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

18. april 2016 opdateret af: Ki Woong Kim, Seoul National University Bundang Hospital

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republikken, 463-707
        • Seoul National University Bundang Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

55 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention_Control group
Phase I: U-SMART for 4 weeks (2 session/week); Washout: for 2 weeks; Phase II: No intervention for 4 weeks
Enhed: Phase I U-SMART (4 wks)
Intervention_Control Group, 4-weeks U-SMART(2 session/week); Control_Intervention Group, no intervention
Andet: Washout (2 wks)
2-weeks wash out period in both arms
Eksperimentel: Control_Intervention group
Phase I: No intervention for 4 weeks; Washout: for 2 weeks; Phase II: U-SMART for 4 weeks (2 session/week)
Andet: Washout (2 wks)
2-weeks wash out period in both arms
Enhed: Phase II U-SMART (4 wks)
Intervention_Control Group, no intervention; Control_Intervention Group, 4-weeks U-SMART(2 session/week, Crossover design)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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)
Tidsramme: 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.
Baseline, 5 weeks, 11weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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)
Tidsramme: 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.
Baseline, 5 weeks, 11weeks
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)
Tidsramme: Baseline, 5 weeks, 11weeks
To evaluate the subjective mood after the U-SMART, the Geriatric Depression Scale was applied to all participants.
Baseline, 5 weeks, 11weeks
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)
Tidsramme: Baseline, 5 weeks, 11weeks
To evaluate the global cognitive function after the U-SMART, the Mini-Mental State Examination was applied to all participants.
Baseline, 5 weeks, 11weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Seoul National University Bundang Hospital

Samarbejdspartnere

KT Corporation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2012

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

12. september 2012

Først indsendt, der opfyldte QC-kriterier

14. september 2012

Først opslået (Skøn)

19. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

20. april 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. april 2016

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • E-1207/162-001

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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