Effectiveness of a Home-Based Cognitive Rehabilitation Program in Patients With MCI

Effectiveness of a Home-Based Cognitive Rehabilitation Program Driven by a Tablet Application in Patients With Mild Cognitive Impairment

In this study, a more specific and systematic Home-Based Cognitive Rehabilitation Program Driven by a Tablet Application is developed and the purpose of the program is to check whether cognitive function is improved when the program is applied to patients with MCI.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; Mild Cognitive Impairment
• Intervention / Treatment: Other: Home based cognitive rehabilitation program

Detailed Description

The subjects of recruitment were the elderly with mild cognitive impairment living in the local community. Assessments were conducted 7 days before and after the intervention. Subjects received Korean-Montreal Cognitive Assessment(MoCA), semantic verbal emory test (SVLT), number memorization test; Digit Span Test (DST), category word fluency test (CWFT), phonemic word fluency test (PWFT), Korean-mini mental state test (K-MMSE), and geriatric depression scale (GDS) before and 8 weeks after the intervention.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yangsan
    • Gyeongsang, Yangsan, Korea, Republic of, 50610
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men and women over the age of 55
2. Those who have visual and auditory abilities without difficulties in conducting this research
3. Those with K-MMSE (Korean-Mini Mental State Examination) score of 24 or higher and 16≤K-MoCA score<23
4. In the case of patients taking dementia treatment, those who have the same treatment regimen and dose for 3 months or more from the screening date
5. A person who can understand and respond to the questionnaire questions.
6. A person who voluntarily decided to participate in this study and gave written consent to the informed consent form

Exclusion Criteria:

1. Those with a history of alcohol or drug abuse,
2. Those with a past history of uniaxial psychiatric disorders, including intellectual disability, schizophrenia, alcoholism, and bipolar disorder
3. A person who is unable to communicate
4. Those who show all neurological symptoms that cause cognitive decline, such as Parkinson's disease, cerebral hemorrhage, brain tumor, and hydrocephalus
5. Those with a record of being unconscious for more than 1 hour due to head trauma or mild repetitive head trauma
6. Those with symptoms of depression that may affect cognitive function

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home based cognitive rehabilitation program; The intervention was conducted for 30 minutes each time, 3 times a week for 8 weeks, a total of 24 times.	Other: Home based cognitive rehabilitation program; The home based cognitive rehabilitation program intervention was conducted for 30 minutes each time, 3 times a week for 8 weeks, a total of 24 times.
No Intervention: No intervention; In the control group, natural cognitive changes with the passage of time were observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the Korean-Montreal cognitive assessment(MoCA) score	It is a tool to evaluate overall cognitive function. Possible scores range from 0(lowest cognitive function) to 30 (highest cognitive function). Change = Paired t-test with baseline score and week 8 score.	Baseline and Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the semantic verbal emory test (SVLT) score	It is a tool to evaluate language memory function. Possible scores range from 0(lowest) to 36 (highest). Change = Paired t-test with baseline score and week 8 score.	Baseline and Week 8
Change of the Digit Span Test (DST) score	It is a tool to evaluate number memorization and attention. Possible scores range from 0(lowest) to 9 (highest). Change = Paired t-test with baseline score and week 8 score.	Baseline and Week 8
Change of the category word fluency test (CWFT) score	It is a tool to evaluate executive function. In one minute, the speak words of the given category is performed, and the number of words spoken within the time is evaluated as a score. Change = Paired t-test with baseline score and week 8 score.	Baseline and Week 8
Change of the phonemic word fluency test (PWFT) score	It is a tool to evaluate executive function. In one minute, the speak words that start with a given phoneme is performed, and the number of words spoken within the time is evaluated as a score. Change = Paired t-test with baseline score and week 8 score.	Baseline and Week 8
Change of the geriatric depression scale (GDS) score	It is a tool to evaluate degree of depression. Possible scores range from 0(lowest depression) to 21 (highest depression). Change = Paired t-test with baseline score and week 8 score.	Baseline and Week 8

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Collaborators: Woorisoft
• Investigators: Principal Investigator: Young-Il Shin, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): August 2, 2021

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 02-2019-018

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