Protocol of Virtual Interactive Memory-Training Program

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462135
• Other study ID #: 201301045
• Status: Completed
• Phase: N/A
• First received: May 28, 2015
• Last updated: December 13, 2017
• Start date: March 2014
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Ministry of Science and Technology, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	Residential care facilities	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.