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

Phase 3

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Device: Phase I U-SMART (4 wks); Other: Washout (2 wks); Device: Phase II U-SMART (4 wks)

• Registration Number: NCT01688128
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-14
• Study First Posted: 2012-09-19
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention_Control group	Phase I U-SMART (4 wks)	Phase I: U-SMART for 4 weeks (2 session/week); Washout: for 2 weeks; Phase II: No intervention for 4 weeks
Control_Intervention group	Phase II U-SMART (4 wks)	Phase I: No intervention for 4 weeks; Washout: for 2 weeks; Phase II: U-SMART for 4 weeks (2 session/week)
Control_Intervention group	Washout (2 wks)	Phase I: No intervention for 4 weeks; Washout: for 2 weeks; Phase II: U-SMART for 4 weeks (2 session/week)
Intervention_Control group	Washout (2 wks)	Phase I: U-SMART for 4 weeks (2 session/week); Washout: for 2 weeks; Phase II: No intervention for 4 weeks

Primary Outcome Measures

Name	Time	Method
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)	Baseline, 5 weeks, 11weeks	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.

Secondary Outcome Measures

Name	Time	Method
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)	Baseline, 5 weeks, 11weeks	To evaluate the subjective memory improvement after the U-SMART, the Subjective Memory Complaints Questionnaire(SMCQ) was applied to all participants.
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)	Baseline, 5 weeks, 11weeks	To evaluate the subjective mood after the U-SMART, the Geriatric Depression Scale was applied to all participants.
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)	Baseline, 5 weeks, 11weeks	To evaluate the global cognitive function after the U-SMART, the Mini-Mental State Examination was applied to all participants.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of