
CompletedNCT02462135Updated Dec 15, 2017

Protocol of Virtual Interactive Memory-Training Program

An interventional study of Virtual interactive memory training and Passive information activities in Mild Cognitive Impairment, sponsored by Ministry of Science and Technology, Taiwan. Completed at 1 site in Taiwan. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-15.

Sponsored by Ministry of Science and Technology, Taiwan · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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).

Read the detailed description

This double-blind randomized controlled study has a 2-arm parallel group design. All subjects will be randomized by the block randomization, into intervention group (Virtual interactive memory training, VIMT), or active control group (Passive information activities, PIA). Training sessions of the VIMT group are 45 minutes/day, 3 days/week, for 12 weeks (36 sessions each). The training of PIA group is the same as VIMT group. We constructed a rigorous VIMT program adhering to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. The investigators expect to determine the improvement in memory function and degree of depression of older adults with mild cognitive impairment after using the VIMT.

02

Conditions studied

  • Mild Cognitive Impairment

Keywords

  • Mild cognitive impairment
  • Memory training
  • Randomized controlled study
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Participants must endorse at least two items from a list of frequent subjective memory complaints by patient and/or an informant
  2. Objective memory impairment on neuropsychological tests of memory 1.5 SD or more below age/education norms
  3. 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)
  4. No impairment in personal activities of daily living (P-ADL) as determined by clinical interview with participant and family

Exclusion criteria

Exclusion Criteria:

  1. The clinical diagnosis of dementia was based on the DSM-IV-TR
  2. Active in another cognitive or memory-related training in the past year
  3. Comorbid medical conditions that would predispose them to imminent functional decline or cognitive impairment
  4. A diagnosis of major neurological or psychiatric illness history and/or behavioral problems that would sufficiently impair performance to make participation impossible
  5. Severe losses in vision, hearing, or communicative ability
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Virtual interactive memory training

    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

  • Active comparator
    Passive information activities

    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

  • BehavioralVirtual interactive memory training

    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

  • BehavioralPassive information activities

    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

05

What researchers measure

Primary outcomes

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

    Time frame: 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).

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

06

Study locations

1 site
  • Residential care facilities
    Taipei, 22176, Taiwan
07

References and documents

Publications

  • 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. PubMed 30989165 ↗
08

Registry details

Key details

Study ID
NCT02462135
Lead sponsor
Ministry of Science and Technology, Taiwan
Responsible party
Yang, Hui-Ling (Ph.D. candidate, Ministry of Science and Technology, Taiwan) — Principal investigator
First posted
Jun 3, 2015
Start date
Mar 2014
Primary completion
Dec 2017
Completion
Dec 2017
Last update
Dec 15, 2017

Study contacts

Hui-Ling Yang, PhD
principal investigator · Taipei Medical University
Kuei-Ru Chou, Professor
study chair · Taipei Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion