Ubiquitous Spaced Retrieval-based Memory Advancement and... | NCT01628653

Studies
Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training

NCT01628653

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Jun 27, 2012Estimated

Enrollment

10Actual

Phase

Phase 1

Conditions

Mild Cognitive Impairment

Interventions

U-SMART

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Jun 23, 2012

First Submission Date that Met QC Criteria

Jun 23, 2012

First Posted Date

Jun 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2012

Last Update Posted Date

Jun 27, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ki Woong Kim, Professor, department of neuropsychiatry, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Name	Class
KT Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
U-SMART	Experimental	U-SMART (Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training)	Device: U-SMART

Interventions

Name	Type	Description	Arm Group Labels	Other Names
U-SMART	Device	4-weeks' training	U-SMART

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	after 4-weeks treatment
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.	after 4-weeks treatment

Secondary Outcomes

Measure	Description	Time Frame
Mini-Mental State Examination (MMSE)		after 4-weeks treatment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ki Woong Kim, M.D., Ph.D.	Seoul National University Bundang Hospital, Seong-nam, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D003704	Dementia

Browse Leaves

Not provided

Browse Branches

Not provided