Senior Driving Simulation Training for Subjective Cognitive Decline and Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: MCI; Subjective Cognitive Decline; Healthy Aging
• Interventions: Other: Waiting list control; Other: Senior Driving Simulation Training

• Registration Number: NCT05380284
• Lead Sponsor: Taipei Medical University

Brief Summary

This study aims to establish the Senior Driving Simulation Training (SDST) for Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI), and explore the effectiveness of Senior Driving Simulation Training (SDST) on the executive function, cognitive function and EEG.

Detailed Description

Driving behavior is a high cognitively demanding task, and whether the Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI) can continue to drive is an important issue. This study will develop the Taiwan version of innovative, immediate feedback and environmentally safe Senior Driving Simulation Training (SDST). This study aims to establish the Senior Driving Simulation Training (SDST) for Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI), and explore the effectiveness of Senior Driving Simulation Training (SDST) on the executive function, cognitive function and EEG. The investigators intend to conduct a single-blind randomized controlled trial using a two-arm parallel-group design. Participants will be randomized by the permuted block randomization, block size of 4, into an experimental group (Senior Driving Simulation Training: 30-mins training session two times per week for 5 weeks, with a total of 10 sessions) or a control group (Waiting list). The investigators plan to blind the therapists and outcome assessors to maintain the blinding methods' quality. The primary outcome indicators are mental set-shifting, working memory, and inhibition. The secondary outcome indicators are cognitive function and EEG. The investigators also evaluate visual awareness and simulator sickness. The short-term (immediate post-test) and the long-term (3, 6, and 12 months) effectiveness of the intervention on individual outcome measures will be analyzed by the generalized estimating equation. The investigators also plan to use the secondary data analysis methods to investigate the relationship between objective indicators of a driving simulator, executive function, cognitive function, EEG, visual awareness, and simulator sickness. Furthermore, the investigators will analyze the trend of EEG while the participants conducting the training, and complete the psychometric properties of the Chinese version of the Cognitive Change Index (C-CCI). This will be the first senior driving simulation training (SDST) for Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI) in Taiwan. Results of the current study will provide valuable information on driving safety decisions and apply to promote the advanced driving policies.

Study Timeline

• Study First Submitted: 2022-04-30
• Study First Submitted QC: 2022-05-14
• Study First Posted: 2022-05-18
• Study Start: 2022-06-28
• Primary Completion: 2023-01-01
• Status Verified: 2023-05
• Study Completion: 2023-05-28
• Last Update Submitted: 2023-05-29
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Subjective cognitive decline( AD-8 scale ≥1 point).
• Mild cognitive impairment (AD-8 scale ≥ 2 points), and MMSE> 24 points, can maintain personal daily activity function.
• Can communicate in Chinese or Taiwanese.
• At least 60 years of age.
• Those with a car driving license.
• No physical impairment.
• In addition to the above conditions, participants must be voluntary and signed informed consent.

Exclusion Criteria

• Dementia, diagnosed by a physician and in compliance with ICD-10.
• Significant mental illness or communication impairment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Waiting list control	Ｗaiting-list
Experimental Group	Senior Driving Simulation Training	Senior Driving Simulation Training

Primary Outcome Measures

Name	Time	Method
Change from Baseline Inhibition, measured by the Stroop Color and Word Test at 3 months	3 months follow-up	Inhibition is one of the sub-categories of executive function
Mental set shifting, measured by Wisconsin Card Sorting Test	immediate post-test	Mental set shifting is one of the sub-categories of executive function
Working memory, measured by Digit span test	immediate post-test	Working memory is one of the sub-categories of executive function
Change from Baseline Working memory, measured by Digit span test at 3 months	3 months follow-up	Working memory is one of the sub-categories of executive function
Change from Baseline Mental set shifting, measured by Wisconsin Card Sorting Test at 3 months	3 months follow-up	Mental set shifting is one of the sub-categories of executive function
Inhibition, measured by the Stroop Color and Word Test	immediate post-test	Inhibition is one of the sub-categories of executive function

Secondary Outcome Measures

Name	Time	Method
Cognitive function measured by Montreal Cognitive Assessment	immediate post-test	Cognitive function measured by Montreal Cognitive Assessment
Change from Baseline EEG at 3 months	3 months follow-up	EEG power in delta, theta, alpha, and beta band
Cognitive function measured by Cognitive Change Index(C-CCI)	immediate post-test	Cognitive function measured by Cognitive Change Index(C-CCI)
Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months	3 months follow-up	Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months
Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 3 months	3 months follow-up	Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 3 months
Visual awareness measured by CANTAB	immediate post-test	Visual awareness measured by CANTAB
EEG	immediate post-test	EEG power in delta, theta, alpha, and beta band
Change from Baseline visual awareness by CANTAB at 3 months	3 months follow-up	Visual awareness measured by CANTAB
simulator sickness	immediate post-test	Simulator Sickness Questionnaire (SSQ). The 16-item SSQ will be used to assess participants' sickness levels. This is the 4-point Likert scale (0 - "None" to 3 - "Severe"), and the higher total score reflects more severe sickness.
Usability	immediate post-test	The System Usability Scale (SUS) will be used to access the usability, this scale consists of 10 items, and the higher total score reflects better usability.
Acceptance	immediate post-test	The Technology Acceptance for Older Adults Scale will be used to access the acceptance, this scale consists of 17 items, and the higher total score reflects better acceptance.
Visual awareness measured by trail making test	immediate post-test	Visual awareness measured by trail making test
Change from Baseline visual awareness by trail making test at 3 months	3 months follow-up	Change from Baseline visual awareness by trail making test at 3 months

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan