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Cognitive Intervention for Persons With Amnestic Mild Cognitive Impairment

13. marts 2019 opdateret af: National Taiwan University Hospital

Cognitive Intervention for Persons With Amnestic Mild Cognitive Impairment: The Efficacy in Enhancement of Cognition and Complex Activities of Daily Living Function

People with mild cognitive impairment (MCI) are at a greater risk of developing dementia. Therefore, it is important to develop effective non-pharmacological interventions to facilitate their cognitive and activities of daily living (ADL) function, which will also prevent or delay their progression to dementia and reduce associated healthcare and social costs. There are currently a variety of cognitive interventions, mainly categorized as remediation and rehabilitation approach. Research to compare their contents and effectiveness is strongly needed. The information can be used to individualize cognitive intervention based on specific cognitive profile of the patient.

This study aims to determine the immediate and long-term efficacy of the remediation approach and rehabilitation approach in enhancing the cognitive and ADL function. The research questions include 1) whether the rehabilitation approach compared with the remediation approach has better effects on improving ADL function; (2) whether the remediation approach may only enhance the performance on the cognitive tests rather than on the ADL function. This study will also explore whether the attitudes of caregivers on providing ADL assistance affect effects of cognitive intervention.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study is designed by a single-blinded randomized control trial. Sixty persons with MCI, confirmed by physicians, will receive 12 weekly 90-minute cognition interventions in a group of 6-8 persons. All participants will be randomly assigned to the following groups: 1) Remediation approach: various cognitive strategies will be taught, and exercises involving the practice of these strategies to enhance the attention, memory, processing speed, and executive functions. 2) Combination of rehabilitation and remediation approaches: The first half of each session will focus on the remediation approach as described above. The second half of the session will apply rehabilitation approach. The investigators will use group discussion to discuss everyday situations with memory problem and specific strategies (internal and external) related to real-life situations. The investigators will also include one individual session in the 12 group sessions.

All participants will be assessed at 3 time points: before intervention, right after intervention, and 12 weeks after the intervention. The primary outcomes are the ADL functions evaluated by subjective and objective measures, and cognitive function evaluated by tests of attention, memory and executive function. The secondary outcomes include the depression, the quality of life of the participants, and the caregivers' load. The intervention effects will be further analyzed by the caregivers' attitude regarding to the level of ADL assistance.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University 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

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Criteria: Inclusion Criteria:

  • over 50 years old
  • years of education > 6
  • mild cognitive impairment diagnosed by physician
  • no dementia diagnosis
  • Barthel Index scored 100
  • Geriatric Depression Scale-Short Form scored < 8

Exclusion Criteria:

  • without concurrent major or significant psychiatric disorders
  • severe physical diseases which might affect cognitive functions
  • difficult to follow instructions due to visual or hearing impairments

