Clinical trial NCT05275153: Effectiveness of a Home-Based Cognitive Rehabilitation Program in Patients With MCI
Official title: Effectiveness of a Home-Based Cognitive Rehabilitation Program Driven by a Tablet Application in Patients With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Mild Cognitive Impairment
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
Collaborators: name: Woorisoft
First posted: 2022-03-11
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of the Korean-Montreal cognitive assessment(MoCA) score
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change of the semantic verbal emory test (SVLT) score
timeFrame: Baseline and Week 8
measure: Change of the Digit Span Test (DST) score
timeFrame: Baseline and Week 8
measure: Change of the category word fluency test (CWFT) score
timeFrame: Baseline and Week 8
measure: Change of the phonemic word fluency test (PWFT) score
timeFrame: Baseline and Week 8
measure: Change of the geriatric depression scale (GDS) score
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: Gyeongsang
country: Korea, Republic of
facility: Pusan national university Yangsan Hospital
state: Yangsan
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Young-Il Shin
role: PRINCIPAL_INVESTIGATOR
References: