NCT03379519

Brief Summary

This study sought to investigate the changes in attention in older adults with mild cognitive impairment after Multi-domain Attention Training .

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

2.8 years

First QC Date

December 10, 2017

Last Update Submit

February 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    Change from baseline in executive attention at Immediate post-test, 3 months, 6 months after intervention.

Secondary Outcomes (1)

  • Change in attention as measured by the Trail Making Test (TMT).

    Change from baseline in spatial orienting attention at Immediate post-test, 3 months, 6 months after intervention.

Study Arms (2)

Multi-domain Attention Training (MAT)

EXPERIMENTAL

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

Behavioral: Multi-domain Attention Training (MAT)

Passive information activities (PIA)

ACTIVE COMPARATOR

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).

Behavioral: Passive information activities (PIA)

Interventions

The training content emphasis three concept of attention include: intensity of attention, executive attention, and spatial orienting attention.

Also known as: Attention training
Multi-domain Attention Training (MAT)

The active control group (Passive information activities) training content included reading online e-books and playing online games.

Also known as: Active control group
Passive information activities (PIA)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. candidate

Study Record Dates

First Submitted

December 10, 2017

First Posted

December 20, 2017

Study Start

August 1, 2016

Primary Completion

May 31, 2019

Study Completion

December 31, 2019

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share