Cognitive Training for Digital Biomarkers

The Effectiveness of Cognitive Training for Digital Biomarkers: Evidence From the Urban and Rural Area

This study aims to conduct cognitive training for digital biomarkers among older adults.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Aging; Cognitive Decline
• Intervention / Treatment: Other: Smartphone-based cognitive training

Detailed Description

The prevalence of dementia in rural areas is higher than in urban areas. However, the resource and research input on cognitive training for rural older adults still needs improvement. There is also no solution for preventing or early detection of dementia in rural areas. Unlike biomarkers that require invasive detection, digital biomarkers have been advocated in recent years for early disease prediction. However, there are still few studies on the effectiveness of digital biomarkers in evaluating cognitive function in the elderly. In addition, although previous studies have confirmed that cognitive training can be effective for older adults, it is difficult for the elderly in rural areas to obtain these cognitive-promoting resources due to distance. Moreover, the autonomy and right of choice of older adults are the keys to the success of their health behavior change.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. At least 60 years of age, Can communicate in Chinese (Taiwanese)
2. Bring your own mobile device with Internet access.
3. Can act alone without physical impairment；full score of basic activities of daily living scale and instrumental activities of daily living scale.

Exclusion Criteria:

1. Dementia diagnosed by a physician and in compliance with ICD-10
2. Physician diagnosed with significant mental illness or communication impairment
3. Participated in other cognitive training studies within the past year
4. Medical conditions associated with rapid functional and cognitive decline
5. Severe visual impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; No intervention
Experimental: Cognitive training; Smartphone-based cognitive training	Other: Smartphone-based cognitive training; Smartphone-based cognitive training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
digital biomarker	wearable device of stress and sleep, EEG power in alpha band, Delta and Theta frequency-bands	pretest, immediate post test, 3 month follow-up, 6 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment(MoCA)	The Montreal Cognitive Assessment (MoCA) is a cognitive screening tool designed to identify mild cognitive impairment, providing a quick assessment of different cognitive domains including memory, attention, language, and executive functions. It is widely utilized in clinical and research settings.The MoCA is scored out of a maximum of 30 points. A score of 26 and above is generally considered to be normal, although the specific cutoff can depend on the individual's age, educational level, and other demographic factors.	pretest, immediate post test, 3 month follow-up, 6 month follow-up
Digit Span(DS)	Digit Span (DS) is a common test used in neuropsychological assessments to measure working memory, attention, and concentration. Each correctly repeated sequence yields one point. There are typically 16 items for the Forward Digit Span. The Backward Digit Span also has 16 items.	pretest, immediate post test, 3 month follow-up, 6 month follow-up
Digit Vigilance Test(DVT)	The Digit Vigilance Test (DVT) is a psychological assessment tool used to measure attention and concentration, mainly focused on visual scanning and processing speed. The number of correct identifications and the time taken to complete the task are typically measured.	pretest, immediate post test, 3 month follow-up, 6 month follow-up
Computerized version of Wisconsin Card Sort Test (WCST)	The Wisconsin Card Sorting Test (WCST) is a well-established neuropsychological test widely used to assess executive functions, mainly focusing on abstract reasoning and the ability to shift cognitive strategies in response to changing environmental contingencies (i.e., set-shifting or cognitive flexibility). The computerized version of the WCST allows for efficient, standardized administration and scoring, often reducing examiner bias and error.	pretest, immediate post test, 3 month follow-up, 6 month follow-up
Stroop color-word test (SCWT)	The Stroop Color-Word Test (SCWT) evaluates cognitive processing speed, selective attention, and cognitive flexibility, which are aspects of executive functioning. It's particularly notable for its ability to detect cognitive interference and inhibition control.Scores are typically based on:Correct Responses, Time Taken, Error Rate and Interference Score.	pretest, immediate post test, 3 month follow-up, 6 month follow-up

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: October 15, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 15, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: digital biomarker
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: N202303103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No