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Completed

NCT Number: NCT01688128

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

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phase I U-SMART (4 wks)

Device

Intervention_Control Group, 4-weeks U-SMART(2 session/week); Control_Intervention Group, no intervention

Washout (2 wks)

Other

2-weeks wash out period in both arms

Phase II U-SMART (4 wks)

Device

Intervention_Control Group, no intervention; Control_Intervention Group, 4-weeks U-SMART(2 session/week, Crossover design)

Primary outcomes

  1. 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)

    Time frame: 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 outcomes

  1. 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)

    Time frame: 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.

  2. 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)

    Time frame: Baseline, 5 weeks, 11weeks

    To evaluate the subjective mood after the U-SMART, the Geriatric Depression Scale was applied to all participants.

  3. 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)

    Time frame: Baseline, 5 weeks, 11weeks

    To evaluate the global cognitive function after the U-SMART, the Mini-Mental State Examination was applied to all participants.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • KT Corporation

Registry information

Official study title

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

Acronym: U-SMART

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 19, 2012
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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