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Protocol of Virtual Interactive Memory-Training Program

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Virtual interactive memory training
Passive information activities
Sponsored by
Ministry of Science and Technology, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring Mild cognitive impairment, Memory training, Randomized controlled study

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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:

  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

Sites / Locations

  • Residential care facilities

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual interactive memory training

Passive information activities

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 28, 2015
Last Updated
December 13, 2017
Sponsor
Ministry of Science and Technology, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT02462135
Brief Title
Protocol of Virtual Interactive Memory-Training Program
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Science and Technology, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild cognitive impairment, Memory training, Randomized controlled study

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual interactive memory training
Arm Type
Experimental
Arm Description
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).
Arm Title
Passive information activities
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual interactive memory training
Other Intervention Name(s)
Memory training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Passive information activities
Other Intervention Name(s)
Active control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Ling Yang, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kuei-Ru Chou, Professor
Organizational Affiliation
Taipei Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Residential care facilities
City
Taipei
ZIP/Postal Code
22176
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
30989165
Citation
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.
Results Reference
derived

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Protocol of Virtual Interactive Memory-Training Program

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