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

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: Recruiting
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Multidomain intervention

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seong Hye Choi, MD, PhD; Phone Number: 82 32 890 3659; Email: seonghye@inha.ac.kr
• Study Contact Backup: Name: Jee Hyang Jeong, MD, PhD; Email: jjeong@ewha.ac.kr

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change of cognition	Repeatable Battery for the Assessment of Neuropsychological Status	Change from Baseline at 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of global cognition	Mini-Mental State Examination (range 0-30). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Change of function	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	Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Change of depression	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	Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Change of nutritional behavior	Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Change of nutrition	Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance.	Change from Baseline at 24 weeks
Change of motor function	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	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	Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance.	Change from Baseline at 24 weeks
Change of motivation	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

• Sponsor: Inha University Hospital
• Investigators: Principal Investigator: Seong Hye Choi, MD, PhD, Inha University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID 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