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Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment (SUPERBRAIN)

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

Inclusion Criteria:

  • 60 to 79 years of age
  • Having at least one modifiable dementia risk factor
  • Complaints of cognitive decline by a participant or informant
  • A performance score that is lower than 1.0 standard deviations below the age-, and education-adjusted normative means for one or more of the delayed recall, naming, visuoconstruction, attention, and executive function tests
  • MMSE Z score ≥ - 1.5
  • Independent activities of daily living
  • 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

  • Dong-A University HospitalRecruiting
  • Chonnam University HospitalRecruiting
  • Inha University HospitalRecruiting
  • Bobath Memorial HospitalRecruiting
  • Ewha Womans Seoul HospitalRecruiting
  • Konkuk University HospitalRecruiting
  • Ajou University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multidomain intervention

Control

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 and social activity; (3) physical exercise; (4) nutritional guidance; and (5) motivational training.

At baseline, the participants in the control group will meet a study doctor, be prescribed medication when necessary, and receive educational booklets corresponding to their risk factors and a booklet on lifestyle guidelines to prevent dementia. They will receive usual care during the study period and be informed that they could participate in the multidomain intervention program after this study end.

Outcomes

Primary Outcome Measures

Change of cognition
Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.

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.
Change of quality of life
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.
Change of sleep quality
Pittsburgh Sleep Quality Index (range 0-21). Higher scores indicate worse performance.
Change of motivation
Self Determination Index (SDI). Higher scores of SDI indicate better performance.

Full Information

First Posted
August 20, 2021
Last Updated
March 28, 2022
Sponsor
Inha University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05023057
Brief Title
Multidomain Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment
Acronym
SUPERBRAIN
Official Title
A Multicenter Randomized Controlled Study to Evaluate the Efficacy of a 24-week Multidomain Intervention Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 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

5. Study Description

Brief Summary
This study will be done to investigate the effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, social activity, and motivational enhancement on the cognitive function compared to the control group 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 MIND diet. They will also meet the study nurse every 4 weeks for anthropometric measurements and monitoring of smoking and alcohol intake. 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.

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
Parallel Assignment
Model Description
outcome assessor-blinded, randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (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 and social activity; (3) physical exercise; (4) nutritional guidance; and (5) motivational training.
Arm Title
Control
Arm Type
No Intervention
Arm Description
At baseline, the participants in the control group will meet a study doctor, be prescribed medication when necessary, and receive educational booklets corresponding to their risk factors and a booklet on lifestyle guidelines to prevent dementia. They will receive usual care during the study period and be informed that they could participate in the multidomain intervention program after this study end.
Intervention Type
Behavioral
Intervention Name(s)
Multidomain intervention
Intervention Description
For 24 weeks, participants will receive cognitive training using the tablet PC application twice a week, exercise 3 times a week, nutrition education 12 times, anthropometric measurements and alcohol and smoking monitoring every 4 weeks, motivation reinforcement training 4 times.
Primary Outcome Measure Information:
Title
Change of cognition
Description
Repeatable Battery for the Assessment of Neuropsychological Status (range 40-160). Higher scores indicate better performance.
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
Change of quality of life
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
Change of sleep quality
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). 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
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 60 to 79 years of age Having at least one modifiable dementia risk factor Complaints of cognitive decline by a participant or informant A performance score that is lower than 1.0 standard deviations below the age-, and education-adjusted normative means for one or more of the delayed recall, naming, visuoconstruction, attention, and executive function tests MMSE Z score ≥ - 1.5 Independent activities of daily living 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
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyung Won Park, MD, PhD
Facility Name
Chonnam University Hospital
City
Gwangju
Country
Korea, Republic of
Individual Site Status
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
Email
seonghye@inha.ac.kr
Facility Name
Bobath Memorial Hospital
City
Seongnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hae Ri Na, MD, PhD
Email
neuna102@paran.com
Facility Name
Ewha Womans Seoul Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jee Hyang Jeong, MD, PhD
Email
jjeong@ewha.ac.kr
Facility Name
Konkuk University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeonsil Moon, MD, PhD
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So Young Moon, MD, PhD
Email
symoon.bv@gmail.com

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 Interventions Via Face-to-face and Video Communication Platforms in Mild Cognitive Impairment

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