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

Primary Purpose

Mild Cognitive Impairment

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Phase I U-SMART (4 wks)

Washout (2 wks)

Phase II U-SMART (4 wks)

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild cognitive impairment, Cognitive rehabilitation, Cognitive therapy, Spaced retrieval Training, Alzheimer's disease, Memory enhancement, U-healthcare

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intervention_Control group

Control_Intervention group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT01688128

First Posted

September 12, 2012

Last Updated

April 18, 2016

Sponsor

Seoul National University Bundang Hospital

Collaborators

KT Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01688128

Brief Title

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

Acronym

U-SMART

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Bundang Hospital

Collaborators

KT Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

Mild cognitive impairment, Cognitive rehabilitation, Cognitive therapy, Spaced retrieval Training, Alzheimer's disease, Memory enhancement, U-healthcare

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention_Control group

Arm Type

Experimental

Arm Description

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

Arm Title

Control_Intervention group

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Phase I U-SMART (4 wks)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Washout (2 wks)

Intervention Description

2-weeks wash out period in both arms

Intervention Type

Device

Intervention Name(s)

Phase II U-SMART (4 wks)

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

Time Frame

Baseline, 5 weeks, 11weeks

Secondary Outcome Measure Information:

Title

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)

Description

To evaluate the subjective memory improvement after the U-SMART, the Subjective Memory Complaints Questionnaire(SMCQ) was applied to all participants.

Time Frame

Baseline, 5 weeks, 11weeks

Title

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)

Description

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

Time Frame

Baseline, 5 weeks, 11weeks

Title

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)

Description

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

Time Frame

Baseline, 5 weeks, 11weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Seoul National University Bundang Hospital, Seong-nam, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam

State/Province

Gyeonggi

ZIP/Postal Code

463-707

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

28587629

Citation

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.

Results Reference

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

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