Protocol of Virtual Interactive Memory-Training Program

NCT ID: NCT02462135

Last Updated: 2017-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-12-31

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.

Conditions

Mild Cognitive Impairment

Keywords

Mild cognitive impairment; Memory training; Randomized controlled study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Virtual interactive memory training

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Passive information activities

Intervention Type: BEHAVIORAL

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.

Interventions

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). 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

Passive 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Memory training; Active control group

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yang, Hui-Ling

Ph.D. candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui-Ling Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Kuei-Ru Chou, Professor

Role: STUDY_CHAIR

Taipei Medical University

Locations

Residential care facilities

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 30989165 (View on PubMed)

Other Identifiers

201301045

Identifier Type: -

Identifier Source: org_study_id