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

NCT05301868 | Unknown DMC

• 1 other identifier: 2022-02-009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Change of cognition

  Repeatable Battery for the Assessment of Neuropsychological Status

  Change from Baseline at 24 weeks

Secondary Outcomes (11)

• Change of global cognition

  Change from Baseline at 24 weeks

• Change of function

  Change from Baseline at 24 weeks

• Change of subjective memory

  Change from Baseline at 24 weeks

• Change of depression

  Change from Baseline at 24 weeks

• Quality of life assessed by the Quality of life-Alzheimer's disease

  Change from Baseline at 24 weeks

Study Arms (1)

Multidomain intervention

EXPERIMENTAL

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

Interventions

Multidomain intervention BEHAVIORAL

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.

Also known as: multidomain cognitive intervention

Multidomain intervention

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inha University Hospital: lead

Study Sites (4)

Chonnam National University Hospital

Gwangju, South Korea

NOT YET RECRUITING

Inha University Hospital

Incheon, 22332, South Korea

RECRUITING

Ewha Womans Seoul Hospital

Seoul, South Korea

NOT YET RECRUITING

Ajou University Hospital

Suwon, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Seong Hye Choi, MD, PhD

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seong Hye Choi, MD, PhD

CONTACT

82 32 890 3659; seonghye@inha.ac.kr

Jee Hyang Jeong, MD, PhD

CONTACT

jjeong@ewha.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: April 11, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available for 2 years since March 2024.
• Access Criteria: Reasonable request

Locations

KR (4)