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

Primary Purpose

Cognitive Impairment, Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Home based cognitive rehabilitation program
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairment

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pusan national university Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Home based cognitive rehabilitation program

No intervention

Arm Description

The intervention was conducted for 30 minutes each time, 3 times a week for 8 weeks, a total of 24 times.

In the control group, natural cognitive changes with the passage of time were observed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
March 2, 2022
Last Updated
March 10, 2022
Sponsor
Pusan National University Yangsan Hospital
Collaborators
Woorisoft
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1. Study Identification

Unique Protocol Identification Number
NCT05275153
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 22, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
August 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital
Collaborators
Woorisoft

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home based cognitive rehabilitation program
Arm Type
Experimental
Arm Description
The intervention was conducted for 30 minutes each time, 3 times a week for 8 weeks, a total of 24 times.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
In the control group, natural cognitive changes with the passage of time were observed.
Intervention Type
Other
Intervention Name(s)
Home based cognitive rehabilitation program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of the Korean-Montreal cognitive assessment(MoCA) score
Description
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.
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Change of the semantic verbal emory test (SVLT) score
Description
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.
Time Frame
Baseline and Week 8
Title
Change of the Digit Span Test (DST) score
Description
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.
Time Frame
Baseline and Week 8
Title
Change of the category word fluency test (CWFT) score
Description
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.
Time Frame
Baseline and Week 8
Title
Change of the phonemic word fluency test (PWFT) score
Description
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.
Time Frame
Baseline and Week 8
Title
Change of the geriatric depression scale (GDS) score
Description
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.
Time Frame
Baseline and Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women over the age of 55 Those who have visual and auditory abilities without difficulties in conducting this research Those with K-MMSE (Korean-Mini Mental State Examination) score of 24 or higher and 16≤K-MoCA score<23 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 A person who can understand and respond to the questionnaire questions. A person who voluntarily decided to participate in this study and gave written consent to the informed consent form Exclusion Criteria: Those with a history of alcohol or drug abuse, Those with a past history of uniaxial psychiatric disorders, including intellectual disability, schizophrenia, alcoholism, and bipolar disorder A person who is unable to communicate Those who show all neurological symptoms that cause cognitive decline, such as Parkinson's disease, cerebral hemorrhage, brain tumor, and hydrocephalus Those with a record of being unconscious for more than 1 hour due to head trauma or mild repetitive head trauma Those with symptoms of depression that may affect cognitive function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Il Shin
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan national university Yangsan Hospital
City
Gyeongsang
State/Province
Yangsan
ZIP/Postal Code
50610
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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