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: rehabilitation & remediation approach
The intervention group will receive 12 weekly 90-minute combined cognition interventions in a group. The first half of each session will be cognitive training which focus on teaching various cognitive strategies and their applications to enhance the attention, memory, processing speed, and executive functions. The second half of the session will apply rehabilitation intervention with various compensatory strategies. Investigators will use group discussion to discuss everyday situations with memory problem and specific strategies (internal and external) related to real-life situations. Investigators will also include one individual session in the 12 group sessions.
Adfærdsmæssigt: rehabilitation & remediation approach
The rehabilitation & remediation approach group will receive 12 weekly 90-minute combined cognition interventions in a group. The first half of each session will be cognitive training which focus on teaching various cognitive strategies to enhance the attention, memory, processing speed, and executive functions. The second half of the session will apply rehabilitation intervention by discussing everyday situations with memory problem and specific strategies related to real-life situations. Investigators will also include one individual session in the 12 group sessions.
Aktiv komparator: remediation approach
The remediation approach will receive 12 weekly 90-minute cognitive training which focus on teaching various cognitive strategies and their applications to enhance the attention, memory, processing speed, and executive functions.
Adfærdsmæssigt: remediation approach
The remediation approach will receive 12 weekly 90-minute cognitive training which focus on teaching various cognitive strategies and their applications to enhance the attention, memory, processing speed, and executive functions.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from Baseline The Brief University of California San Diego (UCSD) Performance-Based Skills Assessment （Traditional Chinese Version）（UPSA-Brief ) at the 12th and 24th weeks
Tidsramme: baseline, 12th and 24th weeks after intervention
baseline, 12th and 24th weeks after intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline Short-form Zarit Caregiver Burden Interview-12 (sCZBI-12) at the 12th and 24th weeks
Tidsramme: baseline, 12th and 24th weeks after intervention
baseline, 12th and 24th weeks after intervention
Change from Baseline Montreal Cognitive Assessment (MoCA) Taiwan Version at the 12th and 24th weeks
Tidsramme: baseline, 12th and 24th weeks after intervention
baseline, 12th and 24th weeks after intervention
Change from Baseline Word Sequence Learning Test at the 12th and 24th weeks
Tidsramme: baseline, 12th and 24th weeks after intervention
baseline, 12th and 24th weeks after intervention
Change from Baseline Minimal-Mental Status Exam (MMSE) at the 12th and 24th weeks
Tidsramme: baseline, 12th and 24th weeks after intervention
baseline, 12th and 24th weeks after intervention
Change from Baseline Miami Prospective Memory Test (MPMT) at the 12th and 24th weeks
Tidsramme: baseline, 12th and 24th weeks after intervention
baseline, 12th and 24th weeks after intervention
Change from Baseline Color Trails Test at the 12th and 24th weeks
Tidsramme: baseline, 12th and 24th weeks after intervention
baseline, 12th and 24th weeks after intervention
Change from Baseline Structure MRI at the 12th and 24th weeks
Tidsramme: baseline, 12th and 24th weeks after intervention
baseline, 12th and 24th weeks after intervention
Change from Baseline PiB-PET and FDG-PET at the 12th and 24th weeks
Tidsramme: baseline, 12th and 24th weeks after intervention
PiB-PET: Pittsburgh Compound B-Positron Emission Tomography FDG-PET:18-Fluoro-deoxyglucose positron emission tomography
baseline, 12th and 24th weeks after intervention
Change from Baseline amyloid Aβ40, Aβ42 and tau proteins at the 12th and 24th weeks
Tidsramme: baseline, 12th and 24th weeks after intervention
baseline, 12th and 24th weeks after intervention
Change from Baseline The Disability Assessment for Dementia (DAD) at the 12th and 24th weeks
Tidsramme: baseline, 12th and 24th weeks after intervention
baseline, 12th and 24th weeks after intervention
Change from Baseline Quality of Life-Alzheimer's Disease scale (QoL-AD) at the 12th and 24th weeks
Tidsramme: baseline, 12th and 24th weeks after intervention
baseline, 12th and 24th weeks after intervention
Change from Baseline Goal Attainment Scaling (GAS) at the 12th and 24th weeks
Tidsramme: baseline, 12th and 24th weeks after intervention
baseline, 12th and 24th weeks after intervention
Change from Baseline Everyday Memory Questionnaire at the 12th and 24th weeks
Tidsramme: baseline, 12th and 24th weeks after intervention
baseline, 12th and 24th weeks after intervention

Samarbejdspartnere og efterforskere

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

Sponsor

National Taiwan University Hospital

Efterforskere

  • Ledende efterforsker: Hui-Fen Mao, National Taiwan University Hospital

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 (Faktiske)

16. december 2014

Primær færdiggørelse (Faktiske)

14. november 2017

Studieafslutning (Faktiske)

14. november 2017

Datoer for studieregistrering

Først indsendt

18. maj 2016

Først indsendt, der opfyldte QC-kriterier

24. maj 2016

Først opslået (Skøn)

27. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 201402028RINC

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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