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

This study has been completed.
Sponsor:
Collaborator:
KT corporation
Information provided by (Responsible Party):
Ki Woong Kim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01628653
First received: June 23, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Mild Cognitive Impairment
 Device: U-SMART
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility and Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) on Mild Cognitive Impairment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • the five-point Likert scales for satisfaction and compliance [ Time Frame: after 4-weeks treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: after 4-weeks treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: after 4-weeks treatment ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: June 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: U-SMART
U-SMART (Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training)
 Device: U-SMART
4-weeks' training

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.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628653

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
KT corporation
Investigators
Principal Investigator: Ki Woong Kim, M.D., Ph.D. Seoul National University Bundang Hospital, Seong-nam, Korea
  More Information

No publications provided

Responsible Party: Ki Woong Kim, Professor, department of neuropsychiatry, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01628653     History of Changes
Other Study ID Numbers: 06-2011-084
Study First Received: June 23, 2012
Last Updated: June 23, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
Mild cognitive impairment
Cognitive rehabilitation
Cognitive therapy
Spaced retrieval Training
 Alzheimer's disease
Memory enhancement
U-healthcare

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013