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Clinical Trials/NCT02462135
NCT02462135
Completed
Not Applicable

The Development and Evaluation of the Effectiveness of a Virtual Interactive Memory Training Program for Older Adults With Mild Cognitive Impairment: Protocol of a Randomized Controlled Study

Ministry of Science and Technology, Taiwan1 site in 1 country60 target enrollmentMarch 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Ministry of Science and Technology, Taiwan
Enrollment
60
Locations
1
Primary Endpoint
Change in objective memory performance as measured by the Chinese version of the Wechsler Memory Scale-III (WMS-III).
Status
Completed
Last Updated
8 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
December 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ministry of Science and Technology, Taiwan
Responsible Party
Principal Investigator
Principal Investigator

Yang, Hui-Ling

Ph.D. candidate

Ministry of Science and Technology, Taiwan

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

  • 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 Sites (1)

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