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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05275153
• Other study ID #: 02-2019-018
• Status: Completed
• Phase: N/A
• Start date: April 22, 2020
• Est. completion date: August 2, 2021

Study information

• Verified date: March 2022
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Pusan national university Yangsan Hospital	Gyeongsang	Yangsan

Sponsors (2)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital	Woorisoft

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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