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Protocol of Multi-domain Attention Training

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multi-domain Attention Training (MAT)
Passive information activities (PIA)
Sponsored by
Ministry of Science and Technology, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants must endorse at least two items from a list of frequent subjective memory complaints by patient and/or an informant
  • Objective memory impairment on neuropsychological tests of memory 1.5 SD or more below age/education norms
  • Clinical neurologic examination by the Mini-Mental State Examination (MMSE) score of 24 or higher
  • No impairment in personal activities of daily living (P-ADL) as determined by clinical interview with participant and family

Exclusion Criteria:

  • The clinical diagnosis of dementia was based on the DSM-IV-TR
  • Active in another cognitive or memory-related training in the past year
  • Comorbid medical conditions that would predispose them to imminent functional decline or cognitive impairment
  • A diagnosis of major neurological or psychiatric illness history and/or behavioral problems that would sufficiently impair performance to make participation impossible
  • Severe losses in vision, hearing, or communicative ability

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Multi-domain Attention Training (MAT)

    Passive information activities (PIA)

    Arm Description

    Training sessions of the MAT group is 45 minutes/day, 3 sessions/week, for 12 weeks (36 sessions).

    The training sessions of PIA is the same as MAT group (45 min/day, 3 days/week, for 12 weeks, for a total of 36 sessions).

    Outcomes

    Primary Outcome Measures

    Change in attention as measured by the Digit Span Task (DS).
    The primary outcome indicators is executive attention assessed by the Digit Span Task (DS).

    Secondary Outcome Measures

    Change in attention as measured by the Trail Making Test (TMT).
    The secondary outcome indicator is spatial orienting attention evaluated by the Trail Making Test.

    Full Information

    First Posted
    December 10, 2017
    Last Updated
    February 19, 2020
    Sponsor
    Ministry of Science and Technology, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03379519
    Brief Title
    Protocol of Multi-domain Attention Training
    Official Title
    The Development and Evaluation of Multi-domain Attention Training for Older Adults With Mild Cognitive Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    May 31, 2019 (Actual)
    Study Completion Date
    December 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ministry of Science and Technology, Taiwan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study sought to investigate the changes in attention in older adults with mild cognitive impairment after Multi-domain Attention Training .
    Detailed Description
    This double-blind randomized controlled study has a 2-arm parallel group design. All subjects will be randomized by the block randomization, into intervention group (Multi-domain Attention Training, MAT), or active control group (Passive information activities, PIA). Training sessions of the MAT group are 45 minutes/day, 3 days/week, for 12 weeks (36 sessions each). The training of PIA group is the same as MAT group. The investigators constructed a rigorous MAT program adhering to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. The investigators expect to determine the improvement in attention function of older adults with mild cognitive impairment after using the MAT program.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Multi-domain Attention Training (MAT)
    Arm Type
    Experimental
    Arm Description
    Training sessions of the MAT group is 45 minutes/day, 3 sessions/week, for 12 weeks (36 sessions).
    Arm Title
    Passive information activities (PIA)
    Arm Type
    Active Comparator
    Arm Description
    The training sessions of PIA is the same as MAT group (45 min/day, 3 days/week, for 12 weeks, for a total of 36 sessions).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Multi-domain Attention Training (MAT)
    Other Intervention Name(s)
    Attention training
    Intervention Description
    The training content emphasis three concept of attention include: intensity of attention, executive attention, and spatial orienting attention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Passive information activities (PIA)
    Other Intervention Name(s)
    Active control group
    Intervention Description
    The active control group (Passive information activities) training content included reading online e-books and playing online games.
    Primary Outcome Measure Information:
    Title
    Change in attention as measured by the Digit Span Task (DS).
    Description
    The primary outcome indicators is executive attention assessed by the Digit Span Task (DS).
    Time Frame
    Change from baseline in executive attention at Immediate post-test, 3 months, 6 months after intervention.
    Secondary Outcome Measure Information:
    Title
    Change in attention as measured by the Trail Making Test (TMT).
    Description
    The secondary outcome indicator is spatial orienting attention evaluated by the Trail Making Test.
    Time Frame
    Change from baseline in spatial orienting attention at Immediate post-test, 3 months, 6 months after intervention.

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants must endorse at least two items from a list of frequent subjective memory complaints by patient and/or an informant Objective memory impairment on neuropsychological tests of memory 1.5 SD or more below age/education norms Clinical neurologic examination by the Mini-Mental State Examination (MMSE) score of 24 or higher No impairment in personal activities of daily living (P-ADL) as determined by clinical interview with participant and family Exclusion Criteria: The clinical diagnosis of dementia was based on the DSM-IV-TR Active in another cognitive or memory-related training in the past year Comorbid medical conditions that would predispose them to imminent functional decline or cognitive impairment A diagnosis of major neurological or psychiatric illness history and/or behavioral problems that would sufficiently impair performance to make participation impossible Severe losses in vision, hearing, or communicative ability

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Protocol of Multi-domain Attention Training

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