- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01628653
Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART)
June 23, 2012 updated by: Ki Woong Kim, Seoul National University Bundang Hospital
Feasibility and Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) on Mild Cognitive Impairment
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).
Study Overview
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
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Gyeonggi
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Seongnam, Gyeonggi, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: U-SMART
U-SMART (Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training)
|
4-weeks' training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the five-point Likert scales for satisfaction and compliance
Time Frame: after 4-weeks treatment
|
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
Time Frame: after 4-weeks treatment
|
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 Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mini-Mental State Examination (MMSE)
Time Frame: after 4-weeks treatment
|
after 4-weeks treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (ACTUAL)
February 1, 2012
Study Completion (ACTUAL)
February 1, 2012
Study Registration Dates
First Submitted
June 23, 2012
First Submitted That Met QC Criteria
June 23, 2012
First Posted (ESTIMATE)
June 27, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
June 27, 2012
Last Update Submitted That Met QC Criteria
June 23, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-2011-084
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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