NCT03612167

Brief Summary

Cognitive intervention for people with subjective cognitive complaints can be categorized into cognitive training, cognitive rehabilitation, psychoeducation, lifestyle intervention, etc. Literature have suggested multicomponent cognitive interventions can have better outcomes. However, studies to support this proposition are still limited. Few studies have also examined the influences of cognitive intervention on functional performance. This study was to examine the effectiveness of a multicomponent cognitive intervention for community-dwelling elderly with subjective cognitive complaints.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

March 1, 2013

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

7.4 years

First QC Date

July 22, 2018

Last Update Submit

September 8, 2020

Conditions

Outcome Measures

Primary Outcomes (6)

  • The Mini-Mental State Examination

    cognition

    3 month

  • the Trail Making Test

    attention

    3 month

  • the Color Trail Test

    attention

    3 month

  • Rivermead Behavioral Memory Test

    memory

    3 month

  • the Contextual Memory Test

    memory

    3 month

  • the Digit Span test

    memory

    3 month

Secondary Outcomes (2)

  • Cognitive Failure Questionnaire and the

    3 month

  • Everyday Memory Questionnaire

    3 month

Study Arms (2)

multi-modal cognitive intervention

EXPERIMENTAL

a 12 consecutive 90-minute weekly cognitive groups that included cognitive training and rehabilitation, with activity-based cognitive exercises and discussions with a focus on applications of cognitive strategies in daily lives.

Behavioral: cognitive intervention

nutritional group

ACTIVE COMPARATOR

A quasi-experimental design with nonequivalent control was adopted in a senior center. The intervention for control group was a 12 consecutive 90-minute weekly nutritional groups that included nutrition classes (lecture and discussion).

Behavioral: nutritional group

Interventions

a 12 consecutive 90-minute weekly cognitive groups that included cognitive training and rehabilitation, with activity-based cognitive exercises and discussions with a focus on applications of cognitive strategies in daily lives.

multi-modal cognitive intervention

12 consecutive 90-minute weekly nutritional groups that included nutrition classes (lecture and discussion).

nutritional group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Subjective cognition complaint by the client or caregiver: In our study, participants reported more than one complaint in Everyday Memory Questionnaire and Cognitive Function Questionnaire will be included.
  • Objective cognition deficits: participants with scores under 1.5 Standard Deviation in Trail making test, Contextual memory test and Rivermead Behavior Memory Test-3rd edition were included.
  • Preserved most daily living function: participants have reported no Activity of Daily Living (ADL) difficulties.

You may not qualify if:

  • A confirmed diagnosis of dementia
  • With visual and auditory impairments, and other neurocognitive disease that can potential influence participation in group activities, including stroke, Parkinson's disease and traumatic brain injury, major depression, and substance abuse.
  • With Mini Mental Status Exam \<=24 (education status beyond primary school); or \<=16 (No education)
  • With less than 10-session participation rate out of 12.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng-Kung University

Tainan, 701, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A quasi-experimental design with nonequivalent control was adopted in a senior center. Experimental variable was a 12 consecutive 90-minute weekly cognitive groups that included cognitive training and rehabilitation, with activity-based cognitive exercises and discussions with a focus on applications of cognitive strategies in daily lives. Participants were allocated into intervention group (cognitive intervention group) and control group (nutrition education group). The group assignment depended on what group they signed up for participate.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 22, 2018

First Posted

August 2, 2018

Study Start

March 1, 2013

Primary Completion

August 1, 2020

Study Completion

August 1, 2022

Last Updated

September 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

On-going research. Individual data will only share within the research team.

Locations