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Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART)

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
U-SMART
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild cognitive impairment, Cognitive rehabilitation, Cognitive therapy, Spaced retrieval Training, Alzheimer's disease, Memory enhancement, U-healthcare

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 55-90
  • Educational level above 1 year and confirmed literacy
  • Diagnosed to mild cognitive impairment by International Working Group on Mild Cognitive Impairment
  • Clinical Dementia Rating (CDR) of 0 or 0.5

Exclusion Criteria:

  • Diagnosed to dementia by DSM-IV
  • Evidence of delirium, confusion
  • Any neurological conditions causing cognitive decline such as Parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus
  • Evidence of severe cerebrovascular pathology
  • History of loss-of-consciousness over 1 hour due to head trauma or repetitive head trauma of mild severity
  • History of substance abuse or dependence such as alcohol
  • Presence of depressive symptoms that could influence cognitive function
  • Presence of medical comorbidities that could result in cognitive decline
  • Use of medication that could influence cognitive function seriously

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

U-SMART

Arm Description

U-SMART (Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training)

Outcomes

Primary Outcome Measures

the five-point Likert scales for satisfaction and compliance
To evaluate the feasibility of the U-SMART, the five-point Likert scales for satisfaction and compliance were applied to all participants.
Word List Memory Test of the CERAD Neuropsychological Assessment Battery
To evaluate the efficacy of the U-SMART, the Word List Memory Test (WLMT) of the CERAD neuropsychological assessment battery was applied to all participants.

Secondary Outcome Measures

Mini-Mental State Examination (MMSE)

Full Information

First Posted
June 23, 2012
Last Updated
June 23, 2012
Sponsor
Seoul National University Bundang Hospital
Collaborators
KT Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01628653
Brief Title
Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training
Acronym
U-SMART
Official Title
Feasibility and Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) on Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
KT Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to examine feasibility and efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild cognitive impairment (MCI).
Detailed Description
The Spaced Retrieval-based Memory Advancement and Rehabilitation Training (SMART) which consisted of 24 one-hour face-to-face sessions (Lee, Park et al. 2009) was developed based on the spaced retrieval training (SRT), which was effective in improving memory retention span of very mild to mild Alzheimer's disease patients. The Ubiquitous SMART (U-SMART) by transforming the current SMART to a self-administered program using an application working on IPAD was developed, and was examined its feasibility and efficacy in the elderly individuals with mild cognitive impairment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild cognitive impairment, Cognitive rehabilitation, Cognitive therapy, Spaced retrieval Training, Alzheimer's disease, Memory enhancement, U-healthcare

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
U-SMART
Arm Type
Experimental
Arm Description
U-SMART (Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training)
Intervention Type
Device
Intervention Name(s)
U-SMART
Intervention Description
4-weeks' training
Primary Outcome Measure Information:
Title
the five-point Likert scales for satisfaction and compliance
Description
To evaluate the feasibility of the U-SMART, the five-point Likert scales for satisfaction and compliance were applied to all participants.
Time Frame
after 4-weeks treatment
Title
Word List Memory Test of the CERAD Neuropsychological Assessment Battery
Description
To evaluate the efficacy of the U-SMART, the Word List Memory Test (WLMT) of the CERAD neuropsychological assessment battery was applied to all participants.
Time Frame
after 4-weeks treatment
Secondary Outcome Measure Information:
Title
Mini-Mental State Examination (MMSE)
Time Frame
after 4-weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 55-90 Educational level above 1 year and confirmed literacy Diagnosed to mild cognitive impairment by International Working Group on Mild Cognitive Impairment Clinical Dementia Rating (CDR) of 0 or 0.5 Exclusion Criteria: Diagnosed to dementia by DSM-IV Evidence of delirium, confusion Any neurological conditions causing cognitive decline such as Parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus Evidence of severe cerebrovascular pathology History of loss-of-consciousness over 1 hour due to head trauma or repetitive head trauma of mild severity History of substance abuse or dependence such as alcohol Presence of depressive symptoms that could influence cognitive function Presence of medical comorbidities that could result in cognitive decline Use of medication that could influence cognitive function seriously
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Woong Kim, M.D., Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital, Seong-nam, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training

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