Cognitive ImpairmentNCT05275153
Effectiveness of a Home-Based Cognitive Rehabilitation Program in Patients With MCI
A study testing Home based cognitive rehabilitation program in people with Cognitive Impairment and Mild Cognitive Impairment, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cognitive Impairment, Mild Cognitive Impairment
- What is being tested?
- Home based cognitive rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Apr 2020to 2 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan national university Yangsan Hospital
Gyeongsang, Yangsan, 50610
About this study
Official title: Effectiveness of a Home-Based Cognitive Rehabilitation Program Driven by a Tablet Application in Patients With Mild Cognitive Impairment
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.
Read the 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.
- Conditions
- Cognitive Impairment, Mild Cognitive Impairment
- Being tested
- Home based cognitive rehabilitation program
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Home based cognitive rehabilitation program |
| No intervention | No intervention | In the control group, natural cognitive changes with the passage of time were observed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 8
Secondary outcomes (5)
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.
Measured: Baseline and Week 8
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.
Measured: Baseline and Week 8
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.
Measured: Baseline and Week 8
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.
Measured: Baseline and Week 8
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.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start22 Apr 2020
- Primary completion30 Jun 2021
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Woorisoft
- Responsible party
- Principal investigator, Yong-il Shin, Pusan National University Yangsan Hospital
- Investigators
- Young-Il Shin, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275153
- Sponsor's protocol ID
- 02-2019-018
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Home-Based Cognitive Rehabilitation Program Driven by a Tablet Application in Patients With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05275153
- Acronym / sponsor ID
- 02-2019-018
- Conditions
- Cognitive Impairment, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Collaborators
- Woorisoft
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home based cognitive rehabilitation program | Experimental | Other: Home based cognitive rehabilitation programThe intervention was conducted for 30 minutes each time, 3 times a week for 8 weeks, a total of 24 times. |
| No intervention | No intervention | –In the control group, natural cognitive changes with the passage of time were observed. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home based cognitive rehabilitation programThe 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. | Other | Home based cognitive rehabilitation program |
Primary outcome
Change of the Korean-Montreal cognitive assessment(MoCA) score
Time frame: 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.
5 secondary outcomes
Change of the semantic verbal emory test (SVLT) score
Time frame: Baseline and Week 8
Change of the Digit Span Test (DST) score
Time frame: Baseline and Week 8
Change of the category word fluency test (CWFT) score
Time frame: Baseline and Week 8
Change of the phonemic word fluency test (PWFT) score
Time frame: Baseline and Week 8
Change of the geriatric depression scale (GDS) score
Time frame: Baseline and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Il Shin principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based cognitive rehabilitation program in people with Cognitive Impairment and Mild Cognitive Impairment, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Korean-Montreal cognitive assessment(MoCA) score (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.