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

NCT ID: NCT05380284

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-28
• Study Completion Date: 2023-05-28

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.

Conditions

MCI; Subjective Cognitive Decline; Healthy Aging

Study Design

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

Study Groups

Experimental Group

Senior Driving Simulation Training

Group Type: EXPERIMENTAL

Senior Driving Simulation Training

Intervention Type: OTHER

The experimental group (Senior Driving Simulation Training: 30-mins training session two times per week for 5 weeks, with a total of 10 sessions) .

Control Group

Ｗaiting-list

Group Type: OTHER

Waiting list control

Intervention Type: OTHER

The control group is waiting list control. They will also receive the (Senior Driving Simulation Training) after all research is done.

Interventions

Senior Driving Simulation Training

The experimental group (Senior Driving Simulation Training: 30-mins training session two times per week for 5 weeks, with a total of 10 sessions) .

Intervention Type: OTHER

Waiting list control

The control group is waiting list control. They will also receive the (Senior Driving Simulation Training) after all research is done.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Huie-Ling Chiu

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huei-Ling Chiu

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

N202002083

Identifier Type: -

Identifier Source: org_study_id