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

Primary Purpose

Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Multidomain intervention
Sponsored by
Inha University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chonnam National University Hospital
  • Inha University HospitalRecruiting
  • Ewha Womans Seoul Hospital
  • Ajou University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multidomain intervention

Arm Description

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).

Outcomes

Primary Outcome Measures

Change of cognition
Repeatable Battery for the Assessment of Neuropsychological Status

Secondary Outcome Measures

Change of global cognition
Mini-Mental State Examination (range 0-30). Higher scores indicate better performance.
Change of function
Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.
Change of subjective memory
Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance.
Change of depression
Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance.
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 of activities of daily living
Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.
Change of nutritional behavior
Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance.
Change of nutrition
Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance.
Change of motor function
Short Physical Performance Battery (range 0-12). Higher scores indicate better performance.
Sleep quality assessed by the Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance.
Change of motivation
Self Determination Index (SDI) (range -66~66). Higher scores of SDI indicate better performance.

Full Information

First Posted
March 21, 2022
Last Updated
April 11, 2022
Sponsor
Inha University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05301868
Brief Title
Multidomain Intervention Via a None-face-to-face Platform in Mild Cognitive Impairment
Acronym
EXTENDED
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inha University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multidomain intervention
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Multidomain intervention
Other Intervention Name(s)
multidomain cognitive intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of cognition
Description
Repeatable Battery for the Assessment of Neuropsychological Status
Time Frame
Change from Baseline at 24 weeks
Secondary Outcome Measure Information:
Title
Change of global cognition
Description
Mini-Mental State Examination (range 0-30). Higher scores indicate better performance.
Time Frame
Change from Baseline at 24 weeks
Title
Change of function
Description
Clinical Dementia Rating scale-Sum of Boxes (range 0-18). Higher scores indicate worse performance.
Time Frame
Change from Baseline at 24 weeks
Title
Change of subjective memory
Description
Prospective and Retrospective Memory Questionnaire (range 16-80). Higher scores indicate worse performance.
Time Frame
Change from Baseline at 24 weeks
Title
Change of depression
Description
Geriatric Depression Scale-15 items (range 0-15). Higher scores indicate worse performance.
Time Frame
Change from Baseline at 24 weeks
Title
Quality of life assessed by the Quality of life-Alzheimer's disease
Description
Quality of life-Alzheimer's disease (range 0-52). Higher scores indicate better performance.
Time Frame
Change from Baseline at 24 weeks
Title
Change of activities of daily living
Description
Bayer Activities of Daily Living (range 1-10). Higher scores indicate worse performance.
Time Frame
Change from Baseline at 24 weeks
Title
Change of nutritional behavior
Description
Nutrition Quotient for elderly (range 0-100). Higher scores indicate better performance.
Time Frame
Change from Baseline at 24 weeks
Title
Change of nutrition
Description
Mini Nutritional Assessment (range 0-14). Higher scores indicate better performance.
Time Frame
Change from Baseline at 24 weeks
Title
Change of motor function
Description
Short Physical Performance Battery (range 0-12). Higher scores indicate better performance.
Time Frame
Change from Baseline at 24 weeks
Title
Sleep quality assessed by the Pittsburgh Sleep Quality Index
Description
Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance.
Time Frame
Change from Baseline at 24 weeks
Title
Change of motivation
Description
Self Determination Index (SDI) (range -66~66). Higher scores of SDI indicate better performance.
Time Frame
Change from Baseline at 24 weeks. Higher scores indicate better performance.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seong Hye Choi, MD, PhD
Phone
82 32 890 3659
Email
seonghye@inha.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jee Hyang Jeong, MD, PhD
Email
jjeong@ewha.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong Hye Choi, MD, PhD
Organizational Affiliation
Inha University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Hyun Cho, MD
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong Hye Choi, MD
Facility Name
Ewha Womans Seoul Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jee Hyang Jeong, MD, PhD
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So Young Moon, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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