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

NCT ID: NCT01688128

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-12-31

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention_Control group

Phase I: U-SMART for 4 weeks (2 session/week); Washout: for 2 weeks; Phase II: No intervention for 4 weeks

Group Type: EXPERIMENTAL

Phase I U-SMART (4 wks)

Intervention Type: DEVICE

Intervention\_Control Group, 4-weeks U-SMART(2 session/week); Control\_Intervention Group, no intervention

Washout (2 wks)

Intervention Type: OTHER

2-weeks wash out period in both arms

Control_Intervention group

Phase I: No intervention for 4 weeks; Washout: for 2 weeks; Phase II: U-SMART for 4 weeks (2 session/week)

Group Type: EXPERIMENTAL

Washout (2 wks)

Intervention Type: OTHER

2-weeks wash out period in both arms

Phase II U-SMART (4 wks)

Intervention Type: DEVICE

Intervention\_Control Group, no intervention; Control\_Intervention Group, 4-weeks U-SMART(2 session/week, Crossover design)

Interventions

Phase I U-SMART (4 wks)

Intervention\_Control Group, 4-weeks U-SMART(2 session/week); Control\_Intervention Group, no intervention

Intervention Type: DEVICE

Washout (2 wks)

2-weeks wash out period in both arms

Intervention Type: OTHER

Phase II U-SMART (4 wks)

Intervention\_Control Group, no intervention; Control\_Intervention Group, 4-weeks U-SMART(2 session/week, Crossover design)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KT Corporation

INDUSTRY

Sponsor Role: collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ki Woong Kim

Professor, department of neuropsychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ki Woong Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital, Seong-nam, Korea

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

References

Han JW, Son KL, Byun HJ, Ko JW, Kim K, Hong JW, Kim TH, Kim KW. Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program among patients with mild cognitive impairment: a randomized controlled crossover trial. Alzheimers Res Ther. 2017 Jun 6;9(1):39. doi: 10.1186/s13195-017-0264-8.

Reference Type: DERIVED

PMID: 28587629 (View on PubMed)

Other Identifiers

E-1207/162-001

Identifier Type: -

Identifier Source: org_study_id