Protocol of Virtual Interactive Memory-Training Program

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Behavioral: Passive information activities; Behavioral: Virtual interactive memory training

• Registration Number: NCT02462135
• Lead Sponsor: Ministry of Science and Technology, Taiwan

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-03
• Status Verified: 2017-12
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2017-12-13
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Passive information activities	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.
Virtual interactive memory training	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Residential care facilities; 🇨🇳 Taipei, Taiwan