NCT01688128

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Phase I U-SMART (4 wks)	Intervention\_Control Group, 4-weeks U-SMART(2 session/week); Control\_Intervention Group, no intervention
OTHER	Washout (2 wks)	2-weeks wash out period in both arms
DEVICE	Phase II U-SMART (4 wks)	Intervention\_Control Group, no intervention; Control\_Intervention Group, 4-weeks U-SMART(2 session/week, Crossover design)

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-09-19
• Last updated: 2016-04-20

Locations

1 site across 1 country: South Korea