Multidomain Intervention Via a None-face-to-face Platform in Mild Cognitive Impairment (EXTENDED)

April 11, 2022 updated by: Seong Hye Choi, MD, Inha University Hospital

A Multicenter Clinical Study to Evaluate the Efficacy and Feasibility of a 24-week Multidomain Intervention Via a None-face-to-face Platform in Mild Cognitive Impairment

This study will be done to investigate the feasibility and effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, and motivational enhancement on the cognitive function via none-face-to-face platform in mild cognitive impairment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The physical exercise program will consist of aerobic exercise, exercise to enhance balance and flexibility, muscle-strengthening activities involving major muscle groups, and finger-toe movements. Cognitive training targets the cognitive domains of episodic memory, executive function, attention, working memory, calculation, and visuospatial function. Cognitive training will be conducted using a tablet-based application. Participants will be advised to eat something according to the recommendation of the Mediterranean-DASH Intervention for Neurodegenerative Delay diet (MIND) diet. They will be educated about vascular risk factor management every 2 weeks. The purpose of the motivational enhancement program is to induce, maintain, and strengthen motivation, which is a psychological resource to help maintain dementia prevention activities. All intervention will be administered via tablet personal computer (PC) application at home.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Gwangju, Korea, Republic of
        • Not yet recruiting
        • Chonnam National University Hospital
        • Contact:
          • Soo Hyun Cho, MD
      • Incheon, Korea, Republic of, 22332
        • Recruiting
        • Inha University Hospital
        • Contact:
          • Seong Hye Choi, MD
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Ewha Womans Seoul Hospital
        • Contact:
          • Jee Hyang Jeong, MD, PhD
      • Suwon, Korea, Republic of
        • Not yet recruiting
        • Ajou University Hospital
        • Contact:
          • So Young Moon, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who completed end-of-study evaluation and participated in the preceding randomized controlled trial (RCT) "Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment".
  • Being able to use the tablet PC through education, or having a person who can help a participant use the tablet PC.
  • Having a reliable informant who could provide investigators with the requested information
  • Provide written informed consent

Exclusion Criteria:

  • Major psychiatric illness such as major depressive disorders
  • Dementia
  • Other neurodegenerative disease (e.g., Parkinson's disease)
  • Malignancy within 5 years
  • Cardiac stent or revascularization within 1 year
  • Serious or unstable symptomatic cardiovascular disease
  • Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease
  • Severe loss of vision, hearing, or communicative disability
  • Any conditions preventing cooperation as judged by the study physician
  • Significant laboratory abnormality that may result in cognitive impairment
  • Illiteracy
  • Unable to participate in exercise program safely
  • Coincident participation in any other intervention trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Multidomain intervention
The participants in the intervention arm will receive all five components of the intervention: (1) monitoring and management of metabolic and vascular risk factors; (2) cognitive training; (3) physical exercise; (4) nutritional guidance; and (5) motivational training via none-face-to-face tablet PC application (app).
Behavioral: Multidomain intervention
For 24 weeks, participants will receive cognitive training twice a week, exercise 3 times a week, nutrition education 12 times, and education about vascular risk factor management every 2 weeks using the tablet PC application.
Other Names:
  • multidomain cognitive intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of cognition
Time Frame: Change from Baseline at 24 weeks
Repeatable Battery for the Assessment of Neuropsychological Status
Change from Baseline at 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of global cognition
Time Frame: Change from Baseline at 24 weeks
Mini-Mental State Examination (range 0-30). Higher scores indicate better performance.
Change from Baseline at 24 weeks
Change of function
Time Frame: Change from Baseline at 24 weeks
Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.
Change from Baseline at 24 weeks
Change of subjective memory
Time Frame: Change from Baseline at 24 weeks
Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance.
Change from Baseline at 24 weeks
Change of depression
Time Frame: Change from Baseline at 24 weeks
Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance.
Change from Baseline at 24 weeks
Change of activities of daily living
Time Frame: Change from Baseline at 24 weeks
Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.
Change from Baseline at 24 weeks
Change of nutritional behavior
Time Frame: Change from Baseline at 24 weeks
Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance.
Change from Baseline at 24 weeks
Change of nutrition
Time Frame: Change from Baseline at 24 weeks
Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance.
Change from Baseline at 24 weeks
Change of motor function
Time Frame: Change from Baseline at 24 weeks
Short Physical Performance Battery (range 0-12). Higher scores indicate better performance.
Change from Baseline at 24 weeks
Quality of life assessed by the Quality of life-Alzheimer's disease
Time Frame: Change from Baseline at 24 weeks
Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance.
Change from Baseline at 24 weeks
Sleep quality assessed by the Pittsburgh Sleep Quality Index
Time Frame: Change from Baseline at 24 weeks
Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance.
Change from Baseline at 24 weeks
Change of motivation
Time Frame: Change from Baseline at 24 weeks. Higher scores indicate better performance.
Self Determination Index (SDI) (range -66~66). Higher scores of SDI indicate better performance.
Change from Baseline at 24 weeks. Higher scores indicate better performance.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inha University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Seong Hye Choi, MD, PhD, Inha University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-02-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data that support the findings of this study will be available from the principal investigator upon reasonable request.

IPD Sharing Time Frame

Data will be available for 2 years since March 2024.

IPD Sharing Access Criteria

Reasonable request

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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