Clinical trial NCT02462135: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild cognitive impairment
Memory training
Randomized controlled study
Lead sponsor: Ministry of Science and Technology, Taiwan
Sponsor class: OTHER_GOV
First posted: 2015-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in objective memory performance as measured by the Chinese version of the Wechsler Memory Scale-III (WMS-III).
timeFrame: Change from baseline in objective memory performance at Immediate post-test, 3 months, 6 months and one year after intervention.
Secondary outcomes:
measure: Change in subjective memory complaints as measured by the Multifactorial Memory Questionnaire (MMQ).
timeFrame: Change from baseline in subjective memory complaints at Immediate post-test, 3 months, 6 months and one year after intervention.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Residential care facilities
Study officials:
affiliation: Taipei Medical University
name: Hui-Ling Yang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Medical University
name: Kuei-Ru Chou, Professor
role: STUDY_CHAIR
References:
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.