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

Tracking Information

First Received Date ^ICMJE

June 23, 2012

Last Updated Date

June 23, 2012

Start Date ^ICMJE

June 2011

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Mini-Mental State Examination (MMSE) [ Time Frame: after 4-weeks treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training

Official Title ^ICMJE

Feasibility and Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) on Mild Cognitive Impairment

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Mild Cognitive Impairment

Intervention ^ICMJE

Device: U-SMART

4-weeks' training

Study Arm (s)

Experimental: U-SMART

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

Intervention: Device: U-SMART

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2012

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

55 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01628653

Other Study ID Numbers ^ICMJE

06-2011-084

Has Data Monitoring Committee

Yes

Responsible Party

Ki Woong Kim, Seoul National University Bundang Hospital

Study Sponsor ^ICMJE

Seoul National University Bundang Hospital

Collaborators ^ICMJE

KT corporation

Investigators ^ICMJE

Principal Investigator:

Ki Woong Kim, M.D., Ph.D.

Seoul National University Bundang Hospital, Seong-nam, Korea

Information Provided By

Seoul National University Bundang Hospital

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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