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

Sponsor
Taipei Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05380284
Collaborator
(none)
100
2
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Senior Driving Simulation Training
  • Other: Waiting list control
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Evaluation of Senior Driving Simulation Training on Executive Function, Cognitive Promotion and EEG in Subjective Cognitive Decline and Mild Cognitive Impairment
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group

Senior Driving Simulation Training

Other: 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) .

Other: Control Group

Waiting-list

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.

Outcome Measures

Primary Outcome Measures

  1. Mental set shifting, measured by Wisconsin Card Sorting Test [immediate post-test]

    Mental set shifting is one of the sub-categories of executive function

  2. 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

  3. Change from Baseline Mental set shifting, measured by Wisconsin Card Sorting Test at 6 months [6 months follow-up]

    Mental set shifting is one of the sub-categories of executive function

  4. Change from Baseline Mental set shifting, measured by Wisconsin Card Sorting Test at 12 months [12 months follow-up]

    Mental set shifting is one of the sub-categories of executive function

  5. Working memory, measured by Digit span test [immediate post-test]

    Working memory is one of the sub-categories of executive function

  6. 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

  7. Change from Baseline Working memory, measured by Digit span test at 6 months [6 months follow-up]

    Working memory is one of the sub-categories of executive function

  8. Change from Baseline Working memory, measured by Digit span test at 12 months [12 months follow-up]

    Working memory is one of the sub-categories of executive function

  9. Inhibition, measured by the Stroop Color and Word Test [immediate post-test]

    Inhibition is one of the sub-categories of executive function

  10. 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

  11. Change from Baseline Inhibition, measured by the Stroop Color and Word Test at 6 months [6 months follow-up]

    Inhibition is one of the sub-categories of executive function

  12. Change from Baseline Inhibition, measured by the Stroop Color and Word Test at 12 months [12 months follow-up]

    Inhibition is one of the sub-categories of executive function

Secondary Outcome Measures

  1. Cognitive function measured by Montreal Cognitive Assessment [immediate post-test]

    Cognitive function measured by Montreal Cognitive Assessment

  2. Cognitive function measured by Cognitive Change Index(C-CCI) [immediate post-test]

    Cognitive function measured by Cognitive Change Index(C-CCI)

  3. 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

  4. Change from Baseline cognitive function by Montreal Cognitive Assessment at 6 months [6 months follow-up]

    Change from Baseline cognitive function by Montreal Cognitive Assessment at 6 months

  5. Change from Baseline cognitive function by Montreal Cognitive Assessment at 12 months [12 months follow-up]

    Change from Baseline cognitive function by Montreal Cognitive Assessment at 12 months

  6. 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

  7. Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 6 months [6 months follow-up]

    Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 6 months

  8. Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 12 months [12 months follow-up]

    Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 12 months

  9. EEG [immediate post-test]

    EEG power in delta, theta, alpha, and beta band

  10. Change from Baseline EEG at 3 months [3 months follow-up]

    EEG power in delta, theta, alpha, and beta band

  11. Change from Baseline EEG at 6 months [6 months follow-up]

    EEG power in delta, theta, alpha, and beta band

  12. Change from Baseline EEG at 12 months [12 months follow-up]

    EEG power in delta, theta, alpha, and beta band

  13. Visual awareness measured by CANTAB [immediate post-test]

    Visual awareness measured by CANTAB

  14. Visual awareness measured by trail making test [immediate post-test]

    Visual awareness measured by trail making test

  15. Change from Baseline visual awareness by CANTAB at 3 months [3 months follow-up]

    Visual awareness measured by CANTAB

  16. Change from Baseline visual awareness by CANTAB at 6 months [6 months follow-up]

    Visual awareness measured by CANTAB

  17. Change from Baseline visual awareness by CANTAB at 12 months [12 months follow-up]

    Visual awareness measured by CANTAB

  18. 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

  19. Change from Baseline visual awareness by trail making test at 6 months [6 months follow-up]

    Change from Baseline visual awareness by trail making test at 6 months

  20. Change from Baseline visual awareness by trail making test at 12 months [12 months follow-up]

    Change from Baseline visual awareness by trail making test at 12 months

  21. 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.

  22. 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.

  23. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Taipei Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Huie-Ling Chiu, Assistant professor, Taipei Medical University
ClinicalTrials.gov Identifier:
NCT05380284
Other Study ID Numbers:
  • N202002083
First Posted:
May 18, 2022
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Huie-Ling Chiu, Assistant professor, Taipei Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022