Efficacy of Ubiquitous SR-based Memory Advancement and Rehabilitation Training (U-SMART)

Study Overview
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Brief Summary
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The purpose of this study is to examine the efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (U-SMART) in the elderly individuals with mild cognitive impairment (MCI) by an open-label, controlled, crossover Trial.

Detailed Description
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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 showed its feasibility and efficacy in the elderly individuals with mild cognitive impairment in the preliminary study. (ClinicalTrials.gov ID: NCT01628653) To validate the efficacy of the U-SMART, an open-label, controlled, crossover design of clinical trial were planned in this study.

Official Title
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An Open-label, Controlled, Cross-over Trial of Ubiquitous SR-based Memory Advancement and Rehabilitation Training (U-SMART) in Mild Cognitive Impairment

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Device: Phase I U-SMART (4 wks)
* Other: Washout (2 wks)
* Device: Phase II U-SMART (4 wks)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention_Control group<br>Phase I: U-SMART for 4 weeks (2 session/week); Washout: for 2 weeks; Phase II: No intervention for 4 weeks | Device: Phase I U-SMART (4 wks)<br>* Intervention_Control Group, 4-weeks U-SMART(2 session/week); Control_Intervention Group, no intervention<br>Other: Washout (2 wks)<br>* 2-weeks wash out period in both arms<br>|
| Experimental: Control_Intervention group<br>Phase I: No intervention for 4 weeks; Washout: for 2 weeks; Phase II: U-SMART for 4 weeks (2 session/week) | Other: Washout (2 wks)<br>* 2-weeks wash out period in both arms<br>Device: Phase II U-SMART (4 wks)<br>* Intervention_Control Group, no intervention; Control_Intervention Group, 4-weeks U-SMART(2 session/week, Crossover design)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Word List Test (memory, recall, recognition) of the CERAD Neuropsychological Assessment Battery before and after phase I intervention and before and after phase II intervention (crossover part of the study) | To evaluate the efficacy of the U-SMART, the Word List Memory Test (WLMT), Word List Recall Test (WLRT), Word List Recognition Test (WLRcT) of the CERAD neuropsychological assessment battery were applied to all participants. | Baseline, 5 weeks, 11weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Subjective Memory Complaints Questionnaire (SMCQ) before and after phase I intervention and before and after phase II intervention (crossover part of the study) | To evaluate the subjective memory improvement after the U-SMART, the Subjective Memory Complaints Questionnaire(SMCQ) was applied to all participants. | Baseline, 5 weeks, 11weeks | 
| Change in the Geriatric Depression Scale (GDS) before and after phase I intervention and before and after phase II intervention (crossover part of the study) | To evaluate the subjective mood after the U-SMART, the Geriatric Depression Scale was applied to all participants. | Baseline, 5 weeks, 11weeks | 
| Change in the Mini-Mental State Examination before and after phase I intervention and before and after phase II intervention (crossover part of the study) | To evaluate the global cognitive function after the U-SMART, the Mini-Mental State Examination was applied to all participants. | Baseline, 5 weeks, 11weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild cognitive impairment, Cognitive rehabilitation, Cognitive therapy, Spaced retrieval Training, Alzheimer's disease, Memory enhancement, U-healthcare