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

Not Applicable

Completed

• Conditions: Cognitive Impairment; Mild Cognitive Impairment
• Interventions: Other: Home based cognitive rehabilitation program

• Registration Number: NCT05275153
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2020-04-22
• Primary Completion: 2021-06-30
• Study Completion: 2021-08-02
• Status Verified: 2022-03
• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-10
• Last Update Submitted: 2022-03-10
• Study First Posted: 2022-03-11
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home based cognitive rehabilitation program	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.

Primary Outcome Measures

Name	Time	Method
Change of the Korean-Montreal cognitive assessment(MoCA) score	Baseline and Week 8	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.

Secondary Outcome Measures

Name	Time	Method
Change of the semantic verbal emory test (SVLT) score	Baseline and Week 8	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.
Change of the phonemic word fluency test (PWFT) score	Baseline and Week 8	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.
Change of the Digit Span Test (DST) score	Baseline and Week 8	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.
Change of the category word fluency test (CWFT) score	Baseline and Week 8	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.
Change of the geriatric depression scale (GDS) score	Baseline and Week 8	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.

Trial Locations

Locations (1)

Pusan national university Yangsan Hospital; 🇰🇷 Gyeongsang, Yangsan, Korea, Republic of