NCT05275153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

March 2, 2022

Last Update Submit

March 10, 2022

Conditions

Cognitive ImpairmentMild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change of the semantic verbal emory test (SVLT) score

    Baseline and Week 8

  • Change of the Digit Span Test (DST) score

    Baseline and Week 8

  • Change of the category word fluency test (CWFT) score

    Baseline and Week 8

  • Change of the phonemic word fluency test (PWFT) score

    Baseline and Week 8

  • Change of the geriatric depression scale (GDS) score

    Baseline and Week 8

Study Arms (2)

Home based cognitive rehabilitation program

EXPERIMENTAL

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

No intervention

NO INTERVENTION

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

Interventions

Home based cognitive rehabilitation programOTHER

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.

Home based cognitive rehabilitation program

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, 50610, South Korea

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Young-Il Shin

    Pusan National University Yangsan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 11, 2022

Study Start

April 22, 2020

Primary Completion

June 30, 2021

Study Completion

August 2, 2021

Last Updated

March 11, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)