Protocol of Multi-domain Attention Training

Mild Cognitive Impairment Clinical Trial

Official title:

The Development and Evaluation of Multi-domain Attention Training for Older Adults With Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379519
• Other study ID #: N201602069
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Ministry of Science and Technology, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Multi-domain Attention Training (MAT)
The training content emphasis three concept of attention include: intensity of attention, executive attention, and spatial orienting attention.
• Passive information activities (PIA)
The active control group (Passive information activities) training content included reading online e-books and playing online games.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Science and Technology, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Change from baseline in spatial orienting attention at Immediate post-test, 3 months, 6 months after intervention.